FINASTERIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)

Available from:

Camber Pharmaceuticals, Inc.

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets USP are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. Finasteride tablets USP are not indicated for use in women. Finasteride tablets USP are contraindicated in the following:  • Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (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 Warnings and Precautions (5.1), Use in Specific Populations (8.1), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.1).] In female rats, low doses of fina

Product summary:

Finasteride tab le t s USP, 1 mg, is brown color, round film coated tablets, debossed with ‘H’ on one side and ‘36’ on other side. They are supp lied as f o llo w s:  NDC 31722-526-30 bottles of 30  NDC  31722-526-90 bottles of 90  NDC  31722-526-10 bottles of 1000 Storage and Handling Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Keep container closed and protect from moisture. Women should not handle crushed or broken finasteride tablets USP 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. finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) and Patient Counseling Information (17.1) ] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS
USP.
FINASTERIDE TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
• Finasteride tablets USP are 5α-reductase inhibitors indicated for
the treatment of male pattern hair loss (androgenetic
alopecia) in MEN ONLY (1).
• Finasteride tablets USP are not indicated for use in women (1, 4,
5.1).
DOSAGE AND ADMINISTRATION
• Finasteride tablets USP may be administered with or without meals
(2).
• One tablet (1 mg) taken once daily (2).
• In general, daily use for three months or more is necessary before
benefit is observed (2).
DOSAGE FORMS AND STRENGTHS
1 mg tablets (3).
CONTRAINDICATIONS
• Pregnancy (4, 5.1, 8.1, 16).
• Hypersensitivity to any components of this product (4).
WARNINGS AND PRECAUTIONS
Finasteride tablets USP are not indicated for use in women or
pediatric patients (5.1, 5.4).
• Women should not handle crushed or broken finasteride tablets USP
when they are pregnant or may potentially be
pregnant due to potential risk to a male fetus (5.1, 8.1,16).
• Finasteride tablets USP causes a decrease in serum PSA levels. Any
confirmed increase in PSA while on finasteride
tablets USP may signal the presence of prostate cancer and should be
evaluated, even if those values are still within the
normal range for men not taking a 5α-reductase inhibitor (5.2).
• 5α-reductase inhibitors may increase the risk of high-grade
prostate cancer (5.3, 6.1).
ADVERSE REACTIONS
The most common adverse reactions, reported in ≥1% of patients
treated with finasteride tablets USP and greater than in
patients treated with placebo are: decreased libido, erectile
dysfunction and ejaculation disorder (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HETERO LABS LIMITED AT
866-495-1995 OR FDA AT 1-80