Active Ingredient: Parecoxib
For the short-term treatment of postoperative pain in adults.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
40 - 80 mg
From 20 To 40 mg 2 time(s) per day every day
The recommended dose is 40 mg administered intravenously (IV), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day.
As the cardiovascular risk of COX-2 specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. There is limited clinical experience with parecoxib treatment beyond three days.
Opioid analgesics can be used concurrently with parecoxib, dosing as described above. In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis.
No dose adjustment is generally necessary in elderly patients (≥65 years). However, for elderly patients weighing less than 50 kg, treatment should be initiated with half the usual recommended dose of parecoxib and reduce the maximum daily dose to 40 mg.
The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.
Precipitation may occur when parecoxib is combined in solution with other medicinal products and therefore parecoxib must not be mixed with any other medicinal product, either during reconstitution or injection. In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after parecoxib injection with a solution of known compatibility.
Intramuscular
40 - 80 mg
From 20 To 40 mg 2 time(s) per day every day
The recommended dose is 40 mg administered intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day.
As the cardiovascular risk of COX-2 specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. There is limited clinical experience with parecoxib treatment beyond three days.
Opioid analgesics can be used concurrently with parecoxib, dosing as described in the paragraph above. In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis.
No dose adjustment is generally necessary in elderly patients (≥65 years). However, for elderly patients weighing less than 50 kg, treatment should be initiated with half the usual recommended dose of parecoxib and reduce the maximum daily dose to 40 mg.
The IM injection should be given slowly and deeply into the muscle.
Precipitation may occur when parecoxib is combined in solution with other medicinal products and therefore parecoxib must not be mixed with any other medicinal product, either during reconstitution or injection.
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