Lately, the only constant in my life has been change. Both at home and at work, I'm going through a series of rapid, dramatic changes. During the past few weeks, even my dreams have centered on scenarios in which I am suffocating, drowning, or finding myself trapped in a tightly confined space. Last night, I woke up coughing and my throat remained tightly constricted for two or three hours. In addition, I haven't been able to write for at least a week, because my mind is so focused on all the upheaval.

On Sunday, I was telling my adopted Mom how I was feeling. She gave me a little book by Richard Carlson called Don't Sweat the Small Stuff—It's All Small Stuff. I keep trying to remember that my current issues are just small stuff. I've survived far worse than this.

But I don't think it is the small stuff, per se, I'm struggling with. I accept that as long as I'm alive, I'll have changes and difficulties to manage. I think what I'm really struggling with is the fact that this lack of stability seems to be ongoing.

I realize that chaos and frenzy are part of family life to a certain degree. And I admit to needing (sometimes demanding) a certain pace to my days. I do like a predictable pattern (but not too predictable or too mundane!). Is this a manifestation of my co-dependency or just a part of my personality? Maybe some of both. I don't know for certain; however, I do know that stability is one of my basic needs. Maybe stability is also a basic need for families.

The reason I need stability is because I equate stability with safety. Stability gives me breathing room to live serenely and creatively. I have a better quality of life when my basic survival needs are met. And for me, lack of stability is a basic survival issue. I think it probably comes from feeling so abandoned and rejected during my divorce.

I'm also trying to approach this problem from the standpoint that I am not alone or unique. If I'm struggling with this, then others can probably relate. Perhaps there is a level of predictability that we all require to survive; a level of safety in which we can find our focus and our balance. When we feel stable and secure, we can attend to our higher level needs—analyzing, synthesizing, and evaluating our contributions to Life. Perhaps as co-dependents, what we are seeking in recovery is a way to deal with the unstable people and circumstances that have been slowly choking the life out of us.

Right now, I only know that I need more stability and predictability in my life. It is OK for me to take care of myself in this area. It is OK for me to struggle and make sense out of everything that is happening. It is OK for me to learn from this situation.

Today, I give myself permission to develop healthy, workable patterns and routines. I give myself permission to develop a degree of predictability and renewed serenity in my life. I give myself permission to find some level of order in the chaos.

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Thank you, God for reminding me that I can survive. Thank You for bringing me through so many challenging situations. Thank You for teaching me to take care of myself. Thank You for showing me how to seek and how to find Your answers. Amen.

next: Adjustments

(vardenafil HCI) Tablets

Contents:

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

DESCRIPTION

LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5- methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4- ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:

Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with "BAYER" cross debossed on one side and "2.5", "5", "10", and "20" on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.

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CLINICAL PHARMACOLOGY

Mechanism of Action

Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMPspecific phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation. In vitro studies have shown that vardenafil is a selective inhibitor of PDE5. The inhibitory effect of vardenafil is more selective on PDE5 than for other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1,000-fold relative to PDE2, 3, 4, 7, 8, 9, and 10).

Pharmacokinetics

The pharmacokinetics of vardenafil are approximately dose proportional over the recommended dose range. Vardenafil is eliminated predominantly by hepatic metabolism, mainly by CYP3A4 and to a minor extent, CYP2C isoforms. Concomitant use with strong CYP3A4 inhibitors such as ritonavir, indinavir, ketoconazole, itraconazole as well as moderate CYP3A inhibitors such as erythromycin results in significant increases of plasma levels of vardenafil (see PRECAUTIONS, WARNINGS and DOSAGE AND ADMINISTRATION). Mean vardenafil plasma concentrations measured after the administration of a single oral dose of 20 mg to healthy male volunteers are depicted in Figure 1.

Figure 1: Plasma Vardenafil Concentration (Mean ± SD) Curve for a Single 20 mg LEVITRA Dose

 

Absorption: Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Maximum observed plasma concentrations after a single 20 mg dose in healthy volunteers are usually reached between 30 minutes and 2 hours (median 60 minutes) after oral dosing in the fasted state. Two foodeffect studies were conducted which showed that high-fat meals caused a reduction in Cmax by 18%-50%.

Distribution: The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. Vardenafil and its major circulating metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1). This protein binding is reversible and independent of total drug concentrations.

Following a single oral dose of 20 mg vardenafil in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing.

Metabolism: Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil. M1 is subject to further metabolism. The plasma concentration of M1 is approximately 26% that of the parent compound. This metabolite shows a phosphodiesterase selectivity profile similar to that of vardenafil and an in vitro inhibitory potency for PDE5 28% of that of vardenafil. Therefore, M1 accounts for approximately 7% of total pharmacologic activity.

Excretion: The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours. After oral administration, vardenafil is excreted as metabolites predominantly in the feces (approximately 91-95% of administered oral dose) and to a lesser extent in the urine (approximately 2-6% of administered oral dose).

Pharmacokinetics in Special Populations

Pediatrics: Vardenafil trials were not conducted in the pediatric population.

Geriatrics: In a healthy volunteer study of elderly males (> 65 years) and younger males (18 - 45 years), mean Cmax and AUC were 34% and 52% higher, respectively, in the elderly males (see PRECAUTIONS, Geriatric Use and DOSAGE AND ADMINISTRATION). Consequently, a lower starting dose of LEVITRA (5 mg) in patients ≥ 65 years of age should be considered.

Renal Insufficiency: In volunteers with mild renal impairment (CLcr = 50-80 ml/min), the pharmacokinetics of vardenafil were similar to those observed in a control group with normal renal function. In the moderate (CLcr = 30-50 ml/min) or severe (CLcr 80 ml/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis (see PRECAUTIONS, Renal Insufficiency, and DOSAGE AND ADMINISTRATION).

Hepatic Insufficiency: In volunteers with mild hepatic impairment (Child- Pugh A), the Cmax and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects. In volunteers with moderate hepatic impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. Consequently, a starting dose of 5 mg is recommended for patients with moderate hepatic impairment, and the maximum dose should not exceed 10 mg (see PRECAUTIONS and DOSAGE AND ADMINISTRATION). Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment.

Pharmacodynamics

Effects on Blood Pressure: In a clinical pharmacology study of patients with erectile dysfunction, single doses of vardenafil 20 mg caused a mean maximum decrease in supine blood pressure of 7 mm Hg systolic and 8 mm Hg diastolic (compared to placebo), accompanied by a mean maximum increase of heart rate of 4 beats per minute. The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents (see CONTRAINDICATIONS, PRECAUTIONS, Drug Interactions).

Effects on Blood Pressure and Heart Rate When LEVITRA is Combined with Nitrates: A study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with LEVITRA 20 mg at various times before NTG administration. LEVITRA 20 mg caused an additional time-related reduction in blood pressure and increase in heart rate in association with NTG administration. The blood pressure effects were observed when LEVITRA 20 mg was dosed 1 or 4 hours before NTG and the heart rate effects were observed when 20 mg was dosed 1, 4, or 8 hours before NTG. Additional blood pressure and heart rate changes were not detected when LEVITRA 20 mg was dosed 24 hours before NTG. (See Figure 2.)

Figure 2: Placebo-subtracted point estimates (with 90% CI) of mean maximal blood pressure and heart rate effects of pre-dosing with LEVITRA 20 mg at 24, 8, 4, and 1 hour before 0.4 mg NTG sublingually.

Because the disease state of patients requiring nitrate therapy is anticipated to increase the likelihood of hypotension, the use of vardenafil by patients on nitrate therapy or on nitric oxide donors is contraindicated (see CONTRAINDICATIONS).

Electrophysiology: The effect of 10 mg and 80 mg vardenafil on QT interval was evaluated in a single-dose, double-blind, randomized, placebo- and active-controlled (moxifloxacin 400 mg) crossover study in 59 healthy males (81% White, 12% Black, 7% Hispanic) aged 45-60 years. The QT interval was measured at one hour post dose because this time point approximates the average time of peak vardenafil concentration. The 80 mg dose of LEVITRA (four times the highest recommended dose) was chosen because this dose yields plasma concentrations covering those observed upon co-administration of a low-dose of LEVITRA (5 mg) and 600 mg BID of ritonavir. Of the CYP3A4 inhibitors that have been studied, ritonavir causes the most significant drug-drug interaction with vardenafil. Table 1 summarizes the effect on mean uncorrected QT and mean corrected QT interval (QTc) with different methods of correction (Fridericia and a linear individual correction method) at one hour post-dose. No single correction method is known to be more valid than the other. In this study, the mean increase in heart rate associated with a 10 mg dose of LEVITRA compared to placebo was 5 beats/minute and with an 80 mg dose of LEVITRA the mean increase was 6 beats/minute.

