Iisrael - inglise - Ministry of Health

abic marketing ltd, israel - finasteride - film coated tablets - finasteride 1 mg - finasteride - finasteride - finasteride teva 1 mg is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.

Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

psm healthcare ltd trading as api consumer brands - finasteride 1mg - film coated tablet - 1 mg - active: finasteride 1mg excipient: docusate sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry brown 03a86790 pregelatinised maize starch purified water sodium starch glycolate - pharmacare finasteride 1 mg film coated tablets: finasteride is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. finasteride is not indicated for use in women (see warnings and precautions, pregnancy) or children. finasteride is not effective in postmenopausal women with androgenetic alopecia.

Ameerika Ühendriigid - inglise - 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)] .

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

ascend laboratories, llc - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 1 mg - 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

Ameerika Ühendriigid - inglise - 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 is 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 inhibi

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

rising health, llc - 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. 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 admi

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

legacy pharmaceutical packaging, llc - 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 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)].

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

avpak - 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 administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of bph (a confirmed greater than or equal to 4 point increase in american urological association (aua) symptom score). finasteride is not approved for the prevention of prostate cancer. 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 5α-dihydrotestosterone (dht), finasteride may cause abnormalities of the external genitalia of a male fetus of a p

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

mckesson packaging services business unit of mckesson corporation - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 5 mg - finasteride 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 doses of finasterid

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - 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: 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: [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 app