Active Ingredient
Aceclofenac 100mg

Therapeutic category
NSAID

Indication
Aceclofenac is indicated for the relief of pain and inflammation associated with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis.

Contraindication
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 Gl bleeding, moderate or severe renal impairment.

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.
• The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of aceclofenac.
• Caution should also be exercised in patients with history of coagulation defects and history of liver dysfunction.
• Renal and hepatic function and blood counts should be monitored during long term treatment. Persistently elevated hepatic enzyme levels necessitate withdrawal of aceclofenac.
• Aceclofenac may trigger attacks in patients with hepatic porphyria, and reversible inhibition of platelet aggregation may occur with the drug.
• Refrain from driving or operating machinery if there is feeling of dizziness or sleepiness whilst taking aceclofenac.

Usage in Pregnancy and Lactation
The drug is not recommended in pregnant or breast feeding

Usage in Paediatrics
There are no clinical data on the use of aceciofenac in children.

Usage in Geriatrics
The pharmacokinetics of aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

Dosage and Administration

• The usual dose of Aceclofenac is 100mg given twice daily. One tablet in the morning and one in the evening.
• There is no evidence that the dosage of aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised. There is some evidence that the dose of aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100mg be used.
• Aceclofenac tablets should be swallowed whole with a sufficient quantity of liquid. When aceclofenac was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected and as such aceclofenac can be taken with food.

Overdosage

• Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.
• There are no human data available on the consequences of aceclofenac overdosage. The therapeutic measures to be taken are: absorption should be prevented, as soon as possible after overdosage by means of gastric lavage and treatment with activated charcoal; supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal irritation, and respiratory depression, specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.

Storage
Store below 30˚C, in a dry place

Variant/Dosage
1 tabs 12 hourly

Product Substitutes
Clansa S capsules, Zulu tab

Manufacturer/Marketer
Ipca Laboratories Ltd

Country of Origin
India

Keep out of reach of children.