Table 1. Mean QT and QTc changes in msec (90% CI) from baseline relative to placebo at 1 hour post-dose with different methodologies to correct for the effect of heart rate.

Therapeutic and supratherapeutic doses of vardenafil and the active control moxifloxacin produced similar increases in QTc interval. This study, however, was not designed to make direct statistical comparisons between the drugs or the dose levels. The actual clinical impact of these QTc changes is unknown. (See PRECAUTIONS).

Effects on Exercise Treadmill Test in Patients with Coronary Artery Disease (CAD): In two independent trials that assessed 10 mg (n=41) and 20 mg (n=39) vardenafil, respectively, vardenafil did not alter the total treadmill exercise time compared to placebo. The patient population included men aged 40-80 years with stable exercise-induced angina documented by at least one of the following: 1) prior history of MI, CABG, PTCA, or stenting (not within 6 months); 2) positive coronary angiogram showing at least 60% narrowing of the diameter of at least one major coronary artery; or 3) a positive stress echocardiogram or stress nuclear perfusion study.

Results of these studies showed that LEVITRA did not alter the total treadmill exercise time compared to placebo (10 mg LEVITRA vs. placebo: 433 ±109 and 426 ±105 seconds, respectively; 20 mg LEVITRA vs. placebo: 414 ±114 and 411 ±124 seconds, respectively). The total time to angina was not altered by LEVITRA when compared to placebo (10 mg LEVITRA vs. placebo: 291 ±123 and 292 ±110 seconds; 20 mg LEVITRA vs. placebo: 354 ±137 and 347 ±143 seconds, respectively). The total time to 1 mm or greater STsegment depression was similar to placebo in both the 10 mg and the 20 mg LEVITRA groups (10 mg LEVITRA vs. placebo: 380 ±108 and 334 ±108 seconds; 20 mg LEVITRA vs. placebo: 364 ±101 and 366 ±105 seconds, respectively).

Effects on Vision: Single oral doses of phosphodiesterase inhibitors have demonstrated transient dose-related impairment of color discrimination (blue/green) using the Farnsworth-Munsell 100-hue test and reductions in electroretinogram (ERG) b-wave amplitudes, with peak effects near the time of peak plasma levels. These finding are consistent with the inhibition of PDE6 in rods and cones, which is involved in phototransduction in the retina. The findings were most evident one hour after administration, diminishing but still present 6 hours after administration. In a single dose study in 25 normal males, LEVITRA 40 mg, twice the maximum daily recommended dose, did not alter visual acuity, intraocular pressure, fundoscopic and slit lamp findings.

CLINICAL STUDIES

Levitra was evaluated in four major double-blind, randomized, placebocontrolled, fixed-dose, parallel design, multi-center trials that enrolled 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The doses of LEVITRA in these studies were 5 mg, 10 mg, and 20 mg. Two of these trials were conducted in the general ED population and two in special ED populations (one in patients with diabetes mellitus and one in post-prostatectomy patients). LEVITRA was dosed without regard to meals on an as needed basis in men with erectile dysfunction (ED), many of whom had multiple other medical conditions. The primary endpoints were assessed at 3 months.

Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3).

In all four fixed-dose efficacy trials, LEVITRA showed clinically meaningful and statistically significant improvement in the EF Domain, SEP2, and SEP3 scores compared to placebo. The mean baseline EF Domain score in these trials was 11.8 (scores range from 0-30 where lower scores represent more severe disease). LEVITRA (5 mg, 10 mg, and 20 mg) was effective in all age categories (<45, 45 to 65 years) and was also effective regardless of race (White, Black, Other).

Trials in a General Erectile Dysfunction Population: In the major North American fixed dose trial, 762 patients (mean age 57, range 20-83 years, 79% White, 13% Black, 4% Hispanic, 2% Asian and 2% Other) were evaluated. The mean baseline EF Domain scores were 13, 13, 13, 14 for the LEVITRA 5 mg, 10 mg, 20 mg and placebo groups, respectively. There was significant improvement (p<0.0001) at three months with LEVITRA (EF Domain scores of 18, 21, 21, for the 5 mg , 10 mg and 20 mg dose groups, respectively) compared to the placebo group (EF Domain score of 15). The European trial (total N=803) confirmed these results. The improvement in mean score was maintained at all doses at six months in the North American trial.

In the North American trial, LEVITRA significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo at 3 months; p< 0.0001). The European trial confirmed these results.

LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo, p< 0.0001) at 3 months in the North American trial. The European trial showed comparable efficacy. This improvement in mean score was maintained at all doses at 6 months in the North American trial.

Trial in Patients with ED and Diabetes Mellitus: LEVITRA demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg LEVITRA), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other).

Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg LEVITRA and 19 on 20 mg LEVITRA compared to 13 on placebo; p< 0.0001).

LEVITRA significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg LEVITRA compared to 36% on placebo; p< 0.0001).

LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10 mg, 54% on 20 mg LEVITRA compared to 23% on placebo; p< 0.0001).

Trial in Patients with ED after Radical Prostatectomy: LEVITRA demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg LEVITRA), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other).

Significant improvements in the EF Domain were shown in this study (EF Domain scores of 15 on 10 mg LEVITRA and 15 on 20 mg LEVITRA compared to 9 on placebo; p< 0.0001).

LEVITRA significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (47% on 10 mg and 48% on 20 mg LEVITRA compared to 22% on placebo; p <0.0001).

LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (37% on 10 mg, 34% on 20 mg LEVITRA compared to 10% on placebo; p< 0.0001).

INDICATIONS AND USAGE

LEVITRA is indicated for the treatment of erectile dysfunction.

CONTRAINDICATIONS

Nitrates: Administration of LEVITRA with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated (see CLINICAL PHARMACOLOGY, Pharmacodynamics, Effects on Blood Pressure and Heart Rate when LEVITRA is Combined with Nitrates). Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates. A suitable time interval following LEVITRA dosing for the safe administration of nitrates or nitric oxide donors has not been determined.

Alpha Blockers: Because the co-administration of alpha-blockers and LEVITRA can produce hypotension, LEVITRA is contraindicated in patients taking alpha-blockers (see PRECAUTIONS, Drug Interactions).

Hypersensitivity: LEVITRA is contraindicated for patients with a known hypersensitivity to any component of the tablet.

WARNINGS

Cardiovascular effects

General: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.

Left Ventricular Outflow Obstruction: Patients with left ventricular outflow obstruction, e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.

Blood Pressure Effects: LEVITRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic) (see CLINICAL PHARMACOLOGY, Pharmacodynamics). While this normally would be expected to be of little consequence in most patients, prior to prescribing LEVITRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.

Effect of Co-administration of Strong CYP3A4 inhibitors

Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors. Concomitant administration with ritonavir or indinavir substantially increases plasma concentrations of vardenafil. To decrease the chance of adverse events in patients concomitantly taking ritonavir or indinavir, which are strong inhibitors of CYP3A4 metabolism, a maximum single dose of 2.5 mg LEVITRA should not be exceeded. Because ritonavir prolongs LEVITRA elimination half-life (5-6-fold), no more than a single 2.5 mg dose of LEVITRA should be taken in a 72-hour period by patients also taking ritonavir. Patients taking indinavir, ketoconazole 400 mg daily, or itraconazole 400 mg daily should not exceed LEVITRA 2.5 mg once daily. For patients taking ketoconazole or itraconazole 200 mg daily, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period (see PRECAUTIONS, Drug Interactions and DOSAGE AND ADMINISTRATION).

Other Effects

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Patient Subgroups Not Studied in Clinical Trials

There is no controlled clinical data on the safety or efficacy of LEVITRA in the following patients; and therefore its use is not recommended until further information is available.

- unstable angina; hypotension (resting systolic blood pressure of 170/110 mm Hg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure - severe hepatic impairment (Child-Pugh C) - end stage renal disease requiring dialysis - known hereditary degenerative retinal disorders, including retinitis pigmentosa

PRECAUTIONS

The evaluation of erectile dysfunction should include a determination of potential underlying causes, a medical assessment, and the identification of appropriate treatment.

Before prescribing LEVITRA, it is important to note the following:

Alpha-blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Phosphodiesterase Type 5 (PDE5) inhibitors, including LEVITRA, and alpha-adrenergic blocking agents are both vasosdilators with blood-pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly (see PRECAUTIONS, Drug Interactions) leading to symptomatic hypotension (e.g., fainting). Consideration should be given to the following:

• Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
• In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose (see DOSAGE and ADMINISTRATION).
• In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor.
• Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.

Hepatic Insufficiency: In volunteers with moderate impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased 130% and 160%, respectively, compared to healthy control subjects. Consequently, a starting dose of 5 mg is recommended for patients with moderate hepatic impairment and the maximum dose should not exceed 10 mg (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations, and DOSAGE AND ADMINISTRATION). Vardenafil has not been evaluated in patients with severe hepatic impairment (Child-Pugh C).

Congenital or Acquired QT Prolongation: In a study of the effect of LEVITRA on QT interval in 59 healthy males (see CLINICAL PHARMACOLOGY, Electrophysiology), therapeutic (10 mg) and supratherapeutic (80 mg) doses of LEVITRA and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. This observation should be considered in clinical decisions when prescribing LEVITRA. Patients with congenital QT prolongation and those taking Class IA (e.g., quinidine, procainamide) or Class III (e.g.,amiodarone, sotalol) antiarrhythmic medications should avoid using LEVITRA.

Renal Insufficiency: In patients with moderate (CLcr = 30-50 ml/min) to severe (CLcr 80 ml/min) (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis.

General: In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. Vardenafil has not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore LEVITRA should be administered to these patients after careful benefit-risk assessment.

Treatment for erectile dysfunction should generally be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

The safety and efficacy of LEVITRA used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Information for Patients

Physicians should discuss with patients the contraindication of LEVITRA with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of LEVITRA with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Physicians should inform their patients that concomitant use of LEVITRA with alpha-blockers is contraindicated because co-administration can produce hypotension (e.g. fainting). Patients prescribed LEVITRA who are taking alpha-blockers should be started on the lowest recommended starting dose of LEVITRA (see Drug Interactiona and DOSAGE AND ADMINISTRATION). Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with LEVITRA are prescribed by another healthcare provider.

Physicians should advise patients to stop use of all PDE5 inhibitors, including LEVITRA, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. It is not possible to determine whether these events were related directly to the use of PDE5 inhibitors or to other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors (see POST-MARKETING EXPERIENCE/Ophthalmologic).

Physicians should discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.

The use of LEVITRA offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.

Physicians should inform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for LEVITRA and this class of compounds. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Drug Interactions

Effect of other drugs on LEVITRA

In vitro studies: Studies in human liver microsomes showed that vardenafil is metabolized primarily by cytochrome P450 (CYP) isoforms 3A4/5, and to a lesser degree by CYP 2C9. Therefore, inhibitors of these enzymes are expected to reduce vardenafil clearance (see WARNINGS and DOSAGE AND ADMINISTRATION).

In vivo studies: Cytochrome P450 Inhibitors

Cimetidine (400 mg b.i.d.) had no effect on vardenafil bioavailability (AUC) and maximum concentration (Cmax) of vardenafil when co-administered with 20 mg LEVITRA in healthy volunteers. Erythromycin (500 mg t.i.d) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax when co-administered with LEVITRA 5 mg in healthy volunteers (see DOSAGE AND ADMINISTRATION). It is recommended not to exceed a single 5 mg dose of LEVITRA in a 24-hour period when used in combination with erythromycin.

Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in Cmax when co-administered with LEVITRA (5 mg) in healthy volunteers. A 5-mg LEVITRA dose should not be exceeded when used in combination with 200 mg once daily ketoconazole. Since higher doses of ketoconazole (400 mg daily) may result in higher increases in Cmax and AUC, a single 2.5 mg dose of LEVITRA should not be exceeded in a 24-hour period when used in combination with ketoconazole 400 mg daily (see WARNINGS and DOSAGE AND ADMINISTRATION).

HIV Protease Inhibitors:

Indinavir (800 mg t.i.d.) co-administered with LEVITRA 10 mg resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in vardenafil Cmax and a 2-fold increase in vardenafil half-life. It is recommended not to exceed a single 2.5 mg LEVITRA dose in a 24-hour period when used in combination with indinavir (see WARNINGS and DOSAGE AND ADMINISTRATION).

Ritonavir (600 mg b.i.d.) co-administered with LEVITRA 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13-fold increase in vardenafil Cmax. The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9. Ritonavir significantly prolonged the half-life of vardenafil to 26 hours. Consequently, it is recommended not to exceed a single 2.5 mg LEVITRA dose in a 72-hour period when used in combination with ritonavir (see WARNINGS and DOSAGE AND ADMINISTRATION).

Other Drug Interactions: No pharmacokinetic interactions were observed between vardenafil and the following drugs: glyburide, warfarin, digoxin, Maalox, and ranitidine. In the warfarin study, vardenafil had no effect on the prothrombin time or other pharmacodynamic parameters.

Effects of LEVITRA on other drugs

In vitro studies:

Vardenafil and its metabolites had no effect on CYP1A2, 2A6, and 2E1 (Ki > 100μM). Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing. The most potent inhibitory activity was observed for vardenafil metabolite M1, which had a Ki of 1.4 μM) toward CYP3A4, which is about 20 times higher than the M1 Cmax values after an 80 mg LEVITRA dose.

In vivo studies:

Nitrates: The blood pressure lowering effects of sublingual nitrates (0.4 mg) taken 1 and 4 hours after vardenafil and increases in heart rate when taken at 1, 4 and 8 hours were potentiated by a 20 mg dose of LEVITRA in healthy middle-aged subjects. These effects were not observed when LEVITRA 20 mg was taken 24 hours before the NTG. Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of LEVITRA and nitrates is contraindicated (see CLINICAL PHARMACOLOGY, Pharmacodynamics, Effects on Blood Pressure and Heart Rate When LEVITRA is Combined with Nitrates; CONTRAINDICATIONS).

Nifedipine: Vardenafil 20 mg, when co-administered with slow-release nifedipine 30 mg or 60 mg once daily, did not affect the relative bioavailability (AUC) or maximum concentration (Cmax) of nifedipine, a drug that is metabolized via CYP3A4. Nifedipine did not alter the plasma levels of LEVITRA when taken in combination. In these patients whose hypertension was controlled with nifedipine, LEVITRA 20 mg produced mean additional supine systolic/diastolic blood pressure reductions of 6/5 mm Hg compared to placebo.

Alpha-blockers:

Blood pressure effects in patients on stable alpha-blocker treatment: Two clinical pharmacology studies were conducted in patients with benign prostatic hyperplasia (BPH) on stable-dose alpha-blocker treatment for at least four weeks.

Study 1: This study was designed to evaluate the effect of 5 mg vardenafil compared to placebo when administered to BPH patients on chronic alpha-blocker therapy in two separate cohorts: tamsulosin 0.4 mg daily (cohort 1, n=21) and terazosin 5 or 10 mg daily (cohort 2, n=21). The design was a randomized, double blind, cross-over study with four treatments: vardenafil 5 mg or placebo administered simultaneously with the alpha-blocker and vardenafil 5 mg or placebo administered 6 hours after the alpha-blocker. Blood pressure and pulse were evaluated over the 6-hour interval after vardenafil dosing. For BP results see Table 2. One patient after simultaneous treatment with 5 mg vardenafil and 10 mg terazosin exhibited symptomatic hypotension with standing blood pressure of 80/60 mmHg occurring one hour after administration and subsequent mild dizziness and moderate lightheadedness lasting for 6 hours. For vardenafil and placebo, five and two patients, respectively, experienced a decrease in standing systolic blood pressure (SBP) of >30 mmHg following simultaneous administration of terazosin. Hypotension was not observed when vardenafil 5 mg and terazosin were administered 6 hours apart. Following simultaneous administration of vardenafil 5 mg and tamsulosin, two patients had a standing SBP of 30 mmHg. When tamsulosin and vardenafil 5 mg were separated by 6 hours, two patients had a standing SBP 30 mmHg. There were no severe adverse events related to hypotension reported during the study. There were no cases of syncope.

Table 2: Mean (95% C.I.) maximal change from baseline in systolic blood pressure (mmH following vardenafil 5 mg in BPH patients on stable alpha-blocker therapy (Study 1)

Alpha-Blocker		Simultaneous dosing of Vardenafil 5 mg and Alpha-Blocker, Placebo-Subtracted	Dosing of Vardenafil 5 mg and Alpha-Blocker Separated by 6 Hours, Placebo-Subtracted
Terazosin 5 or 10 mg daily	Standing SBP	-3 (-6.7, 0.1)	-4 (-7.4, -0.5)
	Supine SBP	-4 (-6.7, -0.5)	-4 (-7.1, -0.7)
Tamsulosin 0.4 mg daily	Standing SBP	-6 (-9.9, -2.1)	-4 (-8.3, -0.5)
	Supine SBP	-4 (-7.0, -0.8)	-5 (-7.9, -1.7)

Study 2: This study was designed to evaluate the effect of 10 mg vardenafil (stage 1) and 20 mg vardenafil (stage 2) compared to placebo, when administered to a single cohort of BPH patients (n=23) on stable therapy with tamsulosin 0.4 mg or 0.8 mg daily for at least four weeks. The design was a randomized, double blind, two-period cross-over study. Vardenafil or placebo was given simultaneously with tamsulosin. Blood pressure and pulse were evaluated over the 6-hour interval after vardenafil dosing. For BP results see Table 3. One patient experienced a decrease from baseline in standing SBP of >30 mmHg following vardenafil 10 mg. There were no other instances of outlier blood pressure values (standing SBP 30 mmHg). Three patients reported dizziness following vardenafil 20 mg. There were no cases of syncope.

