Kategor – non-steroidal anti-inflammatory drug – a derivative of pyrrolysin-carboxylic acid.
Each ml contains:
Ketorolac Tromethamine USP 30mg;
Water for Injection USP q.s.
should be used with the following indications:
Kategor indicated for the short-term management of moderate to severe acute post-operative pain.
Treatment should only be initiated in hospitals. The maximum duration of treatment is 2 days.
For intramuscular or bolus intravenous injection only.
Kategor is for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over at least 15 seconds. Kategor should not be used for epidural or spinal administration.
The time to onset of analgesic effect following both IV and IM administration is similar and is approximately 30 minutes, maximum analgesia occurs within one to two hours. Analgesia
normally lasts for four to six hours.
Dosage should be adjusted according to the severity of the pain and the patient response. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The administration of continuous multiple daily doses of ketorolac intramuscularly or intravenously should not exceed two days because adverse events may increase with prolonged usage.
There has been limited experience with dosing for longer periods since the vast majority of patients have transferred to oral medication or no longer require analgesic therapy after this time.
Adults: The recommended initial dose of Kategor Injection is 10mg followed by 10 to 30mg every four to six hours as required. In the initial post-operative period, Kategor Injection may be given as often as every two hours if needed. The lowest effective dose should be given. A total daily dose of 90mg for non-elderly and 60mg for the elderly, patients with renal impairment
and patients less than 50kg should not be exceeded. The maximum duration of treatment should not exceed two days.The dosage in patients under 50kg should be reduced.
Opioid analgesics (e.g. morphine, pethidine) may be used concomitantly, and may be required for optimal analgesic effect in the early post-operative period when pain is most severe.
Kategor does not interfere with opioid binding and does not exacerbate opioid-related respiratory depression or sedation. When used in association with Kategor Injection, the daily dose of opioid is usually less than that normally required. However, opioid side-effects should still be considered, especially in day-case surgery.
Patients receiving Kategor Injection, and who are converted to oral Ketorolac, should receive a total combined daily dose not exceeding 90mg (60mg for the elderly, patients with renal impairment and patients less than 50kg). The oral component should not exceed 40mg on the day the change of formulation is made. Patients should be converted to oral treatment as soon as possible.
Elderly: For patients over 65 years, the lower end of the dosage range is recommended and a total daily dose of 60mg should not be exceeded. The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used for the shortest possible duration.The patient should be monitored regularly for GI bleeding during NSAID therapy.
Children: Safety and efficacy in children have not been established. Therefore, Kategor Injection is not recommended for use in children under 16 years of age.
Renal impairment: Ketorolac Tromethamine Injection should not be used in moderate to severe renal impairment and a reduced dosage given in lesser impairment (not exceeding 60mg/day
IV or IM).
