ibuprofen + paracetamol: clinical use

Prescribing considerations

• Confirm that combined treatment is appropriate rather than either component alone.
• Reconcile prescription, non-prescription, cold and flu products to prevent duplicate paracetamol, ibuprofen or NSAID exposure.
• Assess gastrointestinal, cardiovascular, renal, hepatic, respiratory and bleeding risks.
• Consider greater susceptibility to gastrointestinal bleeding, renal impairment and other NSAID harms in older or dehydrated patients.
• The combination can mask fever and pain from infection; reassess persistent or worsening infection symptoms.

Contraindications and cautions

• Hypersensitivity to either active ingredient, another NSAID or a formulation excipient
• Previous aspirin- or NSAID-associated asthma, bronchospasm, angioedema, rhinitis or urticaria
• Active or recurrent peptic ulceration, gastrointestinal bleeding or perforation
• Severe hepatic, renal or heart failure
• Active bleeding, coagulation disorder or increased bleeding tendency
• Third trimester of pregnancy
• Age below 18 years for the selected products
• Concurrent paracetamol-containing products or other NSAIDs where prohibited by the product licence
• For the selected intravenous product: active alcoholism or severe dehydration

Monitoring

• Renal function in renal impairment and other high-risk states, including older age, dehydration, cardiac disease or relevant concurrent treatment
• Gastrointestinal symptoms and evidence of bleeding in patients at increased risk
• Liver function when hepatic dysfunction or signs of liver injury are present
• Fluid retention, blood pressure and cardiac status where cardiovascular risk is relevant
• Clinical progress when pain or fever may be masking an infection

Clinical pharmacology

Ibuprofen inhibits cyclo-oxygenase-dependent prostaglandin synthesis, producing analgesic, anti-inflammatory and antipyretic effects and reversible platelet inhibition. Paracetamol has predominantly central analgesic and antipyretic activity. Both are hepatically metabolised, and their metabolites are mainly renally excreted.

Formulation and product differences

• The selected oral product is a film-coated tablet available without prescription for adult self-care within its licence.
• The intravenous product is a clear infusion solution for professionally supervised use when the intravenous route is clinically necessary.
• The intravenous formulation contains ibuprofen sodium dihydrate and has a different component ratio from the selected oral tablet.
• The intravenous product contains sodium, has no antimicrobial preservative and must not be mixed with other medicines or diluents; the oral tablet is essentially sodium-free.

Tablet

Route: Oral

Strengths: 200 mg + 500 mg, 500 mg + 150 mg