Vardenafil

Vardenafil

Goedgekeurde toepassingen

• Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
• Vardenafil tablets are indicated for the treatment of erectile dysfunction.

Vormen en sterktes

• Vardenafil tablets USP, 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate), 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate), 10 mg (equivalent to 11.852 mg...
• Vardenafil 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 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.

Hoe het wordt ingenomen

• Vardenafil tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability.
• A starting dose of 5 mg vardenafil should be considered in patients ≥ 65 years of age.
• Vardenafil tablets are taken orally, approximately 60 minutes before sexual activity.
• The maximum recommended dosing frequency is one tablet per day.
• Vardenafil tablets may be taken with or without food.
• 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-hour period Cobicistat: 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-hour period Ketoconazole 200 mg daily, itraconazole 200...

Mag niet worden gebruikt bij

• Administration with nitrates and nitric oxide donors
• Administration with guanylate cyclase (GC) stimulators, such as riociguat

Interacties

• Vardenafil can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.

Waarschuwingen en voorzorgen

• 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 use of vardenafil, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Vardenafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.
• Sudden Hearing Loss: Patients should stop vardenafil and seek medical attention in the event of sudden decrease or loss in hearing.
• Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered 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.
• 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:

Vaak voorkomende bijwerkingen

• Most common adverse reactions reported (≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.

Zwangerschap

Vardenafil is not indicated for use in females. There are no data with the use of vardenafil in pregnant women to inform any drug-associated risks. In animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of vardenafil during organogenesis at exposures for unbound vardenafil and its major metabolite at approximately 100 and 29 times, respectively, the maximum recommended human dose (MRHD)...

Werkingsmechanisme

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.

Handelsvergunninghouder:

Zydus Pharmaceuticals USA Inc.

Versie van de productinformatie:

5 januari 2026

De secties hierboven zijn geciteerd uit de Engelstalige productinformatie, want dat is het document dat de goedkeuring draagt. Waar een Europese instantie dezelfde informatie in het Nederlands publiceert, staat de link bij de bronnen. Wij vertalen regelgevende teksten niet zelf: een vertaalfout in een contra-indicatie is gevaarlijker dan een regel in een vreemde taal.

Deze sectie geeft de goedgekeurde productinformatie weer. De formulering is ingedikt uit de samenvatting van de toezichthouder zelf, en het volledige document staat bij de bronnen.