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

remedyrepack 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)

xlcare 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. 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 reactions, angioedema) t

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

bryant ranch prepack - 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 reactions, angioedema) t

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

bryant ranch prepack - 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. 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)

aurobindo pharma limited - 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. 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

Malta - English - Medicines Authority

pharmaceutical works polpharma sa 19 pelplinska steet, 83-200 starogard gdanski, poland - dutasteride, tamsulosin hydrochloride - hard capsule - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals

Malta - English - Medicines Authority

doc generici srl via turati, 40-20121, milano, italy - dutasteride, tamsulosin hydrochloride - hard capsule - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals

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

a-s medication solutions - 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, usp is contraindicated for use in: - pregnancy. in animal reproduction and developmental toxicity studies, dutasteride, usp inhibited development of male fetus external genitalia. therefore, dutasteride, usp may cause fetal harm when administered to a pregnant woman. if dutasteride, usp is used during pregnancy or if the patient becomes pregnant while taking dutasteride, usp, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.4), use in s

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

a-s medication solutions - 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