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

preferred pharmaceuticals inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: sumatriptan succinate tablets are contraindicated in patients with: risk summary data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see data). in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the reported rate of major birth defects among

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

nucare pharmaceuticals,inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: - use only if a clear diagnosis of migraine headache has been established. if a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. - sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. - safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache. sumatriptan succinate tablets are contraindicated in patients with: - ischemic coronary artery disease (cad) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including prinzmetal's angina [see warnings and precautions ( 5.1)] - wolff-parkinson-white syndrome or arrhythmias assoc

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

preferred pharmaceuticals inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: sumatriptan succinate tablets are contraindicated in patients with: risk summary data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see data). in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the reported rate of major birth defects among

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

proficient rx lp - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: sumatriptan succinate tablets are contraindicated in patients with: risk summary data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see data). in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the reported rate of major birth defects among

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

quality care products, llc - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan succinate tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. in addition, patients with other significant underlying cardiovascular diseases should not receive sumatriptan succinate tablets. ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina such as the prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see warnings). because sumatriptan succinate tablets may increase blood pressure, they should not be given to patients with uncontrolled hypertension. concurrent administration of mao-a inhibitors or use within 2 weeks of discontinuation of mao-a inhibitor therapy is cont

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

proficient rx lp - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: sumatriptan succinate tablets are contraindicated in patients with: risk summary data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see data). in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the reported rate of major birth defects among

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

proficient rx lp - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: sumatriptan succinate tablets are contraindicated in patients with: risk summary data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see data). in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the reported rate of major birth defects among

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

auromedics pharma llc - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 6 mg in 0.5 ml - sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. limitations of use: - use only if a clear diagnosis of migraine or cluster headache has been established. if a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. - sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks. sumatriptan injection is contraindicated in patients with: - ischemic coronary artery disease (cad) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including prinzmetal’s angina [see warnings and precautions (5.1)]. - wolff-parkinson-white syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see warnings and precautions (5.2)]. -

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

hikma pharmaceuticals usa inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 6 mg in 0.5 ml - sumatriptan injection, usp is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. limitations of use: - use only if a clear diagnosis of migraine or cluster headache has been established. if a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, usp, reconsider the diagnosis before sumatriptan injection, usp is administered to treat any subsequent attacks. - sumatriptan injection, usp is not indicated for the prevention of migraine or cluster headache attacks. sumatriptan injection is contraindicated in patients with: - ischemic coronary artery disease (cad) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including prinzmetal’s angina [see warnings and precautions (5.1)] . - wolff-parkinson-white syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see warnings and precau

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

proficient rx lp - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 25 mg - sumatriptan tablets, usp are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: sumatriptan tablets are contraindicated in patients with: teratogenic effects pregnancy category c: there are no adequate and well-controlled trials in pregnant women. in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal. sumatriptan tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. the highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day, or approximately 3 times the maximum re