Company: A. Menarini Pharmaceuticals Ireland Ltd.
Legal category: Prescription. GMS pending. Sport permitted.
Active ingredient: Avanafil 50mg, 100mg, 200mg.
Description: Pale yellow oval tablets marked 50, 100 or 200 on one side, respectively.
Presentation: 50mg-4, €12.00; 100mg-4, €16.00, 200mg-4, €24.00.
Indication: Treatment of erectile dysfunction (ED).
Pharmacology: Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE-5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Avanafil has no effect in the absence of sexual stimulation.
Dosage: Adult: Males: 100mg taken approximately 30 minutes before sexual activity. May be increased to 200mg (maximum) or decreased to 50mg. Maximum once daily. Mild to moderate hepatic impairment: Initiate with minimum effective dose; adjust based on tolerability. Elderly: ≥70 years, limited data. Children: No relevant use.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Myocardial infarction, stroke or life-threatening arrhythmia within last 6 months. Resting hypotension or hypertension. Unstable angina, angina with sexual intercourse, congestive heart failure ≥NYHA class 2. Severe hepatic/renal impairment. Loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION). Known hereditary degenerative retinal disorders.
Special precautions: Perform medical history/physical examination to diagnose ED. Consider cardiovascular status prior to treatment. Vasodilatory effects. Seek immediate medical advice if erections ≥4 hrs. Caution: Anatomical deformation of the penis (angulation, cavernosal fibrosis, Peyronie’s disease), conditions predisposing to priapism (sickle cell anaemia, multiple myeloma, leukaemia). Visual defects and NAION reported. Discontinue and seek medical advice immediately if sudden visual effects, sudden decrease or loss of hearing occurs. Patients with bleeding disorders or active peptic ulceration (assess benefit/risk). Driving/using machines (dizziness, altered vision).
Drug interactions: Contraindicated: Organic nitrate or nitric oxide donors (e.g. amyl nitrite), potent CYP3A4 inhibitors. Not recommended: CYP inducers. Avoid: Other PDE5 inhibitors, other ED treatments, grapefruit juice (within 24 hours). Caution (maximum 100mg with at least 48 hour interval): Moderate CYP3A4 inhibitors. Alpha-blockers and other antihypertensives, alcohol.
Adverse drug reactions: Headache, flushing, nasal congestion.
Full prescribing information and references available from A. Menarini Pharmaceuticals Ireland Ltd. Telephone: (01) 2846744. Email: ireland@menarini.ie