Naproxen BP + Esomeprazole USP
Composition : Napsec-375: Naproxen BP 325 mg + Esomeprazole USP 20 mg Enteric Coated Tablet.
Napsec-500: Naproxen BP 500 mg + Esomeprazole USP 20 mg Enteric Coated Tablet.
Indication : This is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, dysmenorrhoea and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Dosage and administration : Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis : The dosage is one tablet twice daily of 375mg naproxen and 20mg of esomeprazole or 500mg naproxen and 20mg of esomeprazole The tablets are to be swallowed whole with liquid. This drug is to be taken at least 30 minutes before meals. Geriatric 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 elderly patients. 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 .Hepatic Insufficiency: Monitor patients with mild to moderate hepaticimpairment closely and consider a possible dose reduction based on the naproxen component of this drug.It should be avoided in patients with severe hepatic impairment.Paediatric Patients : The safety and efficacy of this drug in children younger than 18 years has not been established. Or, as directed by the registered physician
Pregnancy and lactation :Pregnancy
Category C. In late pregnancy, it should be
avoided because it may cause premature
closure of ductus arteriosus. Lactation :
Naproxen is distributed in breast milk; avoid
use because of prostaglandin inhibition
effects in newborn.
Packing :
Napsec-375 : 3x10's tablets in blister pack.
Napsec-500 : 3x10's tablets blister pack.