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

mylan pharmaceuticals inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 mg - rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. limitations of use: rizatriptan benzoate tablets are contraindicated in patients with: available human data on the use of rizatriptan benzoate tablets in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. in animal studies, developmental toxicity was observed following oral administration of rizatriptan during pregnancy (decreased fetal body weight in rats) or throughout pregnancy and lactation (increased mortality, decreased body weight, and neurobehavioral impairment in rat offspring) at maternal plasma exposures greater than that expected at therapeutic doses in humans [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 rat

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

physicians total care, inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 10 mg - rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for merck & co., inc.’s rizatriptan benzoate tablets. however, due to merck & co., inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. limitations of use rizatriptan benzoate is contraindicated in patients with: there are no adequate and well-controlled studies in pregnant women. rizatriptan benzoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in a general reproductive study in rats, birth weights and pre- and post-weaning weight gain were reduced in the offspring of females treated prior to and during mating and throughout gestation and lactation with doses of 10 and 100 mg/kg/day. in a pre- and postnatal de

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

physicians total care, inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 10 mg - rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for merck & co., inc.’s rizatriptan benzoate orally disintegrating tablets. however, due to merck & co., inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. limitations of use: - rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks. - rizatriptan benzoate orally disintegrating tablets are not indic

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

organon pharma pty ltd - rizatriptan benzoate, quantity: 7.265 mg (equivalent: rizatriptan, qty 5 mg) - wafer - excipient ingredients: glycine; gelatin; mannitol; aspartame; flavour - maxalt is indicated for the acute treatment of migraine attacks with or without aura.

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

remedyrepack inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 10 mg - rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. limitations of use: - rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. - rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see contraindications (4)] . - rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. - safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache. rizatriptan benzoate tablets are contraindicated in patients with: - ischemic coronary artery disease (angina pectori

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

macleods pharmaceuticals limited - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 mg - ri zatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. limitations of use • rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. • rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see contraindications (4)]. • rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. • safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache. rizatriptan benzoate tablets are contraindicated in patients with: • ischemic coronary artery disease (angina pectoris, history of myocardial infarction,

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

direct_rx - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. limitations of use • rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. • rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see contraindications (4)]. • rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. • safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache. rizatriptan benzoate tablets are contraindicated in patients with: • ischemic coronary artery disease (angina pectoris, history of myocardial inf

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

medis pharma pty ltd - rizatriptan benzoate, quantity: 7.265 mg (equivalent: rizatriptan, qty 5 mg) - tablet, orally disintegrating - excipient ingredients: calcium silicate; aspartame; magnesium stearate; mannitol; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; flavour - rizatriptan act is indicated for the acute treatment of migraine attacks with or without aura.

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

par pharmaceutical inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 mg

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

preferred pharmaceuuticals, inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 10 mg