Vardenafil

VARDENAFIL — vardenafil hydrochloride trihydrate tablet
Macleods Pharmaceuticals Limited

1 INDICATIONS & USAGE

Vardenafil hydrochloride orally disintegrating tablet is indicated for the treatment of erectile dysfunction.

2 DOSAGE & ADMINISTRATION

2.1 General

Vardenafil is available in 10 mg orally disintegrating tablets. Vardenafil hydrochloride orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablet provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). [See Clinical Pharmacology (12.3).]

Vardenafil hydrochloride orally disintegrating tablet should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one Vardenafil hydrochloride orally disintegrating tablet per day. Sexual stimulation is required for a response to treatment.

Vardenafil hydrochloride orally disintegrating tablet should be placed on the tongue where it will disintegrate. The tablet should
be taken without liquid. It should be taken immediately upon removal from the blister.

Those patients who require a lower or higher dose of vardenafil need to be prescribed vardenafil film-coated tablets [see Patient Counseling Information ( 17)] .

2.2 Use with Food

Vardenafil hydrochloride orally disintegrating tablet can be taken with or without food.

2.3 Use in Special Populations

Hepatic Impairment: Do not use vardenafil hydrochloride orally disintegrating tablet in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.8) and Clinical Pharmacology ( 12.3)] .

Renal Impairment: Do not use vardenafil hydrochloride orally disintegrating tablet in patients on renal dialysis [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.3)].

2.4 Concomitant Medications

Nitrates: Concomitant use with nitrates 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: Do not use vardenafil hydrochloride orally disintegrating tablet with potent or moderate CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin and erythromycin [see Warnings and Precautions (5.2) and Drug Interactions (7.2)].

Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. 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 patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablet. Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients [see Dosage and Administration ( 2.4)] .Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may change to vardenafil hydrochloride orally disintegrating tablet at the advice of their healthcare provider. [See Warnings and Precautions (5.6) and Drug Interactions (7.1).]

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

3 DOSAGE FORMS & STRENGTHS

Vardenafil hydrochloride is available in 10 mg white, to off-white round biconvex uncoated tablets debossed with “T 41” on one side and plain on the other side (not scored).

4 CONTRAINDICATIONS

4.1 Nitrates

Administration of vardenafil hydrochloride orally disintegrating tablet 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 hydrochloride orally disintegrating tablet, may potentiate the hypotensive effects of nitrates. A suitable time interval following vardenafil hydrochloride orally disintegrating tablet dosing for the safe administration of nitrates or nitric oxide donors has not been determined.

4.2 Guanylate Cyclase (GC) Stimulators

Do not use vardenafil hydrochloride orally disintegrating tablet in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablet 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 hydrochloride orally disintegrating tablet, 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 hydrochloride orally disintegrating tablet, 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 hydrochloride orally disintegrating tablet, 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 Potent or Moderate CYP3A4 Inhibitors

Concomitant administration with potent CYP3A4 inhibitors (such as ritonavir, indinavir, ketoconazole) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil. Do not use vardenafil hydrochloride orally disintegrating tablet in patients taking potent or moderate CYP3A4 inhibitors. [See Dosage and Administration (2.4), Drug Interactions (7.2) and Patient Counseling Information (17).]

5.3 Risk of Priapism

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.

Vardenafil hydrochloride orally disintegrating tablet should 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).

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