Navafil 100

• Erectile Dysfunction

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.

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.