Trifenac®
(Diclofenac Potassium Tablets USP 50 mg)
COMPOSITION:
Each film-coated tablet contains: Diclofenac Potassium USP 50 mg, Excipients Q.S.
PHARMACOLOGY:
Pharmacodynamics
Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID).
Diclofenac Potassium tablets contain the potassium salt of diclofenac, a non-steroidal compound with pronounced and clinically demonstrable analgesic, anti-inflammatory and anti-pyretic properties.
Diclofenac is a potent inhibitor of prostaglandin biosynthesis and a modulator of arachidonic acid release and uptake.
Diclofenac Potassium tablets have a rapid onset of action and are therefore suitable for the treatment of acute episodes of pain and inflammation.
In migraine attacks Diclofenac Potassium tablets have been shown to be effective in relieving the headache and in improving the accompanying symptom of
nausea.
Pharmacokinetics
Absorption
Diclofenac is rapidly and completely absorbed from sugar-coated tablets. Food intake does not affect absorption.
Indications
Rheumatoid arthritis, osteoarthrosis, low back pain, migraine attacks, acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures, ankylosing spondylitis.
Acute gout.
Control of pain and inflammation in orthopaedic, dental and other minor surgery, pyrophosphate arthropathy and associated disorders.Dosage and Administration
For oral administration. To be taken preferably with or after food. The tablets should be swallowed whole with liquid.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Adults: The recommended daily dose is 100 – 150 mg in two or three divided doses. For milder cases, 75 – 100 mg daily in two or three divided doses is usually sufficient.
In migraine, an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4 – 6 hours, not exceeding a total dose of 200 mg per day.
Paediatric population
For children over 14 years of age, the recommended daily dose is 75-100mg in two or three divided doses. Diclofenac Potassium 25mg Tablets are not recommended for children under 14 years of age.Warnings and Precautions
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
The use of Diclofenac potassium with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.Storage and Handling Instructions
Store in cool & dry place below 30ºC. Protect from light.
KEEP OUT OF REACH OF CHILDREN.Packaging Information
10 X 10 Blister Pack.