XEVOLAC SOLUTION FOR INJECTION 30 MG/ML [SIN16401P]

Product Info

XEVOLAC SOLUTION FOR INJECTION 30 MG/ML

[SIN16401P]

4.1 Therapeutic Indications

Ketorolac Injection is indicated for the short-term management of moderate to severe acute post-operative pain that requires analgesia at the opioid level. Treatment should only be initiated in hospitals. The maximum duration of treatment is 5 days.

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).

4.3 Contraindications

• Active peptic ulcer, or any history of gastrointestinal bleeding, ulceration or perforation.

• Hypersensitivity to ketorolac trometamol or any of the excipients.

• NSAIDS are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (severe anaphylactic-like reactions have been observed in such patients).

• Ketorolac inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients who have had operations with a high risk of haemorrhage or incomplete haemostasis and those at high risk of bleeding such as those with haemorrhagic diatheses, including coagulation disorders.

• Concurrent treatment with aspirin or other NSAIDs including cyclooxygenase 2 specific inhibitors.

• Probenecid

• Advanced renal impairment or in patients at risk for renal failure due to volume depletion or dehydration.

• During pregnancy, labour, delivery or lactation (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Ketorolac is contra-indicated as prophylactic analgesia before surgery due to inhibition of platelet aggregation and is contra-indicated intra-operatively because of the increased risk of bleeding.

• Ketorolac Solution for injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.

• The combination of Ketorolac with pentoxifylline is contraindicated.

• NSAIDs are contraindicated in the setting of Coronary Artery Bypass Graft surgery.