Unimed & Unihealth Manufacturers Ltd.
Edysta- is indicated for Erectile dysfunction, signs and symptoms of benign prostatic hyperplasia (BPH)
Precautions and warnings
Hepatic or renal impairment; CV diseases; anatomical penile deformation; predisposition to priapism; child 4 hr.
Headache, dyspepsia, dizziness, flushing, swelling of eyelids, eye pain, conjunctival hyperemia, back pain, myalgia, visual disturbances, nasal congestion, sudden decrease or loss of hearing, tinnitus.
Potentially Fatal: Stevens-Johnson syndrome, exfoliative dermatitis, severe cardiovascular events e.g. MI, stroke, sudden cardiac death;
Concurrent use increased risk of hypotension with beta-blockers; increased risk of priapism with other drugs for erectile dysfunction, e.g. alprostadil; increased heart rate with theophylline; decreased tadalafil serum concentration with CYP 3A4 inducers e.g. rifampicin, efavirenz, carbamazepine, nevirapine, barbiturates, phenobarbital, phenytoin, ribabutin; increased tadalafil serum concentration with CYP3A4 inhibitors e.g. azole antifungals, protease inhibitors, cimetidine, macrolides.
Potentially Fatal: Enhanced hypotensive effect with nitrates and nicorandil.
Concurrent use of organic nitrates, nitrates and nitric oxide donors. Men with cardiac disease for whom sexual activity is inadvisable. Recent MI (within 90 days) or stroke (within last 6 mth), hypotension (
Mode of actions
Tadalafil is a phosphodiesterase type-5 inhibitor.
Dosage & Administration
Adult: Initially, 10 mg at least 30 min before sexual activity once daily, up to 20 mg as single dose. Max: Not more than once daily. If used with potent inhibitors of CYP3A4, e.g. azole antifungals or protease inhibitors: max 10 mg once every 72 hr.
Benign Prostatic Hyperplasia
The recommended dose is 5 mg, taken at approximately the same time every day.
31-50 Initial dose at 5 mg/day. Max: 10 mg/48hr
Pregnancy & Lactation
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.