Interview with Graywolf Swinney, author, dream therapist and consciousness mentor.

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Tammie: You wrote in, "Beyond the Vision Quest: Bringing it Back" that for much of your youth you'd been preoccupied with success, science and technology. How did those preoccupations shape your life?

Graywolf: I was always fascinated with science and math and in grade school it was the science demonstrations and lessons that challenged my mind and kept my interest. I had heard about Einstein and wanted very much to be able to contribute to science as he had. He became immediately (and still is) one of my heroes, along with Superman, the Lone Ranger and the Cisco Kid. (Add Freud, Perles, Berne and Bohm to that list now)This was in the late forties and early fifties. When I reached high school (in Toronto, Canada), I was mostly drawn to my ninth grade chemistry and physics classes, and just put up with the other stuff because I had to.

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The magic moment of total dedication came as follows: I was considering what seemed to me to be the most likely future problems that science might solve (meaning me) and the one most likely to provide me with fame and fortune. I saw that what we were very dependent on and what most supported our civilization was gas and oil. I reasoned that there was only so much buried under the ground and that it would eventually be all used up. In this I saw my chance. I decided to devise a synthetic replacement for it.

I took these considerations to my ninth grade science teacher (I even remember his name, Mr. Pickering) and asked him what career I should aim for to accomplish this. He advised me that becoming a chemical engineer would be best. That was it for me. From that point on my academic work was all directed to that end.

I was not a nerd, I was also very active as an all star football player and on the track team, president of the photography club, second in command of the school cadet corps, photography editor then editor in chief of the school yearbook, Piper and drummer in the Pipe band etc. etc. and I also played base guitar and sang in the first Toronto Rock Group. In this, I was a revolutionary (which figures in my later willingness to also be so in psychology) since rock was considered the music of the devil back then.

My two favorite fairytale heroes were the little boy in the Emperors New Clothes and David of David and Goliath which also speaks to my fundamental scripting. I also became an atheist, or perhaps more correctly an agnostic, in keeping with my quest to become a pure scientist.

I struggled to be as objective as I could in all circumstances and to a very large degree suppressed my feelings and emotional side. Consequently, I was very susceptible to them and they would pop out much to my consternation. So I would work even harder to suppress them.

Later, in the sixties, Mr. Spock of Star Trek represented my ideal (along with Scottie). By then, I had graduated from college as a Chemical Engineer (1963) and was working for a rubber and plastics raw material producer. I turned out a number of patents and was rising rapidly as a technical service and development engineer. I was working in the field of golf balls since we were developing synthetic rubbers to replace the natural ones used in their production. I dedicated myself to this and soon developed a reputation in the industry as a whiz kid.

I soon moved to the U.S. (1966) where I designed and built a golf ball production factory for Ben Hogan. I continued on totally dedicated to my career and engineering; getting ahead very rapidly. By 1969, after several career moves, I was appointed general manager (at age 29) of the Golf Ball division of Wilson Sporting goods. The position had much to offer, money, notoriety, country club membership, power, (lunches with people such as Jerry Ford shortly before he was president), connections to the White House (I made all the golf balls for the Nixon Administration).

Since I had succeeded in shelving all my emotions and feelings and was virtually a Mr. Spock, I had succeeded well in business but was failing miserably in my personal life.

My original goals of making a vital contribution to humanity had been lost along with my emotions and feelings. I was a robot and doing things (such as firing a close personal friend because we had to reduce overhead by 15%) which did not sit well with my humanity and the revolutionary in me. It set up an inner conflict of which I was not aware. I saw, as was required of good managers, the world as a function of the bottom line, and operated as a machine. The inner conflict and failure in my personal life had resulted in me being overweight (I ate to stuff the pain) and having a very driven (type A) personality.

My preoccupation led me to neglect my personal health and I had developed several executive syndrome disorders. I had hypertension, hypoglycemia, a fast developing ulcer, and my e.k.g. showed that I had already suffered from one or more heart attacks. There were indications of damage to one of the valves. I was overweight and well on my way, if not already, an alcoholic. I smoked about one-and-a-half packs of cigarettes a day. I had missed the pain of the mild heart attacks through my ability to stuff my feelings and sensations. My sports career had also taught me how to do that. (I didn't mention that in college I was the intercollegiate wrestling champion in my freshman year and later became the player-coach of the team. I had won the championship match with torn ligaments in my right knee from an earlier match. I was on crutches for months after that. I was really good at stuffing stuff.)

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However, from my preoccupation with science, I also leaned many positives: That world views can change when the old theories are replaced by new ones. That theories are at best models of reality and not the real thing. That one can often learn more from the failure of an experiment than if it had succeeded. And that many of the important breakthroughs in science came from the cracks, the nagging little things that the current theories didn't quite cover. From engineering, I learned that you have to be adaptable in reality as nothing ever goes exactly as planned. That the theories of pure science are at best approximations, not to trust them completely nor take them as gospel, and finding what actually works is more important than holding on to a favorite theory or practice.

I also learned that I solved far more of my technical and management problems when I was asleep and dreaming than with my technical expertise, although I didn't admit that to anyone. I also noted that dreams were prominent in fundamental scientific breakthroughs. So to a large degree I was fascinated with the nature of dreams, and pursuit of this interest was a major part of my desire to become a psychologist after I left my career in engineering.

Tammie: In 1971, you were informed by your doctor that you'd be dead within three years. I was hoping that you might share what impact his warning had on you?

Graywolf: I had been going through some particularly tricky management issues (i.e. contract negotiations with the Teamsters union) and technical problems at the factory. I had developed a headache that had lasted for three weeks and my usual remedies helped not at all. My wife, who at that time was a nurse, was worried and so set up an appointment for me with a doctor to which I reluctantly went. I was shocked when the doctor immediately scheduled me for a number of tests at the local hospital.

I put it out of my mind until a couple of days later when the results were available. He took me into his office and gave them to me. I was in shock. My mother had died of many of the things that he was saying afflicted me. I asked how serious it was and he told me that he expected I would be dead within three years. He went on to cite my life style, work pressure, marital problems, as contributing causes along with my genetic background, and reiterated that I would be dead within three year without treatment and addressing some of these issues. And it might not work; I was in pretty bad shape mentally and physically.

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My shock continued walking out of his office. I had a very strict diet in hand, a prescription or two, and was to report for checkups regularly. But I was terrified. I was only 32 years old and had watched my mother die young as I might myself.

I didn't tell my wife and I didn't sleep that night. I called in sick for the first time next morning and stayed in bed and thought. I re-evaluated my priorities. That evening was when I told my wife about my condition. I decided, at the very least, if I only had a little while to live, to start having fun and doing things that I had always wanted but never found the time for. Unfortunately, many of these things she wasn't willing to share with me such as going dancing, learning to ski, reactivating my passion for music and playing the rock guitar. I decided that doing them might be more important than my marriage, so I did them with her disapproval. Her idea was medication and a strict regimen of abstinence to heal me.

I began to leave my work at the plant and have fun evenings and weekends. I even began attending a non-denominational liberal church in town. I began to assess where I was and where I was going relative to my childhood ideals. I was falling far short of them. Soon my wife left me and I was in great pain over that. Her parting words were that I was going through a second childhood and she wanted nothing to do with it. I was in a major self-identity crisis.

At that point, neither my career nor my personal life satisfied me. The fun was fun, but my health was still poor. Headaches, shortness of breath, etc.

A concerned friend and business colleague took me out to lunch one day and recommended counseling for me. I wasn't too open to it, so he told me to show up on Friday evening at a certain church. It turned out to be empathy training for perspective crisis phone line workers. I reluctantly started the three-day training and became a convert by the time it was over.

I rediscovered my emotions and sensitivity. I soon dedicated all my off-work hours to this and to another program, drug crisis intervention work. Between the two I was spending all my off-work hours in the alternative community. I took an introduction to TA at the free university. It described my life and offered hope. By then I had dramatically resigned my job. (That is an interesting story in itself.) and had free time. I started training in TA and in my own analysis discovered the patterns that had trapped me and how they contributed to my Type A personality and health problems. I lost about forty pounds and began to get into shape.

I, soon, was totally dedicated to understanding healing from both psychological and medical perspectives. I wanted to become a healer and in the process heal myself. I also began to study dreams through the gestalt therapy and began attending all workshops on dreamwork at the psychology conferences I attended.

Tammie: You've also indicated that during your studies and in your practice as a psychotherapist you came to believe that for the most part current psychotherapy models "didn't really address the full human condition" in your clients or yourself. Would you elaborate on that?

Graywolf: I had completed TA and Gestalt training by 1975. I had, as part of that, studied psychology in considerable depth including Freudian, Jungian, Adlerian, Behavioral and Reichian models, theories and practices as well as a number of fringe practices and several approaches to body work. I also studied medical models of healing with a thought of attending medical school. In these studies I encountered two phenomena that captured my interest, the Placebo Effect and Iatrogenic illness. The former became my interest and ideal for a healing model. However I could find no operational explanation of how they worked.

On returning from my written and oral exams in TA, I met with my supervisor. I recall asking her "Is this all there is?" because I couldn't believe that this was the end state of psychological science. "What is beneath scripting?" I asked her along with other similar questions. She replied that I had all the basics, understood all the theories and practices and was fully qualified. "It's not enough." I told her. Engineers take pride in their tools and the ones I had mastered didn't seem enough.

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However, I practiced for several years putting my concerns in context within myself. They are:

a.) Psychology and medicine ARE quite sophisticated in diagnosing and categorizing the various illnesses, but healing techniques are woefully inadequate and ineffective.

b.) Trained in hard sciences and working as an engineer, I had experienced the limits of Newtonian science. I had expected that psychology and healing arts would have developed specific theories that would explain or deal with the complexities and synergy of the human condition. But all I saw was an attempt to make people fit into this mechanistic and reductionistic approach (Newtonian Mechanics) that didn't work all that well even with inert objects.

I even started developing a practice that I called "Relativity Therapy" based on Einstein's implications that all measurements depend on the frame of reference. I knew that this relativity theory was a better model than the Newtonian one and I found this approach more effective. (It basically involved not defining any absolutes of either health or properfunctioning but understanding the client's frame of reference and working within that.) By the mid-seventies I was also re-exposed to Quantum theory through "The Tao of Physics" and "The Dancing Wu Li Masters" and began to speculate and explore how these theories might also be more applicable to the human condition and healing it.

During this time, I also had my wolf experience which slowly opened me up to spiritual considerations. I found myself returning, in some of my sessions, to the state of consciousness of that experience. I soon discovered that the wolf-state far more helped people to define and solve their issues than all my psychotherapy training accomplished. This was the beginnings of my co-consciousness model in which the therapist, rather than being objective and separate from the client, enters into co-consciousness with them.

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c.) Although many of my colleagues and clients considered me to be a brilliant therapist, I didn't feel that we were really getting much fundamental healing done with conventional therapies. Client's would linger on, continuing on long after we had met their therapeutic contracts. "There's still something missing," they would say. I had to agree with them. Most of my most effective therapy interventions happened in the last minutes of a session when I might make some off-hand remark seemingly entirely out of context. The client would return the next week marveling at how that remark had helped them to change dramatically.

d.) That was driving me along with the unanswered questions I had about the placebo effect. I was interested in how it worked and the implications from it; how intimately the mind, consciousness and body are bound in healing and wellness. Psychology and medicine had nothing to offer on this. Another factor was that I was also beginning to explore an emerging sense of my own spirituality through my Graywolf experiences. Although I wouldn't have labeled it as such then, I was feeling a deeper transpersonal self and connection.

e.) I continued my studies of psychology in Graduate school obtaining a Masters degree in it but chose to pursue shaman's studies rather than continue for a Doctorate. The Masters work was quite unsatisfying and Doctoral work looked like just a continuation of the same pap. I had specialized in schizophrenia and wrote my masters thesis on it. I was told by my advisor that it was worthy of being my Doctoral Dissertation with some minor additional work. But I didn't learn anything from that exercise in futility except to confirm how little is understood about the condition.

