XEVOLAC SOLUTION FOR INJECTION 30 MG/ML

NOVEM HEALTHCARE PTE LTD

NOVEM HEALTHCARE PTE LTD

Therapeutic

Prescription Only

INJECTION, SOLUTION

**4.2 Posology and Method of Administration** Ketorolac Injection is for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over at least 15 seconds. Ketorolac Injection 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 minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The administration of continuous multiple daily doses of ketorolac intramuscularly or intravenously should not exceed five 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. **Single-Dose Treatment: The following regimen should be limited to single administration use only** **Intramuscular Dosing** - Patients <65 years of age: One dose of 60 mg - Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg **Intravenous Dosing** - Patients <65 years of age: One dose of 30 mg - Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg **Multiple-Dose Treatment (Intravenous or Intramuscular)** - Patients <65 years of age: The recommended dose is 30 mg ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. - For patients ≥65 years of age, renally impaired patients (see **WARNINGS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. The lowest effective dose should be given. The maximum duration of treatment should not exceed five 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. Ketorolac does not interfere with opioid binding and does not exacerbate opioid-related respiratory depression or sedation. When used in association with Ketorolac 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. In patients who are converted to oral Ketorolac, the combined duration of use of intravenous or intramuscular dosing of ketorolac and oral ketorolac is not to exceed 5 days. In adults, the use of oral ketorolac is only indicated as continuation therapy to intravenous or intramuscular dosing of ketorolac. Oral formulation should not be given as an initial dose. For breakthrough pain, do not increase the dose or the frequency of ketorolac. For patients over 65 years, a total daily dose of 60mg should not be exceeded (see section 4.4 Special warnings and special precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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, Ketorolac Injection is not indicated for use in children under 17 years of age. Renal impairment Ketorolac 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) (see section 4.3 Contra-indications).