Instructions for Use and Handing: Parecoxib sodium (Dynastat) for injection is a preservative-free lyophilized powder. Parecoxib sodium (Dynastat) should be reconstituted with 1 mL (20 mg vial) or 2 mL (40 mg vial) Sodium Chloride Injection (0.9%).
Alternatively, parecoxib sodium (Dynastat) 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 (Dynastat), as the resulting solution is not isotonic.
Do not refrigerate or freeze the reconstituted product.
Reconstitution Process: Use aseptic technique to reconstitute lyophilized Parecoxib (Dynastat).
Remove the purple flip off cap to expose the central portion of the rubber stopper of the vial. Withdraw, with a sterile needle and syringe, 2 mL of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the 40 mg vial. Dissolve the powder completely using a gentle swirling motion and inspect the reconstituted product before use. The entire contents of the vial should be withdrawn for a single administration.
After reconstitution, parecoxib (Dynastat) should be inspected visually for particulate matter and discoloration prior to administration. The solution should not be used if discolored or cloudy, or if particulate matter is observed. Parecoxib sodium (Dynastat) should be administered within 24 hours of reconstitution, or discarded.
The reconstituted product is isotonic.
Incompatibilities: Following reconstitution with an acceptable diluent, parecoxib sodium (Dynastat) may be injected into an IV line delivering 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Lactated Ringers Injection, or 5% Dextrose and 0.45% Sodium Chloride Injection. Injection into a line delivering 5% Dextrose in Lactated Ringer's, or other IV fluid not listed here, is not recommended, as this may cause precipitation from solution.
Parecoxib sodium (Dynastat) should not be admixed for injection with any other drug.
Do not inject parecoxib (Dynastat) into an IV line delivering any other drug. The IV line must be adequately flushed prior to, and after parecoxib (Dynastat) injection with a solution of known compatibility (see Instructions for Use and Handling).