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:

QUALLENT PHARMACEUTICALS HEALTH LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). Finasteride tablets are not approved for the prevention of prostate cancer. Finasteride tablets are contraindicated in the following: - Hypersensitivity to any component of this medication. - Pregnancy. Finasteride use is contraindicated in females 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 female who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. [See also Warnings and Precautions (5.3), Use in Specific Populations (8.1), and How Supplied/Storage and Handling (16).] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Risk Summary Finasteride is contraindicated in pregnant females and not indicated for use in females. Based on animal studies and the mechanism of action, finasteride may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.1)]. In an embryo-fetal development study in rats, there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring of pregnant rats administered oral finasteride during the period of major organogenesis at doses 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). Decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development were also observed in male offspring at oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), along with decreased anogenital distance in male offspring at oral maternal doses approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). Finasteride 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. 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. Females could be exposed to finasteride through contact with crushed or broken finasteride tablets or semen from a male partner taking finasteride. 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. Females who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets because of possible exposure of a male fetus. With regard to potential finasteride exposure through semen, three studies have been conducted that measured finasteride concentrations in semen in men receiving finasteride 5 mg/day. In these studies the highest amount of finasteride in semen was estimated to be 50- to 100-fold less than the dose of finasteride (5 mcg) that had no effect on circulating DHT levels in men [see Data and Clinical Pharmacology (12.3)]. Data Human Data In 2 studies of healthy subjects (n=69) receiving finasteride 5 mg/day for 6 to 24 weeks, finasteride concentrations in semen ranged from undetectable (<0.1 ng/mL) to 10.54 ng/mL. In an earlier study using a less sensitive assay, finasteride concentrations in semen of 16 subjects receiving finasteride 5 mg/day ranged from undetectable (<1.0 ng/mL) to 21 ng/mL. Using the highest semen level measured and assuming 100% absorption would be up to 105 ng per day, which is 50- to 100-fold less than the dose of finasteride (5 mcg) that had no effect on circulating DHT levels in men [see Clinical Pharmacology (12.3)] . Animal Data 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 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 females 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. Risk Summary Finasteride is not indicated for use in females. Infertility Females Finasteride is not indicated for use in females. Males Treatment with finasteride for 24 weeks to evaluate semen parameters in healthy male volunteers revealed no clinically meaningful effects on sperm concentration, mobility, morphology, or pH. A 0.6 mL (22.1%) median decrease in ejaculate volume with a concomitant reduction in total sperm per ejaculate was observed. These parameters remained within the normal range and were reversible upon discontinuation of therapy with an average time to return to baseline of 84 weeks [see Warnings and Precautions (5.5)]. There have been postmarketing reports of male infertility and/or poor seminal quality; normalization or improvement of seminal quality has been reported after discontinuation of finasteride [see Adverse Reactions (6.2)]. Finasteride 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 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 colored, circular, biconvex, beveled edged film-coated tablets debossed with ‘E’ on one side and ‘61’ on the other side.         Bottles of 500         NDC 82009-061-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Females 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 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
QUALLENT PHARMACEUTICALS HEALTH LLC
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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, 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 acute urinary retention
Reduce the risk of the need for surgery including transurethral
resection of the prostate (TURP) and
prostatectomy.
Finasteride tablets administered in combination with the alpha-blocker
doxazosin are 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 are not approved for the
prevention of prostate cancer (1.3).
DOSAGE AND ADMINISTRATION
Finasteride tablets 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).
Females who are or may potentially be pregnant (4, 5.3, 8.1, 16).
WARNINGS AND PRECAUTIONS
Finasteride reduces serum prostate specific antigen (PSA) levels by
approximately 50%. However, any
confirmed increase in PSA while on finasteride 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 may increase the risk of high-grade prostate cancer (5.2,
6.1).
Females should not handle crushed or broken finasteride tablets when
they are pregnant or may