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Dyfenamic

 

DESCRIPTION

CONTENT

DYFENAMIC CAPSULE

250mg

CAPSULE

Capsule Colour : Ivory/Blue

Capsule Size : #1

Granules Colour : White to Off-white

Each Capsule Contains :

Mefenamic Acid ........ 250mg

DYFENAMIC TABLET

250mg

TABLET

Colour : Yellow

Shape : Round and Biconvex

Coating : Film-coated

Each Tablet Contains :

Mefenamic Acid ........ 250mg

 

DYFENAMIC TABLET

500mg

TABLET

Colour : Yellow

Shape : Round and Biconvex

Coating : Film-coated

Each Tablet Contains :

Mefenamic Acid ........ 500mg

 

 

ACTIONS
Analgesic action: It may block out pain impulse generation via a peripheral action which may involve inhibition of the synthesis of prostaglandin, and possibly inhibition of the synthesis or action of other substances which sensitise pain receptors to mechanical or chemical stimulation.


Anti-inflammatory action: It may act peripherally in inflamed tissue, probably by inhibiting the synthesis of prostaglandin and possibly by inhibiting the synthesis and/or actions of other local mediators of the inflammatory response.


INDICATIONS
Mild to moderate pain such as muscular aches, backaches, dental pain, bursitis, dysmenorrhoea, rheumatic pain, traumatic pain, headaches of most aetiology, postoperative and postpartum pain, rheumatoid arthritis (including Still's disease) osteoarthritis and menorrhagia due to dysfunctional causes.


RECOMMENDED DOSAGE
Adults: Pain - 500 mg initially, followed by 250 mg every 6 hours as necessary. Treatment should not be continued for longer than 7 days.


Dysmenorrhoea - Medication should be initiated with the onset of bleeding and associated symptoms and should not be necessary for more than 2 - 3 days.


Children with Still's disease: 25 mg/kg body weight daily in divided doses (only for tablet).

 

All to be taken with some food or after meal.


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

CONTRAINDICATIONS
Patients hypersensitive to Mefenamic Acid. Patients with ulceration or inflammation of gastrointestinal tract.


PRECAUTIONS
It should be given with care to patients with bleeding disorders, cardiovascular disease, peptic ulceration or a history of such ulceration, and in those who are receiving coumarin anticoagulants. It should be given with caution to patients with renal impairment and patients with impaired liver function. It may impair the ability to perform activities requiring mental alertness or physical co-ordination. Treatment should not be continued for longer than 7 days in children, except in the treatment of Still's disease. It has marked tendency to induce grand mat convulsions in overdose.


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 antihypertensive 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 ulceration occurs 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 Steven-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.

 

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