My own work in the field with schizophrenia taught me much more about it and my notion was that the important elements of it were ignored. The hypersensitivity of schizophrenics, the often extrasensory and psi experiences weren't addressed except to label them as pathology, hallucination or delusion. The very spiritual nature of the condition (religious fascination and fixations). Yet, Psychological Science and Medical Science ignored all this and presented dry mechanistic models of the condition. I also left out these considerations in my thesis on the advice of my advisor.

f.) I was attending two or three psychology conferences a year and many, many workshops. There was nothing new in them, just the same old theories and models warmed up and repeated using different words. That's still happening: codependency is just what we used to work with under the name symbiosis and then enabling; inner child work is a warmed up excerpt from TA, etc. etc.

g.) Humanistic psychology drew my interest because of the fundamental difference of philosophy. If you want to understand health, you must study healthy people. I even became deeply involved with the AHP acting as an unofficial advisor to the Board and helping organize and manage conferences. I lost interest when the AHP began mainstreaming itself and seemed to lose its exploratory bent.

h.) Psychology seemed for the most part to ignore the full range of human experience. It ignored psi experiences, yet from personal experience I knew them to be facts. Its explanation of phenomena such as Deja-vu was trite and didn't really capture the flavor of it. Psychology was unable and seemed unwilling to explore and explain such things as love and intimacy, yet I knew them to be important in healing work, both as a support system and coming from the therapist.

i.) Exposure to fringe theories and practices made me aware of several other problems. For example "Radical Psychiatry" pointed out the inability of psychology to address social change.

j.) But the main issue was that psychology and its science had made no inroads to understanding or exploring the nature of consciousness. That seemed to me the most important element in understanding both the human condition and healing it. It seemed to be the basis of natural healing phenomena such as the placebo effect. It also seemed fundamental to an understanding of the foundations and perception of reality itself. Psychological science seemed for the most part to be withdrawing from exploring and understanding consciousness in favor of drug, behaviorist and emotional cathartic therapies. On the other hand leading edge physics was hot on the trail of consciousness.

I was drawn to Shamanic studies, in part because shamans seemed better versed in using and understanding consciousness. There was a twenty to fifty thousand year background of empirical studies and experience in it. I chose to study this rather than go on for my Doctorate degree. In the process I connected with Dr. Stanley Krippner as a mentor (and now colleague and close friend. I started a doctoral program with him as advisor but soon dropped it, with his full blessings, as irrelevant to my aims.

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During this time I worked on what I called the Shaman-Therapist model. I still have an uncompleted book on the topic in my old abandoned computer. Its fundamental notion was that to have greater depth in healing you need two models or world-views operating simultaneously, much like you need two eyes for depth in visual perception. One eye is that of the scientist, analyst, therapist. The other eye is that of the shaman, mystic, spiritual healer. Both need to be operating at the same time for this depth to realize. This distinguished it from the methods I had seen practiced in Transpersonal Psychology which were like alternately opening one eye and then the other.

I could go on with the many other details but the above should give you a fairly complete idea of my concerns about psychological science and current treatments, and my discontent with them. At the conclusion of my shaman studies, I went through a similar process with shamans practice. This led to my discovery of and development of the Chaos-REM Process of Natural Healing.

Tammie: I'm struck by your adventurous spirit and both the professional and personal risks you've taken in your life. I'm wondering what in retrospect you might consider your greatest risk thus far to have been and what lessons the experience has taught you.

Graywolf: At the time I was "taking risks," they didn't seem like risks at all. In fact they seemed like the most reasonable thing to do at the time. In retrospect, I see that they did appear to be risky but if I were to remain true to myself they were directions I had to follow. While going through them, it was often as though I were watching myself do what I was doing. It didn't feel like dissociation or denial so much as being guided and watched by a powerful and loving presence within which was a deeper and wiser self. Given that disclaimer I offer the following.

My dropping out as a business executive and engineer was very risky. I had an assured future but the cost of that assuredness was too high. Better to live on poor than to die soon wealthy and successful.

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My venture into the North Woods of Canada where I met Graywolf was risky and life threatening. But it seemed less so than living with insecurity within myself about my ability to survive.

My abandoning my practice and career as a psychotherapist was also risky as was taking the name Graywolf. However, I was drawn strongly to this path and knew it was the best thing for me to do to further my interests and studies of healing process.

I suppose, looking at my answers so far, I could summarize. I was always moving on to something more interesting and exciting in my life and was able to let go of the past very easily because of this draw. I was generally done with what I was leaving behind and the draw seemed to be coming from deep within (intuitive). I later found a guiding principle given me by Al Huang. He told me that the Chinese cipher for crisis is made up of two ciphers: one meaning danger, the other meaning opportunity. I guess also that I have a pretty deep level of self confidence that tells me "no matter what you can handle it!" So in all they weren't really risks at all but the only reasonable thing to do to get where I needed to go.

As for lessons this has taught me? I suppose I have always been adventuresome. From defying authority to play Rock Music in the fifties to taking on the task of changing the basis of healing sciences, I have always tended to follow the truth, as did the little boy in the Emperors New Clothes. And taking on giants is no problem for little David, he toppled Goliath with a small stone put in the right place. The main lesson is that this is a very viable and satisfying way to live one's life, and authority means nothing more than having power, it doesn't imply correctness or truth.

Tammie: Recently, you've managed, it seems, to combine your experience and training as an engineer, as a psychotherapist, and your ventures in the wilderness and utilize them in some fascinating ways in the study of consciousness. I would love to hear more about where this particular venture is leading you.

Graywolf: In a sentence it is leading me into REM studies, Holographic theory, combined with consciousness explorations. For example I am about to embark an a project to develop the mathematics of consciousness. I am attaching my two most recent articles which will provide more details.

I do offer comment on the important concepts in my work.

1. The science that currently drives the healing professions is out of date and not really appropriate to complex systems. New science provides far better models for the human condition. I.e. relativity, quantum, chaos and holographic theories.
2. Healing and disease are matters that involve senses more than mind and are matters of consciousness and its structures.
3. Complex systems are self regulating (homeostasis principle) and will generally do so given the opportunity.
4. Healing depends far more on the connection between the practitioner and client than it does on the particular practice.
5. Symptoms are at their base attempts by the organism to solve problems. As such their isolated eradication can result in further symptoms arising in answer to the unsolved deeper issue.
6. There are only self-healers, the best one can do is find and encourage that process in another.
7. Consciousness prevails throughout all reality and is a basic field that is part of all structure in the space time continuum.

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Graywolf Swinney is a dream therapist, consciousness mentor, author, lecturer, scientist, and the founder and director of ASKLEPIA FOUNDATION and THE INSTITUTE FOR APPLIED CONSCIOUSNESS SCIENCE. He operates Aesculapia Wilderness Retreat in Southern Oregon where he offers training in the Creative Consciousness Natural Healing Process. He spends part of each month offering the Creative Consciousness Natural Healing Process in the Puget Sound area as well. Graywolf is also a whitewater river guide on the lower Rogue River.

You can reach Graywolf at:

P.O. Box 301,
Wilderville OR 97543

Phone: (541) 476-0492.
E-mail: asklepia@budget.net

next:Interviews: On Rainbows...

sexual health

When I refer to sexual health, I'm not talking about sexually transmitted diseases. Although that is very important, there are plenty of sites out there that address that.

For our purposes, sexual health here refers to our sexual attitudes and self-esteem; our sexual mental health.

What is the most important aspect of sexual health? To me, it's learning to love yourself and respect yourself enough not to get involved in bad sexual relationships, or any kind of hurtful relationships of any type. One of the other problems people have is being able to open up and talk about sex. Even after the "big" sexual revolution of the 70's, there are still many people who carry a lot of shame and guilt when it comes to sex.

So, welcome. Come inside. Maybe it's time to learn How to Love Yourself.

 

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next: How to Love Yourself or the Sexual Health table of contents for all articles in this section

In "Streetcar Named Desire", Blanche, the sister-in-law of Marlon Brando, is accused by him of inventing a false biography, replete with exciting events and desperate wealthy suitors. She responds that it is preferable to lead an imaginary but enchanted life - than a real but dreary one.

This, approximately, is my attitude, as well. My biography needs no embellishments. It is chock full of adventures, surprising turns of events, governments and billionaires, prisons and luxury hotels, criminals and ministers, fame and infamy, wealth and bankruptcy. I have lived a hundred lives. All I need to do is tell it straight. And yet I can't.

Moreover, I exaggerate everything. If a newspaper publishes my articles, I describe it as "the most widely circulated", or "the most influential". If I meet someone, I make him out to be "the most powerful", "most enigmatic", "most something". If I make a promise, I always promise the impossible or undoable.

To put it less gently, I lie. Compulsively and needlessly.

All the time.

About everything. And I often contradict myself.

Why do I need to do this?

To make myself interesting or attractive. In other words, to secure narcissistic supply (attention, admiration, adulation, gossip). I refuse to believe that I can be of interest to anyone as I am. My mother was interested in me only when I achieved something. Since then I flaunt my achievements - or invent ones. I feel certain that people are more interested in my fantasies than in me.

This way I also avoid the routine, the mundane, the predictable, the boring.

In my mind, I can be anywhere, do anything and I am good at convincing people to participate in my scripts. It is movie-making. I should have been a director.

Pseudologica Fantastica is the compulsive need to lie consistently and about everything, however inconsequential - even if it yields no benefits to the liar. I am not that bad. But when I want to impress - I lie.

I love to see people excited, filled with wonder, bedazzled, dreamy, starry eyed, or hopeful. I guess I am a little like the myth spinners, legend tellers and troubadours of yore. I know that at the end of my rainbow, there is nothing but a broken pot. But I so want to make people happy! I so want to feel the power of a giver, a God, a benefactor, a privileged witness.

So, I lie. Do you believe me?

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next: I Cannot Forgive: Piercing People's Emotional Shields

• Cavett Robert, CSP, CPAE, was the founder of the National Speakers Association. This article is written to honor his memory.

I remember the first time I met Cavett Robert. I was attending my first National Speakers Association convention in Atlanta in 1990. At the end of one of the sessions, I was standing near the front of the room with my good friend, Larry Winget, taking a few pictures of the celebrity speakers. Cavett put his hand on my shoulder, gave me a hearty welcome to my first meeting and said, "Come on. Let's get someone to take our picture together!" That picture became one of my treasures.

One of the highlights of my professional speaking career came almost exactly six years later. The National Association of Sales Professionals had booked me to present a talk at their monthly meeting. Lee Robert, Cavett's daughter introduced me. As I was looking into the audience I saw Cavett Robert, a life-member of that group, listening intently. It was his first opportunity to hear me speak. After the meeting, he came up to me, shook my hand and said, "You are every bit as good as Lee said you were!" I was humbled by his kind words.

Cavett was the most generous man I ever met. He truly was one of the great influences in my life. As founder and Chairman Emeritus of the National Speakers Association, he created opportunity for me and for nearly 3,900 NSA members to learn from one another; to share their expertise unselfishly and to abide by a code of ethics that set the standard for the speaking profession.

He was THE consummate professional speaker, my friend and colleague. His life touched hundreds of thousands of people across the country. His speaking career of over thirty years was a legend. His legacy was love.

I will always remember the last time I saw Cavett. It was June 7th, 1997. We were attending a chapter meeting of the Arizona Speakers Association. He and his daughter, Lee always sat near the front of the room. When I saw him, I went to him and asked how he was doing. He said, "Life is great!" While shaking his hand, I told him that if it weren't for him and the National Speakers Association, I wouldn't be where I am today in my speaking career. He smiled. I said, "I love you, Cavett." He placed his frail hand upon mine and said, "Larry, the feeling is mutual." Those were the last words I ever heard him speak. I shall forever treasure the memory of that very special moment.

The encouragement I received from him and the people in the organization he founded forever changed my life. Had it not been for Cavett, the relationship books I have written, my own personal legacy, may never have been completed. A new course of action was designed; a path I continue on today. Thank you, Cavett!

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Cavett Robert, CSP, CPAE, died on Monday, September 15, 1997 at 1:03 p.m. in Phoenix, Arizona. He was 89.

Goodbye, Cavett. Your lasting legacy lives on in the minds and hearts of those whose lives you have blessed with your generosity. We love you!

next: Domestic Violence Sucks!

Abuse has many forms. Expropriating someone's childhood in favour of adult pursuits is one of the subtlest varieties of soul murder.

