Naprozen S Tablet

Indications

• For the acute treatment of migraine attacks with or without aura in adults and pediatric patients 12 years of age and older.
• Relieves migraine symptoms such as headache, nausea, vomiting, and sensitivity to light or sound.
• Not indicated for migraine prevention, cluster headaches, or hemiplegic/basilar migraines.

Mechanism of Action

• Sumatriptan: Acts as a selective 5HT1-receptor agonist, constricting dilated cranial blood vessels and inhibiting the release of pro-inflammatory neuropeptides, alleviating migraine pain.
• Naproxen: Inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, which decreases inflammation and pain associated with migraines.
• The combination provides synergistic relief by targeting multiple pathways involved in migraine pathogenesis.

Dosage and Administration

• Adults:
  • Recommended dose: 1 tablet (sumatriptan 85 mg/naproxen 500 mg) orally at the onset of migraine symptoms.
  • Maximum dose: 2 tablets in a 24-hour period, taken at least 2 hours apart.
  • Use only if a clear migraine diagnosis is established.
  • Safety of treating more than 5 migraines in a 30-day period has not been established.
• Pediatric Patients (12 years and older):
  • Initial dose: 1 tablet (sumatriptan 10 mg/naproxen 60 mg, where available) or 1 tablet (sumatriptan 85 mg/naproxen 500 mg).
  • Maximum dose: 1 tablet (sumatriptan 85 mg/naproxen 500 mg) in a 24-hour period.
  • Do not take a second dose without consulting a doctor.
• Administration:
  • Swallow the tablet whole with water; do not crush, chew, or break.
  • Can be taken with or without food.
  • Store at room temperature (68°F to 77°F / 20°C to 25°C) in a cool, dry place, protected from light and moisture.

Contraindications

• Hypersensitivity to sumatriptan, naproxen, or any tablet excipients.
• Ischemic coronary artery disease (e.g., angina, myocardial infarction) or coronary artery vasospasm.
• History of stroke, transient ischemic attack, hemiplegic or basilar migraine.
• Wolff-Parkinson-White syndrome or arrhythmias.
• Recent use (within 24 hours) of ergotamine-containing drugs, other triptans, or within 2 weeks of monoamine oxidase (MAO)-A inhibitors.
• Severe hepatic impairment or creatinine clearance <30 mL/min.
• Use in the setting of coronary artery bypass graft (CABG) surgery.
• Asthma, urticaria, or allergic reactions triggered by aspirin or other NSAIDs.

Warnings and Precautions

• Cardiovascular Risks: Increased risk of serious cardiovascular events (e.g., myocardial infarction, stroke), especially with prolonged use or in patients with cardiovascular risk factors.
• Gastrointestinal Risks: NSAIDs may cause serious GI bleeding, ulceration, or perforation, particularly in older adults or those with a history of GI issues.
• Serotonin Syndrome: Rare but serious risk when combined with other serotonergic drugs (e.g., SSRIs, SNRIs).
• Medication Overuse Headache: Overuse (e.g., >10 days/month) may worsen headaches, requiring detoxification.
• Renal/Hepatic Impairment: Use cautiously; contraindicated in severe cases.
• Sodium Content: Contains ~71–90 mg sodium per tablet, relevant for patients on sodium-restricted diets.
• Pregnancy and Breastfeeding:
  • Avoid in the last trimester due to risks of fetal harm and prolonged labor.
  • Use in early pregnancy only if benefits outweigh risks.
  • Passes into breast milk; avoid breastfeeding for 12 hours after dosing.

Common Side Effects

• Nausea, dizziness, heartburn, chest discomfort
• Dry mouth, drowsiness, weakness
• Muscle stiffness, numbness/tingling, hot flashes
• Chest, neck, throat, or jaw pain/tightness (usually transient)

Serious Side Effects (Seek Immediate Medical Attention)

• Signs of heart attack or stroke (e.g., chest pain, shortness of breath, weakness, slurred speech).
• Severe allergic reactions or DRESS syndrome (e.g., rash, fever, swelling).
• GI bleeding (e.g., black/tarry stools, vomit resembling coffee grounds).
• Serotonin syndrome (e.g., agitation, hallucinations, rapid heartbeat).
• Liver or kidney issues (e.g., dark urine, jaundice, swelling).