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

mylan institutional llc - hydroxyprogesterone caproate (unii: 276f2o42f5) (hydroxyprogesterone - unii:21807m87j2) - hydroxyprogesterone caproate 250 mg in 1 ml - hydroxyprogesterone caproate injection, usp is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (stage iii or iv); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation. hydroxyprogesterone caproate is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug. hydroxyprogesterone caproate is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders.

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

slayback pharma 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-s

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

ani pharmaceuticals, inc. - hydroxyprogesterone caproate (unii: 276f2o42f5) (hydroxyprogesterone - unii:21807m87j2) - hydroxyprogesterone caproate 250 mg in 1 ml

United States - English - 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,

United States - English - 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.

United States - English - 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,

United States - English - 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,

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

slayback pharma 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, usp 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-sensit

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

auromedics pharma 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 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

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

auromedics pharma 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 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