FINASTERIDE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Dr Reddys Laboratories Inc

INN (Tarptautinis Pavadinimas):

FINASTERIDE

Sudėtis:

FINASTERIDE 1 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Finasteride tablets 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 are not indicated for use in women. Finasteride tablets 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 finasteride administered

Produkto santrauka:

Finasteride tablets USP, 1 mg, is brown color, round film coated tablets, debossed with ‘H’ on one side and ‘36’ on other side. They are supplied as follows: Bottles of 30 NDC 43598-390-30 Bottles of 90 NDC 43598-390-90 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)].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
DR REDDYS LABORATORIES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS
FINASTERIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
• Finasteride tablets are 5α-reductase inhibitors indicated for the
treatment of male pattern hair loss (androgenetic
alopecia) in MEN ONLY (1).
• Finasteride tablets are not indicated for use in women (1, 4,
5.1).
DOSAGE AND ADMINISTRATION
• Finasteride tablets 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 are 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 tablets 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).
• 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 and greater than in
patients treated with placebo are: decreased libido, erectile
dysfunction and ejaculation disorder (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY'S
LABORATORIES INC., AT 1-888-375-3784 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATC