Parecoxib (Dynastat) may be administered as single or multiple IV or IM doses on a regular or as needed schedule. After initiation of therapy, dosage should be adjusted based on patient response. Clinical studies with parecoxib (Dynastat) were conducted using up to 7 days of treatment.
Parecoxib (Dynastat) is only indicated for patients with a need for parenteral therapy and for whom a similar benefit could not be obtained from alternative oral therapy. It is recommended that patients be transitioned to alternative oral therapy as soon as clinically indicated.
As the cardiovascular (CV) risk of cyclooxygenase-2 (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. However, the relevance of these findings for the short-term use of parecoxib (Dynastat) in the post-operative setting has not been evaluated.
Management of Acute Pain: The recommended single or initial dose for treatment of acute pain is 40 mg, administered either IV or IM, followed by 20 mg or 40 mg every 6 to 12 hours, as required, up to a maximum daily dosage of 80 mg. The IV bolus injection may be given directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle.
Prevention or Reduction of Post-operative Pain: The recommended dose is 40 mg administered IV or IM (but preferably IV) 30 to 45 minutes prior to surgical incision. Continued medication with parecoxib (Dynastat) post-operatively may be needed for adequate analgesic effect.
Concomitant Use with Opioid Analgesics: Opioid analgesics can be used concurrently with parecoxib (Dynastat), dosing as described previously. In clinical trials, the daily requirement for opioids was significantly reduced (20%-40%) when co-administered with parecoxib (Dynastat). An optimal effect is achieved when parecoxib (Dynastat) is given prior to opioid administration. In all clinical assessments parecoxib (Dynastat) was administered at a fixed time interval whereas the opioids were administered on as needed basis (PRN).
Elderly: No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to reduce the initial dose of parecoxib (Dynastat) by 50%. The maximum daily dose should be reduced to 40 mg in elderly patients weighing less than 50 kg.
Hepatic Impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Treatment with parecoxib (Dynastat) should be initiated at the lowest recommended dose in patients with moderate hepatic impairment (Child-Pugh Class B).
Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. The use of parecoxib (Dynastat) in these patients is not recommended.
Renal Impairment: In patients with severe renal impairment (creatinine clearance <30 mL/minute), or patients who may be predisposed to fluid retention, parecoxib (Dynastat) should be initiated at the lowest recommended dose and the patient's kidney function closely monitored.
Co-administration with Fluconazole: When parecoxib (Dynastat) is co-administered with fluconazole, the lowest recommended dose of parecoxib (Dynastat) should be used.
Pediatric Patients: Safety and efficacy have not been established in children under 18 years of age.