Esomeprazole + Naproxen

Indications

Esomeprazole + Naproxen is used for: Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Joint stiffness

Adult Dose

Rheumatoid Arthritis, Osteoarthritis, Alkylosing Spondylitis, and dysmenorrhoea: 375/20 or 500/20 mg, one tablet twice daily.

Child Dose

Renal Dose

Administration

The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet.The tablet is to be taken at least 30 minutes before meals.

Contra Indications

• Known hypersensitivity to any component or substituted benzimidazoles • History of asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs • Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery • Late pregnancy

Precautions

Patients with known CV disease/risk factors may be at greater risk. Progesic should be used with caution in patients with fluid retention or heart failure. Lactation: Should not be used in nursing mother.

Pregnancy-Lactation

Pregnancy Use of NSAIDs during third trimester of pregnancy increases risk of premature closure of fetal ductus arteriosus; avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation (third trimester); there are no adequate and well-controlled studies on this therapy in pregnant women There are no studies on effects of therapy during labor or delivery; in animal studies, NSAIDs, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase incidence of stillbirth Lactation Limited data from published literature report that naproxen anion has been found in milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma; esomeprazole is the S-isomer of omeprazole and limited data from published literature suggest omeprazole may be present in human milk; there is no information on effects of naproxen or omeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition Lactation: Naproxen is distributed in breast milk, not recommended

Interactions

Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. May increase serum concentration of tacrolimus, saquinavir, methotrexate. May interfere the elimination of drugs metabolised by CYP2C19 (e.g. diazepam). May decrease the bioavailability of ketoconazole, erlotinib and Fe salts. Potentially Fatal: May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir and nelfinavir. May decrease the antiplatelet effects of clopidogrel.

Adverse Effects

Side effects of Esomeprazole + Naproxen : In general, The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.

Mechanism of Action

Naproxen, a propionic acid derivative, is a prototypical NSAID. It reversibly inhibits the cyclooxygenase-1 and -2 (COX-1 and -2) enzymes, thus resulting in reduced synthesis of prostaglandin precursors. It can inhibit platelet aggregation, has anti-inflammatory, analgesic and antipyretic actions. Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole.