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SUMATRIPTAN

SUMATRIPTAN

Manufacturer: Padagis Israel Pharmaceuticals Ltd

Score: 141.0

Quick Summary

Sumatriptan is a selective 5-HT 1B/1D receptor agonist used for the acute treatment of migraine with or without aura in adults. It is available in 25 mg, 50 mg, and 100 mg tablets. The recommended dose is 25 mg, 50 mg, or 100 mg, with a maximum daily dose of 200 mg. Sumatriptan is contraindicated in patients with ischemic coronary artery disease, Wolff-Parkinson-White syndrome, history of stroke or transient ischemic attack, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, and severe hepatic impairment. Common adverse reactions include paresthesia, warm/cold sensation, chest pain/tightness/pressure, and vertigo. Special population considerations include use in pregnancy, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Acute treatment of migraine with or without aura in adults
  • Selective 5-HT 1B/1D receptor agonist
  • Available in 25 mg, 50 mg, and 100 mg tablets

Important Safety Information

Warning

Sumatriptan may cause serious cardiovascular and cerebrovascular events, including myocardial infarction, stroke, and transient ischemic attack.

Contraindications

  • Ischemic coronary artery disease
  • Wolff-Parkinson-White syndrome
  • History of stroke or transient ischemic attack
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Severe hepatic impairment

Adverse Reactions

  • Paresthesia
  • Warm/cold sensation
  • Chest pain/tightness/pressure
  • Vertigo

Dosing Recommendations

General Guidance

The maximum daily dose is 200 mg in a 24-hour period. A second dose should only be considered if some response to the first dose was observed, and doses should be separated by at least 2 hours.

Migraine

Adult Dose

25 mg, 50 mg, or 100 mg

Pediatric Dose

Not recommended for use in patients younger than 18 years of age

Special Population Considerations

Pregnancy

  • Sumatriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • There are no adequate and well-controlled trials in pregnant women

Nursing Mothers

  • 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 tablets

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established
  • Sumatriptan tablets are not recommended for use in patients younger than 18 years of age

Geriatric Use

  • Clinical trials of sumatriptan tablets did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients
  • A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors

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