Napro-A Plus 500 mg+20 mg Tablet

Napro-A Plus 500 mg+20 mg Tablet (Delayed Release)

DESCRIPTION

NAPRO-A Plus (Naproxen & Esomeprazole) is a combination of an immediate release Esomeprazole Magnesium layer on an entericcoated (EC) Naproxen core. As a result, Esomeprazole is released first in the stomach, prior to the dissolution of Naproxen in the small intestine. The enteric coating prevents Naproxen release at PH levels below 5 providing protection against possible local gastric toxicity.

Naproxen is a non-steroidal anti-inflammatory drug (NSAID) used as an analgesic and antipyretic. Naproxen is a propionic acid derivative and it inhibits the synthesis of prostaglandins, primarily by inhibiting the enzyme cyclo-oxygenase. Esomeprazole is a proton pump inhibitor and the S-isomer of Omeprazole. It suppresses gastric acid secretion by inhibiting the proton pump in the gastric parietal cell thus reducing gastric acidity.

COMPOSITION

NAPRO-A Plus 375: Each tablet contains delayed release Naproxen

BP 375 mg and immediate release Esomeprazole Magnesium

Trihydrate BP equivalent to Esomeprazole 20 mg.

NAPRO-A Plus 500: Each tablet contains delayed release Naproxen

BP 500 mg and immediate release Esomeprazole Magnesium

Trihydrate BP equivalent to Esomeprazole 20 mg.

INDICATIONS

NAPRO-A Plus (Naproxen & Esomeprazole) is indicated for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk for developing NSAIDassociated gastric ulcers.

DOSAGE AND ADMINISTRATION

The usual recommended dose for NAPRO-A Plus:

Recommended

Strength Medical Condition

Recommended (and

Maximum) Dose per day

NAPRO-A Plus 375 Osteoarthritis, Rheumatoid

Arthritis, Ankylosing

Spondylitis and

Dysmenorrhoea

Twice daily

NAPRO-A Plus 500

The tablet must be swallowed whole with water but not be split, chewed, crushed or dissolved. NAPRO-A Plus should be taken at least 30 minutes before meal.

Geriatric use (>65 years)

Patients older than 65 years and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs. The incidence of these adverse reactions increases with dose and duration of treatment. For such patients, to minimize the potential risk for an

adverse event, the lowest effective dose should be used for the shortest possible duration.

Patients with renal impairment

In patients with mild to moderate renal impairment

Naproxen/Esomeprazole should be used cautiously and renal function should be monitored closely. This preparation is contraindicated in patients with severe renal impairment or deteriorating renal disease.

Patients with hepatic impairment In patients with mild to moderate hepatic impairment

Naproxen/Esomeprazole should be used cautiously and hepatic function should be monitored closely. This preparation is contraindicated in patients with severe hepatic impairment.

Children (<18 years)

Naproxen-Esomeprazole is not recommended for use in children under 18 years of age.

Or as directed by the physician.

SIDE EFFECTS

In general, NAPRO-A Plus is well tolerated. Most common side effects seen with this combination are erosive gastritis, dyspepsia, gastritis, upper abdominal pain, diarrhea, gastric ulcer, nausea, constipation etc.

CONTRAINDICATIONS

Naproxen-Esomeprazole combination is contraindicated in:

 Patients with known hypersensitivity to Naproxen, Esomeprazole, substituted benzimidazoles or to any of the components/ excipients

 Patients with severe uncontrolled heart failure, inflammatory bowel disease, history of asthma, urticaria, or allergic-type reactions after taking Acetylsalicylic acid or other NSAIDs

 Patients with active gastric/duodenal/peptic ulcer, active GI bleeding, cerebrovascular bleeding or other bleeding disorders

 The peri-operative period in the setting of Coronary Artery Bypass Graft (CABG) surgery.

PRECAUTIONS

Caution should be exercised in prescribing NSAIDs such as Naproxen to any patient with ischemic heart disease, cerebrovascular disease and/or congestive heart failure (NYHA II-IV).

USE IN PREGNANCY AND LACTATION

It is contraindicated in the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and prolonged parturition.

Caution should be exercised in prescribing this combination during the first and second trimesters of pregnancy.

DRUG INTERACTIONS

Concomitant use NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics and beta-blockers. Concomitant use with methotrexate may increase methotrexate toxicity and with warfarin may result in increase risk of bleeding complications. Esomeprazole inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric PH is an important determinant of bioavailability (eg.

Ketoconazole, Iron salts and Digoxin).

SUPPLY

NAPRO-A Plus 375: Each box contains 3X10 tablets in alu-alu blister strips.

NAPRO-A Plus 500: Each box contains 3X10 tablets in alu-alu blister strips.