I never was a child. I was a "wunderkind", the answer to my mother's prayers and intellectual frustration. A human computing machine, a walking-talking encyclopedia, a curiosity, a circus freak. I was observed by developmental psychologists, interviewed by the media, endured the envy of my peers and their pushy mothers. I constantly clashed with figures of authority because I felt entitled to special treatment, immune to prosecution and superior. It was a narcissist's dream. Abundant narcissistic supply - rivers of awe, the aura of glamour, incessant attention, open adulation, country-wide fame.

I refused to grow up. In my mind, my tender age was an integral part of the precocious miracle that I became. One looks much less phenomenal and one's exploits and achievements are much less awe-inspiring at the age of 40, I thought. Better stay young forever and thus secure my narcissistic supply.

So, I wouldn't grow up. I never took out a driver's licence.

I do not have children. I rarely have sex. I never settle down in one place. I reject intimacy. In short: I refrain from adulthood and adult chores. I have no adult skills. I assume no adult responsibilities. I expect indulgence from others. I am petulant and haughtily spoiled. I am capricious, infantile and emotionally labile and immature. In short: I am a 40 years old brat.

When I talk to my girlfriend, I do so in a baby's voice, making baby faces and baby gestures. It is a pathetic and repulsive sight, very much like a beached whale trying to imitate a seaborn trout. I want to be her child, you see, I want to regain my lost childhood. I want to be admired as I was when I was one year old and recited poems in three languages to stunned visiting high school teachers. I want to be four again, when I first read a daily paper to the silent astonishment of the neighbours.

I am not preoccupied with my age, nor am I obsessed with my dwindling, fat flapping body. I am no hypochondriac. But There is a streak of sadness in me, like an undercurrent and a defiance of Time itself. Like Dorian Gray, I want to remain as I was when I became the centre of attention, the focus of adoration, the heart of a twister of media attention. I know I can't. And I know that I have failed not only at arresting Chronos - but on a more mundane, degrading level. I failed as an adult.

 

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next: Pseudologica Fantastica: I Lie and I Exaggerate Everything

Razadyne ER is the new name for Reminyl. It's a cholinesterase inhibitor used for treatment of Alzheimer's Disease. Detailed info on uses, dosage and side-effects of Razadyne below.

Brand Name: Razadyne
Generic Name: Galantamine hydrobromide
Pronunciation: gah-LAN-tah-meen

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Razadyne (galantamine) patient information (in plain English)

Description

RAZADYNE™ ER (galantamine hydrobromide) is a reversible, competitive acetylcholinesterase inhibitor. It is known chemically as (4a S ,6 R ,8a S )-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6 H -benzofuro[3a,3,2- ef ][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C ₁₇ H ₂₁ NO ₃ ·HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:

RAZADYNE™ ER is available in opaque hard gelatin extended release capsules of 8 mg (white), 16 mg (pink), and 24 mg (caramel) containing galantamine hydrobromide, equivalent to respectively 8, 16 and 24 mg galantamine base. Inactive ingredients include gelatin, diethyl phthalate, ethylcellulose, hypromellose, polyethylene glycol, titanium dioxide and sugar spheres (sucrose and starch). The 16 mg capsule also contains red ferric oxide. The 24 mg capsule also contains red ferric oxide and yellow ferric oxide.

RAZADYNE™ for oral use is available in circular biconvex film-coated tablets of 4 mg (off-white), 8 mg (pink), and 12 mg (orange-brown). Each 4, 8, and 12 mg (base equivalent) tablet contains 5.126, 10.253, and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, talc, and titanium dioxide. The 4 mg tablets contain yellow ferric oxide. The 8 mg tablets contain red ferric oxide. The 12 mg tablets contain red ferric oxide and FD&C yellow #6 aluminum lake.

RAZADYNE™ is also available as a 4 mg/mL oral solution. The inactive ingredients for this solution are methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharin, sodium hydroxide and purified water.

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Clinical Pharmacology

Mechanism of Action

Although the etiology of cognitive impairment in Alzheimer's disease (AD) is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimer's disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimer's disease).

Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase. While the precise mechanism of galantamine's action is unknown, it is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. If this mechanism is correct, galantamine's effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that galantamine alters the course of the underlying dementing process.

Pharmacokinetics

Galantamine is well absorbed with absolute oral bioavailability of about 90%. It has a terminal elimination half-life of about 7 hours and pharmacokinetics are linear over the range of 8-32 mg/day.

The maximum inhibition of acetylcholinesterase activity of about 40% was achieved about one hour after a single oral dose of 8 mg galantamine in healthy male subjects.

Absorption and Distribution

Galantamine is rapidly and completely absorbed with time to peak concentration about 1 hour. Bioavailability of the tablet was the same as the bioavailability of an oral solution. Food did not affect the AUC of galantamine but C max decreased by 25% and T max was delayed by 1.5 hours. The mean volume of distribution of galantamine is 175 L.

The plasma protein binding of galantamine is 18% at therapeutically relevant concentrations. In whole blood, galantamine is mainly distributed to blood cells (52.7%). The blood to plasma concentration ratio of galantamine is 1.2.

Metabolism and Elimination

Galantamine is metabolized by hepatic cytochrome P450 enzymes, glucuronidated, and excreted unchanged in the urine. In vitro studies indicate that cytochrome CYP2D6 and CYP3A4 were the major cytochrome P450 isoenzymes involved in the metabolism of galantamine, and inhibitors of both pathways increase oral bioavailability of galantamine modestly (see PRECAUTIONS , Drug-Drug Interactions ). O-demethylation, mediated by CYP2D6 was greater in extensive metabolizers of CYP2D6 than in poor metabolizers. In plasma from both poor and extensive metabolizers, however, unchanged galantamine and its glucuronide accounted for most of the sample radioactivity.

In studies of oral 3 H-galantamine, unchanged galantamine and its glucuronide, accounted for most plasma radioactivity in poor and extensive CYP2D6 metabolizers. Up to 8 hours post-dose, unchanged galantamine accounted for 39-77% of the total radioactivity in the plasma, and galantamine glucuronide for 14-24%. By 7 days, 93-99% of the radioactivity had been recovered, with about 95% in urine and about 5% in the feces. Total urinary recovery of unchanged galantamine accounted for, on average, 32% of the dose and that of galantamine glucuronide for another 12% on average.

After i.v. or oral administration, about 20% of the dose was excreted as unchanged galantamine in the urine in 24 hours, representing a renal clearance of about 65 mL/min, about 20-25% of the total plasma clearance of about 300 mL/min.

RAZADYNE™ ER 24 mg extended release capsules administered once daily under fasting conditions are bioequivalent to galantamine tablets 12 mg twice daily with respect to AUC 24h and C min . The C max and T max of the extended release capsules were lower and occurred later, respectively, compared with the immediate release tablets, with C max about 25% lower and median T max occurring about 4.5-5.0 hours after dosing. Dose-proportionality is observed for RAZADYNE™ ER extended release capsules over the dose range of 8 to 24 mg daily and steady state is achieved within a week. There was no effect of age on the pharmacokinetics of RAZADYNE™ ER extended-release capsules. CYP2D6 poor metabolizers had drug exposures that were approximately 50% higher than for extensive metabolizers.

There are no appreciable differences in pharmacokinetic parameters when RAZADYNE™ ER extended-release capsules are given with food compared to when they are given in the fasted state.

Special Populations

CYP2D6 poor metabolizers

Approximately 7% of the normal population has a genetic variation that leads to reduced levels of activity of CYP2D6 isozyme. Such individuals have been referred to as poor metabolizers. After a single oral dose of 4 mg or 8 mg galantamine, CYP2D6 poor metabolizers demonstrated a similar C max and about 35% AUC (infinity) increase of unchanged galantamine compared to extensive metabolizers.

A total of 356 patients with Alzheimer's disease enrolled in two phase 3 studies were genotyped with respect to CYP2D6 (n=210 hetero-extensive metabolizers, 126 homo-extensive metabolizers, and 20 poor metabolizers). Population pharmacokinetic analysis indicated that there was a 25% decrease in median clearance in poor metabolizers compared to extensive metabolizers. Dosage adjustment is not necessary in patients identified as poor metabolizers as the dose of drug is individually titrated to tolerability.

Hepatic Impairment:

Following a single 4 mg dose of galantamine, the pharmacokinetics of galantamine in subjects with mild hepatic impairment (n=8; Child-Pugh score of 5-6) were similar to those in healthy subjects. In patients with moderate hepatic impairment (n=8; Child-Pugh score of 7-9), galantamine clearance was decreased by about 25% compared to normal volunteers. Exposure would be expected to increase further with increasing degree of hepatic impairment (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ).

Renal Impairment:

Following a single 8 mg dose of galantamine, AUC increased by 37% and 67% in moderate and severely renal-impaired patients compared to normal volunteers (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ).

Elderly: Data from clinical trials in patients with Alzheimer's disease indicate that galantamine concentrations are 30-40% higher than in healthy young subjects.

Gender and Race: No specific pharmacokinetic study was conducted to investigate the effect of gender and race on the disposition of RAZADYNE™ (galantamine hydrobromide), but a population pharmacokinetic analysis indicates (n= 539 males and 550 females) that galantamine clearance is about 20% lower in females than in males (explained by lower body weight in females) and race (n=1029 White, 24 Black, 13 Asian and 23 other) did not affect the clearance of RAZADYNE™.

Drug-Drug Interactions

Multiple metabolic pathways and renal excretion are involved in the elimination of galantamine so no single pathway appears predominant. Based on in vitro studies, CYP2D6 and CYP3A4 were the major enzymes involved in the metabolism of galantamine. CYP2D6 was involved in the formation of O-desmethyl-galantamine, whereas CYP3A4 mediated the formation of galantamine-N-oxide. Galantamine is also glucuronidated and excreted unchanged in urine.

(A) Effect of Other Drugs on the Metabolism of RAZADYNE™: Drugs that are potent inhibitors for CYP2D6 or CYP3A4 may increase the AUC of galantamine. Multiple dose pharmacokinetic studies demonstrated that the AUC of galantamine increased 30% and 40%, respectively, during coadministration of ketoconazole and paroxetine. As co-administered with erythromycin, another CYP3A4 inhibitor, the galantamine AUC increased only 10%. Population PK analysis with a database of 852 patients with Alzheimer's disease showed that the clearance of galantamine was decreased about 25-33% by concurrent administration of amitriptyline (n = 17), fluoxetine (n = 48), fluvoxamine (n = 14), and quinidine (n = 7), known inhibitors of CYP2D6.

Concurrent administration of H 2 -antagonists demonstrated that ranitidine did not affect the pharmacokinetics of galantamine, and cimetidine increased the galantamine AUC by approximately 16%.

(B) Effect of RAZADYNE™ on the Metabolism of Other Drugs: In vitro studies show that galantamine did not inhibit the metabolic pathways catalyzed by CYP1A2, CYP2A6, CYP3A4, CYP4A, CYP2C, CYP2D6 and CYP2E1. This indicated that the inhibitory potential of galantamine towards the major forms of cytochrome P450 is very low. Multiple doses of galantamine (24 mg/day) had no effect on the pharmacokinetics of digoxin and warfarin (R- and S- forms). Galantamine had no effect on the increased prothrombin time induced by warfarin.

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CLINICAL TRIALS

The effectiveness of RAZADYNE™ as a treatment for Alzheimer's disease is demonstrated by the results of 5 randomized, double-blind, placebo-controlled clinical investigations in patients with probable Alzheimer's disease, 4 with the immediate-release tablet, and one with the extended-release capsule [diagnosed by NINCDS-ADRDA criteria, with Mini-Mental State Examination scores that were ≥10 and ≤24]. Doses studied were 8-32 mg/day given as twice daily doses (immediate- release tablets). In 3 of the 4 studies with the immediate-release tablet, patients were started on a low dose of 8 mg, then titrated weekly by 8 mg/day to 24 or 32 mg as assigned. In the fourth study (USA 4-week Dose-Escalation Fixed-Dose Study) dose escalation of 8 mg/day occurred over 4 week intervals. The mean age of patients participating in these 4 RAZADYNE™ trials was 75 years with a range of 41 to 100. Approximately 62% of patients were women and 38% were men. The racial distribution was White 94%, Black 3% and other races 3%. Two other studies examined a three times daily dosing regimen; these also showed or suggested benefit but did not suggest an advantage over twice daily dosing.