Table 3: Mean (95% C.I.) maximal change from baseline in systolic blood pressure (mmHg) following vardenafil 10 and 20 mg in BPH patients on stable alpha-blocker therapy with tamsulosin 0.4 or 0.8 mg daily (Study 2)

	Vardenafil 10 mg Placebo-subtracted	Vardenafil 20 mg Placebo-subtracted
Standing SBP	-4 (-6.8, -0.3)	-4 (-6.8, -1.4)
Supine SBP	-5 (-8.2, -0.8)	-4 (-6.3, -1.8)

Concomitant treatment with vardenafil and alpha-blockers should be initiated only if the patient is stable on his alpha-blocker therapy. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at the lowest recommended starting dose (see DOSAGE and ADMINISTRATION).

Blood pressure effects in normotensive men after forced titration with alpha-blockers:

Two randomized, double blind, placebo-controlled clinical pharmacology studies with healthy normotensive volunteers (age range, 45-74 years) were performed after forced titration of the alphablocker terazosin to 10 mg daily over 14 days (n=29), and after initiation of tamsulosin 0.4 mg daily for five days (n=24). There were no severe adverse events related to hypotension in either study. Symptoms of hypotension were a cause for withdrawal in 2 subjects receiving terazosin and in 4 subjects receiving tamsulosin. Instances of outlier blood pressure values (defined as standing SBP 30 mmHg) were observed in 9/24 subjects receiving tamsulosin and 19/29 receiving terazosin. The incidence of subjects with standing SBP <85 mmHg given vardenafil and terazosin to achieve simultaneous Tmax led to early termination of that arm of the study. In most (7/8) of these subjects, instances of standing SBP <85 mmHg were not associated with symptoms. Among subjects treated with terazosin, outlier values were observed more frequently when vardenafil and terazosin were given to achieve simultaneous Tmax than when dosing was administered to separate Tmax by 6 hours. There were 3 cases of dizziness observed with concomitant administration of terazosin and vardenafil. Seven subjects experienced dizziness mainly occurring with simultaneous Tmax administration of tamsulosin. There were no cases of syncope.

Table 4. Mean (95% C.I.) maximal change in baseline in systolic blood pressure (mmHg) following vardenafil 10 and 20 mg in healthy volunteers on daily alpha-blocker therapy

		Dosing of Vardenafil and Alpha-Blocker Separated by 6 Hours		Simultaneous dosing of Vardenafil and Alpha-Blocker
Alphablocker		Vardenafil 10 mg Placebo- Subtracted	Vardenafil 20 mg Placebo- Subtracted	Vardenafil 10 mg Placebo- Subtracted	Vardenafil 20 mg Placebo- Subtracted
Terazosin 10 mg daily	Standing SBP	-7 (-10, -3)	-11 (-14, -7)	-23 (-31, 16)*	-14 (-33, 11)*
	Supine SBP	-5 (-8, -2)	-7 (-11, -4)	-7 (-25, 19)*	-7 (-31, 22)*
Tamsulosi n 0.4 mg daily	Standing SBP	-4 (-8, -1)	-8 (-11, -4)	-8 (-14, -2)	-8 (-14, -1)
	Supine SBP	-4 (-8, 0)	-7 (-11, -3)	-5 (-9, -2)	-3 (-7, 0)

* Due to the sample size, confidence intervals may not be an accurate measure for these data. These values represent the range for the difference.

Figure 6: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg, vardenafil 20 mg or placebo with terazosin (10 mg) in healthy volunteers

Figure 7: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg, vardenafil 20 mg or placebo with tamsulosin (0.4 mg) in healthy volunteers

Ritonavir and Indinavir: Upon concomitant administration of 5 mg of LEVITRA with 600 mg BID ritonavir, the Cmax and AUC of ritonavir were reduced by approximately 20%. Upon administration of 10 mg of LEVITRA with 800 mg TID indinavir , the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively.

Alcohol: Alcohol (0.5 g/kg body weight: approximately 40 mL of absolute alcohol in a 70 kg person) and vardenafil plasma levels were not altered when dosed simultaneously. LEVITRA (20 mg) did not potentiate the hypotensive effects of alcohol during the 4-hour observation period in healthy volunteers when administered with alcohol (0.5 g/kg body weight).

Aspirin: LEVITRA (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets).

Other interactions: LEVITRA had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400- and 170- fold for male and female rats, respectively, and 21- and 37-fold for male and female mice, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 20 mg. Vardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V79 cells. Vardenafil was not clastogenic as assessed in either the in vitro chromosomal aberration test or the in vivo mouse micronucleus test. Vardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in male, and for 14 days prior to mating and through day 7 of gestation in females. In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg.

There was no effect on sperm motility or morphology after single 20 mg oral doses of vardenafil in healthy volunteers.

Pregnancy, Nursing Mothers and Pediatric Use

LEVITRA is not indicated for use in women, newborns, or children. Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma. Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours. It is not known if vardenafil is excreted in human breast milk.

Pregnancy Category B: No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the MRHD of 20 mg. In the rat pre-and postnatal development study, the NOAEL (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day. Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk. The number of living pups born to rats exposed pre- and postnatally was reduced at 60 mg/kg/day. Based on the results of the pre- and postnatal study, the developmental NOAEL is less than 1 mg/kg/day. Based on plasma exposures in the rat developmental toxicity study, 1mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. There are no adequate and well-controlled trials of vardenafil in pregnant women.

Geriatric Use

Elderly males age 65 years and older have higher vardenafil plasma concentrations than younger males (18 - 45 years), mean Cmax and AUC were 34% and 52% higher, respectively (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations, and DOSAGE AND ADMINISTRATION). Phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of LEVITRA 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients. However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years in age.

ADVERSE REACTIONS

LEVITRA was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer, and 880 patients were treated for at least 1 year.

In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for LEVITRA compared to 1.1% for placebo.

When LEVITRA was taken as recommended in placebo-controlled clinical trials, the following adverse events were reported (see Table 2).

Table 5: Adverse Events Reported By ≥ 2% of Patients Treated with LEVITRA and More Frequent on Drug than Placebo in Fixed and Flexible Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil

Back pain was reported in 2.0% of patients treated with LEVITRA and 1.7% of patients on placebo.

Placebo-controlled trials suggested a dose effect in the incidence of some adverse events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA. The following section identifies additional, less frequent events (<2%) reported during the clinical development of LEVITRA. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug.

Body as a whole: anaphylactic reaction (including laryngeal edema), asthenia, face edema, pain

BODY AS A WHOLE: anaphylactic reaction (including laryngeal edema), asthenia, face edema, pain AUDITORY: tinnitus CARDIOVASCULAR: angina pectoris, chest pain, hypertension, hypotension, myocardial ischemia, myocardial infarction, palpitation, postural hypotension, syncope, tachycardia DIGESTIVE: abdominal pain, abnormal liver function tests, diarrhea, dry mouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux, GGTP increased, vomiting MUSCULOSKELETAL: arthralgia, back pain, myalgia, neck pain NERVOUS: hypertonia, hypesthesia, insomnia, paresthesia, somnolence, vertigo RESPIRATORY: dyspnea, epistaxis, pharyngitis SKIN AND APPENDAGES: photosensitivity reaction, pruritus, rash, sweating OPHTHALMOLOGIC: abnormal vision, blurred vision, chromatopsia, changes in color vision, conjunctivitis (increased redness of the eye), dim vision, eye pain, glaucoma, photophobia, watery eyes UROGENITAL: abnormal ejaculation, priapism (including prolonged or painful erections)

POST-MARKETING EXPERIENCE

Ophthalmologic

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including LEVITRA. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors (see PRECAUTIONS/Information for Patients).

Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in post-marketing experience. It is not possible to determine whether these events are related directly to the use of LEVITRA.

OVERDOSAGE

The maximum dose of LEVITRA for which human data are available is a single 120 mg dose administered to eight healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or "abnormal vision".

In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine.

DOSAGE AND ADMINISTRATION

For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. LEVITRA can be taken with or without food. Sexual stimulation is required for response to treatment.

Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age (See CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations and PRECAUTIONS).

