Avanafil

Avanafil

Goedgekeurde toepassingen

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

Vormen en sterktes

• 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

Hoe het wordt ingenomen

• 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.

Mag niet worden gebruikt bij

• 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.

Interacties

• 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.

Waarschuwingen en voorzorgen

• 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.

Vaak voorkomende bijwerkingen

• 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.

Zwangerschap

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...

Werkingsmechanisme

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.

Handelsvergunninghouder:

Camber Pharmaceuticals, Inc.

Versie van de productinformatie:

17 december 2025

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.