Study Outcome Measures: In each study, the primary effectiveness of RAZADYNE™ was evaluated using a dual outcome assessment strategy as measured by the Alzheimer's Disease Assessment Scale (ADAS-cog) and the Clinician's Interview Based Impression of Change that required the use of caregiver information (CIBIC-plus).

The ability of RAZADYNE™ to improve cognitive performance was assessed with the cognitive sub-scale of the Alzheimer's Disease Assessment Scale (ADAS-cog), a multi-item instrument that has been extensively validated in longitudinal cohorts of Alzheimer's disease patients. The ADAS-cog examines selected aspects of cognitive performance including elements of memory, orientation, attention, reasoning, language and praxis. The ADAS-cog scoring range is from 0 to 70, with higher scores indicating greater cognitive impairment. Elderly normal adults may score as low as 0 or 1, but it is not unusual for non-demented adults to score slightly higher.

The patients recruited as participants in each study with the immediate-release tablet had mean scores on ADAS-cog of approximately 27 units, with a range from 5 to 69. Experience gained in longitudinal studies of ambulatory patients with mild to moderate Alzheimer's disease suggests that they gain 6 to 12 units a year on the ADAS-cog. Lesser degrees of change, however, are seen in patients with very mild or very advanced disease because the ADAS-cog is not uniformly sensitive to change over the course of the disease. The annualized rate of decline in the placebo patients participating in galantamine trials was approximately 4.5 units per year.

The ability of RAZADYNE™ to produce an overall clinical effect was assessed using a Clinician's Interview Based Impression of Change that required the use of caregiver information, the CIBIC-plus. The CIBIC-plus is not a single instrument and is not a standardized instrument like the ADAS-cog. Clinical trials for investigational drugs have used a variety of CIBIC formats, each different in terms of depth and structure. As such, results from a CIBIC-plus reflect clinical experience from the trial or trials in which it was used and can not be compared directly with the results of CIBIC-plus evaluations from other clinical trials. The CIBIC-plus used in the trials was a semi-structured instrument based on a comprehensive evaluation at baseline and subsequent time-points of 4 major areas of patient function: general, cognitive, behavioral and activities of daily living. It represents the assessment of a skilled clinician based on his/her observation at an interview with the patient, in combination with information supplied by a caregiver familiar with the behavior of the patient over the interval rated. The CIBIC-plus is scored as a seven point categorical rating, ranging from a score of 1, indicating "markedly improved", to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening". The CIBIC-plus has not been systematically compared directly to assessments not using information from caregivers (CIBIC) or other global methods.

Immediate-Release Tablets

U.S. Twenty-One-Week Fixed-Dose Study

In a study of 21 weeks duration, 978 patients were randomized to doses of 8, 16, or 24 mg of RAZADYNE™ per day, or to placebo, each given in 2 divided doses (immediate release tablets). Treatment was initiated at 8 mg/day for all patients randomized to RAZADYNE™, and increased by 8 mg/day every 4 weeks. Therefore, the maximum titration phase was 8 weeks and the minimum maintenance phase was 13 weeks (in patients randomized to 24 mg/day of RAZADYNE™).

Effects on the ADAS-cog:

Figure 1 illustrates the time course for the change from baseline in ADAS-cog scores for all four dose groups over the 21 weeks of the study. At 21 weeks of treatment, the mean differences in the ADAS-cog change scores for the RAZADYNE™-treated patients compared to the patients on placebo were 1.7, 3.3, and 3.6 units for the 8, 16 and 24 mg/day treatments, respectively. The 16 mg/day and 24 mg/day treatments were statistically significantly superior to placebo and to the 8 mg/day treatment. There was no statistically significant difference between the 16 mg/day and 24 mg/day dose groups.

Figure 2 illustrates the cumulative percentages of patients from each of the four treatment groups who had attained at least the measure of improvement in ADAS-cog score shown on the X-axis. Three change scores (10-point, 7-point and 4-point reductions) and no change in score from baseline have been identified for illustrative purposes, and the percent of patients in each group achieving that result is shown in the inset table. The curves demonstrate that both patients assigned to galantamine and placebo have a wide range of responses, but that the RAZADYNE™ groups are more likely to show the greater improvements.

Figure 2:Cumulative Percentage of Patients Completing 21 Weeks of Double-Blind Treatment With Specified Changes From Baseline in ADAS-cog Scores. The Percentages of Randomized Patients Who Completed the Study Were: Placebo 84%, 8 mg/day 77%, 16 mg/day 78% and 24 mg/day 78%.

Change in ADAS-cog

Treatment	-10	-7	19.6%	41.8%
Placebo	3.6%	7.6%	19.6%	46.5
8 mg/day	5.9%	13.9%	25.7%	46.5%
16 mg/day	7.2%	15.9%	35.6%	65.4%
24 mg/day	10.4%	22.3%	37.0%	64.9%

Effects on the CIBIC-plus:

Figure 3 is a histogram of the percentage distribution of CIBIC-plus scores attained by patients assigned to each of the four treatment groups who completed 21 weeks of treatment. The RAZADYNE™-placebo differences for these groups of patients in mean rating were 0.15, 0.41 and 0.44 units for the 8, 16 and 24 mg/day treatments, respectively. The 16 mg/day and 24 mg/day treatments were statistically significantly superior to placebo. The differences vs. the 8 mg/day treatment for the 16 and 24 mg/day treatments were 0.26 and 0.29, respectively. There were no statistically significant differences between the 16 mg/day and 24 mg/day dose groups.

U.S.Twenty-Six Week Fixed-Dose Study

In a study of 26 weeks duration, 636 patients were randomized to either a dose of 24 mg or 32 mg of RAZADYNE™ per day, or to placebo, each given in two divided doses. The 26-week study was divided into a 3-week dose titration phase and a 23-week maintenance phase. Effects on the ADAS-cog:

Figure 4 illustrates the time course for the change from baseline in ADAS-cog scores for all three dose groups over the 26 weeks of the study. At 26 weeks of treatment, the mean differences in the ADAS-cog change scores for the RAZADYNE™- treated patients compared to the patients on placebo were 3.9 and 3.8 units for the 24 mg/day and 32 mg/day treatments, respectively. Both treatments were statistically significantly superior to placebo, but were not significantly different from each other.

Figure 5 illustrates the cumulative percentages of patients from each of the three treatment groups who had attained at least the measure of improvement in ADAS-cog score shown on the X-axis. Three change scores (10-point, 7-point and 4-point reductions) and no change in score from baseline have been identified for illustrative purposes, and the percent of patients in each group achieving that result is shown in the inset table.

The curves demonstrate that both patients assigned to RAZADYNE™and placebo have a wide range of responses, but that the RAZADYNE™ groups are more likely to show the greater improvements. A curve for an effective treatment would be shifted to the left of the curve for placebo, while an ineffective or deleterious treatment would be superimposed upon, or shifted to the right of the curve for placebo, respectively.

Effects on the CIBIC-plus:

Figure 6 is a histogram of the percentage distribution of CIBIC-plus scores attained by patients assigned to each of the three treatment groups who completed 26 weeks of treatment. The mean RAZADYNE™-placebo differences for these groups of patients in the mean rating were 0.28 and 0.29 units for 24 and 32 mg/day of RAZADYNE™, respectively. The mean ratings for both groups were statistically significantly superior to placebo, but were not significantly different from each other.

International Twenty-Six-Week Fixed-Dose Study

In a study of 26 weeks duration identical in design to the USA 26-Week Fixed-Dose Study, 653 patients were randomized to either a dose of 24 mg or 32 mg of RAZADYNE™ per day, or to placebo, each given in two divided doses (immediate release tablets). The 26-week study was divided into a 3-week dose titration phase and a 23-week maintenance phase.

Effects on the ADAS-cog:

Figure 7 illustrates the time course for the change from baseline in ADAS-cog scores for all three dose groups over the 26 weeks of the study. At 26 weeks of treatment, the mean differences in the ADAS-cog change scores for the RAZADYNE™- treated patients compared to the patients on placebo were 3.1 and 4.1 units for the 24 mg/day and 32 mg/day treatments, respectively. Both treatments were statistically significantly superior to placebo, but were not significantly different from each other.

Figure 8 illustrates the cumulative percentages of patients from each of the three treatment groups who had attained at least the measure of improvement in ADAS-cog score shown on the X-axis. Three change scores (10-point, 7-point and 4-point reductions) and no change in score from baseline have been identified for illustrative purposes, and the percent of patients in each group achieving that result is shown in the inset table.

The curves demonstrate that both patients assigned to RAZADYNE™ and placebo have a wide range of responses, but that the RAZADYNE™ groups are more likely to show the greater improvements.

Effects on the CIBIC-plus: Figure 9 is a histogram of the percentage distribution of CIBIC-plus scores attained by patients assigned to each of the three treatment groups who completed 26 weeks of treatment. The mean RAZADYNE™-placebo differences for these groups of patients in the mean rating of change from baseline were 0.34 and 0.47 for 24 and 32 mg/day of RAZADYNE™, respectively. The mean ratings for the RAZADYNE™ groups were statistically significantly superior to placebo, but were not significantly different from each other.

International Thirteen-Week Flexible-Dose Study

In a study of 13 weeks duration, 386 patients were randomized to either a flexible dose of 24-32 mg/day of RAZADYNE™ or to placebo, each given in two divided doses. The 13-week study was divided into a 3-week dose titration phase and a 10-week maintenance phase. The patients in the active treatment arm of the study were maintained at either 24 mg/day or 32 mg/day at the discretion of the investigator.

Effects on the ADAS-cog:

Figure 10 illustrates the time course for the change from baseline in ADAS-cog scores for both dose groups over the 13 weeks of the study. At 13 weeks of treatment, the mean difference in the ADAS- cog change scores for the treated patients compared to the patients on placebo was 1.9. RAZADYNE™ at a dose of 24-32 mg/day was statistically significantly superior to placebo.

Figure 11 illustrates the cumulative percentages of patients from each of the two treatment groups who had attained at least the measure of improvement in ADAS-cog score shown on the X-axis. Three change scores (10-point, 7-point and 4-point reductions) and no change in score from baseline have been identified for illustrative purposes, and the percent of patients in each group achieving that result is shown in the inset table.

The curves demonstrate that both patients assigned to RAZADYNE™ and placebo have a wide range of responses, but that the RAZADYNE™ group is more likely to show the greater improvement.

Effects on the CIBIC-plus:

Figure 12 is a histogram of the percentage distribution of CIBIC-plus scores attained by patients assigned to each of the two treatment groups who completed 13 weeks of treatment. The mean RAZADYNE™-placebo differences for the group of patients in the mean rating of change from baseline was 0.37 units. The mean rating for the 24-32 mg/day group was statistically significantly superior to placebo.

Age, Gender and Race:
Patient's age, gender, or race did not predict clinical outcome of treatment.

Extended Release Capsules

The efficacy of RAZADYNE™ ER extended-release capsules was studied in a randomized, double-blind, placebo-controlled trial which was 6 months in duration, and had an initial 4-week dose-escalation phase. In this trial, patients were assigned to one of 3 treatment groups: RAZADYNE™ ER extended-release capsules in a flexible dose of 16 to 24 mg once daily; RAZADYNE™ immediate-release tablets in a flexible dose of 8 to 12 mg twice daily; and placebo. The primary efficacy measures in this study were the ADAS-cog and CIBIC-plus. On the protocol-specified primary efficacy analysis at Month 6, a statistically significant improvement favoring RAZADYNE™ ER extended-release capsules over placebo was seen for the ADAS-cog, but not for the CIBIC-plus. RAZADYNE™ ER extended-release capsules showed a statistically significant improvement when compared with placebo on the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, a measure of function, and a secondary efficacy measure in this study. The effects of RAZADYNE™ ER extended release capsules and RAZADYNE™ immediate-release tablets on the ADAS-cog, CIBIC-plus, and ADCS-ADL were similar in this study.

Indications and Usage

RAZADYNE™ ER/RAZADYNE™ (galantamine hydrobromide) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

Contraindications

RAZADYNE™ ER/RAZADYNE™ (galantamine hydrobromide) is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.

Warnings

Anesthesia

Galantamine, as a cholinesterase inhibitor, is likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.

Cardiovascular Conditions

Because of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with supraventricular cardiac conduction disorders or to patients taking other drugs concomitantly that significantly slow heart rate. Postmarketing surveillance of marketed anticholinesterase inhibitors has shown, however, that bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities. Therefore all patients should be considered at risk for adverse effects on cardiac conduction.

In randomized controlled trials, bradycardia was reported more frequently in galantamine-treated patients than in placebo-treated patients, but was rarely severe and rarely led to treatment discontinuation. The overall frequency of this event was 2-3% for galantamine doses up to 24 mg/day compared with <1% for placebo. No increased incidence of heart block was observed at the recommended doses.

Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope (placebo 0.7% [2/286]; 4 mg BID 0.4% [3/692]; 8 mg BID 1.3% [7/552]; 12 mg BID 2.2% [6/273]).

Gastrointestinal Conditions

Through their primary action, cholinomimetics may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk for developing ulcers, e.g., those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs (NSAIDS). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.

RAZADYNE™, as a predictable consequence of its pharmacological properties, has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss (see ADVERSE REACTIONS ).

Genitourinary

Although this was not observed in clinical trials with RAZADYNE™, cholinomimetics may cause bladder outflow obstruction.

Neurological Conditions

Seizures: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. However, seizure activity may also be a manifestation of Alzheimer's disease. In clinical trials, there was no increase in the incidence of convulsions with RAZADYNE™compared to placebo.

Pulmonary Conditions

Because of its cholinomimetic action, galantamine should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease.

Precautions

Information for Patients and Caregivers:
Caregivers should be instructed about the recommended dosage and administration of RAZADYNE™ ER/RAZADYNE™ (galantamine hydrobromide). RAZADYNE™ ER Extended- Release Capsules should be administered once daily in the morning, preferably with food (although not required). RAZADYNE™ Tablets and Oral Solution should be administered twice per day, preferably with the morning and evening meals. Dose escalation (dose increases) should follow a minimum of four weeks at prior dose.

Patients and caregivers should be advised that the most frequent adverse events associated with use of the drug can be minimized by following the recommended dosage and administration. Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for several days or longer, the patient should be restarted at the lowest dose and the dose escalated to the current dose.

Caregivers should be instructed in the correct procedure for administering RAZADYNE™ Oral Solution. In addition, they should be informed of the existence of an Instruction Sheet (included with the product) describing how the solution is to be administered. They should be urged to read this sheet prior to administering RAZADYNE™ Oral Solution. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist.

Deaths in Subjects with Mild Cognitive Impairment (MCI)

In two randomized placebo controlled trials of 2 years duration in subjects with mild cognitive impairment (MCI), a total of 13 subjects on RAZADYNE™ (n=1026) and 1 subject on placebo (n=1022) died. The deaths were due to various causes which could be expected in an elderly population; about half of the RAZADYNE™deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death).

Although the difference in mortality between RAZADYNE™ and placebo-treated groups in these two studies was significant, the results are highly discrepant with other studies of RAZADYNE™. Specifically, in these two MCI studies, the mortality rate in the placebo-treated subjects was markedly lower than the rate in placebo-treated patients in trials of RAZADYNE™ in Alzheimer's disease or other dementias (0.7 per 1000 person years compared to 22-61 per 1000 person years, respectively). Although the mortality rate in the RAZADYNE™-treated MCI subjects was also lower than that observed in RAZADYNE™ -treated patients in Alzheimer's disease and other dementia trials (10.2 per 1000 person years compared to 23-31 per 1000 person years, respectively), the relative difference was much less. When the Alzheimer's disease and other dementia studies were pooled (n=6000), the mortality rate in the placebo group numerically exceeded that in the RAZADYNE™ group. Furthermore, in the MCI studies, no subjects in the placebo group died after 6 months, a highly unexpected finding in this population.

Individuals with mild cognitive impairment demonstrate isolated memory impairment greater than expected for their age and education, but do not meet current diagnostic criteria for Alzheimer's disease.

Individuals with mild cognitive impairment demonstrate isolated memory impairment greater than expected for their age and education, but do not meet current diagnostic criteria for Alzheimer's disease.

Special Populations

Hepatic Impairment

In patients with moderately impaired hepatic function, dose titration should proceed cautiously (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). The use of RAZADYNE™ in patients with severe hepatic impairment is not recommended.

Renal Impairment

In patients with moderately impaired renal function, dose titration should proceed cautiously (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). In patients with severely impaired renal function (CLcr <9 mL/min) the use of RAZADYNE™ is not recommended.

Drug-Drug Interactions (see also CLINICAL PHARMACOLOGY, Drug-Drug Interactions)

Use With Anticholinergics

RAZADYNE™ has the potential to interfere with the activity of anticholinergic medications. Use With Cholinomimetics and Other Cholinesterase Inhibitors

A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol.

A) Effect of Other Drugs on Galantamine

In vitro

CYP3A4 and CYP2D6 are the major enzymes involved in the metabolism of galantamine.CYP3A4 mediates the formation of galantamine-N-oxide; CYP2D6 leads to the formation of O-desmethyl- galantamine. Because galantamine is also glucuronidated and excreted unchanged, no single pathway appears predominant.

In vivo

Warfarin: Galantamine at 24 mg/day had no effect on the pharmacokinetics of R- and S-warfarin (25 mg single dose) or on the prothrombin time. The protein binding of warfarin was unaffected by galantamine.

Digoxin: Galantamine at 24 mg/day had no effect on the steady-state pharmacokinetics of digoxin (0.375 mg once daily) when they were coadministered. In this study, however, one healthy subject was hospitalized for 2nd and 3rd degree heart block and bradycardia.

Carcinogenesis, Mutagenesis and Impairment of Fertility

In a 24-month oral carcinogenicity study in rats, a slight increase in endometrial adenocarcinomas was observed at 10 mg/kg/day (4 times the Maximum Recommended Human Dose [MRHD] on a 2 mg/m basis or 6 times on an exposure [AUC] basis) and 30 mg/kg/day (12 times MRHD on a 2 mg/m basis or 19 times on an AUC basis). No increase in neoplastic changes was observed in 2 females at 2.5 mg/kg/day (equivalent to the MRHD on a mg/m basis or 2 times on an AUC basis) 2 or in males up to the highest dose tested of 30 mg/kg/day (12 times the MRHD on a mg/m and AUC basis).

Galantamine was not carcinogenic in a 6-month oral carcinogenicity study in transgenic (P 53- deficient) mice up to 20 mg/kg/day, or in a 24-month oral carcinogenicity study in male and female 2 mice up to 10 mg/kg/day (2 times the MRHD on a mg/m basis and equivalent on an AUC basis).

Galantamine produced no evidence of genotoxic potential when evaluated in the in vitro Ames S. typhimurium or E. coli reverse mutation assay, in vitro mouse lymphoma assay, in vivo micronucleus test in mice, or in vitro chromosome aberration assay in Chinese hamster ovary cells.

No impairment of fertility was seen in rats given up to 16 mg/kg/day (7 times the MRHD on a mg/m² basis) for 14 days prior to mating in females and for 60 days prior to mating in males.

Pregnancy

Pregnancy Category B: In a study in which rats were dosed from day 14 (females) or day 60 (males) prior to mating through the period of organogenesis, a slightly increased incidence of skeletal variations was observed at doses of 8 mg/kg/day (3 times the Maximum Recommended Human 2 Dose [MRHD] on a mg/m basis) and 16 mg/kg/day. In a study in which pregnant rats were dosed rom the beginning of organogenesis through day 21 post-partum, pup weights were decreased at 8 and 16 mg/kg/day, but no adverse effects on other postnatal developmental parameters were seen. The doses causing the above effects in rats produced slight maternal toxicity. No major malformations were caused in rats given up to 16 mg/kg/day. No drug related teratogenic effects 2 were observed in rabbits given up to 40 mg/kg/day (32 times the MRHD on a mg/m basis) during he period of organogenesis.

There are no adequate and well-controlled studies of RAZADYNE™ in pregnant women. RAZADYNE™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether galantamine is excreted in human breast milk. RAZADYNE™ has no indication for use in nursing mothers.

Pediatric Use

There are no adequate and well-controlled trials documenting the safety and efficacy of galantamine in any illness occurring in children. Therefore, use of RAZADYNE™ in children is not recommended.

Adverse Reactions

Pre-Marketing Clinical Trial Experience:

The specific adverse event data described in this section are based on studies of the immediate- release tablet formulation. In clinical trials, once-daily treatment with RAZADYNE™ ER (galantamine hydrobromide) Extended-Release Capsules was well tolerated and adverse events were similar to those seen with RAZADYNE™ Tablets.

Adverse Events Leading to Discontinuation:

In two large scale, placebo-controlled trials of 6 months duration in which patients were titrated weekly from 8 to 16 to 24, and to 32 mg/day, the risk of discontinuation because of an adverse event in the galantamine group exceeded that in the placebo group by about threefold. In contrast, in a 5-month trial with escalation of the dose by 8 mg/day every 4 weeks, the overall risk of discontinuation because of an adverse event was 7%, 7%, and 10% for the placebo, galantamine 16 mg/day, and galantamine 24 mg/day groups, respectively, with gastrointestinal adverse effects the principle reason for discontinuing galantamine. Table 1 shows the most frequent adverse events leading to discontinuation in this study.

Table 1: Most Frequent Adverse Events Leading to Discontinuation in a Placebo-Controlled, Double-Blind Trial With a 4-Week Dose Escalation Schedule

4-Week Escalation
	Placebo	16 mg/day	24 mg/day
Adverse Event	N=286	N=279	N=273
Nausea	<1%	2%	4%
Vomiting	0%	1%	3%
Anorexia	<1%	1%	<1%
Dizziness	<1%	2%	1%
Syncope	0%	0%	1%

Adverse Events Reported in Controlled Trials: The reported adverse events in trials using RAZADYNE™ (galantamine hydrobromide) Tablets reflect experience gained under closely monitored conditions in a highly selected patient population. In actual practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior and the types of patients treated may differ.

The majority of these adverse events occurred during the dose-escalation period.In those patients who experienced the most frequent adverse event, nausea, the median duration of the nausea was 5-7 days.

Administration of RAZADYNE™ with food, the use of anti-emetic medication, and ensuring adequate fluid intake may reduce the impact of these events.

The most frequent adverse events, defined as those occurring at a frequency of at least 5% and at least twice the rate on placebo with the recommended maintenance dose of either 16 or 24 mg/day of RAZADYNE™ under conditions of every 4-week dose-escalation for each dose increment of 8 mg/day, are shown in Table 2.These events were primarily gastrointestinal and tended to be less frequent with the 16 mg/day recommended initial maintenance dose.

Table 2: The Most Frequent Adverse Events in the Placebo-Controlled Trial With Dose Escalation Every 4 Weeks Occurring in at Least 5% of Patients Receiving Galantamine Immediate-Release Tablets and at Least Twice the Rate on Placebo.

Adverse Event	Placebo N=286	Galantamine 16 mg/day N=279	Galantamine 24 mg/day N=273
Nausea	5%	13%	17%
Vomiting	1%	6%	10%
Diarrhea	6%	12%	6%
Anorexia	3%	7%	9%
Weight decrease	1%	5%	5%

Table 3: The most common adverse events (adverse events occurring with an incidence of at least 2% with RAZADYNE™ treatment and in which the incidence was greater than with placebo reatment) are listed in Table 3 for four placebo-controlled trials for patients treated with 16 or 24 mg/day of RAZADYNE™.

Table 3: Adverse Events Reported in at Least 2% of Patients With Alzheimer's Disease Administered Galantamine Immediate-Release Tablets and at a Frequency Greater Than With Placebo

Body System Adverse Event	Placebo (N=801)	Galantamine a (N=1040)
Body as a whole - general disorders
Fatigue	3%	5%
Syncope	1%	2%
Central & peripheral nervous system disorders
Dizziness	6%	9%
Headache	5%	8%
Tremor	2%	3%
Gastrointestinal system disorders
Nausea	9%	24%
Vomiting	4%	13%
Diarrhea	7%	9%
Abdominal pain	4%	5%
Dyspepsia	2%	5%
Heart rate and rhythm disorders
Bradycardia	1%	2%
Metabolic and nutritional disorders
Weight decrease	2%	7%
Psychiatric disorders
Anorexia	3%	9%
Depression	5%	7%
Insomnia	4%	5%
Somnolence	3%	4%
Red blood cell disorders
Anemia	2%	3%
Respiratory system disorders
Rhinitis	3%	4%
Urinary system disorders
Urinary tract infection	7%	8%
Hematuria	2%	3%
a: Adverse events in patients treated with 16 or 24 mg/day of galantamine in four placebo-controlled trials are included.

Adverse events occurring with an incidence of at least 2% in placebo-treated patients that was either equal to or greater than with RAZADYNE™ treatment were constipation, agitation, confusion, anxiety, hallucination, injury, back pain, peripheral edema, asthenia, chest pain, urinary incontinence, upper respiratory tract infection, bronchitis, coughing, hypertension, fall, and purpura. There were no important differences in adverse event rates related to dose or sex. There were too few non-Caucasian patients to assess the effects of race on adverse event rates.

No clinically relevant abnormalities in laboratory values were observed.

Other Adverse Events Observed During Clinical Trials

RAZADYNE™ Tablets were administered to 3055 patients with Alzheimer's disease. A total of 2357 patients received galantamine in placebo-controlled trials and 761 patients with Alzheimer's disease received galantamine 24 mg/day, the maximum recommended maintenance dose. About 1000 patients received galantamine for at least one year and approximately 200 patients received galantamine for two years.

To establish the rate of adverse events, data from all patients receiving any dose of galantamine in 8 placebo-controlled trials and 6 open-label extension trials were pooled. The methodology to gather and codify these adverse events was standardized across trials, using WHO terminology. All adverse events occurring in approximately 0.1% are included, except for those already listed elsewhere in labeling, WHO terms too general to be informative, or events unlikely to be drug caused. Events are classified by body system and listed using the following definitions: frequent adverse events - those occurring in at least 1/100 patients; infrequent adverse events - those occurring in 1/100 to 1/1000 patients; rare adverse events - those occurring in 1/1000 to 1/10000 patients; very rare adverse events - those occurring in fewer than 1/10000 patients. These adverse events are not necessarily related to RAZADYNE™ treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies.

Body As a Whole - General Disorders: Frequent: chest pain, asthenia, fever, malaise

Cardiovascular System Disorders: Infrequent: postural hypotension, hypotension, dependent edema, cardiac failure, myocardial ischemia or infarction

Central & Peripheral Nervous System Disorders: Infrequent: vertigo, hypertonia, convulsions, involuntary muscle contractions, paresthesia, ataxia, hypokinesia, hyperkinesia, apraxia, aphasia, leg cramps, tinnitus, transient ischemic attack or cerebrovascular accident

Gastrointestinal System Disorders: Frequent: flatulence; Infrequent: gastritis, melena, dysphagia, rectal hemorrhage, dry mouth, saliva increased, diverticulitis, gastroenteritis, hiccup; Rare: esophageal perforation

Heart Rate & Rhythm Disorders: Infrequent: AV block, palpitation, atrial arrhythmias includin atrial fibrillation and supraventricular tachycardia, QT prolonged, bundle branch block, T-wav inversion, ventricular tachycardia; Rare: severe bradycardia

Metabolic & Nutritional Disorders: Infrequent: hyperglycemia, alkaline phosphatase increased

Platelet, Bleeding & Clotting Disorders: Infrequent: purpura, epistaxis, thrombocytopenia

Psychiatric Disorders: Infrequent: apathy, paroniria, paranoid reaction, libido increased, delirium Rare: suicidal ideation; Very rare: suicide

Urinary System Disorders: Frequent: incontinence; Infrequent: hematuria, micturition frequency cystitis, urinary retention, nocturia, renal calculi

Post-Marketing Experience:

Other adverse events from post-approval controlled and uncontrolled clinical trials and post marketing experience observed in patients treated with RAZADYNE™ include:

Body as a Whole - General Disorders: dehydration (including rare, severe cases leading to rena insufficiency and renal failure)

Psychiatric Disorders: aggression

Gastrointestinal System Disorders: upper and lower GI bleeding

Metabolic & Nutritional Disorders: hypokalemia

These adverse events may or may not be causally related to the drug.

Overdose

Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of a overdose of any drug.

As in any case of overdose, general supportive measures should be utilized. Signs and symptom of significant overdosing of galantamine are predicted to be similar to those of overdosing of othe cholinomimetics. These effects generally involve the central nervous system, the parasympatheti nervous system, and the neuromuscular junction. In addition to muscle weakness or fasciculation some or all of the following signs of cholinergic crisis may develop: severe nausea, vomiting gastrointestinal cramping, salivation, lacrimation, urination, defecation, sweating, bradycardia hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is possibility and may result in death if respiratory muscles are involved.

Tertiary anticholinergics such as atropine may be used as an antidote for RAZADYNE (galantamine hydrobromide) overdosage. Intravenous atropine sulfate titrated to effect i recommended at an initial dose of 0.5 to 1.0 mg i.v. with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with othe cholinomimetics when coadministered with quaternary anticholinergics. It is not known whether RAZADYNE™ and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysi or hemofiltration). Dose-related signs of toxicity in animals included hypoactivity, tremors, cloni convulsions, salivation, lacrimation, chromodacryorrhea, mucoid feces, and dyspnea.

In one postmarketing report, one patient who had been taking 4 mg of galantamine daily for a week inadvertently ingested eight 4 mg tablets (32 mg total) on a single day. Subsequently, she developed bradycardia, QT prolongation, ventricular tachycardia and torsades de pointes accompanied by a brief loss of consciousness for which she required hospital treatment.Two additional cases of accidental ingestion of 32 mg (nausea, vomiting, and dry mouth; nausea, vomiting, and substernal chest pain) and one of 40 mg (vomiting), resulted in brief hospitalizations for observation with full recovery. One patient, who was prescribed 24 mg/day and had a history of hallucinations over the previous two years, mistakenly received 24 mg twice daily for 34 days and developed hallucinations requiring hospitalization. Another patient, who was prescribed 16 mg/day of oral solution, inadvertently ingested 160 mg (40 mL) and experienced sweating, vomiting, bradycardia, and near-syncope one hour later, which necessitated hospital treatment. His symptoms resolved within 24 hours.

Dosage and Administration

The dosage of RAZADYNE™ER (galantamine hydrobromide) Extended-Release Capsules shown to be effective in a controlled clinical trial is 16-24mg/day.

The recommended starting dose of RAZADYNE™ ER is 8 mg/day. The dose should be increased to the initial maintenance dose of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day should be attempted after a minimum of 4 weeks at 16 mg/day. Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.

The dosage of RAZADYNE™ Tablets shown to be effective in controlled clinical trials is 16-32mg/day given as twice daily dosing. As the dose of 32 mg/day is less well tolerated than lower doses and does not provide increased effectiveness, the recommended dose range is 16-24 mg/day given in a BID regimen.The dose of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dose of 24 mg of RAZADYNE™ might provide additional benefit for some patients.

The recommended starting dose of RAZADYNE™ Tablets and Oral Solution is 4 mg twice a day (8 mg/day). The dose should be increased to the initial maintenance dose of 8 mg twice a day (16 mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice a day (24 mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice a day (16 mg/day). Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.

RAZADYNE™ ER should be administered once daily in the morning, preferably with food. RAZADYNE™ Tablets and Oral Solution should be administered twice a day, preferably with morning and evening meals.

Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for several days or longer, the patient should be restarted at the lowest dose and the dose escalated to the current dose.

Caregivers should be instructed in the correct procedure for administering RAZADYNE™ Oral Solution. In addition, they should be informed of the existence of an Instruction Sheet (included with the product) describing how the solution is to be administered. They should be urged to read this sheet prior to administering RAZADYNE™ Oral Solution. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist.

The abrupt withdrawal of RAZADYNE™ in those patients who had been receiving doses in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same doses of that drug. The beneficial effects of RAZADYNE™ are lost, however, when the drug is discontinued.

Doses in Special Populations

Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment. In patients with moderately impaired hepatic function (Child-Pugh score of 7-9), the dose should generally not exceed 16 mg/day.The use of RAZADYNE™ in patients with severe hepatic impairment (Child-Pugh score of 10-15) is not recommended.

For patients with moderate renal impairment the dose should generally not exceed 16 mg/day. In patients with severe renal impairment (creatinine clearance <9 mL/min), the use of RAZADYNE™ is not recommended.

How Supplied

RAZADYNE™ ER (galantamine hydrobromide) Extended-Release Capsules contain white to off- white pellets.

8 mg white opaque, size 4 hard gelatin capsules with the inscription "GAL 8."

16 mg pink opaque, size 2 hard gelatin capsules with the inscription "GAL 16."

24 mg caramel opaque, size 1 hard gelatin capsules with the inscription "GAL 24."

The capsules are supplied as follows:
8 mg capsules - bottles of 30 NDC 50458-387-30
16 mg capsules - bottles of 30 NDC 50458-388-30
24 mg capsules - bottles of 30 NDC 50458-389-30

RAZADYNE™ Tablets are imprinted "JANSSEN" on one side, and "G" and the strength "4", "8", or "12"on the other.

4 mg off-white tablet:bottles of 60 NDC 50458-396-60
8 mg pink tablet:bottles of 60 NDC 50458-397-60
12 mg orange-brown tablet:bottles of 60 NDC 50458-398-60

RAZADYNE™ 4 mg/mL oral solution (NDC 50458-490-10) is a clear colorless solution supplied in 100 mL bottles with a calibrated (in milligrams and milliliters) pipette.The minimum calibrated volume is 0.5 mL, while the maximum calibrated volume is 4 mL.

Storage and Handling

RAZADYNE™ ER Extended-Release Capsules should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

RAZADYNE™Tablets should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) see USP Controlled Room Temperature].

RAZADYNE™ Oral Solution should be stored at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Keep out of reach of children.

RAZADYNE™ ER Extended-Release Capsules and RAZADYNE™ Tablets are manufactured by:

JOLLC, Gurabo, Puerto Rico or Janssen-Cilag SpA, Latina, Italy

RAZADYNE™ Oral Solution is manufactured by:

Janssen Pharmaceutica N.V., Beerse, Belgium

RAZADYNE™ ER Extended-Release Capsules and RAZADYNE™ Tablets and Oral Solution are distributed by:

ORTHO-McNEIL NEUROLOGICS, INC., Titusville, NJ 08560

 

IMPORTANT: The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 4/05.

Source: Ortho-McNeil Neurologics, Jannsen Pharmaceutical, U.S. distributor of Razadyne. Last updated Aug. 2006

back to: Psychiatric Medications Pharmacology Homepage

• Watch the video on Narcissist Types

Narcissists are either cerebral or somatic. In other words, they either generate their narcissistic supply by applying their bodies or by applying their minds.

The somatic narcissist flaunts his sexual conquests, parades his possessions, exhibits his muscles, brags about his physical aesthetics or sexual prowess or exploits, is often a health freak and a hypochondriac. The cerebral narcissist is a know-it-all, haughty and intelligent "computer". He uses his awesome intellect, or knowledge (real or pretended) to secure adoration, adulation and admiration. To him, his body and its maintenance are a burden and a distraction.

Both types are auto-erotic (psychosexually in love with themselves, with their bodies and with their brain). Both types prefer masturbation to adult, mature, interactive, multi-dimensional and emotion-laden sex.

The cerebral narcissist is often celibate (even when he has a girlfriend or a spouse). He prefers pornography and sexual auto-stimulation to the real thing. The cerebral narcissist is sometimes a latent (hidden, not yet outed) homosexual.

The somatic narcissist uses other people's bodies to masturbate. Sex with him - pyrotechnics and acrobatics aside - is likely to be an impersonal and emotionally alienating and draining experience. The partner is often treated as an object, an extension of the somatic narcissist, a toy, a warm and pulsating vibrator.

It is a mistake to assume type-constancy. In other words, all narcissists are BOTH cerebral and somatic. In each narcissist, one of the types is dominant. So, the narcissist is either OVERWHELMINGLY cerebral - or DOMINANTLY somatic. But the other type, the recessive (manifested less frequently) type, is there. It is lurking, waiting to erupt.

 

The narcissist swings between his dominant type and his recessive type. The latter is expressed mainly as a result of a major narcissistic injury or life crisis.

I can give you hundreds of examples from my correspondence but, instead, let's talk about me (of course...:o))

I am a cerebral narcissist. I brandish my brainpower, exhibit my intellectual achievements, bask in the attention given to my mind and its products. I hate my body and neglect it. It is a nuisance, a burden, a derided appendix, an inconvenience, a punishment. Needless to add that I rarely have sex (often years apart). I masturbate regularly, very mechanically, as one would change water in an aquarium. I stay away from women because I perceive them to be ruthless predators who are out to consume me and mine.

I have had quite a few major life crises. I got divorced, lost millions a few times, did time in one of the worst prisons in the world, fled countries as a political refugee, was threatened, harassed and stalked by powerful people and groups. I have been devalued, betrayed, denigrated and insulted.

Invariably, following every life crisis, the somatic narcissist in me took over. I became a lascivious lecher. When this happened, I had a few relationships - replete with abundant and addictive sex - going simultaneously. I participated in and initiated group sex and mass orgies. I exercised, lost weight and honed my body into an irresistible proposition.

This outburst of unrestrained, primordial lust waned in a few months and I settled back into my cerebral ways. No sex, no women, no body.

These total reversals of character stun my mates. My girlfriends and spouse found it impossible to digest this eerie transformation from the gregarious, darkly handsome, well-built and sexually insatiable person that swept them off their feet - to the bodiless, bookwormish hermit with not an inkling of interest in either sex or other carnal pleasures.

I miss my somatic half. I wish I could find a balance, but I know it is a doomed quest. This sexual beast of mine will forever be trapped in the intellectual cage that is I, Sam Vaknin, the Brain.

 

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next: Portrait of a Narcissist as a Young Man

As famous names and established companies get involved, opposition to Internet gambling is appearing to crumble.

It's illegal for Americans to offer gambling over the Internet, right? That's why the industry is hidden in Caribbean shadows, right? Tell it to Kenny Rogers.

The singer who immortalized "The Gambler" is not, his associates say, much of a gambler himself. But in mid-1998, he authorized the construction and operation of Kenny Rogers Casino on the Internet (www.kennyrogerscasino.com), where Web surfers with credit cards can hold 'em and fold 'em until they walk away (or run).

It's true that, in keeping with most people's perceptions of Web gambling, Kenny's virtual casino is not physically located in the United States. It resides a few dozen miles off the coast of Venezuela, in the Netherlands Antilles. The outfit that handles its cybercash transactions is in Toronto. And Kenny's site maintains a squeaky-clean distinction that many similar sites do not: A disclaimer in tiny type on several pages reads, "This site does not allow for gambling for money by persons within the United States." Unless you have a credit card registered with a non-U.S. address, a U.S. citizen can't trick the casino into letting him or her gamble, except in a free "practice" area.

But for all that fastidiousness, Kenny Rogers Casino is essentially controlled by a company in the United States. Not only can you walk right into its San Diego headquarters, you can buy its stock on the Nasdaq. Yes, the casino's license is held by a firm called Bardenac, but the substantial duties of operating the site - building it, advertising it, maintaining customer service - fall to a consulting company called Worldwide Media Holdings, which receives a percentage of all casino profits. WMH is a wholly owned subsidiary of Inland Entertainment, a San Diego-based company that trades under the ticker symbol INLD.

Inland was initially founded in the 1980s as a consultant to the Barona tribe of Mission Indians, which operates a casino on a reservation near San Diego. A few years ago, the Barona tribe decided to bring in Kenny Rogers as a spokesman. "It was very successful, in the sense that Indian gambling was still going through a lot of political challenges," says Fritz Opel, Inland's chief of online gaming. California's governor - and much of the local business community - opposed the Barona casino, and Rogers' involvement was a political turning point.

"People said, How can it be so bad if Kenny Rogers likes it?'" recalls Opel. As Internet gambling became a technological reality, Opel says he "saw some parallels" to the Indians' situation, and reached out to Rogers again. "He's been very helpful in creating credibility. It's important with our players to know they're dealing with a legitimate business." Rogers and Inland are not alone. Increasingly, the world of "legitimate" business is throwing its weight behind online gambling.

Online horse racing has been an especially active area of late. In early 1999, a Los Angeles-based firm called Youbet.com started Webcasting live races over the Web from 18 tracks across the country and offering surfers the ability to wager over the Internet. It is perfectly legal in 40 states and the District of Columbia to place a bet on Youbet.com. In late February, the New York Racing Association approved online Webcasts on its own site (www.nyra.com) of horse races in the state (although bettors, for now, will still have to call an 800 number). This summer, TCI and News Corp. plan to launch the Television Games Network, which will feature four to six races per hour packaged into a live, hosted television program, with access to a full menu of wagering opportunities from tracks across the country.

The explosion of online betting isn't limited to the ponies. In March, a site called Bingohour.com went live. It enables players to buy virtual bingo cards for $1 and win jackpots as large as $100,000.

Playboy has announced that it will offer a line of casino-style games on its Internet site that, like those on Kennyrogerscasino.com, U.S. citizens can play only for fun. But Playboy.com will also link to offshore gambling sites that play for real money. With such upstanding media corporations dipping their toes into the pool of online gaming, some in the Internet industry are betting that the day when a "legitimate" online casino opens in the United States is not far behind.

The potential action is too compelling for even the largest tech tycoons to resist. One of Microsoft (MSFT) 's less-publicized adventures is Ninemsn, an Australia-based Internet service to which Bill Gates has pledged tens of millions of dollars. His equal partner is Australian tycoon Kerry Packer of the Crown Casino in Victoria. Packer is a man with a voracious gambling appetite.

That partnership leads many observers to believe that an online casino - using Microsoft platforms, of course - is in the works. A Ninemsn spokesperson says that the site does not now offer online gambling and would not comment on future plans. Tony Cabot, an attorney specializing in gaming issues, says flatly, "When you see Kerry Packer get together with Microsoft, you have to believe there is a future for this type of wagering."

You might think that the prospect of competing against the likes of Microsoft would terrify a $20 million company like Inland. But they say the more bettors, the better. Says Opel, "Bringing in the big names and established companies only adds credibility and visibility to what we're already doing."

A few hurdles have to be cleared before such ventures can take off - beginning with the federal government. The Justice Department doesn't think that online casinos (including those that offer gambling on sports events) can legally conduct business in the United States, even if they are based in places where gambling is legal. In a highly publicized March 1998 "raid," Mary Jo White, the U.S. attorney for the Southern District of New York, indicted 14 managers of six Internet companies for offering gambling on their sites. The defendants, many of whom live abroad, were threatened with up to five years in prison and $250,000 fines.

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More than a year later, however, no cases have come to trial, and nine defendants have accepted plea bargains for state misdemeanor charges with no jail time. That may suggest that, as some legal observers have argued, the 1961 federal Wire Act is too old and too loosely written to prohibit online gambling. In 1998, the Senate passed, by a large margin, an amendment prohibiting Internet gambling, but that bill died before becoming law.

But the growing acceptance of online betting and the Internet's inherent ability to shatter jurisdictions bring the inconsistencies of American gaming law to a boil. Why should it be legal to bet online on a horse race in another state, but not legal to bet on a basketball game in one's own state? If Native American tribes can establish new, legal, physical places where adults can gamble, why shouldn't someone be able to do the same in cyberspace?

Gambling is as at least as old as Christianity (that is, if Ben Hur can be trusted). About 2,000 years later, Bugsy Siegel took the concept a step further and built the Flamingo Hotel in the desert town of Las Vegas. For decades, Vegas was about the only legal option for gamblers. In the '70s, Atlantic City legalized casino gambling; in the ensuing decades, state lotteries, Indian casinos, gaming ships, off-track betting parlors and card clubs have sprouted across the landscape.

Today, Americans spend some $600 billion a year on legal gambling, making it by far the favored national pastime. As Timothy L. O'Brien observes in Bad Bet, his comprehensive account of America's gambling industry, "Judging by dollars spent, gambling is now more popular in America than baseball, the movies and Disneyland combined."

The amount spent on Internet gambling is harder to calculate. Estimates range from $650 million to $1 billion a year, worldwide - a tiny fraction of the amount spent on more traditional formats. Even the precise number of online casinos is hard to calculate. In 1997, published reports put the total number of operating online casinos at 15. Today, a roster on one "gambling portal" site lists well over 200. That figure exaggerates the size of the Internet gambling sector, since some companies operate more than one online betting parlor. Inland, for example, operates two Web sites in addition to the one bearing Kenny Rogers' likeness: Casinoaustralia.com and Goodluckclub.com. Together, these sites have about 4,300 registered customers in 96 countries around the world.

Running an online casino carries all the usual challenges of Internet businesses, from low click-through rates to servers that fail. But according to Inland CEO Don Speer, elusive profits need not be one of them. He claims Inland's Internet gambling business went slightly into the black in March, on annualized revenues of about $1 million. (The company's Indian casino and Web-development divisions make more.) "This is the really exciting point, because I know where it goes from here," Speer said in an interview.

One major barrier to profitability is the law. "Think about what would happen to Wal-Mart (WMT) , General Motors or Microsoft if these companies had to continue to dodge federal roadblocks to access their customers," says Sebastian Sinclair, senior associate at Christiansen/Cummings Associates, a management consulting firm.

Take Interactive Gaming and Communications, another publicly traded company, located in Blue Bell, Pa. At one point, Interactive Gaming looked like it could be an industry leader. But following a 1997 indictment, the state of Missouri settled a suit against the company and its president, Michael Simone, for about $35,000. But the travails associated with fending off lawsuits have essentially put the company out of business. (The company did not respond to repeated requests for an interview.)

For years, another barrier to the growth of Internet gambling has been strong opposition from those most threatened by gambling sites: legal American casinos. The American Gaming Association, a trade group of gaming firms, maintains this view regarding online wagering: "The industry has been state-regulated and we think it should remain that way. The Internet is presently unregulated and we support a federal law regulating Internet gambling."

But over the last several months, at least some traditional casinos have pursued the time-honored strategy of joining an Internet gambling trend that they can't beat. In most cases, this means operating out of Australia. In November 1998, for example, a division of Hilton Hotels acquired the company that runs Centrebet, a Web and telephone sports-wagering system based in Australia (www.centrebet.com.au). Anyone over the age of 18 can set up an account with Centrebet and place money on a variety of worldwide sporting events, including U.S. college and professional sports.

Similarly, the Las Vegas-based public company American Wagering, owner of Leroy's Horse and Sports Place in Nevada, also operates a sports gambling site located in Canberra called MegaSports (www.megasports.com.au). In January, MegaSports began taking Internet bets from Australians; it expects soon to allow global gambling on sporting events.

So how is it that these companies appear to operate legally, but a dozen Caribbean cowboys found themselves under felony indictment?

It's not because they operate in any fundamentally different way. Almost all online gambling sites work the same. Would-be wagerers open an account with a credit card, although some sites also accept cash and cashier's checks. The minimum amount to begin an account varies. Casino games are available on a site or via downloadable software. They almost always include slots, blackjack and video poker, but many sites carry more exotic games, from baccarat to pai gow. Bets generally range from $1 to as much as $300.

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Although it uses a CryptoLogic template similar to several other online casinos, Kennyrogerscasino.com may be unique in letting bettors wager as little as a penny at a time. "We get daily reports, and you'll see these people who spend a couple of hours gambling, and the total amount they bet is like $1.81," says Thomas Holmes, Inland's head of technology.

Intriguingly, though, all the bets that make up the U.S. attorney's case involved the casinos' sportsbooks. FBI agents placed bets on games - uniformly National Football League matches, although many other options are available - and followed up, whether they won or lost.

The prosecutors' focus on sports bets appears to stem from legal precedent in the law they relied on. Their case is based on the 1961 Wire Act. Passed during the term of crime-fighter Attorney General Robert Kennedy, the law was intended to outlaw betting over telephone lines. Like the Communications Act passed in the 1930s, technology has now leapfrogged the law. The Wire Act obviously has no mention of wagering over the Internet.

Nonetheless, some experts think the case could be made to stick. "The telephone is being used to facilitate these wagers and I believe the government has a solid case," explains Tony Cabot, a Las Vegas-based gaming lawyer and author of a book on Internet gaming. "And it is possible that records could be subpoenaed of various banks where these companies maintain accounts."

The office of U.S. Attorney White has proceeded slowly and quietly. White's hesitancy suggests that the law may not be as solid as she thought when she indicted. Her higher-ups in the Justice Department appear to agree. The Standard obtained a Department of Justice analysis of the bill S. 474, introduced into the Senate by Arizona's John Kyl in 1997 as the Internet Gambling Prohibition Act. Justice believes that any legislation addressing criminal misuse of computers or computer systems (including the Internet) should have three vital characteristics.