Hepatic Impairment: For patients with mild hepatic impairment (Child- Pugh A), no dose adjustment of LEVITRA is required. Vardenafil clearance is reduced in patients with moderate hepatic impairment (Child-Pugh B), and a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. LEVITRA has not been evaluated in patients with severe hepatic impairment (Child-Pugh C) (see CLINICAL PHARMACOLOGY, Metabolism and Excretion, WARNINGS and PRECAUTIONS).

Renal Impairment: For patients with mild (CLcr = 50-80 ml/min), moderate (CLcr = 30-50 ml/min), or severe (CLcr <30 ml/min) renal impairment, no dose adjustment is required. LEVITRA has not been evaluated in patients on renal dialysis (see CLINICAL PHARMACOLOGY, Metabolism and Excretion and PRECAUTIONS).

Concomitant Medications: The dosage of LEVITRA may require adjustment in patients receiving certain CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, and erythromycin) (see WARNINGS, PRECAUTIONS, Drug Interactions). For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period. For indinavir, ketoconazole 400 mg daily, and itraconazole 400 mg daily, a single dose of 2.5 mg LEVITRA should not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period. For alpha-blockers, caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with alpha-blockers because of the potential for an additive effect on blood pressure. In some patients, concomitant use of these two drug classes can lower blood pressure significantly (see PRECAUTIONS, Alpha-blockers and Drug Interactions) leading to symptomatic hypotension (e.g., fainting). Concomitant treatment should be initiated only if the patient is stable on his alpha blocker therapy. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors - see Drug Interactions).

HOW SUPPLIED

LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed "BAYER" cross on one side and "2.5", "5", "10", and "20" on the other side equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively.

Package	Strength	NDC Code
Bottles of 30	2.5 mg	0026-8710-69
	5 mg	0026-8720-69
	10 mg	0026-8730-69
	20 mg	0026-8740-69

Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature].

Bayer Pharmaceuticals Corporation 400 Morgan Lane West Haven, CT 06516 Made in Germany

LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation.

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Taking Responsibility For Your Life

I am reminded of the biblical quote around giving a man a fishing rod to catch his own fish, rather than feeding him a daily diet. Mental health issues are no different in this sense, than any other of the elements of life we must face. If we wish to have a chocolate bar, we must do a number of things to achieve that goal; such as walk to the shop, ensure we have enough money etc. Too often in my work, I meet people who have never taken responsibility for their lives, let alone their illness. Too often behavioural factors are blamed on mental health, as an excuse for not moving forward and making the most of life's abundance. We can liken this to many of the societal problems we see in our poorer areas. Lack of hope, self determination, living a preconceived idea of what is expected, rather than breaking free of the bounds that have taken us to this stage in life.

Mental illness is not a reason to roll over and rely on others who have no vested interest in our recovery. It is a valid reason to take charge and make the most of what we have. Our strengths in being able to survive are phenomenal, and give us a greater advantage, I feel, over the general population. How can you gain insight and strength if you have never been challenged in the ways that we have in our personal development? In this I can only look to my own personal development over the years; and the steps I have had to take to achieve a level of wellness that has allowed me to participate fully in life.

For me, hope was an issue that had to be addressed in order to consider moving on to the other steps of recovery. I had to accept my life was not over, that I was not baggage that could be disposed of in a corner and forgotten by society. I spent my life till 35 years with no label and no understanding that I had a mental illness (even though as a teenager I had been institutionalised for a period). I had lived my whole life with feelings of depression and suicidation. In not understanding what was wrong, I battled on and continued to suffer, striving constantly to be able to achieve the goals I knew I should be able to. When I hit a particularly bad low and was told I was suffering depression I felt like I had been released. With the knowledge that there was a legitimate reason for my feelings, I was able to actually begin to grow. For me, a label was a positive experience in that it allowed me to make sense of my life.

Slowly, I began to find out as much as I could about my illness and the rapid cycling nature of it. This knowledge was the basis that I could then re-build my self-esteem and life around. The more knowledge I gained, the more knowledge I realised I needed to know. I questioned my doctor, my community psychiatric nurse, other service users my friends I searched the Internet. It was from these varied sources I began to understand more about what was normal to feel and what was illness. I looked at the behavioural triggers and undertook counselling to remove as many as I could. If I realised I was reacting due to a past event from my childhood I acknowledged it and re-evaluated from my adult. I maintained a mood chart, studied the medications I was on, the side effects, combinations and expected outcomes. It took ten years to get my medication right, and I was the one in the end who suggested the combination that has proved to work.

Luckily I had a very good doctor who treated me as a peer and respected my input. This is not to say I always had such professional input. I have seen many doctors with varying results, some good some bad. But the knowledge and the will to live a full life made me question the opinions of the professionals. If I was not satisfied with the treatment or their response to me I took another. I had to be strong in advocating for my needs to be met. I could not sit back and allow others to decide what was in my best interest. This of course did not happen overnight. It has taken many years to reach the level I am at now. Especially learning to question the medical professions choices and rational.

I am well now and working full time because I have done the hard yards. Have taken responsibility for my life and my recovery (ability to live well in the presence or absence of mental illness). Created a supportive network of friends I can call if I need to. Though I must admit I still tend to isolate more than I should. Where hope was once an impossible dream, a term I never really believed in or accepted for my life. I am now living my life the way I want to. Achieving the goals I set for myself, participating in the way I wish to in life. Hope is now a term belonging to the past; I no longer need to hope as I have achieved that goal. I have the self-esteem I once lacked. I no longer try to hide my illness from others in fear of rejection, or feel that I am inferior to others. I control my life with the support of professionals and friends. I, like all who recover (be it mental illness or alcoholism etc), have learnt that the only thing that will make a difference is self-determination, the willingness to take full responsibility for my life.

next: Join a Support Group!
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~ depression library articles
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As a recovering co-dependent, I want to maintain a healthy sense of adult responsibility for my choices—including my decision to recover and solve my problems in a healthy way.

Here are some examples of irresponsible recovery (some from personal experience):

• Abusing recovery slogans and principles. For instance, interpreting and misapplying "Let Go and Let God" in a fatalistic sense. Suppose I need to find a job. Instead of pounding the pavement, networking, circulating my resume, etc., I sit on my couch in front of the TV all day, waiting for God to supply me with a job.
• Using the principle of detachment as an excuse for abandoning my spouse and children. "I just couldn't take another day in that situation, so I had to detach."
• Using recovery as a means of getting my needs met.
• Going to recovery meetings and so dominating the sharing time that no one else gets time to speak. Or, rather than exploring my own issues and finding my own solutions, I talk exclusively about my abusive spouse, whine about the unfairness of life in general, or give unsolicited, subtle, or insensitive advice to others. Or, I only attend meetings because I think it will help someone else.
• Transferring my addiction to recovery from drugs, alcohol, work, sex, religion, credit cards, pornography, or people. Using recovery to escape from my feelings or to deny responsibility for the problems in my life or in my relationships.
• Going through the motions of recovery only as a social outlet.
• Going to six meetings a week and neglecting my children or spouse. Spending excessively on recovery books and workshops. Becoming emotionally unavailable because I am focused on "working my program."
• Abusing the group phone list by extending my telephone addiction to include group members. Using the phone list to solicit for a network marketing business. Using the phone list to find someone to date.
• Expecting my sponsor to wallow in self-pity with me. Calling my sponsor once every hour because I'm having a "really bad day."
• Spending excessive and inordinate amounts of time surfing the web for recovery sites and/or topics, IRC chats, building a recovery web site, running a recovery mailing list, or writing about recovery topics.
• Ignoring the Twelve Steps.

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Responsible recovery is:

• A conscious choice to love myself, practice healthy self-esteem, and be a source of support for others as I work through my feelings, solve my problems, and explore my core issues.
• Taking my own personal moral inventory, holding myself accountable for my time, my actions, and my motives.
• Making the decision to change what I can about myself, and attaining a sustained measure of serenity.
• Maintaining a proper balance between my other life activities and working my recovery program.
• Building clean, healthy relationships based on principles of good communication, being emotionally available, and creating a safe atmosphere of acceptance, compassion, support, nurturing, and love.
• An adult process of learning to recognize and practice healthy self-love, self-growth, self-discovery, and self-acceptance.

Responsible recovery is not about "getting" or "taking." It is about learning to supply my own needs; learning how to give—primarily to myself first. Then, from the abundance of my healthy self-love and self-esteem, I can give the unconditional gifts of nurturing, support, acceptance, and clean communication to others.

next: Self-Love

Specialized Affirmation Cards Boost Self Esteem

Eating disorders and low self-esteem are on the rise in girls. Super-thin models and ads focusing on appearance negatively affect girls' self-image, as does sexual abuse. It's important to boost girls' self esteem and positive body image; Love Yourself affirmation cards help do this.

