Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NAPROXEN SODIUM
SUNWARD PHARMACEUTICAL SDN. BHD.
NAPROXEN SODIUM
1000 Tablets; 100 Tablets; 500 Tablets; 250 Tablets; 200 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
PLEASE REFER TO COLUMN E12 Read the complete document
SUNPROX / SUNPROX 550 TABLET Each tablet contains: Sunprox Tablet Sunprox 550 Tablet Naproxen sodium 275mg 550mg equivalent to Naproxen 250mg 500mg PHARMACOLOGY Naproxen sodium is a non-steroidal anti-inflammatory drug with analgesic and antipyretic activity. The exact mechanisms of action have not been clearly established, but many of the actions appear to be associated principally with the inhibition of prostaglandin synthesis. Naproxen inhibits the synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase, an enzyme that catalyzes the formation of prostaglandin precursors (endoperoxides) from arachidonic acid. Prostaglandins appear to sensitize pain receptors to mechanical stimulation and to other chemical mediators (e.g. bradykinin, histamine). Naproxen sodium is rapidly and completely absorbed from the gastrointestinal tract. After administration of naproxen sodium, peak plasma levels of naproxen anion are attained in 1 to 2 hours, with steady state conditions normally achieved after 4 –5 doses. The mean biological half-life of the anion in humans is approximately 13 hours and at the therapeutic levels it is greater than 99% albumin bound. Approximately 95% of the dose is excreted in the urine, primarily as naproxen, 6-0-desmethylnaproxen or their conjugates. The rate of excretion has been found to coincide closely with the rate of drug disappearance from the plasma. INDICATIONS Naproxen sodium is indicated in the relief of mild to moderate pain and for the treatment of primary dysmenorrhea. It is also indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis and bursitis and acute gout. SIDE-EFFECTS / ADVERSE REACTIONS Adverse reactions to naproxen mainly involve the GI tract. Constipation, heartburn, abdominal pain and nausea occur in about 3- 9% of patients receiving the drug. Less frequently, dyspepsia, diarrhea, stomatitis, vomiting, anorexia and flatulence occur. Naproxen may reactivate latent peptic ulcer and may cause peptic ulcers in pat Read the complete document