MAXIGESIC

What it is

Maxigesic IV is a solution for infusion containing paracetamol 1000 mg and ibuprofen (as sodium dihydrate) 300 mg in 100 mL. It is a clear, colourless solution, free from visible particles. Maxigesic IV possesses anti-inflammatory, analgesic, and antipyretic activity.

Approved indications

— Relief of mild to moderate pain and the reduction of fever in adults, where an intravenous route of administration is considered clinically necessary.

Dosing overview

Maxigesic IV should be administered as one vial (100 mL) as a 15-minute infusion every 6 hours, as necessary. The total daily dose of paracetamol should not exceed 4000 mg (4 g). The maximum dose of Maxigesic IV has only been studied for a period of up to 2 days.

Key safety warnings

All NSAIDs, including the ibuprofen in Maxigesic IV, have been associated with an increased risk of cardiovascular and thrombotic adverse events when taken long term. Clinical trials have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation of the stomach, small intestine or large intestine can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Upper gastrointestinal ulcers, gross bleeding or perforation caused by NSAIDs appear to occur in approximately 1% of patients treated for 3–6 months, and in about 2–4% of patients treated for one year. NSAIDs, including the ibuprofen in Maxigesic IV, can cause serious skin adverse reactions such as acute generalised exanthematous pustulosis, exfoliative dermatitis, Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia with Systemic Symptoms, and toxic epidermal necrolysis, which can be fatal. Borderline elevations of one or more liver tests may occur in some patients taking NSAIDs, including the ibuprofen in Maxigesic IV. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST have been reported in small numbers of patients in clinical trials. Rare cases of severe hepatic reactions have been reported, including jaundice, fulminant hepatitis, liver necrosis and hepatic failure, some with fatal outcomes.

Contraindications

Maxigesic IV is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients; in patients with active alcoholism, as chronic excessive alcohol ingestion may predispose patients to paracetamol hepatotoxicity; and in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Maxigesic IV is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery; in patients with impaired kidney function, impaired liver function, heart problems or heart failure; in patients with active gastrointestinal bleeding, peptic ulceration or other stomach disorders; in patients with spinal cord injuries; during pregnancy or in patients planning to become pregnant; and during breastfeeding.

PBS listing

Maxigesic IV is not listed on the Pharmaceutical Benefits Scheme. The product is supplied as a prescription medicine through private prescriptions and hospital use.

Regulatory history

Maxigesic IV was first listed on the ARTG on 22 July 2019. The product date of first approval was 22 July 2019.