FINASTERIDE tablet, coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

REMEDYREPACK INC.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in  MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets is not indicated for use in women. Finasteride tablets 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 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).]  In  female  rats,  low  doses  of  finasteride  administered  during  pregnancy  have  produced  abnormalities  of  the  external  genitalia  in  male  offspring. - Hypersensitivity  to  any  component  of  this  medication. Pregnancy Category X [ see Contraindications (4)] . Finasteride tablets is contraindicated for use in women who are or may become pregnant. Finasteride tablets is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal studies, finasteride caused abnormal development of external genitalia in male fetuses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. Abnormal male genital development is an expected consequence when conversion of testosterone to 5α- dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors. These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency. Women could be exposed to finasteride through contact with crushed or broken finasteride tablets or semen from a male partner taking finasteride tablets. With regard to finasteride exposure through the skin, finasteride tablets are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken. Women who are pregnant or may become pregnant should not handle crushed or broken finasteride tablets because of possible exposure of a male fetus. If a pregnant woman comes in contact with crushed or broken finasteride tablets, the contact area should be washed immediately with soap and water. With regard to potential finasteride exposure through semen, a study has been conducted in men receiving finasteride tablets 1 mg/day that measured finasteride concentrations in semen [ see Clinical Pharmacology (12.3) ]. In an embryo-fetal development study, pregnant rats received finasteride during the period of major organogenesis (gestation days 6 to 17). At maternal doses of oral finasteride approximately 1 to 684 times the recommended human dose (RHD) of 1 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring.  Exposure multiples were estimated using data from nonpregnant rats. Days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia. At oral maternal doses approximately 0.2 times the RHD (based on AUC at animal dose of 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development. Decreased anogenital distance occurred in male offspring of pregnant rats that received approximately 0.02 times the RHD (based on AUC at animal dose of 0.003 mg/kg/day). No abnormalities were observed in female offspring exposed to any dose of finasteride in utero. No developmental abnormalities were observed in the offspring of untreated females mated with finasteride-treated male rats that received approximately 488 times the RHD (based on AUC at animal dose of 80 mg/kg/day). Slightly decreased fertility was observed in male offspring after administration of about 20 times the RHD (based on AUC at animal dose of 3 mg/kg/day) to female rats during late gestation and lactation. No effects on fertility were seen in female offspring under these conditions. No evidence of male external genital malformations or other abnormalities were observed in rabbit fetuses exposed to finasteride during the period of major organogenesis (gestation days 6 to 18) at maternal doses up to 100 mg/kg/day (finasteride exposure levels were not measured in rabbits). However, this study may not have included the critical period for finasteride effects on development of male external genitalia in the rabbit. The fetal effects of maternal finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (gestation days 20 to 100), in a species and development period more predictive of specific effects in humans than the studies in rats and rabbits. Intravenous administration of finasteride to pregnant monkeys at doses as high as 800 ng/day (estimated maximal blood concentration of 1.86 ng/mL or about 930 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 1 mg/day) resulted in no abnormalities in male fetuses. In confirmation of the relevance of the rhesus model for human fetal development, oral administration of a dose of finasteride (2 mg/kg/day or approximately 120,000 times the highest estimated blood levels of finasteride from semen of men taking 1 mg/day) to pregnant  monkeys resulted in external genital abnormalities in male fetuses. No other abnormalities were observed in male fetuses and no finasteride- related abnormalities were observed in female fetuses at any dose. Finasteride tablets is not indicated for use in women. It is not known whether finasteride is excreted in human milk. Finasteride tablets is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established. Clinical efficacy studies with finasteride tablets did not include subjects aged 65 and over. Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly for finasteride tablets  [see   Clinical   Pharmacology  ( 12.3)] .  However the efficacy of finasteride tablets in the elderly has not been established. Caution should be exercised in the administration of finasteride tablets in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver  [ see  Clinical  Pharmacology  (12.3)] . No  dosage  adjustment  is  necessary  in  patients  with  renal  impairment  [ see   Clinical  Pharmacology  ( 12.3)] .

Tóm tắt sản phẩm:

Finasteride tablets, USP 1 mg are available as reddish brown colored, 7 mm round, biconvex, film coated tablets, marked “F1” on one side and plain on other side. They are supplied as follows: NDC: 70518-2287-00 NDC: 70518-2287-01 NDC: 70518-2287-02 PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK Storage and Handling Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Preserve in a tight, light-resistant container. 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 tablets, USP 1 mg 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)] . Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FINASTERIDE- FINASTERIDE TABLET, COATED
REMEDYREPACK 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 is a 5α-reductase inhibitor indicated for the
treatment
of male pattern hair loss (androgenetic alopecia) in MEN ONLY( 1).
Finasteride tablets is 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 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 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 ASCEND LABORATORIES,
LLC AT 1-877-272-
7901 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
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