Aventy 50

• Erectile Dysfunction

Avanafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. During sexual stimulation, nitric oxide (NO) is released in the corpus cavernosum, which activates guanylate cyclase and increases cyclic guanosine monophosphate (cGMP) production. cGMP causes smooth muscle relaxation and increased blood flow, leading to erection. Avanafil inhibits PDE5 enzyme, preventing cGMP degradation, thereby prolonging erection.

Avanafil is rapidly absorbed, reaching peak plasma concentration (Tmax) in approximately 0.5-1 hour. It is primarily metabolized in the liver by CYP3A4 enzyme.

Recommended Dose:

• Starting dose: 100 mg, taken 15-30 minutes before sexual activity.
• Dose Adjustment: Based on efficacy and tolerability, can be adjusted to 50 mg (30 minutes before) or 200 mg (15 minutes before).
• Maximum dose: Not to exceed 1 dose per day.
• Mild-moderate hepatic/renal impairment: No dose adjustment needed.
• Severe hepatic/renal impairment (CrCl 15-29 mL/min): Do not use (safety and efficacy not established).

With moderate CYP3A4 inhibitors: Dose should not exceed 50 mg/24 hours.

Common (>2%):

• Headache (5.6%)
• Flushing (3.5%)
• Nasopharyngitis (3.4%)
• Back pain (2.5%)
• Nasal congestion (2.1%)

Less than 2%:

• Bronchitis, Influenza, Sinusitis, Sinus congestion, Hypertension, Dyspepsia, Nausea, Constipation, Rash

Less than 1%:

• Peripheral edema, Fatigue, Angina, Deep vein thrombosis, Palpitations, Gastritis, GERD, Hypoglycemia, Hyperglycemia, Depression, Insomnia, Cough, Dyspnea, Pruritus, Urinary tract infection, Increased erection, etc.

Pregnancy Category C: Avanafil is not indicated for use in pregnant women. There are no adequate and well-controlled studies in pregnant women. Use only if potential benefit justifies the potential risk to the fetus.

Serious Precautions:

• Patients with underlying cardiovascular conditions may have cardiovascular risk during sexual activity.
• Monitor patients with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic subaortic stenosis).
• If sudden vision loss in one or both eyes occurs (NAION), discontinue therapy.
• If sudden hearing loss or tinnitus occurs, discontinue therapy.
• Priapism may occur, especially in patients with predisposing conditions (sickle cell anemia, multiple myeloma, leukemia).
• Not recommended in patients with retinitis pigmentosa.
• Alcohol may increase risk of orthostatic hypotension and cause dizziness, headache.

Clinical data on avanafil overdose is limited. Overdose may cause headache, flushing, nasal congestion, dizziness, hypotension, priapism. Treatment: Symptomatic and supportive measures. No specific antidote.

Store below 30°C, in a cool and dry place, away from light. Keep out of reach of children.