Naproxen and Sumatriptan

Sumatriptan and Naproxen Sodium Tablets is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Sumatriptan and Naproxen Sodium Tablets is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. Not indicated for the prophylactic therapy of migraine attacks. Not indicated for the treatment of cluster headache.

Sumatriptan and Naproxen Sodium Tablets contains sumatriptan and naproxen. Sumatriptan binds with high affinity to cloned 5-HT 1B / 1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of neuropeptide release. Sumatriptan and Naproxen Sodium Tablets has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Sumatriptan and Naproxen Sodium Tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen is a potent inhibitor of prostaglandin synthesis in vitro. Naproxen concentrations reached during therapy have produced in vivo effects.

Adults Recommended dosage: 1 tablet of 85/500 mg. Maximum dosage in a 24-hour period: 2 tablets of 85/500 mg, separate doses by at least 2 hours. Pediatric Patients 12 to 17 years of Age Recommended dosage: 1 tablet of 10/60 mg. Maximum dosage in a 24-hour period: 1 tablet of 85/500 mg. Mild to Moderate Hepatic Impairment Recommended dosage: 1 tablet of 10/60 mg.

Sumatriptan and Naproxen Sodium Tablets is contraindicated in the following patients: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina. In the setting of coronary artery bypass graft (CABG) surgery. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [s ee Warnings and Precautions ]. Peripheral vascular disease. Ischemic bowel disease.

Boxed warning: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Sumatriptan and Naproxen Sodium Tablets is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Cardiovascular Thrombotic Events: Perform cardiac evaluation in patients with cardiovascular risk factors. Arrhythmias: Discontinue Sumatriptan and Naproxen Sodium Tablets if occurs. Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure: Generally not associated with myocardial ischemia, evaluate for coronary artery disease in patients at high risk. Cerebrovascular Events: Discontinue Sumatriptan and Naproxen Sodium Tablets if occurs.

The following serious adverse reactions are described below and elsewhere in labeling: Cardiovascular Thrombotic Events GI Bleeding, Ulceration and Perforation Arrhythmias Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Cerebrovascular Events Other Vasospasm Reactions Hepatotoxicity Hypertension Heart Failure and Edema Medication Overuse Headache Serotonin Syndrome Renal Toxicity and Hyperkalemia Anaphylactic Reactions Serious Skin Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Hematological Toxicity Exacerbation Asthma Related to Aspirin Sensitivity Seizures The most common adverse reactions (incidence ≥2%) were: Adults: Dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth. Pediatrics: Hot flush (i.e., hot flash[es]) and muscle tightness.

Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking Sumatriptan and Naproxen Sodium Tablets with drugs that interfere with hemostasis. Concomitant use of Sumatriptan and Naproxen Sodium Tablets and analgesic doses of aspirin is not generally recommended. ACE Inhibitors and ARBs: Concomitant use with Sumatriptan and Naproxen Sodium Tablets in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. Diuretics: NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.

Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). Do not repackage, dispense and store in original container with desiccant.