Estados Unidos - inglés - NLM (National Library of Medicine)

asclemed usa, inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions: - progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. - known liver dysfunction or disease. - known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

asclemed usa, inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions: - progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. - known liver dysfunction or disease. - known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions: - progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. - known liver dysfunction or disease. - known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions: - progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. - known liver dysfunction or disease. - known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions:

Estados Unidos - inglés - NLM (National Library of Medicine)

aurobindo pharma limited - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions: - progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. - known liver dysfunction or disease. - known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

prasco laboratories - hydroxyprogesterone caproate (unii: 276f2o42f5) (hydroxyprogesterone - unii:21807m87j2) - hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. the effectiveness of hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation. there are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. limitation of use : while there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. it is not intended for use in women with multiple gestations or other risk factors for preterm birth. do not use hydroxyprogesterone caproate in women with any of the following conditions: - current or history of thrombosis or thromboembolic disorders - known or suspected breast cancer, other hormone-sensitive cancer,

Estados Unidos - inglés - NLM (National Library of Medicine)

american regent, inc. - hydroxyprogesterone caproate (unii: 276f2o42f5) (hydroxyprogesterone - unii:21807m87j2) - hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. the effectiveness of hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation. there are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. limitation of use : while there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. it is not intended for use in women with multiple gestations or other risk factors for preterm birth. do not use hydroxyprogesterone caproate injection in women with any of the following conditions: - current or history of thrombosis or thromboembolic disorders - known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions - undiagnosed abnormal vaginal bleeding unrelated to pregnancy - cholestatic jaundice of pregnancy - liver tumors, benign or malignant, or active liver disease - uncontrolled hypertension risk summary hydroxyprogesterone caproate injection is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. fetal, neonatal, and maternal risks are discussed throughout labeling. data from the placebo-controlled clinical trial and the infant follow-up safety study [see clinical studies (14.1, 14.2)] did not show a difference in adverse developmental outcomes between children of hydroxyprogesterone caproate injection-treated women and children of control subjects. however, these data are insufficient to determine a drug-associated risk of adverse developmental outcomes as none of the hydroxyprogesterone caproate injection-treated women received the drug during the first trimester of pregnancy. in animal reproduction studies, intramuscular administration of hydroxyprogesterone caproate to pregnant rats during gestation at doses 5 times the human dose equivalent based on a 60-kg human was not associated with adverse developmental outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data reproduction studies of hydroxyprogesterone caproate administered to various animal species have been reported in the literature. in nonhuman primates, embryolethality was reported in rhesus monkeys administered hydroxyprogesterone caproate up to 2.4 and 24 times the human dose equivalent, but not in cynomolgus monkeys administered hydroxyprogesterone caproate at doses up to 2.4 times the human dose equivalent, every 7 days between days 20 and 146 of gestation. there were no teratogenic effects in either strain of monkey. reproduction studies have been performed in mice and rats at doses up to 95 and 5, respectively, times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to hydroxyprogesterone caproate. risk summary low levels of progestins are present in human milk with the use of progestin-containing products, including hydroxyprogesterone caproate. published studies have reported no adverse effects of progestins on the breastfed child or on milk production. hydroxyprogesterone caproate injection is not indicated for use in women under 16 years of age. safety and effectiveness in patients less than 16 years of age have not been established. a small number of women under age 18 years were studied; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and older [see clinical studies ( 14 )]. no studies have been conducted to examine the pharmacokinetics of hydroxyprogesterone caproate injection in patients with hepatic impairment. hydroxyprogesterone caproate injection is extensively metabolized and hepatic impairment may reduce the elimination of hydroxyprogesterone caproate injection.

Estados Unidos - inglés - NLM (National Library of Medicine)

american regent, inc. - hydroxyprogesterone caproate (unii: 276f2o42f5) (hydroxyprogesterone - unii:21807m87j2) - hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. the effectiveness of hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation. there are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. limitation of use : while there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. it is not intended for use in women with multiple gestations or other risk factors for preterm birth. do not use hydroxyprogesterone caproate injection in women with any of the following conditions: - current or history of thrombosis or thromboembolic disorders - known or suspected breast cancer, other hormone-sensitive cancer,

Estados Unidos - inglés - NLM (National Library of Medicine)

amneal pharmaceuticals of ny llc - hydroxyprogesterone caproate (unii: 276f2o42f5) (hydroxyprogesterone - unii:21807m87j2) - hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. the effectiveness of hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation. there are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. limitation of use : while there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. it is not intended for use in women with multiple gestations or other risk factors for preterm birth. do not use hydroxyprogesterone caproate injection in women with any of the following conditions: - current or history of thrombosis or thromboembolic disorders - known or suspected breast cancer, other hormone-sensitive cancer,