United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 1 mg - finasteride tablets usp 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 usp are not indicated for use in women. finasteride tablets usp 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 fina

United States - English - NLM (National Library of Medicine)

cipla usa inc. - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 1 mg - 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

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 1 mg - finasteride tablets, usp 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, usp are not indicated for use in women. - finasteride is contraindicated in the following: finasteride 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 (17.1).

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 1 mg - 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 category x [see contraindications (4)] . finasteride is contraindicated for use in women who are or may become pregnant. 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. 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. 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 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 is not indicated for use in women. it is not known whether finasteride is excreted in human milk. finasteride is not indicated for use in pediatric patients. safety and effectiveness in pediatric patients have not been established. clinical efficacy studies with finasteride 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 [see clinical pharmacology (12.3)] . however the efficacy of finasteride in the elderly has not been established. 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)] .

United States - English - NLM (National Library of Medicine)

exelan pharmaceuticals inc. - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 5 mg - 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 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 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 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 abnormalitie

United States - English - NLM (National Library of Medicine)

new horizon rx group, llc - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 5 mg - finasteride tablets usp, 5 mg is 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 is 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 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, exposure of women —risk to male fetus and precautions, information for patients and pregnancy.) in female rats, low

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals inc. - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 5 mg - 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 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 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, exposure of women — risk to male fetus and precautions, information for patients and pregnancy .) in female

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - finasteride, quantity: 5 mg - tablet, film coated - excipient ingredients: magnesium stearate; lauroyl macrogolglycerides; lactose monohydrate; pregelatinised maize starch; microcrystalline cellulose; sodium starch glycollate type a; titanium dioxide; hypromellose; macrogol 6000; indigo carmine aluminium lake - finasteride gh 5 5 mg is indicated for the treatment of patients with symptomatic benign prostatic hyperplasia (bph) with an enlarged prostate.

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - finasteride, quantity: 1 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; sodium starch glycollate type a; magnesium stearate; lauroyl macrogolglycerides; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; iron oxide red - finasteride gh 1 mg is indicated for the treatment of male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss in men 18 years or older. efficacy has not been demonstrated in men over the age of 41 years. finasteride gh 1 mg is not indicated for use in women (see use in pregnancy and clinical studies) or children.

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 5 mg - 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 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 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 pre