First, legislation should treat physical activity and cyberactivity in the same way. If an activity is prohibited in the physical world but not on the Internet, the Internet becomes a safe haven for that criminal activity. If, on the other hand, an activity is in the physical world - betting on horses, or casino betting with Indian tribes - it becomes subject to federal criminal sanction when it occurs in cyberspace.

Second, legislation should be technology-neutral. Legislation tied to a particular technology may quickly become obsolete and require further amendment.

Finally, the DoJ believes that any federal law must recognize that the Internet is different from other communications media: It's a multifaceted communications medium that allows for both point-to-point transmission between two parties (like the telephone), as well as the widespread dissemination of information to a vast audience (like a newspaper). Failure to account for that specificity in legislation could stifle the Internet's growth or chill its use as a communications tool.

The original version of Kyl's bill failed most of these tests. Kyl introduced a revised version earlier this year, removing some of the more onerous and hard-to-enforce provisions. According to an analysis by Sue Schieder of Rolling Good Times, the online gambling magazine, the new legislation would not punish the casual bettor. Nor would it prohibit online fantasy sports leagues, online lotteries in states where they are legal, or online betting on any live horse race where it would otherwise be lawful to wager. Legislators have considered enlisting Internet service providers to patrol for undesirable sites, although Internet gambling insiders consider that proposal dead on arrival.

But even if Congress comes up with the best-crafted legislation in history, there are significant factors beyond its control. "Federal legislation will make it difficult but not impossible for Internet gamblers in the U.S. to gain access to offshore sites," says Sebastian Sinclair of Christiansen/Cummings. "Ultimately, Internet gambling operators are selling a product. The vast majority of customers will satisfy their demand for commercial gambling through less onerous and risky alternatives, such as lotteries, bingo, pari-mutuels and casinos."

But a hard-core base will continue to turn to Internet betting for its clear advantages. For one thing, gambling from one's home allows for a variety of techniques that would get one tossed out of a regular casino. Blackjack players can very easily count cards, or even consult odds charts; the Kennyrogerscasino.com site actually has a printable chart showing the best strategy for every possible hand of blackjack. And for sports bettors - who make up a majority of online gamblers, according to industry insiders - the ease of using cyberbookies can't be beat. "I use the service because it's convenient and I have access to it when I want," says one online gambler. "I wager on football games and usually bet in the neighborhood of $1,000 every weekend. I've not had problems being paid."

If such gamblers are not satisfied by options available to U.S. citizens, it will be increasingly tempting for them to turn to locations abroad. One Australian state, Queensland, is already awarding licenses for online gambling, and others may follow soon. That makes for an Internet gambling environment too porous for U.S. law enforcement to plug.

All the sites indicted by the U.S. attorney's office theoretically operate out of the Caribbean. (However, an HBO sports program attempted to locate one of these ventures in Aruba, and ultimately found that the genuine server was in a residential neighborhood in Bethlehem, Pa.) And the Caribbean nations would like to keep their haven status. Aruba, for one, is refusing to extradite any indicted individuals to the U.S., and thus far the U.S. has had little cooperation from any other nation.

Does the seeming invincibility of online gambling make it an enticing business? Jason Ader of Bear Stearns, urges caution. "Since there are no controls at present regarding Internet wagering, I would urge investors to shun these firms at present," he says. Even the firms that have enjoyed some stock-price popularity - such as Youbet.com - have shaky fundamentals. But as more and more traditional firms become involved, the consumer will look for the brand name. Says Sinclair of Christiansen/Cummings: "You are going to feel more comfortable wagering with a Hilton than you will with Joe's Casino."

Source: TheStandard.com

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next: What Makes the Internet Addictive: Potential Explanations for Pathological Internet Use
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Parent writes in to say that vitamin C and niacinamide were very helpful in treating hyperactivity in her son with ADHD.

Natural Alternatives for ADHD

Gail from Canada writes:

"I hope you don't mind me e-mailing you about your son as I too had a son with the same problem. He is now 29 and doing very well. Here is what I did.

I was the president of the Association for Children with Learning Disabilities here in British Columbia and when my son was just starting school (in grade one) my family  doctor suggested that I put Darrin on Ritalin (which is the drug used here for hyperactive kids).   Instead, I went to every lecture through the Health and University system that I could and came to the conclusion that drugs didn't help. It broke my heart to see these kids (who were on the drugs) up on a stage trying to do the different tests that were put to them. So I looked for a different solution. It was through two learning assistant teachers that I found a solution:

1. I took Darrin off of all food colouring and of course sugar and this helped somewhat.
2. Then I took him to a  doctor in Victoria that specialized in hyperactive kids. This is where the breakthrough occurred.

Dr. Hoffer put Darrin on Vitamin C and Niacinamide (a form of B3). He started out on 500 mg - 3 times a day of each. And then we slowly increased the amount to 1000mg - 3 times a day of each. Before this took place, Darrin was not only hyperactive but also had a reading disability. I thought he could read but he was getting other kids to read to him and then he was memorizing the pages. Nothing wrong with the kids brain.

Well after taking the vitamins for a couple of weeks, he settled right down and to my surprise he started reading. By the time that all this took place, he was in grade four and a lot of damage had been done to his self-esteem. You know the old story of how they think they are dumb. Well, let me tell you, that Darrin completed grade one, two, three and half of grade four that year. We were all elated.

I remember back to when I was in school and there would be maybe 5 or 6 children with learning disabilities and now there are so many. You have to ask yourself - why? If they can't find anything physical i.e. ears - eyes - brain, then what is causing it? As one specialist from New York described it, it is like having measles on the brain and it needs scratching. And I found that the vitamins got rid of the itch.

If you would like more info from the doctor here, I could send his mailing address. But please try this with your son. These vitamins are non-toxic and will pass through the body - the body will only keep what it needs."

Editor's Note: We have recently been advised of some concerns regarding Vitamin C and adverse effects at high doses. We have taken some extracts about this from cspinet.org

"The current Daily Value is 60 mg, but some vitamin-C experts think that intakes should be at least 100 mg or, more likely, 200 mg.

If you eat the eight to ten servings of fruits and vegetables a day that we recommend, you should get at least 200 mg. So far there is no Upper Tolerable Intake Level (UL) for vitamin C. It should be 1,000 mg a day, some argue, because more than that may raise the risk of kidney stones."

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Please remember, we do not endorse any treatments and strongly advise you to check with your doctor before using, stopping or changing treatment.

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teenage sex

Are you trying to decide whether it's right for you to have sex? You're not alone. Many teenagers feel pressure to have sex from both their peers and the media; to "do what everyone else is doing." And this sometimes makes the choice a hard one.

Sometimes it might seem like everyone in school is talking about who's a virgin, who isn't, and who might be. For both girls and guys, the pressure can sometimes be intense.

But deciding whether it's right for you to have sex is one of the most important decisions you'll ever have to make. Each person must use his or her own judgment and decide if it's the right time - and the right person.

This means considering some very important factors - both physical ones, like the possibility of becoming pregnant or getting a sexually transmitted disease - and emotional factors, too. Though a person's body may feel ready for sex, sex also has very serious emotional consequences.

For many teens, moral factors are very important as well. Family attitudes, personal values, or religious beliefs provide them with an inner voice that guides them in resisting pressures to get sexually involved before the time is right.

Peer Pressure Problems and Movie Madness

Nobody wants to feel left out of things - it's natural to want to be liked and feel as if you're part of a group of friends. Unfortunately, some teens feel that they have to lose their virginity to keep up with their friends or to be accepted.

Nobody wants to feel left out of things - it's natural to want to be liked and feel as if you're part of a group of friends. Unfortunately, some teens feel that they have to lose their virginity to keep up with their friends or to be accepted.

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It doesn't sound like it's all that complicated; maybe most of your friends have already had sex with their boyfriends or girlfriends and act like it isn't a big deal. But sex isn't something that's only physical; it's emotional, too. And because everyone's emotions are different, it's hard to rely on your friends' opinions to decide if it's the right time for you to have sex.

What matters to you is the most important thing, and your values may not match those of your friends. That's OK - it's what makes people unique. Having sex to impress someone or to make your friends happy or feel like you have something in common with them won't make you feel very good about yourself in the long run. True friends don't really care whether a person is a virgin - they will respect your decisions, no matter what.

Even if your friends are cool with your decision, it's easy to be misled by TV shows and movies into thinking that every teen in America is having sex. Writers and producers may make a show or movie plot exciting by showing teens being sexually active, but these teens are actors, not real people with real concerns. They don't have to worry about being ready for sex, how they will feel later on, or what might happen as a result. In other words, these TV and movie plots are stories, not real life. In real life, every teen can, and should, make his or her own decision.

When you're a teen, there can be a lot of pressure to have sex.

Boyfriend Blues or Girlfriend Gripes

Although some teens who are going out don't pressure each other about sex, the truth is that in many relationships, one person wants to have sex although the other one doesn't.

Again, what matters most differs from person to person. Maybe one person in a relationship is more curious and has stronger sexual feelings than the other. Or another person has religious reasons why he or she doesn't want to have sex and the other person doesn't share those beliefs.

Whatever the situation, it can place stress and strain on a relationship - you want to keep your boyfriend or girlfriend happy, but you don't want to compromise what you think is right.

As with almost every other major decision in life, you need to do what is right for you and not anyone else. If you think sex is a good idea because a boyfriend or girlfriend wants to begin a sexual relationship, think again.

Anyone who tries to pressure you into having sex by saying, "if you truly cared, you wouldn't say no," or "if you loved me, you'd show it by having sex" isn't really looking out for you and what matters most to you. They're looking to satisfy their own feelings and urges about sex.

If someone says that not having sex after doing other kinds of fooling around will cause him or her physical pain, that's also a sign that that person is thinking only of himself or herself. If you feel that you should have sex because you're afraid of losing that person, it may be a good time to end the relationship.

Sex should be an expression of love - not something a person feels that he or she must do. If a boyfriend or girlfriend truly loves you, he or she won't push or pressure you to do something you don't believe in or aren't ready for yet.

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Feeling Curious

You might have a lot of new sexual feelings or thoughts. These feelings and thoughts are totally normal - it means that all of your hormones are working properly. But sometimes your curiosity or sexual feelings can make you feel like it's the right time to have sex, even though it may not be.

Though your body may have the ability to have sex and you may really want to satisfy your curiosity, it doesn't mean your mind is ready. Although some teens understand how sex can affect them emotionally, many don't - and this can lead to confusion and deeply hurt feelings later.

But at the same time, don't beat yourself up or be too hard on yourself if you do have sex and then wish you hadn't. Having sexual feelings is normal and handling them can sometimes seem difficult, even if you planned otherwise. Just because you had sex once doesn't mean you have to continue or say yes later on, no matter what anyone tells you. Making mistakes is not only human, it's a major part of being a teen - and you can learn from mistakes.

Why Some Teens Wait to Have Sex

Some teens are waiting longer to have sex - they are thinking more carefully about what it means to lose their virginity and begin a sexual relationship.

For these teens, there are many reasons for abstinence (not having sex). Some don't want to worry about unplanned pregnancy and all its consequences. Others see abstinence as a way to protect themselves completely from sexually transmitted diseases (STDs). Some STDs (like AIDS) can literally make sex a life-or-death situation, and many teens take this very seriously.

Some teens don't have sex because their religion prohibits it or because they simply have a very strong belief system of their own. Other teens may recognize that they aren't ready emotionally and they want to wait until they're absolutely sure they can handle it.

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When it comes to sex, there are two very important things to remember: one, that you are ultimately the person in charge of your own happiness and your own body; and two, you have a lot of time to wait until you're totally sure about it. If you decide to put off sex, it's OK - no matter what anyone says. Being a virgin is one of the things that proves you are in charge, and it shows that you are powerful enough to make your own decisions about your mind and body.

If you find yourself feeling confused about decisions related to sex, you may be able to talk to an adult (like a parent, doctor, older sibling, aunt, or uncle) for advice. Keep in mind, though, that everyone's opinion about sex is different. Even though another person may be able to share useful advice, in the end, the decision is up to you.

next: It's Okay to Say: No Way! to Teen Sex