FLEXI
ACECLOFENAC
COMPOSITION
Fle xi® Tablet : Each film-coated tablet contains Aceclofenac BP 100 mg.Fle xi® SRTablet : Each sustained release tablet contains Aceclofenac BP 200 mg.
PHARMACOLOGY
Fle xi® SR(Aceclofenac) is a non-ster oidal agent with marked anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cycloxygenase which is in volved in the production of prostaglandin.Pharmacokinetics:After oral administration, Aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentr ations ar e reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates in to the synovial fluid, where the concentr ations reach approximately 57% of those in plasma. The mean plasma elimination half-life is ar ound 4 hours. Aceclofenac is highly protein-bound (>99%). Aceclofenac circulates mainly as unchanged drug, 4-hydroxy aceclofenac is the main metabolite detected in plasma. A pproximately two-thirds of the administer ed dose is excr et ed via the urine, mainly as hydroxymetabolites.Pharmacodynamics: Aceclofenac has multi-factor mechanism of action. Outside the inflammatory cell, Aceclofenac is metabolized to 4'-hydroxyaceclofenac. The parent drug and the metabolite penetrate the inflammatory cells and then hydrolyzed to the active metabolites diclofenac and 4'-hydroxydiclofenac, which inhibit IL-1 and TNF released by the inflammatory cells and theref ore suppress production of PGE2 at the site of inflammation. Aceclofenac prevents neutrophil adhesion and accumulation at the inflammatory site in the early phase and thus blocks the pro-inflammatory actions of neutrophils
NDICATIONFor the relief of pain and inflammation in osteoarthritis, rheumatoid ar thritis and ankylosing spondylitis.DOSAGE AND ADMINISTRATIONFle xi® Tablet :Adults : The recommended dose is 100 mg, t wice daily.Children : There are no clinical data on the use of Aceclofenac in children.Elderly : The pharmacokinetics of Aceclofenac is not alter ed in elderly patients , theref ore it is not considered necessary to modify the dose or dose frequency.Fle xi® SRTablet : The recommended dose is 200 mg, once daily.CONTRAINDICATION AND PRECAUTIONAceclofenac should not be administer ed to patients with active or suspected peptic ulcer or gastro-intestinal bleeding. It should not be given to patients with moderate to sever e renal impairment. Close medical surveillance is also imper ative in patients suffer ing fr om sever e impairment of hepatic function. It should not be prescrib ed during pregnancy, unless there ar e compelling reasons for doing so. The lo west effective dosage should be used. Aceclofenac should not be administer ed to patients previously sensitive to Aceclofenac or in whom aspirin or NSAIDs precipitate attacks of asthma, acute rhinitis or urticaria or who are hypersensitive to these drugs.SIDE EFFECTThe majorit y of side-effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea and diarrhea) and occasional occurrence of dizziness. Der matological complaints including pruritus and rash and abnormal hepatic enzyme levels and r
