MEFENAMIC ACID is a brand name for Mefenamate (also known as Mefenamic Acid). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mefenamic acid is a non-steroidal anti-inflammatory agent with analgesic properties, and a demonstrable antipyretic effect. It has been shown to inhibit prostaglandin activity. Indications 1. As an anti-inflammatory analgesic for the symptomatic relief of rheumatoid arthritis (including Still’s disease),…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults: 2 capsules (500 mg) three times daily, to be taken with or after food In menorrhagia to be administered on the first day of excessive bleeding and continued according to the judgement of the physician. In dysmenorrhoea to be administered at the onset of menstrual pain and continued according to the judgement of the physician.
Elderly (over 65 years):
As for adults. Whilst no pharmacokinetic or clinical studies specific to the elderly have been undertaken, it has been used at normal dosage in trials which include many elderly patients. However, it should be used with caution in elderly patients suffering from dehydration and renal failure.
Non-oliguric renal failure and proctocolitis have been reported mainly in elderly patients who have not discontinued mefenamic acid after the development of diarrhoea. The elderly are at increased risk of the serious consequences of adverse reactions.
If an NSAID is considered necessary, the lowest dose should be used and for the shortest possible duration. The patient should be monitored regularly for gastro-intestinal bleeding during NSAID therapy.
Children (under 12 years):
Not recommended. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. 4). The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy Administration: Oral, the capsules should be swallowed with a drink of water.
To be taken preferably with or after food.
Gastro-intestinal:
The most commonly observed adverse events are gastro- intestinal in nature. 4). 4-) have been reported following administration. Pancreatitis has been reported. Less frequently, gastritis has been observed. Elderly or debilitated patients seem to tolerate gastrointestinal ulceration or bleeding less well than other individuals and most spontaneous reports of fatal GI events are in this population.
Diarrhoea occasionally occurs following the use of mefenamic acid. Although diarrhoea may occur soon after starting treatment, it may also occur after several months of continuous use. The diarrhoea has been investigated in some patients who have continued this drug in spite of its continued presence.
These patients were found to have associated proctocolitis. If diarrhoea does develop the drug should be withdrawn immediately and this patient should not receive mefenamic acid again. Colitis, enterocolitis, gastric ulceration with or without haemorrhage, steatorrhea, anorexia have been reported.
Immune system disorders:
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, less commonly exfoliative or bullous dermatoses (including epidermal necrolysis and erythema multiforme) The occurrence of a rash is a definite indication to withdraw medication.
Cardiac / Vascular disorders:
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Hypotension and palpitations have been reported rarely. 4) Respiratory, thoracic and mediastinal disorders: Asthma, dyspnoea.
2, and GI and cardiovascular risks below). Patients on prolonged therapy should be kept under regular surveillance with particular attention to liver dysfunction, rash, blood dyscrasias or development of diarrhoea. 8). 5). Prolonged use of any type of painkiller for headaches can make them worse.
If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of 'Medication Overuse Headache' should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications Precaution should be taken in patients suffering from dehydration and renal disease, particularly the elderly.
2-Posology and administration).
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.
Cardiovascular, Renal and Hepatic Impairment:
The administration of NSAIDs may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at great risk of this reaction is those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and elderly.
3-Contraindication) Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/ or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Hypersensitivity to Mefenamic acid or any of the other ingredients. Because the potential exists for cross-sensitivity to aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs, mefenamic acid should not be given to patients who have previously shown hypersensitivity reactions as these drugs induce symptoms of asthma, bronchospasm, allergic rhinitis, angioedema or urticaria.
Mefenamic acid is also contra-indicated in patients with inflammatory bowel disease (eg ulcerative colitis, Crohn’s disease), intestinal ulceration and history of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Use with concomitant NSAIDs including cyclo oxygenase 2 specific inhibitors (See section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Other adverse events reported less commonly include:
Renal and urinary disorders: Nephrotoxicity in various forms, including renal papillary necrosis. As with other prostaglandin inhibitors allergic glomerulonephritis has occurred occasionally. There have also been reports of acute interstitial nephritis, dysuria, with haematuria, proteinuria, renal failure including renal papillary necrosis and occasionally nephroitic syndrome.
