Posology : מינונים

4.2.   Posology and method of administration

The time to onset of analgesic effect following both intramuscular and the intravenous administration is similar and is approximately 30 minutes, the maximum analgesia occurring within 1 - 2 hours.

The median duration of the analgesia is generally four to six hours.

Dosage should be adjusted individually, according to the severity of pain and the patient's response.
The administration of continuous multiple daily doses of ketorolac intramuscularly or intravenously should not exceed 2 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).

Posology

The product is not approved for use after heart surgeries.
Adults and adolescents over 16 years

The recommended initial dose is 10 mg of ketorolac trometamol, followed by 10 to 30 mg every 4 to 6 hours, as required.
The minimum effective dose is recommended.

The recommended maximum daily dose is 90 mg of ketorolac trometamol (3 ampoules of Ketorolac Trometamol Rompharm) for adults and 60 mg ketorolac trometamol (2 ampoules of Ketorolac Trometamol Rompharm) for elderly patients and patients less than 50 kg.

The maximum duration of treatment should not exceed 2 days.

Patients receiving ketorolac trometamol on intravenous or intramuscular route, and who are converted to oral ketorolac, should receive a total combined daily dose of both pharmaceutical form not exceeding 90 mg ketorolac trometamol (3 ampoules of Ketorolac Trometamol Rompharm) for adults and 60 mg ketorolac trometamol (2 ampoules of Ketorolac Trometamol Rompharm) for the elderly, and patients less than 50kg.

Also, the oral component should not exceed 40 mg ketorolac trometamol on the day when the change of formulation is made from intramuscular route or intravenous to the oral route of administration.
Patients should be converted to oral treatment as soon as possible.

The dosage should be reduced in patients under 50 kg.

Opioid analgesics (e.g., morphine, pethidine) may be administered concomitantly if they are necessary for an optimal analgesic effect or for their anxiolytic and/or sedative effects.

Ketorolac Trometamol Rompharm 30 mg/ml is not an opioid analgesic.
Ketorolac trometamol does not interfere with the opioid binding and does not exacerbate opioid- related respiratory depression or sedation.
When opioids are used in association with Ketorolac Trometamol Rompharm 30 mg/ml administered intramuscularly or intravenously, the daily dose of opioids should be lower than the usual one.
However, opioids side-effects should still be considered, especially in the day of the surgical intervention.

Elderly (over 65 years)
The elderly have an increased risk of severe adverse reactions. If the administration of the anti- inflammatory drugs is considered necessary, the lowest effective dose should be used for the shortest possible duration. The patients should be monitored regularly for gastrointestinal bleeding during treatment with non-steroidal anti-inflammatory drugs. The maximum daily dose should not exceed 60 mg of ketorolac trometamol (2 ampoules of Ketorolac Trometamol Rompharm). The doses should be reduced in the patients less than 50 kg.

Patients with renal impairment
Ketorolac Trometamol Rompharm 30 mg/ml is contraindicated in patients with moderate to severe renal impairment (See section 4.3); reduce dosage in lesser impairment (not exceeding 45mg/day IV or IM).

Children and adolescents
The safety and the efficacy of the administration in children and adolescents have not been established. For this reason, Ketorolac Trometamol Rompharm 30 mg/ml is contraindicated in children less than 16 years of age.

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

Method of administration

Ketorolac Trometamol Rompharm is for administration by intramuscular or bolus intravenous injection.
Bolus intravenous doses should be given over at least 15 seconds. Ketorolac Trometamol Rompharm 30 mg/ml should not be administered epidural or intrathecal. The treatment should be initiated and administered by qualified personnel.