Label: VARDENAFIL tablet, orally disintegrating

placebo: 433±109 and 426±105 seconds, respectively; 20 mg vardenafil vs. placebo: 414±114 and 411±124 seconds, respectively). The total time to 1 mm or greater ST-segment depression was similar to placebo in both the 10 mg and the 20 mg vardenafil groups (10 mg LEVITRA vs.

• Vardenafil 10 mg is a popular choice for ED treatment.
• Dose can be adjusted by a healthcare provider.
• Avoid using vardenafil with recreational drugs like poppers.
• Do not use after consuming large amounts of alcohol.
• The pill is generally taken before planned intercourse.
• Its effects are dose-dependent and subject to individual variation.
• Adherence to prescribed dose helps prevent adverse effects.
• The medication can be used long-term if prescribed.
• Regular checkups can help monitor effectiveness and safety.
• Never double the dose if the first does not work immediately.

placebo: 380±108 and 334±108 seconds; 20 mg vardenafil vs. placebo: 364±101 and 366±105 seconds, respectively).

• Vardenafil 10 mg may be used by men over 18 years.
• The medication is not approved for use in women or children.
• May be contraindicated in patients with certain eye conditions.
• Use caution if you have a history of stroke.
• The drug’s chemical action involves improving blood flow.
• It is important to distinguish ED causes before treatment.
• Use only medications prescribed by a healthcare professional.
• Avoid combining with other erectile dysfunction medications.
• Keep medication out of sunlight and moisture.
• Seek emergency medical help for severe side effects.

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.

16.1 How Supplied

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 vardenafil (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 vardenafil (5 mg) and 600 mg BID of ritonavir. In this study, the mean increase in heart rate associated with a 10 mg dose of vardenafil compared to placebo was 5 beats/minute and with an 80 mg dose the mean increase was 6 beats/minute. The clinical impact of these QTc changes is unknown. In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg vardenafil resulted in a placebo-subtracted mean change from baseline of QTcF (Fridericia correction) of 5 msec (90% CI: 2,8).

Other Interactions

When vardenafil 10 mg and gatifloxacin 400 mg were co-administered, the mean QTcF change from baseline was additive when compared to either drug alone and produced a mean QTcF change of 9 msec from baseline (90% CI: 6,11). The clinical impact of these QT changes is unknown. 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 myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (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 vardenafil did not alter the total treadmill exercise time compared to placebo (10 mg vardenafil vs. In a single dose study in 25 normal males, vardenafil 40 mg, twice the maximum daily recommended dose, did not alter visual acuity, intraocular pressure, fundoscopic and slit lamp findings.

In another double blind, placebo controlled clinical trial, at least 15 doses of 20 mg vardenafil were administered over 8 weeks versus placebo to 52 males.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

10 mg as needed, 60 minutes prior to sexual activity Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability For patients taking potent or moderate inhibitors of CYP3A4, dose adjustment is as follows: Ritonavir: no more than 2.5 mg in a 72-hour period Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: no more than 2.5 mg in a 24-hour period Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: no more than 5 mg in a 24-hour period. Cardiovascular effects - patients should not use Vardenafil if sex is inadvisable due to cardiovascular status. Risk of priapism - in the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance Effects on the eye - patients should stop treatment and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be sign of nonarteritic anterior ischemic optic neuropathy (NAION). Use with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowed" optic disc may also be at an increased risk of NAION.

Consumer Information Use and Disclaimer

Sudden hearing loss - patients should stop treatment and seek medical attention in the event of sudden decrease or loss in hearing Alpha-blockers - caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting) QT prolongation - patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using Vardenafil Other erectile dysfunction therapies - the safety and efficacy of vardenafil used in combination with other treatments for ED have not been studied. Signs and symptoms may include reversible back pain/myalgia and/or "abnormal vision." Standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine. Pregnancy: Pregnancy Category B; not indicated for use in women. Absorption: Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Distribution: The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. Metabolism: Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. Elimination: 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.

4.1 Nitrates

Nursing Mothers: Not indicated for use in women. Renal Impairment: Do not use in patients on renal dialysis; no dosage adjustment necessary in patients with ClCr 30-80 mL/min. Hepatic Impairment: Do not use in patients with severe impairment (Child-Pugh C); dosage adjustment is necessary in patients with moderate impairment. Pediatric Patients: Not indicated for use in pediatric patients; safety and efficacy have not been established in this population. Geriatric Patients: No differences in safety and effectiveness noted between elderly (≥65 years of age) and younger patients.

What are the side effects of vardenafil?

However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg should be considered in the elderly. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents. Effects on Blood Pressure and Heart Rate when 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 vardenafil 20 mg at various times before NTG administration. Additional blood pressure and heart rate changes were not detected when vardenafil 20 mg was dosed 24 hours before NTG. 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. Pediatrics: Vardenafil is not indicated for use in pediatric patients. Vardenafil trials were not conducted in the pediatric population.

Overdose/Missed Dose

Blood Pressure Effects in Patients on Stable Alpha-Blocker Treatment: Three clinical pharmacology studies were conducted in patients with benign prostatic hyperplasia (BPH) on stable-dose alpha-blocker treatment, consisting of alfuzosin, tamsulosin or terazosin. 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. 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. Study 3: This study was designed to evaluate the effect of single doses cenforce100 of 5 mg vardenafil (stage 1) and 10 mg vardenafil (stage 2) compared to placebo, when administered to a single cohort of BPH patients (n=24) on stable therapy with alfuzosin 10 mg daily for at least four weeks.

Pulmonary Arterial Hypertension (Orphan)

The design was a randomized, double blind, 3-period cross- over study. One patient experienced decreases from baseline in standing systolic blood pressure >30 mm Hg after administration of vardenafil 5 mg film-coated tablet and vardenafil 10 mg film-coated tablet. Blood pressure effects (standing SBP) in normotensive men on a stable dose of alfuzosin 10 mg following administration of vardenafil 5 mg, vardenafil 10 mg, or placebo separated by 4 hours 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 alpha-blocker terazosin to 10 mg daily over 14 days (n=29), and after initiation of tamsulosin 0.4 mg daily for five days (n=24). Instances of outlier blood pressure values (defined as standing SBP <85 mmHg and/ or a decrease from baseline of standing SBP >30 mmHg) were observed in 9/24 subjects receiving tamsulosin and 19/29 receiving terazosin. 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. Geriatric: 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.

Hepatic Impairment: 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.