More Information About - Napro-A plus 500 mg 500 MG+20 MG
Description
Generic Name
Esomeprazole + Naproxen
Precaution
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.
? 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
Dose
N/A
Side Effect
In general,The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
Pregnancy Category
Name :
Not Classified
Description
FDA has not yet classified the drug into a specified pregnancy category.
Mode 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.
Interaction
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.
Pregnancy Category Note
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
Adult Dose
Rheumatoid Arthritis, Osteoarthritis, Alkylosing Spondylitis, and dysmenorrhoea:
375/20 or 500/20 mg, one tablet twice daily.
Child Dose
N/A
Renal Dose
N/A
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.
Disclaimer
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