Aceclofenac is indicated for the relief of pain and inflammation associated with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis
Aceclofenac should not be administered to patients hypersensitive to Aceclofenac or other NSAIDs, or patients with a history of Aspirin or NSAID-related allergic or anaphylactic reactions or with peptic ulcers or GI bleeding, moderate or severe renal impairment
Drug interactions associated with Aceclofenac are similar to those observed with other NSAIDs. Aceclofenac may increase plasma concentrations of Lithium, digoxin and Methotrexate, increase the activity of anticoagulants, inhibit the activity of diuretics, enhance cyclosporine nephrotoxicity and precipitate convulsions when co-administered with quionolone antibiotics. Caution should be exercised if NSAID and methotrexate are administered within 2-4 hours of each other, since NSAIDs may increase methotrexate plasma levels, resulting in increased toxicity
Dosage regimen and direction for use: As directed by the physician or; the usual dose is 100 mg given daily orally with sufficient quantity of liquid.
Contraindications:
Aceclofenac should not be administered to patients hypersensitive to Aceclofenac or other NSAIDs, or patients with a history of Aspirin or NSAID-related allergic or anaphylactic reactions or with peptic ulcers or GI bleeding, moderate or severe renal impairment
Side effects and adverse reactions
Aceclofenac is well tolerated, with, most adverse events being minor and reversible and affecting mainly the Gastro Intestinal System. Most common events include dyspepsia, and abdominal pain. Dizziness, vertigo, nausea, diarrhea, flatulence, gastritis, constipation, vomiting and ulcerative stomatitis pruritis, rash and dermatitis have been reported with Aceclofenac, but the incidence of these events is low
Drug interactions:
Drug interactions associated with Aceclofenac are similar to those observed with other NSAIDs. Aceclofenac may increase plasma concentrations of Lithium, digoxin and Methotrexate, increase the activity of anticoagulants, inhibit the activity of diuretics, enhance cyclosporine nephrotoxicity and precipitate convulsions when co-administered with quionolone antibiotics. Caution should be exercised if NSAID and methotrexate are administered within 2-4 hours of each other, since NSAIDs may increase methotrexate plasma levels, resulting in increased toxicity
Warnings:
Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders, with a history suggestive of gastrointestinal ulceration, with ulceration colitis or with Crohn’s disease, bleeding diathesis or haematological abnormalities
Precautions
Aceclofenac should be given with caution to elderly patients with renal, hepatic or cardiovascular impairment and to those receiving other medication. The lowest effective dose should be used and renal function monitored regularly. Refrain from driving or operating machinery if there is feeling of dizziness or sleepiness whilst taking Aceclofenac. Do not perform any of these actions until the effects wear off.
Use in pregnancy and lactation
The drug is not recommended in pregnant or breast-feeding women.
Use in paediatrics
There are no clinical data on the use of Aceclofenac in children
