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Aceclofenac indications, dose, side effects & concise monograph


Ankylosing spondylitis, Rheumatoid arthritis, Osteoarthritis
Adult: 100 mg bid.
Hepatic impairment: Reduce initial dose to 100 mg daily .

Special Populations: Reduce initial dose to 100 mg daily in patients with hepatic impairment.
Hypersensitivity to aspirin or NSAIDs; moderate to severe renal impairment; pregnancy (3rd trimester); history of peptic ulceration or GI bleed; patients with infections.
Warnings / Precautions
Cautiously administer to patients with GI disease, ulcerative colitis, Crohn's disease, haematological abnormalities, hepatic porphyria; history of bronchial asthma; history of heart failure or hypertension; mild renal, hepatic or cardiac impairment. May impair ability to drive or operate machinery. Elderly.
Adverse Reactions
Diarrhoea, nausea, dyspepsia, abdominal pain, dizziness, rashes; increased LFTs.
Potentially Fatal: Severe GI bleeding; nephrotoxicity; blood dyscrasias.
Overdose Reactions
Mangagement: Gastric lavage and treatment with activated characoal. Treatment is supportive and symptomatic. Dialysis, haemoperfusion unlikely to be useful.
Drug Interactions
May increase plasma concentrations of lithium and digoxin. Increased nephrotoxicity when used with diuretics or ciclosporin. Monitor serum potassium when used with potassium-sparing diuretics and ACE inhibitors. May enhance activity of anticoagulants. May increase risk of methotrexate toxicity when administered within 24 hr of methotrexate admin. Increased risk of GI bleed with other NSAIDs. Increased risk of convulsion with quinolones.
See Below for More aceclofenac Drug Interactions
Mechanism of Actions
Aceclofenac, a phenylacetic acid derivative, has antiinflammatory and analgesic properties. It is a potent inhibitor of cyclo-oxygenase which is involved in the production of prostaglandins.
Absorption: Well absorbed from the GI tract (oral); peak plasma concentrations after 1-3 hr.
Distribution: Protein-binding: 99%.
Excretion: Urine (as hydroxymetabolites); 4 hr (elimination half-life).
Should be taken with food. (Take w/ or immediately after meals.)
Storage Conditions
Oral: Store below 30°C.
ATC Classification
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
M02AA25 - aceclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Oral: Store below 30°C.
Available As
  • Aceclofenac 1.5%
  • Aceclofenac 1.5% w/w
  • Aceclofenac 10 mg
  • Aceclofenac 100 mg
  • Aceclofenac Sodium 100 mg
  • Aceclofenac 110 mg
  • Aceclofenac 150 mg
  • Aceclofenac 2.5% w/w
  • Aceclofenac 200 mg
  • Aceclofenac Sodium 50 mg
  • Aceclofenac 50 mg
  • Aceclofenac 500 mg
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