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Generic Propecia, Finasteride Patient Information Sheet

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For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory

 

Finasteride Tablets USP 1mg

Finpecia

 

COMPOSITION

Each film-coated tablet contains

Finasteride USD ……….1 mg

 

Colours:

Titanium Dioxide and Quinoline Yellow WS

 

DESCRIPTION

Finpecia a synthetic 4- azasteroid compound is a specific inhibitor of 5a- reductase, an intracellular, enzyme that converts androgenic testosterone to dihydrotestosterone (DHT). Administration of finasteride 1 mg decreases scalp and serum SHT concentration, increased amounts of which are thought to be responsible for male pattern hair loss (androgenetic alopecia)

 

INDICATIONS:

Finpecia is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Safety and efficacy have been demonstrate in men between the ages of 18 and 41 years with mild to moderate hair loss of the vertex and anterior mid-scalp area.

 

DOSAGE AND ADMINISTRATION

The Recommended dosage is 1mg once a day, with or without meals. In general, daily use of three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefits. Withdrawal of treatment leads to reversal of effect within 12 months.

 

In impaired renal function: No dosage adjustments are required. In impaired hepatic function. To be used with caution since finasteride is metabolized extensively in the liver.

 

CONTRAINDICATION

Hypersensitivity to any ingredient in the formulation.

Finpecia is contraindicated in women and children.

 

WARNINGS AND PRECAUTONS

Finpecia is not indicated for use in pediatric patients or women. Women should not handle crushed or broken Finpecia 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.

 


DRUG INTERACTION

No drug interactions of clinical importance have been identified.

Finasteride does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system. Compound that have been tested in man include antipyrine, digoxin, propranolol, theophyline, and warfarin and no interactions were found.

 

SIDE EFFECT

Finpecia is generally well tolerated and side effects have usually been mild and transient. These include decreased libido, erectile dysfunction, and ejaculation disorders (primarily decreased volume of ejaculate)

 

OVERDOSAGE:

No adverse effects have been noticed in patients who received single doses of 400mg finasteride and multiple doses of upto 80mg/day for three months.

 

STORAGE:

Protect from light.

 

PRESENTATION:

Finpecia Blister pack of 10 tablets.