Dynastat Dosage/Direction for Use

Posology: Parecoxib 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.
Parecoxib is a prodrug of valdecoxib which is a non-steroidal anti-inflammatory drug (NSAID).
The mechanism of action is believed to be due to inhibition of prostaglandin synthesis primarily through inhibition of selective cyclooxygenase-2 (COX-2). Parecoxib 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 and non-specific NSAIDs may increase with dose and duration of exposure, the shortest duration possible, not to exceed 3 days, and the lowest effective daily dose should be used. However, the relevance of these findings for the short-term use of parecoxib in the post-operative setting has not been evaluated.
Clinical studies with parecoxib were conducted using up to 7 days of treatment.
Management of Acute Pain and Treatment of Post-operative 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.
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 by 50%. The maximum daily dose should be reduced to 40 mg in elderly patients weighing less than 50 kg. Caution should be used when treating elderly patients as they have cardiovascular risk factors.
Hepatic Impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Treatment with parecoxib 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 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 should be initiated at the lowest recommended dose and the patient's kidney function closely monitored.
Co-administration with Fluconazole: When parecoxib is co-administered with fluconazole, the lowest recommended dose of parecoxib should be used (see Interactions).
Pediatric Patients: Safety and efficacy have not been established in children under 18 years of age.
Method of Administration: Parecoxib sodium for injection is a preservative-free lyophilized powder. Parecoxib sodium should be reconstituted with 1 mL (20 mg vial) or 2 mL (40 mg vial) Sodium Chloride Injection (0.9%).
Alternatively, parecoxib sodium may be reconstituted with bacteriostatic 0.9% Sodium Chloride Injection, 5% Dextrose Injection or 5% Dextrose and 0.45% Sodium Chloride Injection.
Use of Lactated Ringer's Injection, or 5% Dextrose in Lactated Ringer's Injection, are not recommended for reconstitution as they will cause the drug to precipitate from solution. Use of Water for Injection is not recommended for reconstitution of parecoxib sodium, as the resulting solution is not isotonic.
Do not refrigerate or freeze the reconstituted product.