KETOROLAC-BAXTER

What it is

Ketorolac-Baxter (ketorolac trometamol) is a non-narcotic analgesic belonging to the non-steroidal anti-inflammatory drug (NSAID) class of medicines with analgesic, anti-inflammatory and antipyretic properties. It is a solution for injection. Ketorolac trometamol inhibits the cyclo-oxygenase enzyme system and hence synthesis of prostaglandins. Ketorolac-Baxter is a potent NSAID analgesic and the resulting NSAID-related adverse effects can be serious, for example gastrointestinal haemorrhage, surgical haemorrhage and renal impairment.

Approved indications

— Short-term management of moderately severe, acute pain following surgical procedures.

Dosing overview

Ketorolac-Baxter dosage should be adjusted according to the severity of the pain and the response of the patient. The lowest effective dose should be used for the shortest possible time in all patient populations. For intramuscular administration, adults under 65 years of age receive an initial intramuscular dose of 10 mg to 30 mg, followed by 10 mg to 30 mg at 4 to 6 hourly intervals, up to a maximum daily dose of 90 mg. Elderly patients (65 years of age and older) receive an initial intramuscular dose of 10 mg to 15 mg, followed by 10 mg to 15 mg at 4 to 6 hourly intervals, up to a maximum daily dose of 60 mg. For patients under 50 kg in body weight or for patients with less severe pain, the lower end of the intramuscular dosage range is recommended. The total daily dose should not exceed 60 mg. The total duration of ketorolac use should not exceed five days.

Key safety warnings

Ketorolac-Baxter can cause gastrointestinal irritation, ulcers, perforation or bleeding, which can be fatal, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. Upper gastrointestinal ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3–6 months and in about 2–4% of patients treated for one year. The risk of gastrointestinal bleeding, ulceration or perforation increases with dose and duration of treatment; in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation; in the elderly; and in those with a history of smoking or alcoholism. Caution is advised in these patients and treatment should commence on the lowest dose available. Ketorolac trometamol inhibits platelet aggregation and may prolong bleeding time. Unlike the prolonged effects from aspirin, the inhibition of platelet function by ketorolac trometamol resolves within 24 to 48 hours after the medicine is discontinued. In post-marketing experience, post-operative wound haemorrhage has been reported in association with the immediate peri-operative use of intramuscular ketorolac trometamol. Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use. Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk. NSAIDs may very rarely cause serious cutaneous adverse effects such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) and toxic epidermal necrolysis (TEN), which can be fatal and occur without warning. These serious adverse effects are idiosyncratic and are independent of dose or duration of use.

Contraindications

Ketorolac-Baxter is contraindicated in patients with severe heart failure; undergoing treatment of perioperative pain in the setting of coronary artery surgery (CABG); with dehydration or hypovolaemia from any other cause; with severe hepatic impairment; with moderate or severe renal impairment (serum creatinine > 180 micromol/L), or in patients at risk of renal failure due to volume depletion or dehydration; with active or a history of gastrointestinal bleeding or perforation related to previous NSAIDs therapy; with active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding); with a history of haemorrhagic diatheses, including coagulation disorders; who have had surgery with a high risk of haemorrhage or incomplete haemostasis and those at high risk of bleeding; with suspected or confirmed cerebrovascular (intracranial) bleeding; on anticoagulation therapy; receiving aspirin, other NSAIDs, pentoxifylline (oxpentifylline), probenecid or lithium; with hypersensitivity to ketorolac trometamol or other NSAIDs and those patients in whom aspirin or other prostaglandin synthetase inhibitors induce allergic reactions; with the complete or partial syndrome of nasal polyps, angioedema or bronchospasm; with a history of asthma; with neuraxial (epidural or intrathecal) administration due to the alcohol content of the solution for injection; for prophylactic administration before surgery due to inhibition of platelet aggregation and intraoperatively because of the increased risk of bleeding; for use in pregnancy, labour, delivery or lactation; and in children under 16 years of age.

Regulatory history

Ketorolac-Baxter was first listed on the ARTG on 19 December 2014 with two registered variants: 10 mg/1 mL solution for injection ampoule (ARTG 218876) and 30 mg/1 mL solution for injection ampoule (ARTG 218877).