FINASTERIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cipla USA Inc.

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablet, USP is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablet, USP is not indicated for use in women. Finasteride tablet is 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 5 α-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 (1

Product summary:

Finasteride tablets, USP are reddish brown, circular, biconvex, film coated tablets, debossed with 'C' on one side and '112' on other side Finasteride tablets, USP are available in bottles of 30 tablets (NDC 69097-112-02) bottles of 90 tablets (NDC 69097-112-05). Storage and Handling Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Keep container closed and protect from light and moisture. 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. Finasteride tablets1mg 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
CIPLA USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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 tablet, USP is a 5α-reductase inhibitor indicated for the
treatment of male pattern hair loss (androgenetic
alopecia) inMEN ONLY (1).
Finasteride tablet, USP is 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 tablet is not indicated for use in women or pediatric
patients (5.1, 5.4).
Women should not handle crushed or broken Finasteride tablets when
they are pregnant or may potentially be
pregnant due to potential risk to a male fetus (5.1, 8.1,16).
Finasteride tablet causes a decrease in serum PSA levels. Any
confirmed increase in PSA while on Finasteride tablets
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).
5 α -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 and greater than in
patients treated with placebo are: decreased libido, erectile
dysfunction and ejaculation disorder (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CIPLA LIMITED, INDIA AT
1- 866 -604 -3268 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR