Pongesic

Pongesic is a round, yellow, film-coated tablet with characteristic markings.
Each film-coated tablet contains mefenamic acid 250 mg.

Mefenamic acid has analgesic, anti-inflammatory and antipyretic properties. It is an inhibitor of cyclo-oxygenase, resulting in decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid. Also, mefenamic acid has been shown to inhibit competitively the actions of prostaglandins.

Indicated for short-term use (7 days or less) for the relief of mild to moderate pain including headache, dental pain, postoperative and postpartum pain and dysmenorrhoea. It is also used in musculoskeletal and joint disorders such as osteoarthritis and rheumatoid arthritis. Mefenamic acid may also be used in menorrhagia.

Usual adult dose: Analgesic or anti-dysmenorrhoeal: 500 mg initially, followed by 250 mg every 6 hours as needed. It is recommended that mefenamic acid be used for no longer than 7 days at a time.
Usual paediatric dose: Children up to 14 years of age: Safety and efficacy have not been established.

Symptoms: Extended effect of the adverse reactions. Gastrointestinal haemorrhage, acute renal failure, convulsions, coma and hypoprothrombinaemia have been reported following overdose.
Treatment: Empty the stomach via induction of emesis (in alert patients only) or gastric lavage. Syrup of ipecac may induce symptoms similar to those of NSAID toxicity, which may complicate diagnosis, and therefore, not recommended for induction of emesis.
Administering activated charcoal.
Monitoring and supporting vital functions.
Instituting symptomatic and other supportive treatment.
Administering as required plasma volume expanders for severe hypotension, diazepam (5 to 10 mg for adults or 0.1 to 0.3 mg per kg bodyweight for children) or other appropriate benzodiazepine anticonvulsant for convulsions; Vitamin K1 (10 to 20 mg intravenously) for hypoprothrombinaemia, and/or dopamine (2.5 mcg per kg bodyweight per minute) plus dobutamine (5 to 40 mcg per kg bodyweight per minute) intravenously, to prevent or reverse early indications of renal failure.

Mefenamic acid is contraindicated in active peptic ulceration; inflammatory bowel disease; patients with hypersensitivity including asthma, urticaria, rhinitis; and in nursing and pregnant women.

Risk of GI Ulceration, Bleeding and Perforation with NSAID: Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms. In patients observed in clinical trials of several months to 2 years duration, symptomatic upper GI ulcers, gross bleeding or perforation occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for 1 year. Higher percentages have been reported by other independent studies. Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with poor history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.
Measurers such as the use of physical therapy and mild analgesics like paracetamol (when inflammation is not a major factor) should be instituted prior to initiation of therapy with NSAIDs. NSAIDs should only be used after proper appraisal of potential risk to patients. It should be used with the lowest effective dose for only as long as needed. This drug should not be co-administered with other NSAIDs. Prescribers should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur. In considering the use of relatively large doses (within the recommended dosage range) sufficient benefit should offset the potential increased risk of GI toxicity.

Caution should be exercised when used in the elderly, patients with bronchospasm, bleeding disorders, cardiovascular disease, and in liver or renal failure.
Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency require local synthesis of vasodilating prostaglandins to maintain renal perfusion, and therefore, these patients are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.
Patients who develop diarrhoea or rash while receiving mefenamic acid should discontinue therapy.

The commonest adverse effects occurring with mefenamic acid are gastrointestinal disturbances including diarrhoea, nausea, vomiting, and abdominal pain. Peptic ulceration and gastrointestinal bleeding have also been reported.
Headache, drowsiness, dizziness, nervousness, and visual disturbances have been reported. There may be hypersensitivity reactions including skin rashes and urticaria, and occasionally allergic glomerulonephritis; asthma may be precipitated.
Reported haematological effects include haemolytic anaemia, agranulocytosis, pancytopenia, thrombocytopenia or thrombocytopenic purpura and bone marrow aplasia. Renal failure, glomerulonephritis and papillary necrosis have been reported. Therapy should be discontinued if diarrhoea or skin rash occur.

Notable interactions involving NSAIDs include possible enhancement of the effects of oral anticoagulants and increased plasma concentrations of lithium, methotrexate, and cardiac glycosides. The risk of nephrotoxicity may be increased if given with angiotensin-converting enzyme inhibitors, cyclosporin, or diuretics. There may also be an increased risk of hyperkalaemia with angiotensin-converting enzyme inhibitors and potassium-sparing diuretics. The antihypertensive effects of some antihypertensive agents including angiotensin-converting enzyme inhibitors, beta blockers, and diuretics may be reduced. Convulsions may occur due to an interaction with quinolones. NSAIDs may enhance the effects of phenytoin and sulphonylurea anti-diabetics. The concomitant use of more than one NSAID should be avoided because of the increased risk of adverse effects. The risk of gastrointestinal bleeding and ulceration associated with NSAIDs is increased when used with corticosteroids. Some NSAIDs can interfere with thyroid function tests by lowering serum thyroid hormone concentrations.

Store below 25°C.
Protect from light.
Keep container tightly closed.
Shelf Life: 36 months.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AG01 - mefenamic acid ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, fenamates.

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