Treximet

SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM

Manufacturer: Currax Pharmaceuticals LLC

Score: 144.0

Quick Summary

Sumatriptan Succinate and Naproxen Sodium is a combination medication used for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. The medication contains sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist, and naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID). It is contraindicated in patients with certain medical conditions, such as ischemic coronary artery disease, and has important safety information, including the risk of serious cardiovascular and gastrointestinal events. The recommended dosage for adults is 1 tablet of 85/500 mg, with a maximum of 2 tablets in a 24-hour period. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older
Combination of sumatriptan and naproxen sodium

Important Safety Information

Warning

Risk of serious cardiovascular and gastrointestinal events

Contraindications

Ischemic coronary artery disease
History of stroke or transient ischemic attack
Uncontrolled hypertension
Recent use of ergotamine-containing medication or other 5-HT1 agonists
Concurrent administration of a monoamine oxidase (MAO)-A inhibitor
Known hypersensitivity to sumatriptan, naproxen, or any components of the medication

Adverse Reactions

Cardiovascular thrombotic events
Gastrointestinal bleeding, ulceration, and perforation
Arrhythmias
Chest, throat, neck, and/or jaw pain/tightness/pressure
Cerebrovascular events

Dosing Recommendations

General Guidance

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals

Migraine

Adult Dose

1 tablet of 85/500 mg

Pediatric Dose

1 tablet of 10/60 mg for patients 12 to 17 years of age

Special Population Considerations

Pregnancy

Use of NSAIDs, including Sumatriptan and Naproxen Sodium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction
Avoid use at about 30 weeks gestation and later in pregnancy

Nursing Mothers

Caution should be exercised when administering Sumatriptan and Naproxen Sodium to nursing mothers

Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been established
Recommended dosage for pediatric patients 12 to 17 years of age is 1 tablet of 10/60 mg

Geriatric Use

Elderly patients are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions
Not recommended for use in elderly patients with decreased renal function or higher risk for unrecognized CAD