diclofenac sodium + misoprostol: clinical use

Prescribing considerations

• Confirm that diclofenac is needed and that NSAID-induced gastric and duodenal ulcer prophylaxis is particularly required.
• Exclude pregnancy before initiation and counsel anyone who could become pregnant about effective contraception and action if pregnancy is suspected.
• Assess gastrointestinal, cardiovascular, renal, hepatic and bleeding risks, concurrent medicines and previous NSAID reactions.
• Older people and patients with renal, cardiac or hepatic impairment require closer surveillance.
• Avoid concurrent systemic NSAIDs; low-dose antiplatelet aspirin still requires caution and monitoring.

Contraindications and cautions

• Pregnancy, planned pregnancy, or childbearing potential without effective contraception
• Active peptic ulcer, gastrointestinal haemorrhage or perforation, or other active bleeding
• Hypersensitivity to diclofenac, misoprostol, other prostaglandins, aspirin, another NSAID or an excipient
• Previous aspirin- or NSAID-triggered asthma, urticaria or acute rhinitis
• Established heart failure, ischaemic heart disease, peripheral arterial disease or cerebrovascular disease
• Severe renal or hepatic failure
• Peri-operative pain associated with coronary artery bypass graft surgery

Monitoring

• Review ongoing need and treatment response periodically.
• Monitor renal and hepatic function and blood counts during prolonged treatment or when clinical risk warrants.
• Monitor for gastrointestinal bleeding, fluid retention, hypertension and cardiovascular symptoms.
• Monitor anticoagulation where applicable; check potassium with potassium-sparing diuretics.
• Investigate persistent or worsening liver-test abnormalities or symptoms of liver disease.

Clinical pharmacology

Diclofenac provides analgesic and anti-inflammatory activity through cyclo-oxygenase inhibition and reduced prostaglandin synthesis. Misoprostol is rapidly converted to active misoprostol acid and strengthens gastroduodenal mucosal protective mechanisms.

Formulation and product differences

• Both selected products are modified-release tablets with diclofenac in a gastro-resistant core and misoprostol in an outer mantle.
• The presentations differ in diclofenac content, tablet markings and lactose content.
• Both contain hydrogenated castor oil, which may contribute to stomach upset or diarrhoea.