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:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets USP, are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:  -Improve symptoms -Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets USP administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). Finasteride tablets USP are not approved for the prevention of prostate cancer. Finasteride tablets USP are 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 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 also Warnings and Precautions (5.3) , Use in Specific Populations (8.1) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2) .] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Teratogenic Effects: Pregnancy Category X. [See Contraindications (4).] Finasteride tablets USP are contraindicated for use in women who are or may become pregnant. Finasteride tablets USP 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 USP or semen from a male partner taking finasteride tablets USP. With regard to finasteride exposure through the skin, finasteride tablets USP 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 USP because of possible exposure of a male fetus. If a pregnant woman comes in contact with crushed or broken finasteride tablets USP, the contact area should be washed immediately with soap and water. With regard to potential finasteride exposure through semen, two studies have been conducted in men receiving finasteride tablets USP, 5 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 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 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 days of gestation is a critical period in male fetal rats for differentiation of the external genitalia. At oral maternal doses approximately 0.03 times the MRHD (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 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). No abnormalities were observed in female offspring at any maternal dose of finasteride. No developmental abnormalities were observed in the offspring of untreated females mated with finasteride treated male rats that received approximately 61 times the MRHD (based on AUC at animal dose of 80 mg/kg/day). Slightly decreased fertility was observed in male offspring after administration of about 3 times the MRHD (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 oral 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 143 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 5 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 18,000 times the highest estimated blood levels of finasteride from semen of men taking 5 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 USP is not indicated for use in women. It is not known whether finasteride is excreted in human milk. Finasteride tablets USP is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established. Of the total number of subjects included in a long-term efficacy and safety study, 1480 and 105 subjects were 65 and over and 75 and over, respectively. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment is necessary in the elderly [see Clinical Pharmacology (12.3) and Clinical Studies (14)]. Caution should be exercised in the administration of finasteride tablets USP 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)].

Product summary:

Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other sideon other side. They are supplied as follows: NDC: 70518-3182-00 NDC: 70518-3182-01 NDC: 70518-3182-02 NDC: 70518-3182-03 PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH PACKAGING; 30 in 1 BOX PACKAGING: 1 in 1 POUCH Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Women should not handle crushed or broken finasteride tablets USP 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 and Precautions (5.3), Use in Specific Populations (8.1) and Patient Counseling Information (17.2)]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
REMEDYREPACK 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, 5 MG FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Finasteride tablets USP, is a 5α-reductase inhibitor, indicated for
the treatment of symptomatic benign
prostatic hyperplasia (BPH) in men with an enlarged prostate to (
1.1):
• Improve symptoms
• Reduce the risk of the need for surgery including transurethral
resection of the prostate (TURP) and
prostatectomy.
Finasteride tablets USP administered in combination with the
alpha-blocker doxazosin is indicated to
reduce the risk of symptomatic progression of BPH (a confirmed ≥4
point increase in American Urological
Association(AUA) symptom score) ( 1.2).
LIMITATIONS OF USE: Finasteride tablets USP is not approved for the
prevention of prostate cancer ( 1.3).
DOSAGE AND ADMINISTRATION
Finasteride tablets USP may be administered with or without meals (
2).
Monotherapy: One tablet (5 mg) taken once a day ( 2.1).
Combination with Doxazosin: One tablet (5 mg) taken once a day in
combination with the alpha-blocker
doxazosin ( 2.2).
DOSAGE FORMS AND STRENGTHS
5 mg film-coated tablets ( 3).
CONTRAINDICATIONS
Hypersensitivity to any components of this product ( 4).
Women who are or may potentially be pregnant ( 4, 5.4, 8.1, 16).
WARNINGS AND PRECAUTIONS
• Finasteride tablets USP reduces serum prostate specific antigen
(PSA) levels by approximately 50%.
However, 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 ( 5.1).
• Finasteride tablets USP may increase the risk of high-grade
prostate cancer ( 5.2, 6.1).
• Women should not handle crushed or broken finasterid