INDICATION
Rheumatoid arthritis, osteoarthritis, low back pain, and other acute
musculoskeletal disorders such as tendinitis, tenosynovitis, bursitis, sprains,
strains, dislocation, ankylosing spondylitis, acute gout, control of pain and
inflammation in orthopedics, dental and other minor surgery, post operative
pain, juvenile chronic arthritis and pain of renal colic.
DOSAGE AND ADMINISTRATION
Adults: The recommended daily dosage is 2-3 tablets and the maximum
daily dose is 150 mg. In milder cases, 2 tablets of Clofenac® DT per day are
sufficient. Clofenac® DT should preferably be taken before meals.
Children: Diclofenac is not recommended in children for other indications
except juvenile rheumatoid arthritis where the recommended dose is 1-3
mg/kg body weight.
Clofenac® DT is to be dropped into a half-glass of water and the liquid is to
be stirred to aid dispersion before swallowing. There is no information on
the use of Clofenac® DT for more than 03 months.
CONTRAINDICATION AND PRECAUTION
Diclofenac is contraindicated in peptic ulcer. Known hypersensitivity to
Diclofenac is also a contraindication. Like other NSAIDs, Diclofenac is also
contraindicated in patient in whom attacks of asthma, urticaria or acute
rhinitis are precipitated by aspirin or other drugs with prostaglandin
synthetase inhibiting activity.
Diclofenac should be used with caution in peptic ulcer, hepatic and renal
impairment, pregnancy and allergic disorders. Like other NSAIDs,
Diclofenac may temporarily inhibit platelet aggregation. Patients with
defects of hemostasis should be carefully monitored, when they are having
treatment with Diclofenac.
SIDE EFFECT
Side effects are generally mild and infrequent but include gastrointestinal
discomfort or occasional bleeding, nausea, hypersensitivity reaction,
headache, vertigo and hearing disturbances such as tinnitus. Severe
adverse effects such as peptic ulcer, perforation of peptic ulcer, blood
dyscrasias may rarely occur.
Clofenac® DT
DRUG INTERACTION
Lithium & digoxin: Diclofenac may increase plasma concentration of lithium
& digoxin.
Anticoagulants: There are isolated reports of an increased risk of
hemorrhage with the combined use of Diclofenac and Anticoagulant
therapy.
Antidiabetic agents: Clinical studies have shown that Diclofenac can be
given together with oral antidiabetic agents without influencing their clinical
effects.
Cyclosporin: Cases of nephrotoxicity have been reported in patients
receiving concomitant cyclosporin and NSAIDs.
Methotrexate: Cases of serious toxicity have been reported when
methotrexate and NSAIDs are given within 24 hours of each other.
Diuretics: Various NSAIDs are liable to inhibit the activity of diuretics.
USE IN PREGNANCY AND LACTATION
Diclofenac should not be prescribed during pregnancy unless there is some
compelling reasons. Following oral doses of 50 mg administered every 8
hours, the active substance passes into the breast milk, but in quantities so
small that no undesirable effects are to be expected.
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