Generic Name

Aceclofenac

Precaution

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. Patients suffering from severe hepatic impairment must be monitored.

Indication

Indicated for the relief of pain and inflammation in both acute and chronic pain like, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain.

Contra Indication

Hypersensitivity to aspirin or NSAIDs; moderate to severe renal impairment; pregnancy (3rd trimester); history of peptic ulceration or GI bleed; patients with infections.

Dose

N/A

Side Effect

Gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported. Potentially Fatal: Severe GI bleeding; nephrotoxicity; blood dyscrasias.

Pregnancy Category

Mode of Action

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.

Interaction

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.

Pregnancy Category Note

USE IN PREGNANCY AND NURSING MOTHERS Since there is no information on the safe use of Aceclofenac during pregnancy and lactation, the use of Aceclofenac should therefore be avoided in pregnancy and lactation.

Adult Dose

Adult: PO Ankylosing spondylitis; Osteoarthritis; Rheumatoid arthritis 100 mg twice daily. SR Tablet : The recommended dose is 200 mg, once daily. Elderly: The pharmacokinetics of aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose and dose frequency. Hepatic Impairment Reduce initial dose to 100 mg daily .

Child Dose

Safety & Efficacy not established.

Renal Dose

No dose adjustment needed.

Administration

Should be taken with food. Take w/ or immediately after meals.