TORADOL

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 available as a solution for injection. Ketorolac trometamol inhibits the cyclo-oxygenase enzyme system and hence synthesis of prostaglandins.

Approved indications

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

Dosing overview

Ketorolac dosage should be adjusted according to the severity of the pain and the response of the patient, with the lowest effective dose used for the shortest possible time in all patient populations. The total duration of ketorolac use should not exceed five days.

Key safety warnings

Ketorolac is a potent NSAID analgesic and the resulting NSAID-related adverse effects can be serious, including gastrointestinal haemorrhage, surgical haemorrhage and renal impairment. Increasing the dose beyond the recommendations will not provide better efficacy but will result in increasing risk of developing serious adverse effects. Ketorolac 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. 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, and caution is advised in these patients with treatment commencing on the lowest dose available. Ketorolac trometamol inhibits platelet aggregation and may prolong bleeding time, though unlike the prolonged effects from aspirin, the inhibition of platelet function resolves within 24 to 48 hours after the medicine is discontinued. Patients on anticoagulation therapy (for example, heparin or warfarin) may be at increased risk of bleeding if given ketorolac concurrently. NSAIDs may very rarely cause serious cutaneous adverse effects such as exfoliative dermatitis, Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia with Systemic Symptoms and toxic epidermal necrolysis, which can be fatal and occur without warning.

Contraindications

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

Regulatory history

The TORADOL 30 mg per 1 mL injection ampoule (ARTG 34357) and the TORADOL 10 mg per 1 mL injection ampoule (ARTG 34356) were first listed on the Australian Register of Therapeutic Goods on 2 April 1992.