Non-oliguric renal failure has been reported on a few occasions in elderly patients with dehydration usually from diarrhoea. Toxicity has been seen in patients with pre-renal condition leading to a reduction in renal blood flow or blood volume.
Patients at greatest risk of this reaction are those with impaired renal function, heart failure, and liver dysfunction those taking diuretics and elderly. The drug should not be administered to patients with significantly impaired renal function.
It has been suggested that the recovery is more rapid and complete with other forms of analgesic induced renal impairment, with discontinuation of NSAID therapy being typically followed by recovery to the pre-treatment state.
Hepato-bilary disorders:
Borderline elevations of one or more liver function tests may occur in some patients receiving mefenamic acid therapy. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should have their therapy discontinued.
Patients on prolonged therapy should be kept under surveillance with particular attention to liver dysfunction. Mild hepatotoxicity, hepatorenal syndrome, hepatitis and cholestatic jaundice have been reported with NSAID therapy. 4), dizziness, malaise, fatigue and drowsiness, convulsions, insomnia.
Psychiatric disorders:
Confusion, depression, hallucinations, nervousness Eye disorders: Eye irritation, optic neuritis, reversible loss of colour vision, visual disturbances and blurred vision.
Ear and labyrinth disorders:
Ear pain, tinnitus, vertigo.
General disorders and administration site conditions:
Fatigue, malaise, multi-organ failure, pyrexia.
Blood and lymphatic system disorders:
Thrombocytopenia purpura, neutropenia, hypoplasia bone marrow, haematocrit decreased, anaemia, aplastic anaemia has been reported. In some cases reversible haemolytic anaemia has occurred. Temporary lowering of the white blood cell count (leukopenia) with a risk of infection, sepsis, and disseminated intravascular coagulation, which may have been due to mefenamic acid has been reported.
Rarely eosinophilia, agranulocytosis and pancytopenia have been reported. Blood studies should therefore be carried out during long term administration and the appearance of any dyscrasisas is an indication to discontinue therapy.
Skin and subcutaneous tissue disorders:
Angioedema, laryngeal oedema, erythema multiforme, face oedema, bullous reactions including Lyell's syndrome ((toxic epidermal necrolysis, (very rare)) and Stevens-Johnson syndrome, perspiration, rash, photosensitivity reaction, purpura, fixed drug eruption (see Immune system disorders for other skin reactions), pruritus and urticaria.
Metabolism and nutritional disorders:
Glucose intolerance in diabetic patients has been reported rarely.
Hyponatraemia Investigations:
A positive […]
There are insufficient data to exclude such a risk for Mefenamic Acid. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with mefenamic Acid after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus and smoking). As NSAIDs can interfere with platelet function, they should be used in caution in patients with intracranial haemorrhage and bleeding diathesis.
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Smoking and alcohol use are added risk factors.
3), and in the elderly These patients should commence treatment on the lowest dose available. 5) Patients with a history of GI toxicity, particular when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
5 Interactions). When GI bleeding or ulceration occurs in patients receiving mefenamic acid, the treatment should be withdrawn. ). Diarrhoea occasionally occurs following the use of mefenamic acid. Although this may occur soon after starting treatment, it may also occur after several months of continuous use.
The diarrhoea has been investigated in some patients, who have continued the drug in spite of its continued presence; these patients were found to have associated proctocolitis. If diarrhoea does develop, the drug should be withdrawn immediately and the patient should not receive mefenamic acid again.
8 – Undesirable effects). 8). Patients appear to be at highest risk for these reactions, early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment. Mefenamic acid should be discontinued at the first appearance of skin rash, mucosal lesions, or any […]