Avanafil

Avanafil

Zugelassene Anwendungsgebiete

• Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.

Darreichungsformen und Stärken

• Avanafil tablets, 100 mg are white to off-white, oval shape, biconvex tablets debossed with 'A42' on one side and 'H' on the other side.
• Tablets: 50 mg, 100 mg, 200 mg

Einnahme

• The starting dose is 100 mg taken as early as approximately 15 minutes before sexual activity, on an as needed basis
• Take avanafil tablet no more than once a day.
• Based on efficacy and/or tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity or decreased to 50 mg taken approximately 30 minutes before sexual activity. Use the lowest dose that provides benefit.
• Avanafil tablet may be taken with or without food
• Do not use avanafil tablet with strong CYP3A4 inhibitors
• If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period.

Darf nicht angewendet werden bei

• Administration of avanafil tablet to patients using any form of organic nitrate is contraindicated
• Hypersensitivity to any component of the avanafil tablet
• Administration with guanylate cyclase (GC) stimulators such as riociguat and vericiguat Nitrates Administration of avanafil tablets with any form of organic nitrates, either regularly and/or intermittently, is contraindicated.

Wechselwirkungen

• Avanafil can potentiate the hypotensive effect of nitrates, alpha-blockers, antihypertensives, and alcohol
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure Potential for Pharmacodynamic Interactions with Avanafil Nitrates Administration of avanafil to patients who are using any form of organic nitrate, is contraindicated. In a clinical pharmacology trial, avanafil was shown to potentiate the hypotensive effect of nitrates.

Warnhinweise und Vorsichtsmaßnahmen

• Patients should not use avanafil if sexual activity is inadvisable due to cardiovascular status or any other reason
• Use of avanafil with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension
• Patients should seek emergency treatment if an erection lasts greater than 4 hours
• Patients should stop avanafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Avanafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION
• Patients should stop taking avanafil and seek prompt medical attention in the event of sudden decrease or loss of hearing Cardiovascular Risk There is a potential for cardiac risk during sexual activity in patients with pre-existing cardiovascular disease.

Häufige Nebenwirkungen

• Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.

Schwangerschaft

Avanafil is not indicated for use in females. There are no data with the use of avanafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of avanafil during organogenesis at exposures for total avanafil at approximately 8 and 6 times, respectively, the Maximum Recommended Human Dose (MRHD) of...

Wirkmechanismus

The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cGMP, producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Avanafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of NO by inhibiting PDE5, which is responsible for degradation of cGMP in the corpus cavernosum.

Zulassungsinhaber:

Camber Pharmaceuticals, Inc.

Stand der Fachinformation:

17. Dezember 2025

Die Abschnitte oben sind aus der englischsprachigen Fachinformation zitiert, denn dieses Dokument trägt die Zulassung. Wo eine europäische Behörde dieselbe Produktinformation auf Deutsch veröffentlicht, ist sie unter Quellen verlinkt. Wir übersetzen behördliche Texte nicht selbst: Ein Übersetzungsfehler in einer Gegenanzeige wäre gefährlicher als eine fremdsprachige Zeile.

Dieser Abschnitt gibt die genehmigte Produktinformation wieder. Der Wortlaut ist aus der Zusammenfassung der Behörde verdichtet, das vollständige Dokument steht unter Quellen.