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dr. reddy's laboratories limited - 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)]. - his

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mylan pharmaceuticals inc. - 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: sumatriptan tablets are contraindicated in patients with: 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 range

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

nucare pharmaceuticals,inc. - 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: - 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)

aidarex pharmaceuticals llc - 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: - 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 accessory conduction pathway disorders [see warnings an

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

direct rx - 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, 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 a

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

proficient rx lp - 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:  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

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

preferred pharmaceuticals inc. - 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: 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

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

teva pharmaceuticals usa inc - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 4 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)] . - history of stroke or transient ischemic attack (tia) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see warnings and precautions (5.4)] . - peripheral vascular disease [see warnings and precautions (5.5)]. - ischemic bowel disease [see warnings and precautions (5.5)] . - uncontrolled hypertension [see warnings and precautions (5.8)]. - recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-ht1 ) agonist [see drug interactions (7.1, 7.3)]. - concurrent administration of a monoamine oxidase (mao-)-a inhibitor or recent (within 2 weeks) use of an mao-a inhibitor [see drug interactions (7.2), clinical pharmacology (12.3)]. - hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see warnings and precautions (5.9)]. - severe hepatic impairment [see clinical pharmacology (12.3)] . pregnancy category c. there are no adequate and well-controlled trials of sumatriptan injection in pregnant women. in development 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 rats was 60 mg/kg/day, or approximately 100 times the single maximum recommended human dose (mrhd) of 6 mg administered subcutaneously 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 and 0.75 mg/kg/day, or approximately 50 and 2 times, respectively, the single mrhd of 6 mg administered subcutaneously on a mg/m2 basis. 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 80 times the single mrhd of 6 mg administered subcutaneously 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 100 times the single mrhd of 6 mg administered subcutaneously 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 160 times the single mrhd of 6 mg administered subcutaneously on a mg/m2 basis. sumatriptan is excreted in human milk following subcutaneous administration. infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with sumatriptan injection. safety and effectiveness in pediatric patients have not been established. sumatriptan injection is not recommended for use in patients younger than 18 years of age. two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 pediatric migraineurs 12 to 17 years of age who treated a single attack. the trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in pediatric patients. 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 sumatriptan (25 to 100 mg) in pediatric patients 12 to 17 years of age enrolled a total of 701 pediatric migraineurs. these trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in pediatric patients. 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 pediatric patients. postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. 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 sumatriptan; 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 sumatriptan are not presently available. clinical trials of sumatriptan injection did not include sufficient numbers of patients 65 years of age 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 sumatriptan injection [see warnings and precautions (5.1)]. these instructions apply to both the 4 mg and 6 mg dose sumatriptan injection (autoinjector). make sure that you have the dose that has been prescribed for you (the 4 mg autoinjector safety cap is yellow, the 6 mg autoinjector safety cap is blue). read this patient instructions for use before you start to use your autoinjector. there may be new information. this information does not take the place of talking with your healthcare provider about your medical condition or treatment. you and your healthcare provider should talk about sumatriptan injection when you start taking it and at regular checkups. each autoinjector is a single dose, disposable device. important things that you need to know: - use the autoinjector immediately once the cap has been removed; it is advised not to postpone the injection. - keep the autoinjector out of reach of children. - if you have any further questions, ask your doctor or pharmacist. getting ready for the injection: - wash your hands thoroughly. - before injecting, identify an area with an adequate fatty tissue layer on the outer thigh or back of the arm. - do not inject into areas where the skin is tender, bruised, red, or hard. - ask your healthcare provider if you have a question about where to inject your medicine. - clean the skin area to be injected with alcohol and cotton wipe. do not touch this area again before giving the injection. step 1: inspect viewing window - check the viewing window; make sure the window is clear. see figure b. - do not inject the solution if it looks discolored or cloudy or contains lumps, flakes, or particles. - do not remove safety cap until you are ready to give an injection. - do not touch the blue injection button on top of the autoinjector until ready to inject. - a tamper-evident seal can be found on the flat side of the autoinjector at the safety cap. do not use the autoinjector if this safety seal is broken. step 2: remove safety cap - twist and remove the safety cap. see figure c. - the autoinjector is ready only when the safety cap is removed. step 3: insert the needle - without pressing the blue button , place the needle guard against the injection site at a 90° angle. see figure d. - to insert the needle, firmly push the autoinjector against the skin until the needle guard is pushed in as far as it will go. see figure e. you may feel the needle being inserted as you push. figures f or g: injection sites. step 4: inject the drug - while holding the autoinjector firmly against the skin, push the blue button until you hear an audible "click" signaling the start of the injection. hold the blue button for 5 seconds to complete the injection. see figure h. step 5: confirm successful injection - after 5 seconds , carefully remove the autoinjector from the injection site. - the needle guard should automatically cover the needle and lock in this position. see figure i. - the viewing window will be blue confirming the injection is complete. see figure i. - if the viewing window is not blue, do not try to use the autoinjector again. - do not repeat the injection using a new autoinjector. step 6: dispose of sumatriptan injection (autoinjector) - ​discard the whole autoinjector after use. - do not attempt to reuse the autoinjector this instructions for use has been approved by the u.s. food and drug administration. manufactured in israel for: antares pharma, inc. ewing, nj 08628 distributed by: teva pharmaceuticals usa, inc. north wales, pa 19454 05/2018 lb-0065 v03

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

sun pharmaceutical industries, inc. - 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)]. - his

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

preferred pharmaceuticals, inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 100 mg - sumatriptan tablets 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