Indications

It is indicated for the relief of signs and symptoms of osteoarthritis, rehumatoid arthritis and ankylosing spondylitis, dysmenorrhoea and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID induced gastric ulcers.

Dosage

Carefully consider the potential benefits and risks of Naproflex and other treatment options before deciding to use Naproflex. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. lf a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis and Dysmenorrhoea  Naproflex 375/20  mg, Naproflex 500/20  mg 1 tablet twice daily Do not split, chew, crush or dissolve the tablet. Naproflex is to be taken at least 30 minutes before meals. 

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 and 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 Renat 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 and consider a possible dose reduction based on the naproxen component of Naproflex. Naproflex 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.
 

Interaction

w Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors,
 diuretics, and beta-blockers
w Concomitant use of Progesic and warfarin may result in increased risk of bleeding
 complications.
w 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)

Contraindications

w Known hypersensitivity to any component of Naproflex or substituted benzimidazoles
w History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
w Use during the peri-operative period in the setting of coronary artery bypass graft (CABG)
 surgery
w Late pregnancy
 

Side Effects

In general, Naproflex is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain and nausea etc.
 

Pregnancy & Lactation

ln pregnancy: Pregnancy category C. In late pregnancy, it should be avoid because it may cause premature closure of the ductus arteriosus.
In Lactation: Naproflex should not be used in nursing mothers due to the Naproxen component. 
 

Precautions & Warnings

Patients with known CV disease/risk factors may be at greater risk. Naproflex should be used with caution in patients with fluid retention or heart failure.

Overdose Effects

There is no clinical data on overdosage with Naproflex.
Overdose of Naproxen: Significant Naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.