Diclofenac sodium with misoprostol

How it works

Diclofenac inhibits cyclo-oxygenase to reduce prostaglandins and inflammation, while misoprostol replaces protective mucosal prostaglandins, lowering gastric acid secretion and enhancing mucosal defence to counter the gastrointestinal harm of the NSAID component.

Prescribing in practice

• Misoprostol is abortifacient and uterotonic, so this combination is contraindicated in pregnancy and in women who may become pregnant unless effective contraception is used and pregnancy excluded.
• The diclofenac component retains the higher cardiovascular thrombotic risk of diclofenac and is contraindicated in established cardiovascular and cerebrovascular disease and heart failure.
• Misoprostol commonly causes diarrhoea and abdominal cramps; use caution in inflammatory bowel disease and where dehydration would be hazardous.

Monitoring

Monitor for gastrointestinal symptoms (including diarrhoea from misoprostol and bleeding from diclofenac), blood pressure and renal function during treatment.

Counselling the patient

• Do not take if you are or could become pregnant, and use reliable contraception while on treatment.
• Take with food; diarrhoea and cramping are common and usually settle.
• Report severe or persistent diarrhoea, or any black stools or vomiting of blood.

Evidence & guidelines

The combination is established for NSAID therapy in patients at high gastrointestinal risk, with misoprostol's mucosal-protective benefit and pregnancy contraindication documented in the SPC and prescribing references.