| DESCRIPTION |
Naprox® is a preparation of naproxen, a member of the arylacetic acid group of nonsteroidal anti-inflammatory agent (NSAIDs). It is an inhibitor of prostaglandin synthesis, which exhibits anti-inflammatory, analgesic and antipyretic activity. |
| INDICATIONS |
Naprox® is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendonitis, bursitis, and acute gout. It is also indicated for the relief of mild to moderate pain, and the treatment of primary dysmenorrhoea. |
| DOSAGE AND ADMINISTRATION |
Naprox® oral preparations should be taken with liquid preferably after meals.
Naprox® enteric coated tablet
Adult:
For rheumatoid arthritis/ osteoarthritis/ ankylosing spondylitis:
500-1000 mg per day taken in two devided doses at 12- hour intervals. The maintenance dose is usually 500 mg per day taken in two devided doses at 12 –hour intervals.
The total daily dose of naproxen should not exceed 1000 mg maintaining 12-hour interval adminisrtration.
For acute gout:
750 mg should be given initially, followed in 8 hours with 500 mg, and thereafter 250 mg at 8- hour intervals until the attack has subsided.
For dysmennorhoea:
500 mjg should be given initially, followed by 250 mg at 6-8 hour intervals for upto 5 days, if necessary.
For other indications like analgesia and acute musculoskeletal disorders:
500 mg should be given initially, followed by 250 mg at 6-8 hour intervals, if necessary.
Naprox® Suspension
Children:
For juvenile rheumatoid arthritis:
The usual dose for children over 5 years is 10 mg/kg/day given as two divided doses at 12-hour intervals. Therapy in children under 5 years of age is not recommended or as directed by the physician.
The following may be used as a guide for dosage of suspension:
| Child’s weight |
Dose |
|
13 kg
|
2.5 ml b.i.d |
| 25 kg |
5 ml b.i.d |
| 38 kg |
7.5 ml b.i.d |
Or as directed by the physician.
Naprox® Gel
Apply to affected area not more than 2 to 6 times daily, or as directed by the physician.
|
| CONTRAINDICATIONS |
It is contraindicated in acute peptic ulcer or if there is any hypersensitivity to naproxen. Naproxen should not be given to patients in whom aspirin or other nonsteroidal anti-inflammatory/ analgesic drugs induce asthma, rhinitis or urticaria. |
| USE IN PREGNANCY AND LACTATION |
As with other medicines of this type, Naprox® produces delay in parturition in animals, and also affects the human foetal cardiovascular system (closure of ductus arteriosus). Therefore, naproxen should not be used during pregnancy unless clearly needed. Naproxen anion has been found in the milk of lactating women. Because of the adverse effects of prostaglandin- inhibiting drugs on neonates, use in nursing mother should be avoided. |
| PRECAUTIONS |
Naprox® should be given with precautions if there is any gastrointestinal diseases, bronchial asthma, allergic diseases, impaired renal function etc. |
| SIDE-EFFECTS |
The more frequent reactions are nausea, vomiting, abdominal discomfort and epigastric distress, skin rashes, urticaria, angioedema, alopecia, erythema multiforme, stevens Johnson syndrome, epidermal necrolysis, photosensitivity reactions, headache, insomnia, cognitive dysfunction, thrombocytopenia, aplastic anemia, haemolytic anemia etc. The more serious reactions like gastrointestinal bleeding, peptic ulceration, haemorrhage and perforation, colitis etc may occur occasionally. |
| OVERDOSE |
Significant over dosage of the drug may be characterized by drowsiness, heartburn, indigestion, and nausea or vomiting. It is not known what doses of the drug would be life threatening. |
| PHARMACEUTICAL PRECAUTION |
Store in a cool, dry place, away from light. Keep out of reach of children. |
| PACKAGING |
Naprox® 250 mg tablet: Box containing 5 strips of 10 tablets each. Each enteric-coated tablet contains naproxen BP 250 mg.
Naprox® 500 mg tablet: Box containing 5 strips of 10 tablets each. Each enteric-coated tablet contains naproxen BP 500 mg.
Naprox® suspension: Bottle containing 50 ml oral suspension. Each 5 ml contains naproxen BP 125 mg.
Naprox® gel: Tube containing 15 g gel. Each gram gel contains Naproxen BP 100 gm.

Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK |
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