CALDOLOR

What it is

Caldolor is ibuprofen concentrated solution for injection. Each 4 mL vial contains 400 mg of ibuprofen and each 8 mL vial contains 800 mg of ibuprofen. The sterile concentrated injection is a clear, colourless to slightly yellow solution and is intended for intravenous administration by infusion following dilution only.

Approved indications

— Management of acute mild to moderate post-operative pain in adults. — Management of moderate to severe post-operative pain with adjunctive reduced morphine dosage in adults, where an intravenous route of administration is considered clinically necessary. — Reduction of fever in adults where an intravenous route of administration is considered clinically necessary.

Dosing overview

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Do not exceed a total daily dose of 3200 mg ibuprofen. Caldolor concentrated injection must be diluted prior to intravenous infusion to a final concentration of 4 mg/mL or less using 0.9% Sodium Chloride Injection USP or 5% Glucose Injection. Infusion time is 30 minutes. Use of the recommended maximum dose of 800 mg every 6 hours has only been studied for a period of up to 2 days.

Key safety warnings

All NSAIDs have been associated with an increased risk of cardiovascular and thrombotic adverse events when taken long term, with clinical trials showing an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. To minimise the potential risk for an adverse cardiovascular event, use the lowest effective dose for the shortest duration possible. 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. Patients with a prior history of peptic ulcer disease or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold higher risk for developing a gastrointestinal bleed than patients with neither of these risk factors. NSAIDs, including ibuprofen, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal. Drug Reaction with Eosinophilia and Systemic Symptoms has been reported in patients taking NSAIDs such as Caldolor, with some of these events being fatal or life-threatening. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion, with administration of an NSAID causing a dose-dependent reduction in renal blood flow. Patients must be well hydrated prior to administration of Caldolor to reduce the risk of renal adverse reactions.

Contraindications

Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen, including anaphylactoid reactions and serious skin reactions. Caldolor is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, as severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients. Caldolor is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery. Caldolor is contraindicated in patients with active gastrointestinal bleeding. Caldolor is contraindicated in patients with spinal cord injuries.

PBS listing

No information on PBS listing is available in the provided sources.

Regulatory history

Caldolor was first listed on the Australian Register of Therapeutic Goods on 12 December 2012 as ARTG 175190 (400 mg/4 mL) and ARTG 175191 (800 mg/8 mL). The TGA approved Caldolor on 28 February 2012, making it the first injectable form of ibuprofen, for the management of acute mild to moderate post-operative pain, moderate to severe post-operative pain as an adjunct to opioid analgesics, and for the reduction of fever in adults.