Canada - English - Health Canada

endo pharmaceuticals inc. - frovatriptan (frovatriptan succinate) - tablet - 2.5mg - frovatriptan (frovatriptan succinate) 2.5mg - selective serotonin agonists

Canada - English - Health Canada

apotex inc - frovatriptan (frovatriptan succinate monohydrate) - tablet - 2.5mg - frovatriptan (frovatriptan succinate monohydrate) 2.5mg - selective serotonin agonists

Canada - English - Health Canada

mint pharmaceuticals inc - frovatriptan (frovatriptan succinate) - tablet - 2.5mg - frovatriptan (frovatriptan succinate) 2.5mg - selective serotonin agonists

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

glenmark pharmaceuticals inc., usa - frovatriptan succinate (unii: d28j6w18hy) (frovatriptan - unii:h82q2d5wa7) - frovatriptan 2.5 mg - frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use frovatriptan succinate tablets are contraindicated in patients with: risk summary there are no adequate data on the developmental risk associated with the use of frovatriptan in pregnant women. in animal studies, frovatriptan produced developmental toxicity (embryofetal lethality, fetal abnormalities, and decreased embryofetal growth) when administered to pregnant rats and rabbits at doses greater than those used clinically [see animal 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 published data have suggested that women with migraines may be at increased risk of preeclampsia during pregnancy. data animal data when pregnant rats were administered frovatriptan (oral doses of 0, 100, 500, or 1000 mg/kg/day) throughout organogenesis, increased embryofetal mortality and an increased incidence of fetal malformations were observed at the high dose; decreased fetal body weights and increased incidences of fetal structural variations associated with growth impairment were observed at all doses. the lowest effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) is approximately 130 times the maximum recommended human dose (mrhd) of 7.5 mg/day on a body surface area (mg/m2 ) basis. when pregnant rabbits were administered frovatriptan (oral doses of 0, 5, 20, or 80 mg/kg/day) throughout organogenesis, embryofetal mortality was increased at the mid and high doses. the no-effect dose for embryofetal developmental toxicity in rabbits (5 mg/kg/day) is approximately 13 times the mrhd on a mg/m2 basis. oral administration of frovatriptan (0, 100, 500, or 1000 mg/kg/day) to female rats throughout pregnancy and lactation resulted in increased embryofetal mortality at the high dose. the no effect dose for pre- and postnatal developmental toxicity in rats (500 mg/kg/day) is approximately 650 times the mrhd on a mg/m2 basis. risk summary there are no data on the presence of frovatriptan in human milk, the effects of frovatriptan on the breastfed infant, or the effects of frovatriptan on milk production. in rats, oral dosing with frovatriptan resulted in levels of frovatriptan and/or its metabolites in milk up to four times higher than in plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for frovatriptan and any potential adverse effects on the breastfed infant from frovatriptan or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. therefore, frovatriptan is not recommended for use in patients under 18 years of age. there are no additional adverse reactions identified in pediatric patients based on postmarketing experience that were not previously identified in adults. mean blood concentrations of frovatriptan in elderly patients were 1.5 to 2 times higher than those seen in younger adults [see clinical pharmacology (12.3) ].   no dosage adjustment is necessary. no dosage adjustment is necessary when frovatriptan is given to patients with mild to moderate hepatic impairment. there is no clinical or pharmacokinetic experience with frovatriptan in patients with severe hepatic impairment. because a greater than two-fold increase in auc is predicted in patients with severe hepatic impairment, there is a greater potential for adverse events in these patients, and frovatriptan should therefore be used with caution in that population.

