Each capsule contains
Mefenamic Acid 250 mg
Powder blue opaque cap and ivory opaque body, size 1 hard gelatin capsule.
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
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.
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.
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.
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withdrawn immediately.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.
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
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.
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.
Fluid retention and oedema have been observed in some patients taking NSAIDs,
there caution is advised in patients with fluid retention or heart failure.
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
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.
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.
Mefenamic Acid may enhance the effects of the coumarin anticoagulants.
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.
Keep container well closed. Store below 30°C. Protect from light.
Available in plastic container of 1000's and blister pack of 10's x 100 &
10's x 10.