Girls, more than ever before, are struggling with distorted body images, low self-esteem, and eating disorders. The average girl views 400 to 600 ads per day (that's 250,000 ads by the time she's 17), with many of those ads featuring models who weigh 23% less than the average woman. It's no wonder that the number one wish for girls ages 11 to 17 is to be thinner. Many girls buy into the beauty myth, believing that in order to be liked or be attractive they must be thin. And when you consider how many girls also experience sexual abuse - 1 out of every 3 girls before the age of 18 - it's easy to see why so many girls hate their bodies and struggle with eating disorders and low self-esteem, and why it's so important to help girls love themselves for who they are.

Incest survivor Cheryl Rainfield knows how important loving yourself can be. Rainfield says, "I struggled with self-hate, low self-esteem, and body issues all my life. It's only when I started to treat myself with compassion that I could begin to love myself. Rainfield created Love Yourself affirmation cards to offer girls and women positive messages. "I drew the cards to help counteract some of the negative messages so many of us hear and see, Rainfield says. "Each of us deserves to be loved, and to love ourselves - yet that can be so hard to do."

Positive messages, especially when repeated, can help build self-esteem and challenge negative self-image. Rainfield's cards show girls and women of many shapes, sizes, races, and ages, and encourage the reader to see their inner beauty, to love and accept their bodies, and to love themselves.

"The cards are terrific! Pamela Verona says, from Eating Disorders Online. "I believe any parent with a young daughter (or son) should have these. I now have a one-year-old daughter and making sure she grows up with a healthy body image and self esteem is very important. I will show these cards to her as she grows.

Love Yourself cards are especially appropriate this month, as February 27 through March 5 is National Eating Disorder Awareness Week, and February is International Boost Self-Esteem Month. However, the messages of these cards are needed all-year round.

Rainfield says, "There are very few images and messages that reflect the true diversity of girls and women. It's time we had positive messages and images about ourselves."

next: Eating Disorders: Common in Young Girls
~ eating disorders library
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Dear Stanton:

Why can't people just stop using drugs, and should addicts be maintained on drugs?

Maureen

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A big distinction, obviously, is between controlled and addicted use. It's oversimplified, but obviously why people don't give up occasional or moderate drug use is a non sequitor — why would they want to? In one case at my site, a man who was formerly addicted worked to resume moderate substance use, which he finds a great and desirable pleasure in life.

In a number of places, I answer the question that people give up drugs when they have something reliable with which to provide replacement (and superior) rewards. Check my review of the book, "The Steel Drug."

I will return to the methadone question. People do give up opiates all the time, but some don't and some take a while. So (harm reduction goes), let's allow them to lead a life in the meantime. Isn't that a modern, humane, medical approach?

Best,
Stanton

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Dear Stanton,

The question, "Why can't people just give up?" has still got me confused. As you said, some people give up, some don't and some take a while. Methadone is a fine compromise for those who take a while. Is methadone treatment part of "therapy impeding the cure" (that you speak of) which makes giving up opiates harder by taking away the dependant person's sense of power and self control? Or does methadone allow for periods of "time out" from the hassles of heroin use until the person reaches the appropriate time for them to give up all opiates completely?

It would be ideal to have a methadone program which allowed you to drop in and out of treatment and didn't punish you for using heroin when you wanted to. Hassle-free heroin use!

bye for now,
Maureen

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Dear Maureen

I can't add much to your excellent summary, other than to add something to the question of, "Why don't people just stop using drugs?" It's the same as asking, "If addiction isn't a disease, then what continues to propel the addict in using drugs?"

My answer is that not much off an explanation is needed for why people do more or less the same things over time. When you wake up in the morning, and think of your day, you think of yesterday. Familiarity and habit dominate. It's the human condition.

Meanwhile, I talk below with a woman who wants to continue here addiction without hassle, raising some of the same pros and cons you do about maintenance.

Best,
Stanton

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Dear Stanton:

First, I would like to thank you and your staff for this informative and enlightening website. I found it through DRCnet while doing research for my problem.

I am a recovering addict (drug of choice was prescription opiates, barbiturates). I have been clean of these drugs for three years now. However, I continue to have problems for which my questions will be forthcoming.

First, I need to give you some background on my particular situation. I suffered from endometriosis as a very young teenager and was finally given narcotics for the pain in my early twenties. My doctor apparently did not realize the severity of the situation, but continued to prescribe the drug (phenaphin #3) for over six years to me before he finally did a laproscopy and found the reason for my pain. This was in 1986 and I finally had a complete hysterectomy in 1987. I was free of narcotics for the next four years until I developed migraines for which I sought help from a neurologist. He put me on several drugs (elavil, fioricet, fiorinal). It was finally discovered that I had a severe hormone imbalance and was suffering from rebound headaches due to the drugs I was taking.

That's when the addiction, in my opinion, finally took hold of my life. I had always enjoyed the tingling sensation of well-being that the drugs produced as an asset second to the primary reason of pain relief. But now I missed that feeling and wanted to maintain it daily, if possible. In addition, I had another pain problem from consecutive herpes outbreaks, which had been diagnosed in 1981. Now, I've learned the nerves have been permanently damaged as a result of all the outbreaks I've had over a 17 year period. To conclude, the addiction progressed from 1992 to the end of 1995 when I finally went in for treatment after a 48 hour blackout. I got off the drugs, but the other problems persisted. A couple of months later I was prescribed Ultram for pain, supposedly because it was not a narcotic and non-addictive. Then in 1997 a warning by the FDA came out that said Tramadol did have the potential for abuse. To be perfectly honest with you, I was already aware of this because I was having problems with it by that time myself. I wasn't abusing heavily, but was taking the maximum daily dose of 400 mg. daily. This dose achieved the level of pain relief I needed.

---

I realize now after reading your website extensively that my environment, lack of self-worth and interaction with people have all contributed to my being an addict. I was always a good girl growing up. I stayed away from drugs in the 70's and did what I thought was expected of me, but when the doctors gave me the narcotics a sleeping demon awakened, and frankly it hasn't gone back to sleep since. I am presently off the Ultram, but still my pain from herpes persists. Also, I am currently being treated by an addictionologist. She has prescribed Serzone for depression and neurontin for the herpes pain and headaches that I still get occasionally.

Finally, for my questions. Do you think or believe it's possible that now after all that my addiction has taken me through that my body might never recover fully to the way it was before I started taking narcotics, and would it not be beneficial or at least more humane to give the body what it craves in regulated doses? I actually feel better with a certain amount of narcotics in my system. My brain seems to function better, I'm more centered and motivated, I'm not in pain. I know this is done with people withdrawing from heroin or other drugs. But what about *just* maintenance? Wouldn't it be more humane for the addict in the long run? In other words just give them what they crave and let it go. I know, I'm asking for a license to use. But several of the articles I've read here says that drug abuse is a disease for which relapse is more probable than curable. And please believe me I've tried everything from Narcotics Anonymous to religion to therapy. My life is not perfect, but I'm not shopping for doctors, walking the streets for dealers or robbing drug stores for drugs.

I would like to be the person I was before a drug was ever put into my body, but that's not my reality today. I want to be free of pain and feel good about myself, but I don't know where else to turn. I am seeking answers though, and by the grace of God I hope I find one one day.

I appreciate your reading and listening to my story.

Lynn

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Dear Lynn:

I have mixed feelings about your plans, as many people do.

But first, before considering whether you should be maintained on opiates, we should acknowledge that you are currently being maintained on psychoactive drugs by your addictionologist! These seem to be antidepressants, but also an analgesic? Of course, this is true for many people in the United States and elsewhere who do not even think they are being maintained on drugs. (According to the N.Y. Times Business Section on October 11, 1998, "Sales of antidepressants. . . are expected to reach $8 billion in the United States at about the time Lily loses its exclusive rights to Prozac [@2001]."

Second, I would like to point out that at this late date, pharmacology confidently prescribes painkillers said to be nonaddictive, but which people who use analgesics for addictive purposes continue to become addicted to. This is because they imagine that addiction occurs in relation to a specific chemical structure of a given drug, when in fact it is the analgesic experience itself to which they are addicted.

Third, I am sorry to see you feel you have little choice but to be addicted. That is, I am constitutionally against people deciding that (a) they were born addicted, (b) they were habituated to being addicted (both of which you seem to say about yourself). It is for this reason that, when I wrote Love and Addiction and for some time thereafter, I opposed methadone maintenance. One of the main things I still cringe at is the way those who support methadone, from Dole and Nyswander on, have reacted to the discovery that most of those they released from methadone relapsed by agreeing with the disease concept that people are born/made into lifelong, irreversible addicts.