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

amneal pharmaceuticals ny llc - frovatriptan succinate (unii: d28j6w18hy) (frovatriptan - unii:h82q2d5wa7) - frovatriptan 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 has been established. if a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks. - frovatriptan succinate tablets are not indicated for the prevention of migraine attacks. - safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. frovatriptan succinate tablets are contraindicated in patients with: - ischemic coronary artery disease (cad) (e.g., 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, 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 another 5-ht1 agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (dhe) or methysergide [see drug interactions (7.1, 7.2)] . - hypersensitivity to frovatriptan succinate (angioedema and anaphylaxis seen) [see warnings and precautions (5.9)] . risk summary there are no adequate data on the developmental risk associated with the use of frovatriptan succinate in pregnant women.  in animal studies, frovatriptan produced developmental toxicity (embryofetal lethality, fetal abnormalities, and decreased embryofetal growth) when administered to pregnant rats and rabbits at doses greater than those used clinically [see animal 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 published data have suggested that women with migraines may be at increased risk of preeclampsia during pregnancy. data animal data when pregnant rats were administered frovatriptan (oral doses of 0, 100, 500, or 1,000 mg/kg/day) throughout organogenesis, increased embryofetal mortality and an increased incidence of fetal malformations were observed at the high dose; decreased fetal body weights and increased incidences of fetal structural variations associated with growth impairment were observed at all doses.   the lowest effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) is approximately 130 times the maximum recommended human dose (mrhd) of 7.5 mg/day on a body surface area (mg/m2 ) basis.   when pregnant rabbits were administered frovatriptan (oral doses of 0, 5, 20, or 80 mg/kg/day) throughout organogenesis, embryofetal mortality was increased at the mid and high doses. the no-effect dose for embryofetal developmental toxicity in rabbits (5 mg/kg/day) is approximately 13 times the mrhd on a mg/m2 basis. oral administration of frovatriptan (0, 100, 500, or 1000 mg/kg/day) to female rats throughout pregnancy and lactation resulted in increased embryofetal mortality at the high dose. the no effect dose for pre- and postnatal developmental toxicity in rats (500 mg/kg/day) is approximately 650 times the mrhd on a mg/m2 basis. risk summary there are no data on the presence of frovatriptan in human milk, the effects of frovatriptan on the breastfed infant, or the effects of frovatriptan on milk production. in rats, oral dosing with frovatriptan resulted in levels of frovatriptan and/or its metabolites in milk up to four times higher than in plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for frovatriptan succinate and any potential adverse effects on the breastfed infant from frovatriptan or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. therefore, frovatriptan succinate is not recommended for use in patients under 18 years of age. there are no additional adverse reactions identified in pediatric patients based on postmarketing experience that were not previously identified in adults. mean blood concentrations of frovatriptan in elderly patients were 1.5 to 2 times higher than those seen in younger adults [see clinical pharmacology (12.3)] .  no dosage adjustment is necessary. no dosage adjustment is necessary when frovatriptan succinate is given to patients with mild to moderate hepatic impairment. there is no clinical or pharmacokinetic experience with frovatriptan succinate in patients with severe hepatic impairment. because a greater than two-fold increase in auc is predicted in patients with severe hepatic impairment, there is a greater potential for adverse events in these patients, and frovatriptan succinate should therefore be used with caution in that population.

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

mylan pharmaceuticals inc. - frovatriptan succinate (unii: d28j6w18hy) (frovatriptan - unii:h82q2d5wa7) - frovatriptan 2.5 mg - frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use: frovatriptan succinate tablets are contraindicated in patients with: there are no adequate data on the developmental risk associated with the use of frovatriptan succinate tablets in pregnant women. in animal studies, frovatriptan produced developmental toxicity (embryofetal lethality, fetal abnormalities, and decreased embryofetal growth) when administered to pregnant rats and rabbits at doses greater than those used clinically [see animal 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. published data have suggested that wome

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

par pharmaceutical - frovatriptan succinate (unii: d28j6w18hy) (frovatriptan - unii:h82q2d5wa7) - frovatriptan 2.5 mg - frovatriptan 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 has been established. if a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks. use only if a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks. - frovatriptan succinate tablets are not indicated for the prevention of migraine attacks. frovatriptan succinate tablets are not indicated for the prevention of migraine attacks. - safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. safety an

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

ingenus pharmaceuticals, llc - frovatriptan succinate (unii: d28j6w18hy) (frovatriptan - unii:h82q2d5wa7) - frovatriptan 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 has been established. if a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks. - frovatriptan succinate tablets are not indicated for the prevention of migraine attacks. - safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. frovatriptan succinate tablets are contraindicated in patients with: - ischemic coronary artery disease (cad) (e.g., 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

Canada - English - Health Canada

sanis health inc - frovatriptan (frovatriptan succinate) - tablet - 2.5mg - frovatriptan (frovatriptan succinate) 2.5mg

Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle medical unlimited company - frovatriptan succinate monohydrate - film-coated tablet - 2.5 milligram(s) - selective serotonin (5ht1) agonists; frovatriptan