AGUSTA
NAPROXEN AND ESOMEPRAZOLE · by MCOLSON
Composition
Tab 375/20 mg: Delayed Release Naproxen USP 375 mg and Immediate Release Esomeprazole 20 mg. Tab 500/20 mg: Delayed Release Naproxen USP 500 mg and Immediate Release Esomeprazole 20 mg
Indications & Dosage
Pain of osteoarthritis, rheumatoid arthritis & ankylosing spondylitis in patients at risk of developing NSAID associated gastric ulcers: Adult: 375/20 mg to 500/20 mg twice daily. Reduced dose in elderly patients.
Contraindications
Hypersensitivity to any component of medicines or substituted benzimidazoles, history of asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs, during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery, late pregnancy, hepatic, and renal failure.
Precautions
Allergic disorders, cardiac impairment, cerebrovascular disease, coagulation defects, connective-tissue disorders, Crohn-s disease, elderly, heart failure, ischaemic heart disease, peripheral arterial disease, risk factors for cardiovascular events, uncontrolled hypertension, renal or hepatic impairment, monitor on long-term therapy, asthma.
Interactions
Anticoagulants, antiplatelets, hydantoins, sulfo-nylureas, quinolones, sulphonamides, diuretics, lithium, beta-blockers, probenecid, methotrexate, cyclosporin, corticosteroids, SSRIs, cardiac glycosides, mifepristone, tacrolimus, zidovudine, other NSAIDs.
Pregnancy
Contraindicated in pregnancy
Lactation
Contraindicated
Side Effects
Angioedema, blood disorders, bronchospasm, colitis, Crohns disease, depression, diarrhoea, dizziness, drowsiness, fluid retention, haematuria, headache, hypersensitivity reactions, nausea, nervousness, photosensitivity, raised blood pressure, rashes, renal failure, tinnitus, vertigo. Rare: Hepatic damage, interstitial fibrosis associated with NSAIDs, Stevens-Johnson syndrome, toxic epidermal necrolysis, visual disturbances, exacerbation of symptoms in asthma, thrombocytopenia, aseptic meningitis, CNS disturbances.