Spedra

Spedra

avanafil

Manufacturer:

A. Menarini

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Avanafil
Indications/Uses
Dosage/Direction for Use
Adult 100 mg once daily as needed, taken approx 15-30 min before sexual activity, may be increased to 200 mg or decreased to 50 mg. Max: 200 mg once daily.
Administration
May be taken with or without food: Onset may be delayed when administered w/ food.
Contraindications
Hypersensitivity. Men w/ preexisting CV disease for whom sexual activity is inadvisable. Patients w/ history of MI, stroke or life-threatening arrhythmia w/in last 6 mth; resting hypotension (<90/50 mmHg) or HTN (>170/100 mmHg); unstable angina or angina occurring during sexual intercourse, CHF (NYHA class ≥2). Loss of vision in 1 eye due to non-arteritic anterior ischemic optic neuropathy (NAION); known hereditary degenerative retinal disorders. Co-administration w/ organic nitrates or nitric oxide donors eg, amyl nitrite; guanylate cyclase stimulators eg, riociguat; potent CYP3A4 inhibitors eg, ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin. Severe hepatic (Child-Pugh C) & renal impairment (CrCl <30 mL/min).
Special Precautions
Discontinue use if sudden visual defects, decreased or hearing loss occur. Increased risk of NAION. Patients w/ left ventricular outflow obstruction eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis; anatomical penis deformation eg, angulation, cavernosal fibrosis or Peyronie's disease, or conditions predisposing to priapism eg, sickle cell anaemia, multiple myeloma or leukaemia; erectile dysfunction due to spinal cord injury or other neurological disorders; bleeding disorders or active peptic ulceration. Consider CV status prior to treatment. Concomitant use w/ α-blockers; PDE5 inhibitors; alcohol. May affect ability to drive & use machines. Not to be used in women. Elderly ≥70 yr.
Adverse Reactions
Headache; flushing; nasal congestion.
Drug Interactions
Augmented hypotensive effects of nitrates. Symptomatic hypotension w/ α-blockers eg, doxazosin, tamsulosin; alcohol. Potentiated BP-lowering of amlodipine, enalapril. Increased Cmax, AUC & prolonged t½ w/ strong CYP3A4 inhibitors eg, ketoconazole, ritonavir, itraconazole, voriconazole, clarithromycin, nefazodone, saquinavir, nelfinavir, indinavir, atazanavir, telithromycin; moderate CYP3A4 inhibitors eg, erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, verapamil; grapefruit juice. Decreased efficacy by CYP3A4 inducers eg, bosentan, carbamazepine, efavirenz, phenobarb, rifampicin. Additive BP-lowering effect w/ riociguat.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE10 - avanafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Spedra tab 100 mg
Packing/Price
4's
Form
Spedra tab 200 mg
Packing/Price
4's
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