But, perhaps as I have aged, I do agree that not every addiction is remediable, and certainly not in the short run. Of course, the advent of harm reduction as a treatment policy has moved me in this direction. That is, accepting needle exchange because it saves people's lives while they are taking drugs they would be better of quitting altogether, has led me to accept that taking narcotics in a situation that is constructive for their overall lives (control of quality, avoidance of criminal underworld, reliable sources) is a better way to be addicted. (For me, the difference between methadone and heroin or other narcotic maintenance is insignificant. Incidentally, your explication of the value of narcotic maintenance is eloquent.)

Now, turning to your situation: whether you would do better to be maintained on narcotics. I can't say no. I believe you can find a comfortable range of narcotics use. I even believe that, after a period of maintenance, some percentage of the maintained feels like struggling free altogether from narcotics et al. I can only ask a series of questions: (a) Is this practically possible? (b) What will be the consequences for your work, your relationships, your free time? (c) That is, please be inclusive in calculating the costs and benefits to yourself (some of which you have done), so that you can both make an informed decision, and so that you can evaluate the impact of this course of action on your existence.

I am glad you could discuss this question with me. It is my view that many people who are seeing addictionologists (or psychiatrists) are unable to ask fundamental questions about their situation, and I welcome treating them at the same time that they see conventional therapists. Of course, you might simply propose the questions you ask me to them and compare the answers!

All best,
Stanton

next: Sex Addiction Destroyed My Life
~ all Stanton Peele articles
~ addictions library articles
~ all addictions articles

Our Focus Is On: Helping ADD Kids Become Winners

These pages provide information about Attention Deficit Hyperactivity Disorder - ADHD/ADD including diagnosis, treatment, classroom management, parent education, behavior modification, communication and family relationships. Here you will find comprehensive information, practical suggestions and useful materials for teaching and parenting children and teens with Attention Deficit Hyperactivity Disorder - ADD/ADHD.

Useful Information, Practical Solutions.

Attention Deficit Hyperactivity Disorder: What is ADD/ADHD, diagnosis, causes, long-term outlook, social problems, and much more information.

Learning Issues: What is a learning disability, dyslexia, overcoming visual - spatial problems, arithmetic disabilities, and more.

Treatments and Medications: Types of medications used for ADD/ADHD, Adderal, Cylert, Desoxyn, Dexedrine, Ritalin, psychological treatments, diet, brain research, supplements and more.

Parenting: Good parent-child communication, words of encouragement, building your child's self-esteem, behavior communication, and more.

Improving Your Child's Learning Ability: Improving: attention, concentration, reading skills, spelling, reading, math, vocabulary building, and much more.

Tips for Teachers: Classroom interventions, strategies and suggestions for specific behaviors and more.

ADD Focus Store: Books, tapes, games on ADHD, dyslexia, parent education, social & emotional development and more.

Resources: Resources and organization that offer a wide range of information and services related to children, adolescents and adults with ADD/ADHD.

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Table of Contents

• General Information on Attention Deficit Disorder
• 10 Years of Brain Imaging Research Shows the Brain Reads Sound by Sound
• About Learning Disabilities
• Attention Deficit Disorder ADD / ADHD Educational Material
• Treatments and Medications for Attention Deficit Disorder
• How to Parent Children with Attention Deficit Hyperactivity Disorder ADHD / ADD
• About Dyslexia and Reading Problems
• Dyslexia and Learning Disabilities Educational Material
• Educational Material to Improve Reading and Writing Skills
• Helping Your Child Overcome Spatial Problems
• Helping Your Child with Creative Writing Assignments
• Helping Your Child with Handwriting
• Reading Checkup Guide
• Tips for Teachers
• Parenting 101
• Handling Sibling Rivalry
• Establishing a Parent-Teacher Relationship
• About Dr. Robert Myers
• ADD - ADHD Bibliography
• The BAIR Filtering System
• Junior Phonics Has Children Reading As Early As Three Years Old
• Mathematics and Arithmetic Skill Building Educational Material
• ADD - ADHD Support Organizations
• Famous People with Attention Deficit and Learning Disorders
• Guidelines For Good Communication With Children
• Helping Children Overcome Reading Difficulties
• Helping Your Child At Home With The Neurological Impress Method of Reading
• Improving Reading For Children and Teens
• Parenting Skills and Parent Education Educational Material
• Phonics Information
• Social Problems Often Associated with Attention Deficit Disorder
• The Phonics Game
• The Use of Focus with Children and Young Teens with Attention Deficit Disorder Is Backed by Clinical Research and Professional Practice
• Tips for Helping Kids and Teens with Homework and Study Habits
• Treatments for Attention Deficit Disorder Overview

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next: General Information on Attention Deficit Disorder
~ adhd library articles
~ all add/adhd articles

Knowing how to dress an Alzheimer's patient with a minimum of fuss can greatly ease the caregiver's burden.

The way we dress says a lot about who we are. But as Alzheimer's progresses people increasingly need more help with dressing. As a caregiver, if you help the person with Alzheimer's to choose what they wear and retain their own individual style, you can help them to preserve their identity.

For most of us, dressing is a very personal and private activity - and one in which we are used to making our own decisions. It's important to enable people with Alzheimer's to make their own choices for as long as they can. If they do need assistance, be sure to offer it tactfully and sensitively. 

Make it fun

If you are helping someone with Alzheimer's to dress, allow plenty of time so that neither of you feels rushed. A person with Alzheimer's may take longer to process information than they used to, and this will affect their ability to make choices. If you can make dressing an enjoyable activity, they will feel more relaxed and confident.

• Try to use the time to chat about what you are doing and anything else that might be of interest.
• If the person resists your efforts to help, try leaving them for a while. They may be more amenable if you try again a little later.

There's plenty you can do to help the person retain some choice and their own personal style while making sure that they are clean, warm and comfortable. Here are some ideas.

Encourage independence

• Lay out clothes in the order the person will put them on. Sensitively remind them which garment comes next, or hand them the next item that they need.
• If they are confused, give instructions in very short steps, such as, 'Now put your arm through the sleeve.'
• If they get it wrong - for example, by putting something on the wrong way round - be tactful, or find a way for you both to laugh about it.
• Label drawers where particular items of clothing are kept, or store whole outfits together.

Keeping comfortable

When the person is getting dressed:

• Make sure that the room is warm enough.
• Try to encourage them to go to the toilet before getting dressed.
• Try to keep to the routine the person is used to - for example, they may prefer to put on all their underwear before putting on anything else.
• If they wear several layers of thin clothing rather than one thick layer, you can suggest removing a layer if it gets too warm.
• Remember that the person may no longer be able to tell you if they are too hot or cold, so keep an eye out for signs of discomfort.

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Giving the person choice

• Wherever possible, ask the person what they would like to put on. People with Alzheimer's need the dignity of having choice in what they wear, but too many options can be confusing. It's probably better to make suggestions one at a time.
• If they live on their own and have lots of clothes, select the ones that they're most likely to wear and put them in an accessible place. This will make it easier for the person to choose.

Buying clothes and Alzheimer's

• If you're buying clothes for the person with Alzheimer's, make every effort to take them with you, so that they can choose the style and the colors they prefer.
• Check their size. They may have lost or gained weight without you realizing it.
• Look for clothes that are machine washable and need little ironing. This will save you time.

Sources:

• NIH Senior Health, Caring for Someone with Alzheimer's, March 19, 2002.
• Alzheimer's Society - UK, Information Sheet 510, June 2005.

next: Alzheimer's Patient: Changing Clothe

• Still My Mind
• Wait in Peace
• The Reason
• Keep Dreaming
• Don't let go of your dreams
• The Believing Way
• It's gonna be alright.

For more of my song's lyrics, click here.

Lyrics: Still My Mind by Adrian Newington © 1991

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Commentary:

A song born out of a serene moment in meditation during a time of personal difficulties. These experiences can only serve to strengthen ones delicate and vulnerable faith through direct experience.

(Chorus)
Still, my mind. Still, my mind.

Verse:
Still my mind, from the troubles of the day,
as I come to you and pray,
take me far away.

Verse:
Still my mind, like a distant mountain haze,
like a quiet Autumn day,
bathed in golden rays.

Verse:
Still my mind, with the gentlest of sounds,
like soft Cathedral bells,
Saying all is well.

(Repeat Chorus)

Verse:
Still my mind, with a comfort I once new,
like a field in wild bloom,
blowing sweet perfume.

Verse:
Still my mind, in a way so that I,
like stars that walk the sky,
I will take my time.

Still My Mind
Still My Mind
Still My Mind

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Lyrics: Wait in Peace by Adrian Newington © 1991

• Listen and download by song for mp3 players
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Commentary:

One of the hardest lessons to learn is Patience, and patience coupled with Faith is even more demanding. Keep on being brave and courageous in the interim when God is working silently in your life. There will be a day when all things will come together and you will reap the fruit of His work. All God asks is to believe. Do the simple things that are yours to do; that is... "your duty", but let him do the really hard bit.

