VARDENAFIL

VARDENAFIL- vardenafil hydrochloride trihydrate tablet, film coated
Golden State Medical Supply, Inc.

1 INDICATIONS AND USAGE

Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.

2 DOSAGE AND ADMINISTRATION

2.1 General Dose Information

For most patients, the recommended starting dose of vardenafil is 10 mg, taken orally, as needed, 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. Sexual stimulation is required for a response to treatment.

2.2 Use with Food

Vardenafil hydrochloride tablets can be taken with or without food.

2.3 Use in Specific Populations

Geriatrics: A starting dose of 5 mg vardenafil should be considered in patients ≥ 65 years of age [see Use in Specific Populations ( 8.5)].

Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg.

Do not use vardenafil in patients with severe hepatic impairment (Child-Pugh C) [ see Warnings and Precautions ( 5.8), Use in Specific Populations ( 8.6) and Clinical Pharmacology ( 12.3)] .

Renal Impairment: Do not use vardenafil in patients on renal dialysis [see Warnings and Precautions ( 5.9), Use in Specific Populations ( 8.7) and Clinical Pharmacology ( 12.3)].

2.4 Concomitant Medications

Nitrates

Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications ( 4.1)] .

Guanylate Cyclase (GC) Stimulators, such as riociguat

Concomitant use is contraindicated [ see Contraindications ( 4.2)] .

CYP3A4 Inhibitors

The dosage of vardenafil may require adjustment in patients receiving strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, cobicistat and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions ( 7.2)].

If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil should be adjusted as follows:

  • Ritonavir: No more than 2.5 mg in a 72 hours period
  • Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24 hours period
  • Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24 hours period.
  • Cobicistat: No more than 2.5 mg in a 72 hours period.

Alpha-Blockers

In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors). [See Warnings and Precautions (5.6) and Drug Interactions ( 7.1).]

A time interval between dosing should be considered when vardenafil is prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology ( 12.2)].

3 DOSAGE FORMS AND STRENGTHS

Vardenafil hydrochloride tablets are available as 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride), 5 mg (equivalent to 5.926 mg vardenafil hydrochloride), 10 mg (equivalent to 11.852 mg vardenafil hydrochloride), 20 mg (equivalent to 23.705 mg vardenafil hydrochloride).

Vardenafil hydrochloride tablets, 2.5 mg are white to off-white colored, round, biconvex, bevel edged, film-coated tablets, debossed with “10” on one side and “68” on other side.

Vardenafil hydrochloride tablets, 5 mg are light yellow colored, round, biconvex, bevel edged, film-coated tablets, debossed with “10” on one side and “69” on other side.

Vardenafil hydrochloride tablets, 10 mg are light yellow to orange colored, round, biconvex, bevel edged, film-coated tablets, de bossed with “10” on one side and “70” on other side.

Vardenafil hydrochloride tablets, 20 mg are light yellow to orange colored, round, biconvex, bevel edged, film-coated tablets, debossed with “10” on one side and “71” on other side.

4 CONTRAINDICATIONS

4.1 Nitrates

Administration of vardenafil with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology ( 12.2)] . Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including vardenafil, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil for the safe administration of nitrates or nitric oxide donors has not been determined.

4.2 Guanylate Cyclase (GC) Stimulators

Do not use vardenafil in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil may potentiate the hypotensive effects of GC stimulators.

5 WARNINGS AND PRECAUTIONS

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

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

5.1 Cardiovascular Effects

General

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatment for erectile dysfunction, including vardenafil, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status.

There are no controlled clinical data on the safety or efficacy of vardenafil in the following patients; and therefore its use is not recommended until further information is available: unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure.

Left Ventricular Outflow Obstruction

Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors.

Blood Pressure Effects

Vardenafil 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 ( 12.2)] . While this normally would be expected to be of little consequence in most patients, prior to prescribing vardenafil, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.

5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors

Concomitant administration with strong CYP3A4 inhibitors (such as ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil. Dosage adjustment is necessary when vardenafil is administered with certain CYP3A4 inhibitors [see Dosage and Administration ( 2.4) and Drug Interactions ( 7.2)].

Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors.

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