PROSTERIDE Tablets
(FINASTERIDE 1 mg)

DESCRIPTION:
(Finasteride), a synthetic 4 -azasteroid compound, is a specific inhibitor of steroid 5α-reductase, an intracellular enzyme that converts testosterone into the potent androgen 5α-dihydrotestosterone (DHT)
 

PHARMACOKINETICS:
PROSTERIDE is variably absorbed following oral administration, with a mean bioavailability of about 63%, peak plasma concentrations are achieved 1 to 2 hours after a dose by mouth. It is about 90% bound to plasma protein. PROSTERIDE is metabolized in the liver and excreted in urine and feces as metabolites. Mean half-life is 6 hours in patients under 60 years of age but may be prolonged to about 8 hours in subjects 70 years of age or older.
 

INDICATIONS AND USAGE
PROSTERIDE is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Safety and efficacy were demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid-scalp area. Efficacy in bitemporal recession has not been established.
 

CONTRAINDICATIONS:
PROSTERIDE is contraindicated in the following:
Pregnancy: PROSTERIDE use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of 5α – reductase inhibitors to inhibit the conversion of testosterone to DHT, PROSTERIDE may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives PROSTERIDE.
Hypersensitivity to any component of this medication.
 

SIDE EFFECTS:
Decreased libido, impotence, and reduced volume of ejaculate have been reported with PROSTERIDE in ≥ 1 % patients. Sexual adverse experiences resolved with continued treatment in over 60 % of patients who reported them.
There are reports of hypersensitivity, skin rash, swelling of lips.
 

WARNINGS:
PROSTERIDE is not indicated for use in pediatric patients and women.
 

PRECAUTIONS:
General: Caution should be used in the administration of PROSTERIDE in patients with liver function abnormalities, as Finasteride is metabolized extensively in the liver.
Information for patients: Women should not handle crushed or broken PROSTERIDE tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of Finasteride and the subsequent potential risk to a male fetus.
PROSTERIDE tablets are coated and will prevent contact with the active ingredient during normal handing, provided that the tablets have not been broken or crushed.
 

DRUG INTERACTIONS:
PROSTERIDE was concomitantly used in clinical studies with (alpha)-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics,
H2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (NSAIDs), and quinolone anti-infectives digoxin, theophylline and warfarin,
without evidence of clinically significant adverse interactions.

DOSAGE AND ADMINISTRATION:
The recommended dose is 1 mg once a day.
PROSTERIDE may be administered with or without meals.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit. Withdrawal of treatment leads to relapse after 12 months.
 

OVERDOSAGE:
Patients have received single doses of Finasteride up to 400 mg and multiple doses of Finasteride up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with Finasteride can be recommended.
PACKAGE AND COMPOSITION:
PROSTERIDE 1 mg: 2 strips × 10 F. C. Tablets ,each F. C. Tablet contains: Finasteride 1 mg.
 

STORAGE:
Store at room temperature, (15-30) °C.
Keep container tightly closed and protect from light and moisture.
Should not be dispensed without prescription.
Keep out of reach of children.