Australia - English - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - sumatriptan succinate, quantity: 70 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; lactose; titanium dioxide; hypromellose; iron oxide red; iron oxide black; macrogol 400 - for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.

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

sun pharmaceutical industries, inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 100 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: 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 deliveries to women w

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

northstar rx llc - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 25 mg - sumatriptan 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, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks. - sumatriptan is not indicated for the prevention of migraine attacks. - safety and effectiveness of sumatriptan tablets have not been established for cluster headache. sumatriptan 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 associated with other cardiac accessory conduction pathway disorders [see warnings and precautions (5.2)] - history of stroke or transient isc

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

hikma pharmaceutical - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan succinate 25 mg

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

proficient rx lp - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - 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 : sumatriptan injection is contraindicated in patients with: pregnancy category c. there are no adequate and well-controlled trials of sumatriptan injection 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 injection 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

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

nucare pharmaceuticals,inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 100 mg - sumatriptan tablets, usp 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 tablets, usp, reconsider the diagnosis of migraine before sumatriptan tablets, usp are administered to treat any subsequent attacks. - sumatriptan tablets, usp are not indicated for the prevention of migraine attacks. - safety and effectiveness of sumatriptan tablets, usp have not been established for cluster headache. sumatriptan 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 associated with other cardiac accesso

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

proficient rx lp - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 50 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

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - sumatriptan succinate, quantity: 139.98 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hypromellose; microcrystalline cellulose; lactose monohydrate; magnesium stearate; titanium dioxide - sumatrip tablets are indicated for the acute relief of migraine attacks with or without aura.

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - sumatriptan succinate, quantity: 69.99 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; hypromellose; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; triacetin; iron oxide red - sumatrip tablets are indicated for the acute relief of migraine attacks with or without aura.

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

asclemed usa, inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 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, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. • sumatriptan tablets are not indicated for the prevention of migraine attacks. • safety and effectiveness of sumatriptan tablets have not been established for cluster headache. sumatriptan 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 associated with other cardiac accessory conduction pathway disorders [see warnings and precautions (