Paincare 375 Tablet
Generic : Naproxen & Esomeprazole
Therapeutic : Naproxen & Esomeprazole
Description :
Paincare consists of an immediate release Esomeprazole Magnesium layer & an enteric coated Naproxen core. As a result Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine. Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATP ase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Indications :
It is indicated for the relief of sign and symptoms of osteoarthritis, rheumatic arthritis and ankylosingspondylities and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers.
Dosage and Administration :
Carefully consider the potential benefits & risks of Paincare& other treatment options before deciding to use Paincare. 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.
1 tablet twice dailyPaincare 500Paincare 375Rheumatoid Arthritis, Osteoarthritis
AnkylosingSpondylitisFrequency
DoseIndication
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 & 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 & consider a possible dose reduction based on the Naproxen component of Paincare. Paincare is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Children: Dosage in children less than 18 years has not been established.
Side Effects :
In general, Paincare is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
Use in Special Group :
Pregnancy : Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductusarteriosus.
Lactation :Paincare should not be used in nursing mothers due to the Naproxen component.
Contraindication :
l Known hypersensitivity to any component of Paincare.
l History of asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
l Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
l Late pregnancy.
Precautions :
Patients with known CV disease/ risk factor may be at greater risk. Paincare should be used with caution in patients with fluid retention or heart failure.
Drug Interaction :
l Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers.
l Concomitant use of Paincare and warfarin may result in increased risk of bleeding complication.
l Esomeprazole inhibits gastric acid secretion & may interfere with absorption of drugs where gastric pH is an important determinant of bioavailability
(eg. Ketoconazole, iron salts and digoxin).
Storage :
Keep away from light & moisture and store below 300 temperature. Keep out of reach of children.
Commercial Pack :
Paincare 375 Tablet : Each box contains 3 X 10 tablets in blister pack.
Paincare 500 Tablet : Each box contains 3 X 10 tablets in blister pack.
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