(Chorus)
Wait in peace, I'm coming soon.
Wait in love, my gifts you'll know.
Wait In hope, and don't let go.
Wait In peace, wait in peace for me.

Verse:
I see you trying, so very hard.
I see the Love, deep within your heart.
I know your Patience, is from your Love.
Believe I'm always with you.

(Repeat Chorus)

Verse:
Do not forget me, I'm here for you.
Just ask me gently, and stand by me.
I can move mountains, and peoples hearts.
To help you live once again.

(Repeat Chorus)

Lyrics: The Reason by Adrian Newington. © 2003

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Commentary:

There is a reason for everything in life, but we are only aware of miniscule amount of the purpose of heaven and earth. However, if we care to contemplate, it is possible to penetrate the layers of illusion which abound as part of existence on earth

Chorus:
The reason, the reason.

Verse:
The reason, you can breathe
The reason, your mind can see.
The reason, you can strive,
The reason, you're alive.

Repeat Chorus:

Verse:
The reason, you can open your heart
The reason, you can let in the love
The reason, you can believe,
The reason, you can find peace.

Bridge 1:
God is the reason, you can, live with a vision,
You can, create with a passion,
You can know what's right from wrong.
Your inspiration, is bound to all creation.
For the reason in our lives, is found in love.

Instrumental based on chorus

Bridge 2:
Don't be confused, by illusions of the world.
And see it all as separate; disconnected from your world.
'Cause what flows through me, also, flows through you,
For the reason in our lives, is found in love.

Instrumental based on chorus

Outro:
God is the reason.
God is the reason.
God is the reason.
God is the reason.
God is the reason.

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Lyrics: Keep Dreaming by Adrian Newington © 2003

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Commentary:

Whether it's something earthly or heavenly, the pursuit of a dream requires faith and persistence.

"No don't you ever... don't you hesitate!"

Have you found the little spark inside.
that shines a light on your dreams.
Its a light that opens up your mind.
Where nothings as big as it seems.

You can believe,
in things of heaven or earth.
But whatever you follow,
give it the faith it deserves.

Keep Dreaming, uphold your faith.
keep strivin' don't you hesitate.
Keep movin' true to the word.
keep faith in all that you've heard.
Keep believing, you're not alone.
I can guarantee you're not on your own.

Keep Dreaming, uphold your faith.
keep strivin' don't you hesitate.
no don't you ever... dont you hesitate.
keep strivin' don't you hesitate.

Keep Dreaming, uphold your faith.th.
Keep Dreaming, uphold your faith.
Keep Dreaming, uphold your faith.
Keep Dreaming, uphold your faith.

Lyrics: Don't let go of your dreams by Adrian Newington. © 1990

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This is the day,
the rest of your life will begin.
A new world of Love,
a new world of Peace to live in.
And the walls that you've built can come down.
And the Love in your heart can come out.

(Chorus)
Don't let go of your dreams.
Always believe, in the freedom they'll bring.
Don't let go of your dreams.
In your Love is your Life,
and your life has meaning and worth.

Quite and still,
this is the way you will learn.
There in your heart,
a Love to help you return.
From the many rods, you have crossed.
While searching for Love never lost.

(Chorus)
Don't let go of your dreams.
Always believe, in the freedom they'll bring.
Don't let go of your dreams.
In your Love is your Life,
and your life has meaning and worth.
So long you've been away,
trying to find your love.
So long you've been confused,
from daring to be,
what you thought you should be.

(Chorus)
Don't let go of your dreams.
Always believe, in the freedom they'll bring.
Don't let go of your dreams.
In your Love is your Life,
and your life has meaning and worth.

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The Believing Way by Adrian Newington. © 1990

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Commentary:

Composed by my Awakening to the value of Persistence of Faith in ones own abilities, and the Actions of Life which respond to those who maintain such attitudes.

Let me tell you 'bout a way to change your life.
That can make your dreams unfold before you eyes.
But you've got to break the link.
and change the way you think.
For there's a chain that binds,
and it'll drag you down each time.

First of all you've got to open up your heart.
And let go of feelings locked within your past.
Then a wonderful peace,
will come when you release,
and you start to see,
how your life can turn around.

(Chorus)
It's the believing way.
And it'll bring you happy days.
And it's a Giving way,
it's a Loving way
It's the believing way.
And you will come to understand.
That your destiny can change,
by your own hand.

Anything that you believe in can come true.
But your Patience and your Faith must see you through.
Keep your head up high.
Don't let the world deny,
all the things,
that you believe can come your way.

(Repeat Chorus)

back to the Lyrics Index

It's Gonna Be Alright by Adrian Newington. © 1990

• Listen and download by song for mp3 players
• Listen and download from itunes
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Commentary:

This song will always remind me of a profound Peace that descended upon me in a period of sorrow. In an touch, I was transported from sorrow to joy, and could not help but immediately respond to this new peace and joy by the expression through song. Within five or so minutes, I had the essence of the song, and the rest just followed very soon after.

A peaceful feeling came to me today.
What I needed most, to take my tears away.
In a touch the shadows deep inside,
made way for Love as tears subside,
by a voice that whispered gently to my heart.
And it said...

(Chorus)
It's gonna be alright.
Everything is gonna work out fine.
It's gonna be alright.
Everything is work out fine.
It's gonna be alright,
it's gonna be alright.

I never knew this peace could ever be.
To think it's always been inside of me.
There when I was most in need,
gentle thoughts would come to me.
To teach me how to listen to my heart.

(Repeat Chorus)

next: Getting Off the Rollercoaster Book and Music

Interview with Marlene Blaszczyk

Marlene Blaszczyk is the co-founder of "Motivating Moments," one of the most inspirational and respected sites on the internet. She's also a partner at "Majestic Systems."

Tammie: What inspired you to create, "Motivating Moments?"

Marlene: When we first opened our company: Majestic Systems, I brought my collection of books, tapes, posters -- everything I owned that dealt with motivation, inspiration, customer service and personal growth with me. My partners and I discussed starting a web page with motivational thoughts so we could keep ourselves pumped up, and also to share these words with our growing customer base. I have always walked my own path, defiant to conventional negative reinforcement, and have tried to live my life looking for the good in people and reinforcing the positive behaviors I wanted to see more of.

Tammie: Who would you consider to have been your most influential role models, and what struck you most about them?

Marlene: Two people come to mind right off the bat, my father, Stan and my childhood neighbor Larry McGovern. My dad was a complex, interesting man. An entrepreneur who was very outgoing, fearless, generous and loving to his friends and family, although controlling and judgmental.

My neighbor Larry was his opposite. He had similar qualities, but expressed them in a positive way, not needing to control, but open and loving to me whenever I needed someone to help me make sense of my dad's sometimes confusing behavior.

The best example I can think of was when I was 16, and just got my green paper license. My parents had gone to our cottages, I had our station wagon and decided to take one of my friends up to McDonalds about 6 blocks away. We got there safely, but upon leaving, I turned too quickly out of the drive on wet pavement and ended up smashing the car into a pole.

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Luckily we weren't hurt, but I can't say that the car was unscathed. My parents didn't have a phone at the lake and wouldn't be home for hours. I was panicking, knowing my dad would kill me when he found out. I called Larry, he rushed over, made sure I was okay first, then proceeded to get the car towed to our house. He knew how my dad would react, so when they got back, he bravely went with me to explain what happened.

My dad reacted as I thought he would first demanding to know what happened to the car, not even asking if I was okay - he was ticked. But you know what, I wasn't sure I was going to drive again in the rain, but my dad looked me straight in the eye and said " we are going out together, and you will drive in the rain, because if you don't confront this fear now, you will regret it for the rest of your life. And so we did, that was his way of showing love and trust in me and I will always be grateful for his insistence.

Tammie: What makes you the most hopeful about the future?

Marlene: The goodness and optimism in the people I met and the people I converse with through email, especially the teens.

Tammie: If your life is your message, what do you think the message of your life might be?

Marlene: That I never tried to intentionally hurt anybody.

Tammie: What offers you the most inspiration?

Marlene: When someone emails me and shares a bit of their life with me, and how our website has helped them. It is probably the most inspiring and humbling experience I have at the same time.

Tammie: What would you consider your greatest lessons to have been?

Marlene: That you can only control yourself and not other people.

That change is hard even when you want it.

Nothing lasts forever.

Letting go is painful.

I can survive anything.

Expectations are hidden words and no one can read your mind.

Being effective is sometimes better than being right.

I can ask for help, I don't have t do it all by myself.

If you expect the best out of people you usually get it.

There are a lot of people on my side.

Laughter makes your life easier.

Don't take yourself too seriously.

Love yourself, love others, be willing to give 110%.

Be thankful for what you have.

next:Joel Metzger from the Online Noetic Network