Vardenafil

What it is and how it works

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.

Indications

Vardenafil hydrochloride orally disintegrating tablets are indicated for the treatment of erectile dysfunction. • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. .

Dosage and administration (summary)

• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). • Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. • The maximum recommended dosing frequency is one tablet per day. • Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. It should be taken without liquid.

Contraindications

Administration with nitrates and nitric oxide donors ( 2.4 , 4.1 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 2.4 , 4.2 ) Nitrates Administration of vardenafil hydrochloride orally disintegrating tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated .

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 tablets, it is important to note the following: • Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status.

Pregnancy

Pregnancy Risk Summary Vardenafil hydrochloride orally disintegrating tablets are not indicated for use in females. There are no data with the use of vardenafil hydrochloride orally disintegrating tablets in pregnant women to inform any drug-associated risks.

Storage and supply

How Supplied Vardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side. Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit.

Source: Vardenafil (Vardenafil) — US FDA prescribing information, 2025-07-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.