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| Finasteride Tablets |
| 【DESCRIPTION】 |
Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5áα,17a)-. The empirical formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:  |
| Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in
chloroform and in lower alcohol solvents, but is practically insoluble in water.
Finasteride tablets for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: hydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl cellulose LF, hydroxypropyl methylcellulose,titanium dioxide, magnesium stearate, talc, docusate sodium, FD&C Blue 2 aluminum lake and yellow iron oxide.
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INDICATIONS AND USAGE 】 |
| Finasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
-Improve symptoms
-Reduce the risk of acute urinary retention
-Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and
prostatectomy.
Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed e4 point increase in AUA symptom score).
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CONTRAINDICATIONS 】 |
| Finasteride is contraindicated in the following:
Hypersensitivity to any component of this medication.
Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant.
Because of the ability of Type II 5á-reductase inhibitors to inhibit the conversion of testosterone to DHT,
finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who
receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug,
the pregnant woman should be apprised of the potential hazard to the male fetus. (See also WARNINGS,
EXPOSURE OF WOMEN — RISK TO MALE FETUS and PRECAUTIONS, Information for Patients and
Pregnancy.) In female rats, low doses of finasteride administered during pregnancy have produced
abnormalities of the external genitalia in male offspring.
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DOSAGE AND ADMINISTRATION 】 |
| The recommended dose is 5 mg orally once a day.
Finasteride can be administered alone or in combination with the alpha-blocker doxazosin (see CLINICAL PHARMACOLOGY, Clinical Studies).
Finasteride may be administered with or without meals.
No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
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STORAGE AND HANDLING 】 |
| Store at room temperatures below 30°C (86°F). Protect from light and keep container tightly closed.
Women should not handle crushed or broken FINASTERIDE 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 (see WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS, and
PRECAUTIONS, Information for Patients and Pregnancy).
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