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Rizatriptan Benzoate

RIZATRIPTAN BENZOATE

Manufacturer: Cipla USA Inc.

Score: 142.0

Quick Summary

Rizatriptan Benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. The recommended starting dose is either 5 mg or 10 mg for adults, and 5 mg for pediatric patients weighing less than 40 kg and 10 mg for those weighing 40 kg or more. The maximum daily dose should not exceed 30 mg in any 24-hour period. Rizatriptan Benzoate is contraindicated in patients with ischemic heart disease, coronary artery vasospasm, history of stroke or transient ischemic attack, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, and recent use of another 5-HT1 agonist or ergotamine-containing medication.

Key Clinical Findings and Indications

  • Acute treatment of migraine with or without aura in adults and pediatric patients 6 to 17 years of age
  • Selective 5-HT 1B/1D receptor agonist

Important Safety Information

Warning

Rizatriptan Benzoate may cause serious cardiovascular side effects, including myocardial infarction, stroke, and vasospasm. It is contraindicated in patients with certain cardiovascular conditions.

Contraindications

  • Ischemic heart disease or coronary artery vasospasm
  • History of stroke or transient ischemic attack
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent use of another 5-HT1 agonist or ergotamine-containing medication

Adverse Reactions

  • Asthenia/fatigue
  • Somnolence
  • Pain/pressure sensation
  • Dizziness
  • Nausea
  • Dry mouth

Dosing Recommendations

General Guidance

The dose of Rizatriptan Benzoate should be adjusted in propranolol-treated patients, and the maximum daily dose should not exceed 30 mg in any 24-hour period.

Migraine

Adult Dose

5 mg or 10 mg single dose

Pediatric Dose

5 mg for patients weighing less than 40 kg, 10 mg for patients weighing 40 kg or more

Special Population Considerations

Pregnancy

  • Available human data are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage
  • Developmental toxicity was observed in animal studies

Nursing Mothers

  • There are no data on the presence of Rizatriptan Benzoate in human milk
  • Rizatriptan was excreted in rat milk

Pediatric Use

  • Safety and effectiveness in pediatric patients under 6 years of age have not been established
  • The efficacy and safety of Rizatriptan Benzoate in the acute treatment of migraine in patients aged 6 to 17 years was established in an adequate and well-controlled study

Geriatric Use

  • Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
  • Dose selection for an elderly patient should be cautious, starting at the low end of the dosing range