Sumatriptan Succinate

SUMATRIPTAN SUCCINATE

Manufacturer: RPK Pharmaceuticals, Inc.

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 in a 24-hour period. 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 recent use of ergotamine-containing medication or another 5-HT 1 agonist. 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 events, including myocardial infarction, arrhythmias, and cerebral vasospasm. It may also cause serotonin syndrome, especially when used with other serotonergic agents.

Contraindications

Ischemic coronary artery disease
Wolff-Parkinson-White syndrome
History of stroke or transient ischemic attack
Peripheral vascular disease
Ischemic bowel disease
Uncontrolled hypertension
Recent use of ergotamine-containing medication or another 5-HT 1 agonist

Adverse Reactions

Myocardial ischemia
Myocardial infarction
Arrhythmias
Chest, throat, neck, and/or jaw pain/tightness/pressure
Cerebrovascular events
Other vasospasm reactions
Medication overuse headache
Serotonin syndrome
Increase in blood pressure
Hypersensitivity reactions
Seizures

Dosing Recommendations

General Guidance

The maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment.

Migraine with or without aura

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
Oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel abnormalities

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 prior to receiving sumatriptan tablets