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

viona pharmaceuticals inc - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - 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 capsules are 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 populations (8.1)] . - wom

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)

proficient rx lp - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - dutasteride 0.5 mg

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

vensun pharmaceuticals, inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - 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. 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. if dutasteride capsules are used during pregnancy or if the patient becomes pregnant while taking dutasteride capsules, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5

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

nucare pharmaceuticals,inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - 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, 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: - 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 populati

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

remedyrepack inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - 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 populations ( 8.1)] .

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

zydus pharmaceuticals usa inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - 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 of

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

puracap pharmaceutical llc - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - 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: pregnancy category x. dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. dutasteride are 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 cause fetal harm when administered to a pregnant woman. if dutasteride is used during pregnancy or if the patient becomes

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

golden state medical supply, inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - 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)

nucare pharmaceuticals,inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - 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. 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 populations