Generic Name

Naproxen Sodium; Sumatriptan Succinate

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Classification

FDA Approved Indications

• Migraine relieving and preventing migraines with or without aura

Mechanism of Action

Naproxen sodium inhibits cyclooxygenase enzymes (COX-1 and COX-2), reducing prostaglandin synthesis. Sumatriptan is a selective 5-HT1B/1D receptor agonist that causes vasoconstriction of intracranial blood vessels and inhibits neuropeptide release, thereby alleviating migraine symptoms.

Dosage and Administration

Adult: Typically 85 mg/500 mg orally at onset of migraine, can repeat after 12 hours if needed, max 2 tablets per day.

Pediatric: Not generally recommended for children; consult specific guidelines.

Geriatric: Dose may need adjustment due to increased risk of adverse effects; start at lower end of dosing range.

Renal Impairment: Use with caution; may require dose adjustments or avoidance in severe impairment.

Hepatic Impairment: Use with caution; dose adjustment recommended.

Pharmacokinetics

Absorption: Rapidly absorbed, peak plasma levels in about 1-2 hours.

Distribution: Naproxen approximately 99% bound to plasma proteins, sumatriptan approximately 14% bound.

Metabolism: Naproxen mainly metabolized in the liver; sumatriptan metabolized via monoamine oxidase (MAO-A).

Excretion: Renal excretion of unchanged drugs and metabolites.

Half Life: Naproxen approx. 12-17 hours; sumatriptan approx. 2 hours.

Contraindications

• History of cardiovascular disease, uncontrolled hypertension, cerebrovascular disease, or history of stroke.
• Allergy to NSAIDs or triptans.
• Use within 24 hours of other triptans or ergotamines.

Precautions

• Use with caution in patients with risk factors for cardiovascular disease, hepatic or renal impairment, or those with predisposition to cerebrovascular events.

Adverse Reactions - Common

• Naproxen sodium: gastrointestinal upset, nausea, dyspepsia, dizziness. (Common)
• Sumatriptan: sensation of tingling, warm or cold sensations, pressure or tightness in chest/arms/neck. (Common)

Adverse Reactions - Serious

• Cardiovascular events (angina, myocardial infarction). (Serious but rare, especially in patients with risk factors.)
• Serotonin syndrome — when combined with other serotonergic drugs. (Rare.)

Drug-Drug Interactions

• Other NSAIDs, anticoagulants, SSRIs, other serotonergic drugs, triptans, ergot alkaloids.

Drug-Food Interactions

• Avoid alcohol which increases gastrointestinal bleeding risk.

Drug-Herb Interactions

• St. John's Wort (risk of serotonin syndrome).

Nursing Implications

Patient/Family Teaching

• Take at first sign of migraine attack.
• Do not exceed recommended dose.
• Report chest pain, unusual symptoms, or signs of serotonin syndrome.
• Avoid activities requiring alertness if dizziness occurs.

Special Considerations

Black Box Warnings:

• Serious cardiovascular and cerebrovascular events. Use only when clearly indicated.
• Serotonin syndrome risk.

Genetic Factors: Genetic predispositions to enzyme polymorphisms affecting drug metabolism.

Lab Test Interference: None significant.

Overdose Management

Signs/Symptoms: Dizziness, drowsiness, nausea, vomiting, increased blood pressure, signs of serotonin syndrome like agitation, hallucinations, hyperthermia.

Treatment: Supportive care, activated charcoal if early, and management of symptoms. Cardiac monitoring if needed.

Storage and Handling

Storage: Store at room temperature, away from moisture and light.

Stability: Stable for the duration of the labeled expiration date.