Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - sumatriptan as succinate - film coated tablets - sumatriptan as succinate 100 mg - sumatriptan - sumatriptan - imitrex tablets are indicated for the acute relief of migraine attacks, with or without aura. imitrex should only be used where there is a clear diagnosis of migraine.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - sumatriptan as succinate - film coated tablets - sumatriptan as succinate 50 mg - sumatriptan - sumatriptan - imitrex tablets are indicated for the acute relief of migraine attacks, with or without aura. imitrex should only be used where there is a clear diagnosis of migraine.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

city medical store - sole proprietorship l.l.c france - 20 's (10's blister x 2) - tablet - 25mg/tablet - cardiovascular system-diuretics

Canada - English - Health Canada

glaxosmithkline inc - sumatriptan (sumatriptan succinate) - tablet - 50mg - sumatriptan (sumatriptan succinate) 50mg - selective serotonin agonists

Canada - English - Health Canada

glaxosmithkline inc - sumatriptan (sumatriptan succinate) - tablet - 100mg - sumatriptan (sumatriptan succinate) 100mg - selective serotonin agonists

Canada - English - Health Canada

glaxosmithkline inc - sumatriptan (sumatriptan succinate) - tablet - 25mg - sumatriptan (sumatriptan succinate) 25mg - selective serotonin agonists

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

glaxosmithkline llc - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 25 mg - imitrex tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: imitrex 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 with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk: several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. data human data: the sumatriptan/naratriptan/treximet (sumatriptan and naproxen sodium) pregnancy registry, a population-based international prospective study, collected data for sumatriptan from january 1996 to september 2012. the registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). the occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% ci: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% ci: 2.7% to 6.2%]). the sample size in this study had 80% power to detect at least a 1.73- to 1.91-fold increase in the rate of major malformations. the number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis. no other birth defect was reported for more than 2 infants in this group. in a study using data from the swedish medical birth register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% ci: 0.91 to 1.21]). a study using linked data from the medical birth registry of norway to the norwegian prescription database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (or 1.16 [95% ci: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (or 1.83 [95% ci: 1.17 to 2.88]), each compared with the population comparison group. additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. animal data: 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 recommended human dose (mrhd) of 200 mg/day on a mg/m2 basis. oral administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryolethality and fetal cervicothoracic vascular and skeletal abnormalities. intravenous administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryolethality. the highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 (approximately 2 times the mrhd on a mg/m2 basis) and 0.75 mg/kg/day, respectively. oral administration of sumatriptan to rats prior to and throughout gestation resulted in embryofetal toxicity (decreased body weight, decreased ossification, increased incidence of skeletal abnormalities). the highest no-effect dose was 50 mg/kg/day, or approximately 2 times the mrhd on a mg/m2 basis. in offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. the highest no-effect dose for this effect was 60 mg/kg/day, or approximately 3 times the mrhd on a mg/m2 basis. oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. the highest no-effect dose for this finding was 100 mg/kg/day, or approximately 5 times the mrhd on a mg/m2 basis. risk summary sumatriptan is excreted in human milk following subcutaneous administration (see data) . there is no information regarding sumatriptan concentrations in milk from lactating women following administration of imitrex tablets. there are no data on the effects of sumatriptan on the breastfed infant or the effects of sumatriptan on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for imitrex tablets and any potential adverse effects on the breastfed infant from sumatriptan or from the underlying maternal condition. clinical considerations infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with imitrex tablets. data following subcutaneous administration of a 6-mg dose of imitrex injection in 5 lactating volunteers, sumatriptan was present in milk. safety and effectiveness in pediatric patients have not been established. imitrex tablets are not recommended for use in patients younger than 18 years of age. two controlled clinical trials evaluated imitrex nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack. the trials did not establish the efficacy of imitrex nasal spray compared with placebo in the treatment of migraine in adolescents. adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral imitrex (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. these trials did not establish the efficacy of oral imitrex compared with placebo in the treatment of migraine in adolescents. adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. the frequency of all adverse reactions in these patients appeared to be both dose- and age‑dependent, with younger patients reporting reactions more commonly than older adolescents. postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal imitrex. these reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. a myocardial infarction has been reported in a 14‑year‑old male following the use of oral imitrex; clinical signs occurred within 1 day of drug administration. clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal imitrex are not presently available. clinical trials of imitrex tablets did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. a cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of cad) prior to receiving imitrex tablets [see warnings and precautions (5.1)] . the maximum single dose in patients with mild to moderate hepatic impairment should not exceed 50 mg. imitrex tablets are contraindicated in patients with severe hepatic impairment [see clinical pharmacology (12.3)] .

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

glaxosmithkline llc - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 4 mg in 0.5 ml - imitrex 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 imitrex injection is 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

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

glaxosmithkline llc - sumatriptan (unii: 8r78f6l9vo) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 5 mg - imitrex nasal spray is indicated for the acute treatment of migraine with or without aura in adults. limitations of use: imitrex nasal spray is 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 with mig

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

physicians total care, inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 6 mg in 0.5 ml - imitrex injection is indicated for 1) the acute treatment of migraine attacks with or without aura and 2) the acute treatment of cluster headache episodes. imitrex injection is not for use in the management of hemiplegic or basilar migraine (see contraindications). imitrex injection should not be given intravenously because of its potential to cause coronary vasospasm. imitrex injection 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 imitrex injection. ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, 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 v