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Dyfenamic
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DESCRIPTION |
CONTENT |
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DYFENAMIC CAPSULE
250mg |
CAPSULE
Capsule Colour :
Ivory/Blue
Capsule Size : #1
Granules Colour : White
to Off-white |
Each Capsule Contains :
Mefenamic Acid ........
250mg |
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DYFENAMIC TABLET
250mg |
TABLET
Colour : Yellow
Shape : Round and
Biconvex
Coating : Film-coated |
Each Tablet Contains :
Mefenamic Acid ........
250mg
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|
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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