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Composition
Each enteric coated tablet contains :
Diclofenac Sodium B.P. 50 mg
Actions
Diclofenac is a potent non-steroidal anti-inflammatory
drug (NSAID) with analgesic and antipyretic properties. It also has some
uricosuric effect. Diclofenac inhibits cyclo-oxygenase activity with a
reduction in the tissue production of prostaglandins such as PgF2
and PgE2.
Indications
1. Rheumatoid arthritis
2. Osteoarthritis
3. Low back pain and other acute musculoskeletal disorderssuch as
periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains and
dislocations
4. Ankylosing spondylitis
5. Acute gout
6. Control of pain and inflammation in orthopaedic, dental and other minor
surgery
7. Juvenile chronic arthritis
8. Postoperative pain
9. Pain of renal colic.
Dosage
The dose range for the oral tablets is 75 - 200 mg daily in two or three divided doses with meals. Patients should be generally maintained on the lowest dosage of diclofenac consistent with achieving a satisfactory therapeutic response.In osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses. In rheumatoid arthritis the recommendeddose is 150 - 200 mg/day in divided doses and in ankylosing spondylitis, it is 100 - 125 mg/day, administered as 25 mg q.i.d. with an extra 25 mg dose at bedtime.
In children over one year (usually in juvenile chronic arthritis) the dose is 1 - 3 mg/kg per day in divided doses.
Pharmacokinetics are not impaired in elderly patients and
standard adult doses can be used.
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Side Effects
Initially, some patients may complain of epigastric pain,
nausea and diarrhoea, headache and slight dizziness. These
symptoms are often transient and disappear with continuation
of medication. Drowsiness and tiredness occur rarely and
disturbance of sensation, vision, behaviour and hearing or convulsions have only been reported in isolated cases.
There have also been isolated reports of severe skin
reactions (erythema multiforme, Stevens-Jhonson syndrome,
Lyell's syndrome and bullous reactions), loss of hair and
photosensitivity.
In a study of Diclofenac tolerability involving over 18000
patients, the incidence of 'serious' gastrointestinal
effects was 0.01%.
Contraindications
Diclofenac is contraindicated in active or suspected peptic ulcer or gastrointestinal bleeding, previous sensitivity to diclofenac sodium or in asthmatic patients in whom attacks of asthma are precipitated by aspirin or other NSAIDs.
Presentation
Blister pack of 10 tablets
10 blister packs in a carton
Manufactured by :
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