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

glaxosmithkline australia pty ltd - dutasteride, quantity: 500 microgram; tamsulosin hydrochloride, quantity: 400 microgram - capsule, modified release - excipient ingredients: maize starch; carrageenan; gelatin; purified talc; butylated hydroxytoluene; iron oxide yellow; titanium dioxide; iron oxide red; glycerol; medium chain triglycerides; potassium chloride; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); purified water; triethyl citrate; lecithin; glyceryl caprylate/caprate; sunset yellow fcf; carnauba wax; hypromellose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - duodart is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (bph).

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

glaxosmithkline australia pty ltd - dutasteride, quantity: 500 microgram; tamsulosin hydrochloride, quantity: 400 microgram - capsule, modified release - excipient ingredients: maize starch; carrageenan; gelatin; purified talc; butylated hydroxytoluene; iron oxide yellow; titanium dioxide; iron oxide red; glycerol; medium chain triglycerides; potassium chloride; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); purified water; triethyl citrate; lecithin; glyceryl caprylate/caprate; sunset yellow fcf; carnauba wax; hypromellose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - doubluts is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (bph).

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

epic pharma, llc - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - dutasteride 0.5 mg - dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with an enlarged prostate to: dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride capsules are not approved for the prevention of prostate cancer. dutasteride capsules are contraindicated for use in: risk summary dutasteride is contraindicated for use in pregnancy because it may cause harm to the male fetus [see contraindications (4)]. dutasteride is not indicated for use in women. dutasteridem is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (dht), a hormone necessary for normal development of male genitalia. abnormalities in the genitalia of male fetuses is an expected physiological consequence of inhibition of this conversion. these results are similar to observations in male infants with genetic 5 alpha-reductase deficienc

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

par pharmaceutical, inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - dutasteride 0.5 mg - dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in: - pregnancy. dutasteride use is contraindicated in females who are pregnant. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, dutasteride and tamsulosin hydrochloride capsules may cause fetal harm when administered to a pregnant female. [see warnings and precautions (5.6), use in specific populations (8.1) ] . - patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any other component o

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

prasco laboratories - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - dutasteride 0.5 mg - dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in: pregnancy category x. there are no adequate and well-controlled studies in pregnant women with the fixed-dose formulation of dutasteride and tamsulosin hydrochloride capsules or its individual components. dutasteride dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. dutasteride is a 5-alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (dht), a hormone necessary for normal development of male genitalia. in animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male fetuses. therefore, dutasteride may

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

actavis pharma, inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - dutasteride 0.5 mg - dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in: - pregnancy. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, dutasteride and tamsulosin hydrochloride capsules may cause fetal harm when administered to a pregnant woman. if dutasteride and tamsulosin hydrochloride capsules are used during pregnancy, or if the patient becomes pregnant while taking dutasteride and tamsulosin hydrochloride capsules, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.6), use in specific populations (8.1)] . - women of childbearing potential [see warnings and precautions (5.6), use

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

strides pharma science limited - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - dutasteride 0.5 mg - dutasteride capsules 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 (aur), and - reduce the risk of the need for bph-related surgery. dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride is not approved for the prevention of prostate cancer. dutasteride is contraindicated for use in: -   pregnancy. dutasteride use is contraindicated in women who are pregnant. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, dutasteride may cause fetal harm when administered to a pregnant woman [see warnings and precautions (5.4), use in specific populations (8.1)] . -   patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reaction

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

apotex corp. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - dutasteride 0.5 mg - dutasteride capsules 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 (aur), and - reduce the risk of the need for bph-related surgery. dutasteride capsules in combination with the alpha adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride capsules are not approved for the prevention of prostate cancer. dutasteride capsules are contraindicated for use in: - pregnancy. dutasteride use is contraindicated in women who are pregnant. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, dutasteride capsules may cause fetal harm when administered to a pregnant woman [see warnings and precautions (5.4), use in specific populations (8.1)]. - patients with previously demonstrated clinically significant hypersensitivity (e.g.,

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

amneal pharmaceuticals llc - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - dutasteride 0.5 mg - dutasteride capsules 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 (aur), and - reduce the risk of the need for bph-related surgery. dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride capsules are not approved for the prevention of prostate cancer. dutasteride is contraindicated for use in: - pregnancy. dutasteride use is contraindicated in women who are pregnant. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, dutasteride may cause fetal harm when administered to a pregnant woman [see warnings and precautions (5.4), use in specific populations (8.1)] . - patients with previously demonstrated clinically significant hypersensitivity (e.g., serious skin reac

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

rising pharmaceuticals, inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - dutasteride 0.5 mg - dutasteride (dutasteride) soft gelatin capsules 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 (aur), and - reduce the risk of the need for bph-related surgery. dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride is not approved for the prevention of prostate cancer. dutasteride is contraindicated for use in: - pregnancy. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, dutasteride may cause fetal harm when administered to a pregnant woman. if dutasteride is used during pregnancy or if the patient becomes pregnant while taking dutasteride, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.4), use in specific population