INDICATION
Clofenac® tablets, Clofenac® injection, Clofenac® Plus injection and Clofenac® suppositories contain diclofenac sodium, which is used to relief all grades of pain and inflammation in a wide range of conditions including: a) Arthritic conditions: Rheumatoid Arthritis, Osteoarthritis, Ankylosing spondylitis, Acute gout. b) acute musculoskeletal disorders such as periarthritis (e.g., frozen shoulder), tendinitis, tenosynovitis, bursitis. c) other
painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. Clofenac® Plus injection also contains lidocaine, which acts as a local anaesthetic. Therefore, the possibility of pain at the injection site, which is most likely to occur after intramuscular injection of normal diclofenac, is minimized if Clofenac® Plus Injection is used. Clofenac® Gel is used for the local symptomatic relief of pain and inflammation in: a) trauma of the tendons, ligaments, muscles and joints, e.g, due to sprains, strains and bruises, b) localised forms of soft tissue rheumatism.
DOSAGE AND ADMINISTRATION
Clofenac® 25 mg and 50 mg enteric coated tablets :
Adults: 75 – 150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.
Clofenac® SR : 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium are not impaired to any clinically relevant extent in elderly patients.
Clofenac® injection/Clofenac® Plus injection :
Adults: One ampoule once (or in severe cases, twice) daily by intramuscular injection.
Renal colic: One ampoule once daily intramuscularly. A further ampoule may be administered after 30 minutes, if necessary. The recommended maximum daily dose of diclofenac is 150 mg, by any route. The recommended
maximum daily dose of lidocaine is 200 mg.
Children: In juvenile chronic arthritis, 1-3 mg of diclofenac/kg body wt. daily in divided doses.
Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status.
Clofenac® Gel : Clofenac® Gel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2 – 4 gm Clofenac® Gel should be applied 3 – 4 times daily and rubbed in lightly. After application, the hands should be washed unless they are the site being treated.
SIDE EFFECT
Side effects to diclofenac are usually mild and transient. However, if serious side effects occur, diclofenac should be discontinued.Gastrointestinal: Occasional: epigastric pain, other gastro-intestinal disorders(e.g., nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence,anorexia). Rare: gastro-intestinal bleeding, peptic ulcer (with or without bleeding or perforation), bloody diarrhoea. In isolated cases: lower gut disorders (e.g., non-specific haemorrhagic colitis and exacerbations of ulcerative colitis or Crohn’s proctocolitis), pancreatitis, glossitis,constipation, etc.
Clofenac® Plus injection: In very rare instances, injection site disorders may occur. In isolated cases, abscesses and local necrosis may occur. The adverse effects due to lidocaine mainly involve the CNS, are usually of short
duration, and are dose related. The CNS reactions may be manifested by drowsiness, dizziness, disorientation, confusion, lightheadedness, etc. Clofenac® Gel is usually well tolerated. Local irritation, erythema, pruritus or
dermatitis may occasionally occur. Although the gel has low systemic absorption, yet the possibility of the systemic side-effects cannot be completely excluded because of use to a relatively large area of skin
USE IN PREGNANCY AND LACTATION
Diclofenac tablets and injection should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. This type of drugs are not recommended during the last trimester of pregnancy. Very small quantities of diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.
Since no experience has been acquired with diclofenac gel in pregnancy or lactation, it is not recommended for use in these circumstances.
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