Each capsule contains: Mefenamic Acid BP 500 mg.
Non-Steroidal Anti-Inflammatory Drug (NSAIDs).
Pharmacology: Mechanism of Action: Mefenamic Acid has analgesic, anti-inflammatory and antipyretic properties. It is a derivative of N-phenyl anthranilic acid. Mefenamic acid shows central as well as peripheral analgesia. It is an inhibitor of cyclo-oxygenase. It also antagonizes certain effects of prostaglandins.
Mefenamic acid is used in painful and inflammatory conditions and relief of mild to moderate pain including: Headache; Dental pain; Post operative and postpartum pain and dysmenorrhea.
It is also used in: Musculoskeletal and joint disorders: Such as osteoarthritis and rheumatoid arthritis; Menorrhagia; Soft tissue injuries; Still's disease.
Administration is by oral route, preferably with food.
Regimen for acute pain: Adults and children over 14 yrs of age: 500 mg as an initial dose followed by 250 mg every 6 hrs as needed.
Suggested dose for children is 25 mg/kg body wt/day.
Regimen for primary dysmenorrhea: 500 mg as an initial dose followed by 250 mg every 6 hrs; starting with onset of bleeding and associated symptoms.
(Clinical studies indicate that effective treatment can be initiated with start of menses and should not be necessary for more than 2 to 3 days).
Treatment should not be continued for longer than 7 days.
Although doses up to 6,000 mg/day have been given, no specific information is available on the management of acute massive overdosage.
Should accidental overdosage occur, the stomach should be emptied by inducing emesis or by careful gastric lavage followed by the administration of activated charcoal.
Contraindicated in patients hypersensitive to it or any other NSAIDs, patients with previous or active ulceration or chronic inflammation of either upper and lower gastrointestinal tract. Use with caution in patients with cardiac, liver and renal disease. Dose adjustment like using the lowest effective dose and monitoring of renal and liver functions should be instituted.
Absolute contraindications: Not to be given to those patients who have history of: Stroke: cerebrovascular accident, CVA; Heart attack: Myocardial infarction, MI; Coronary artery bypass graft: CABG; Uncontrolled hypertension; Congestive heart failure (CHF) NYHA II-IV.
Do not take for pain for more than 10 days or for fever more than 3 days, unless directed by physician. May cause problems in unborn child or complications during delivery.
Mefenamic acid should not be given in patients with inflammatory bowel disease and nursing mothers. Patients who develop diarrhea or rash while receiving Mefenamic acid should discontinue therapy.
The most common adverse effects are gastrointestinal disturbances including diarrhea, nausea, vomiting & abdominal pain.
Reaction like headache, drowsiness, nervousness are reported.
Hemotological reactions: thrombocytopenia, leukopenia, pancytopenia, agranulocytosis, and bloody dyscrasias.
Gastrointestinal disorders: anorexia, abdominal pain.
Allergic reactions: skin rashes and other allergic reactions.
Store at temperatures not exceeding 30°C.
M01AG01 - mefenamic acid ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, fenamates.