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Mefenamic Acid

capsules

 

COMPOSITION
Each capsule contains
Mefenamic Acid 250 mg


PRESENTATION
Powder blue opaque cap and ivory opaque body, size 1 hard gelatin capsule.


INDICATIONS
For the relief of mild to moderate pain including muscular pain, traumatic pain, headaches of most aetiology, dental pain, post-operative and post-partum pain, rheumatoid arthritis (including Still's Disease) and dysmenorrhoea.


ACTION
Mefenamic Acid is an analgesic with anti-inflammatory properties suitable for the treatment of various types of pain encountered in medical practice. A potent antipyretic action has been demonstrated in children and adults suffering from a wide variety of febrile conditions.


PHARMACOLOGY
Mefenamic Acid is absorbed from the gastrointestinal tract and peak concentrations in the circulation may occur about 2 hours after oral administration. It is extensively bound to plasma protein. Mefenamic Acid is excreted mainly as conjugated metabolites in the urine.

DOSAGE AND ADMINISTRATION
For oral administration.
Adult : 2 capsules 3 times daily.
Apart from treatment of Still's Disease, therapy should not be continued for longer than 7 days.


After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.

CONTRAINDICATIONS
Mefenamic Acid is contra-indicated in inflammatory bowel disease and in patients with ulceration or inflammation of the gastrointestinal tract. The drug should be used with caution in renal impairment and hepatic impairment.


SIDE EFFECTS
The most common side effects encountered with the use of Mefenamic Acid are gastrointestinal disturbances. Headache, drowsiness, nervousness, visual disturbances, reversible haemolytic anaemia, diarrhoea and skin rashes may occasionally occur. If diarrhoea or a rash occurs, the medication should be withdrawn immediately. Patients on prolonged therapy should be kept under surveillance with particular attention to liver dysfunction. Should this appear the therapy should be discontinued. Bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma or allergic disease.


PRECAUTION
Product should be taken with caution in patients with impaired renal or liver functions, asthma and those who are taking coumarin anticoagulants, as Mefenamic Acid may cause an acute exacerbation of asthma, and enhance the effects of coumarin anticoagulants. Safety and efficacy of the drug for use in pregnancy and in children under 14 years of age have not been established.

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 NSAIDs, 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 NSAIDs 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 NSAIDs treatment and at regular intervals thereafter.


Heart Failure
Fluid retention and oedema have been observed in some patients taking NSAIDs, there 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 serious skin reactions and to consult their doctor at the first appearance of a skin rash or any other sign of hypersensitivity.

 

WARNINGS


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 NSAIDs therapy. Although minor GI problems (eg. 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 prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, 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 events.


Measures 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 risks 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.


DRUG INTERACTION
Mefenamic Acid may enhance the effects of the coumarin anticoagulants.


OVERDOSAGE
Mefenamic Acid has a marked tendency to induce grand mal-convulsions in overdosage. Other possible symptoms include gastrointestinal disturbances with bleeding or peptic ulceration.


TREATMENT OF OVERDOSAGE
Gastric lavage in the conscious patient and intensive supportive therapy where necessary. Studies in experimental animals showed that a 5 to 1 ratio of activated charcoal to Mefenamic Acid resulted in considerable suppression of absorption of the drug.

STORAGE
Keep container well closed. Store below 30C. Protect from light.

PACKAGE QUANTITIES
Available in plastic container of 1000's and blister pack of 10's x 100 & 10's x 10.

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