Regulatory Information
SUNWARD PHARMACEUTICAL PRIVATE LIMITED
SUNWARD PHARMACEUTICAL PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**Dosage:** Oral administration. The recommended regimen in acute pain for adults and children over 14 years of age is 500mg as an initial dose followed by 250mg every six hours as needed, usually not to exceed one week. For the treatment of primary dysmenorrhoea, the recommended dosage is 500mg as an initial dose followed by 250mg every 6 hours, starting with the onset of bleeding and associated symptoms. Mefenamic acid should not be used for more than 7 days at a time. After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.
ORAL
Medical Information
**Indications:** Mefenamic acid is indicated for the treatment of primary dysmenorrhoea and the relief of moderate pain when therapy will not exceed one week.
**Contraindications:** Mefenamic acid should not be used in patients who have previously exhibited hypersensitivity to it. Because the potential exists for cross-sensitivity to aspirin or other NSAIDs, mefenamic acid should not be given to patients in whom these drugs induce symptoms of bronchospasm, allergic rhinitis or urticaria. Mefenamic acid is contraindicated in patients with active ulceration or chronic inflammation of either the upper or lower gastrointestinal tract. Mefenamic acid should be avoided in patients with pre existing renal disease. Since mefenamic acid is eliminated primarily by the kidneys, the drug should not be administered to patients with significantly impaired renal function. NSAIDS, including mefenamic acid, are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
M01AG01
mefenamic acid
Manufacturer Information
SUNWARD PHARMACEUTICAL PRIVATE LIMITED
SUNWARD PHARMACEUTICAL PRIVATE LIMITED
Active Ingredients
Documents
Package Inserts
Fenagesic Tablet 500mg PI.pdf
Approved: May 26, 2022