Postoperative pain

Indication for Parecoxib

Population group: Suitable for both men and women, only adults (18 years old or older)
Therapeutic intent: Curative procedure

For the short-term treatment of postoperative pain in adults.

For this indication, competent medicine agencies globally authorize below treatments:

40 mg and 20 mg every 6 hours or 40 mg every 12 hours thereafter

Route of admnistration

Intravenous

Defined daily dose

40 - 80 mg

Dosage regimen

From 20 To 40 mg 2 time(s) per day every day

Detailed description

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.

Concomitant use with opioid analgesics

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.

Elderly

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.

Dosage considerations

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.

40mg and 20mg every 6 hours or 40mg every 12 hours thereafter

Route of admnistration

Intramuscular

Defined daily dose

40 - 80 mg

Dosage regimen

From 20 To 40 mg 2 time(s) per day every day

Detailed description

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.

Concomitant use with opioid analgesics

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.

Elderly

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.

Dosage considerations

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.

Active ingredient

Parecoxib is a prodrug of valdecoxib. Valdecoxib is a selective COX-2 inhibitor within the clinical dose range. Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.

Read more about Parecoxib

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