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Fenagesic

Capsule / 250 Tablet / 500 Tablet
Capsule : 250mg of Mefenamic Acid per capsule

Tablet : 250 or 500mg Mefenamic Acid per tablet

Pharmacodynamics
It is a nonsteroidal agent with demonstrated anti-inflammatory, analgesic and antipyretic activity in animal studies. It was found to inhibit prostaglandin synthesis and to compete for binding at the prostaglandin receptor site. Its exact mode of action is not known.

Pharmacokinetics
Following a single one gram oral dose, peak plasma level of 10 ug/ml occurred in 2 to 4 hours with a half-life of 2 hours. Following multiple doses, plasma levels are proportional to dose with no evidence of drug accumulation. One gram of Mefenamic Acid given four times daily produces peak blood level of 20 ug/ml by the second day of administration. Following a single dose, sixty-seven percent of the total dose is excreted in the urine as unchanged drug or as one of two metabolites. Twenty to twenty-five percent of the dose is excreted in the faeces during the first three days.

Indications
Mefenamic Acid is indicated for the treatment of primary dysmenorrhea and the relief of moderate pain when therapy will not exceed one week.

Adverse effects
Mefenamic Acid may give rise to occasional gastro-intestinal upsets or rashes. Gastro-intestinal haemorrhage may rarely occur. Other haematological effects include haemolytic anaemia, agranulocytosis, pancytopenia, thrombocytopenia, thrombocytopenic purpura and bone marrow aplasia.


The occurrence of diarrhoea or skin rash is an indication for discontinuing treatment.

Precautions / Warnings
Cardiovascular Thrombotic Events
Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, principally myocardial infarction, which may increase with dose or duration of use. Patients with cardiovascular disease or cardiovascular risk of an adverse cardiovascular event in patient taking NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration.


There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.

Hypertension
NSAIDs may lead to the onset of new hypertension or worsening the pre-existing hypertension and patients taking antihypertensive with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.

Heart Failure
Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure.

Gastrointestinal Events
All NSAIDs can cause gastrointestinal discomfort and rarely serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation which may increase with dose or duration of use, but can occur at any time without warning. Caution is advised in patients with risk factors for gastrointestinal events e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism. When gastrointestinal bleeding or ulcerations occur in patients receiving NSAIDs, the drug should be withdrawn immediately. Doctors should warn patient about signs and symptoms of serious gastrointestinal toxicity. The concurrent use of aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.

Severe Skin Reactions
NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash or any other sign of hypersensitivity.

Mefenamic Acid should be used with caution in patients with impaired renal function or a history of kidney or liver disease and it may exacerbate asthma and hypertension.


Caution should be observed when anti-coagulant is administered concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDS), to be certain that no change in anticoagulation dosage is required. In addition to specific drug interactions that might affect prothrombin time, NSAIDs can inhibit platelet aggregation, and can cause gastrointestinal bleeding, peptic ulceration and /or perforation.


Safety and effectiveness in children below the age of 14 have not been established.


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