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unichem pharmaceuticals (usa), inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 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. 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 indicated for use in the management of hemiplegic or basilar migraine [see contraindications (4)] . -   rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. -   safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache. rizatri

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

cipla usa 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 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 has not been established for cluster headache. rizatriptan benzoate tablets are contraindicated in patients with: - ischemic coronary artery disease (angina pectoris, history of

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

panacea biotec limited - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 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. 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, usp, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, usp are administered to treat any subsequent attacks. - rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see  contraindications (4)] . - rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. - safety and effectiv

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

ascend laboratories, llc - 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 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  i

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

bionpharma inc., - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 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. 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, usp, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, usp are administered to treat any subsequent attacks. - rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see  contraindications (4)] . - rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. - safety and effectiv

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

macleods pharmaceuticals limited - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 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. 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 tablets are administered to treat any subsequent attacks. • rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see contraindications (4)]. • rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. • safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache. rizatriptan benzoate o

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

jubilant cadista 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 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 is contraindicated in patients with: - ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent

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

camber 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. information related 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 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

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