Anaflex Max 375 mg Tablet: Each delayed release tablet contains Naproxen BP 375 mg and Esomeprazole 20 mg as Magnesium Trihydrate USP.
Anaflex Max 500 mg Tablet: Each delayed release tablet contains Naproxen BP 500 mg and Esomeprazole 20 mg as Magnesium Trihydrate USP.
Anaflex Max is a preparation of Naproxen and Esomeprazole. Naproxen is a NSAID with analgesic and antipyretic properties. The mechanism of action of Naproxen is like that of other NSAIDs, related to prostaglandin synthetase inhibition. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Carefully consider the potential benefits and risks of Anaflex Max and other treatment options before deciding to use Anaflex Max. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and dysmenorrhoea : Anaflex Max 375 or 500 one tablet twice daily or as directed by the physician. Do not split, chew, crush, or dissolve the tablet. Anaflex Max is to be taken at least 30 minutes before meals.
Elderly patients : Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.
Patients with moderate to severe renal impairment : Naproxen containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance < 30 ml/min).
Hepatic insufficiency : Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of Anaflex Max. This combination is not recommended in patients with severe hepatic impairment because esomeprazole dosage should not exceed 20 mg daily in these patients.
NSAIDs with antiplatelets or anticoagulants heighten bleeding risk; methotrexate and lithium levels increase; esomeprazole reduces absorption of ketoconazole, itraconazole, and iron salts; clopidogrel antiplatelet activation may be diminished; rifampin reduces esomeprazole exposure.
Contraindicated in known hypersensitivity to any component of this combination or substituted benzimidazoles, history of asthma, urticaria or other allergic type reactions after taking aspirin or other NSAIDs, use during the peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery and late pregnancy.
Common: Erosive gastritis, dyspepsia, esophagitis, diarrhea, gastric ulcer, upper abdominal pain, nausea.
Overdose
There is no clinical data on overdosage with this combination. Overdose of naproxen: significant naproxen overdose may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, and vomiting. Overdose of esomeprazole: the major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions.
Category C (1st/2nd trimesters), Category D (3rd trimester). Contraindicated in late pregnancy due to premature closure of ductus arteriosus. Lactation: Excreted in breast milk; avoid in nursing mothers.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep container tightly closed.