aceclofenac: clinical use

Prescribing considerations

• Assess gastrointestinal, renal, hepatic and cardiovascular risk and regularly review clinical need.
• Older people and those taking interacting medicines are more vulnerable to serious NSAID adverse effects.
• Consider gastroprotection in patients at increased gastrointestinal risk.
• Avoid during varicella because NSAIDs may worsen serious skin and soft-tissue complications.
• Aceclofenac may impair female fertility; review treatment when conception is planned or infertility is being investigated.

Contraindications and cautions

• Recurrent or active peptic ulcer or gastrointestinal haemorrhage, or previous NSAID-related gastrointestinal bleeding or perforation
• Previous asthma, rhinitis, angioedema, urticaria or other hypersensitivity triggered by aspirin or another NSAID
• Renal failure or hepatic failure
• Established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or NYHA class II–IV heart failure
• Active bleeding or a bleeding disorder
• Third-trimester pregnancy
• Hypersensitivity to aceclofenac or an excipient

Monitoring

• Consider blood pressure, renal function and full blood count; assess liver function where hepatic impairment is present.
• Monitor according to individual risk, particularly in older people and those with cardiovascular, gastrointestinal or renal disease or interacting medicines.

Clinical pharmacology

Aceclofenac inhibits cyclo-oxygenase-dependent prostaglandin synthesis. It is rapidly absorbed orally, highly protein bound, reaches synovial fluid and is predominantly excreted in urine as hydroxylated metabolites.

Formulation and product differences

• The selected product is an immediate-release, film-coated oral tablet intended to be swallowed whole.
• The tablet is described as essentially sodium-free.
• No paediatric formulation is represented, and clinical data in children are lacking.