TORADOL Solution for injection Ref.[116966] Active ingredients: Ketorolac

Posology

The time to onset of analgesic effect following both IV and IM administration is similar and is approximately 30 minutes, with maximum analgesia occurring within one to two hours. The median duration of analgesia is generally four to six hours.

Dosage should be adjusted according to the severity of the pain and the patient response.

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.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Adults

The recommended initial dose of Toradol is 10 mg, followed by 10 to 30 mg every four to six hours as required. In the initial post-operative period, Toradol may be given as often as every two hours if needed. The lowest effective dose should be given. A total daily dose of 90 mg for non-elderly and 60 mg for the elderly, renally-impaired patients and patients less than 50 kg should not be exceeded. The maximum duration of treatment should not exceed two days.

Reduce dosage in patients under 50 kg.

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 Toradol IM/IV, 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.

Elderly

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 and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. A total daily dose of 60 mg should not be exceeded (see section 4.4).

Paediatric population

Safety and efficacy in children have not been established. Therefore, Toradol is not recommended for use in children under 16 years of age.

Renal impairment

Contraindicated in moderate to severe renal impairment; reduce dosage in lesser impairment (not exceeding 60 mg/ day IV or IM) (see section 4.3).

Method of administration

Toradol is for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over no less than 15 seconds. Toradol should not be used for epidural or spinal administration.

Symptoms and signs

Single overdoses of ketorolac have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.

Gastrointestinal bleeding may occur. Hypertension, acute renal failure, respiratory depression and coma may occur after the ingestion of NSAIDs but are rare.

Headache, epigastric pain, disorientation, excitation, drowsiness, dizziness, tinnitus and fainting have also been observed.

Rare cases of diarrhoea and occasional convulsions have been reported.

Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose.

Treatment

Patients should be managed by symptomatic and supportive care following NSAIDs overdose. There are no specific antidotes. Dialysis does not significantly clear ketorolac from the blood stream.

Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition.

3 years.

Keep the ampoules in the outer carton. Do not refrigerate or freeze. Do not use if particulate matter is present.

Toradol 30 mg is available in single-dose ampoules containing 1 ml of solution in cartons of 1, 5 or 10.

No special instructions applicable.