Tedizolid

Important Administration Instructions for Pediatric Patients Weighing Less than 35 kg Do not administer SIVEXTRO Tablets to pediatric patients weighing less than 35 kg [see Dosage and Administration 2.3 ].

Preparation and Administration of Intravenous Solution SIVEXTRO is supplied as a sterile, lyophilized powder for injection in single-dose vials of 200 mg. Each 200 mg vial must be reconstituted with Sterile Water for Injection and subsequently diluted with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.

SIVEXTRO vials contain no antimicrobial preservatives and are intended for single dose only. Discard any unused portion. Preparation of SIVEXTRO for Injection Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The contents of the vial should be reconstituted using aseptic technique as follows: Note: To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution.

For Adults and Pediatric Patients Weighing at Least 35 kg: Reconstitute the SIVEXTRO vial with 4 mL of Sterile Water for Injection to provide a concentration of 50 mg/mL in each vial. Gently swirl the contents and let the vial stand until the cake has completely dissolved and any foam disperses. Inspect the vial to ensure the solution contains no particulate matter and no cake or powder remains attached to the sides of the vial.

If necessary, invert the vial to dissolve any remaining powder and swirl gently to prevent foaming. The reconstituted solution is clear and colorless to pale-yellow in color; the total time from reconstitution to the end of administration should not exceed 24 hours at either room temperature or under refrigeration at 2°C to 8°C (36°F to 46°F).

Tilt the upright vial and insert a syringe with appropriately sized needle into the bottom corner of the vial and remove 4 mL of the reconstituted solution for the 200 mg dose. Do not invert the vial during extraction. The reconstituted solution must be further diluted in 250 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.

Slowly inject the required volume of reconstituted solution as determined in Step 2 into a 250 mL bag of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Invert the bag gently to mix. Do NOT shake the bag as this may cause foaming. For Pediatric Patients Weighing Less than 35 kg: Reconstitute the SIVEXTRO vial with 4 mL of Sterile Water for Injection to provide a concentration of 50 mg/mL in each vial.

Gently swirl the contents and let the vial stand until the cake has completely dissolved and any foam disperses. Inspect the vial to ensure the solution contains no particulate matter and no cake or powder remains attached to the sides of the vial. If necessary, invert the vial to dissolve any remaining powder and swirl gently to prevent foaming.

The reconstituted solution is clear and colorless to pale-yellow in color; the total time from reconstitution to the end of administration should not exceed 24 hours at either room temperature or under refrigeration at 2°C to 8°C (36°F to 46°F). Prepare a stock solution (100 mL of 0.8 mg/mL tedizolid phosphate): Tilt the upright vial and insert a syringe with appropriately sized needle into the bottom corner of the vial and remove 1.6 mL of the reconstituted solution and add it to an infusion bag containing 98.4 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.

Do not invert the vial during extraction. Prepare the required volume of stock solution for infusion: Refer to Table 4 to convert the dose in mg to the appropriate volume of stock solution to be administered. Transfer this volume of stock solution to an adequately sized infusion bag or infusion syringe. It may be necessary to round to the nearest graduation mark of an appropriately sized syringe for smaller volumes.

The total time from reconstitution to the end of administration should not exceed 24 hours at either room temperature or under refrigeration at 2°C to 8°C (36°F to 46°F). [See table below.] /kg Pediatric Patients Weighing at Least 2 kg 2 to less than 3 6 mg 7.5 mL 3 to less than 6 12 mg 15 mL 6 to less than 10 20 mg 25 mL 10 to less than 14 30 mg 37.5 mL 14 to less than 20 40 mg 50 mL 20 to less than 35 60 mg 75 mL Administration of SIVEXTRO for Injection Administer SIVEXTRO for Injection as an intravenous infusion only.

Do not administer as an intravenous push or bolus. Do not mix SIVEXTRO for Injection with other drugs when administering. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The intravenous bag containing the reconstituted and diluted intravenous solution should be inspected visually for particulate matter prior to administration.

Discard if visible particles are observed. The resulting solution is clear and colorless to pale-yellow in color. After reconstitution and dilution, SIVEXTRO for Injection is to be administered via intravenous infusion using a total time of 1 hour. The total time from reconstitution to the end of administration of SIVEXTRO for Injection should not exceed 24 hours at either room temperature or under refrigeration at 2°C to 8°C (36°F to 46°F).

Discard unused portion.

Compatible Intravenous Solutions SIVEXTRO is compatible with 0.9% Sodium Chloride Injection, USP and 5% Dextrose Injection, USP. Limited data are available on the compatibility of SIVEXTRO for Injection with other intravenous substances, additives or other medications and they should not be added to SIVEXTRO single-dose vials or infused simultaneously.

If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of SIVEXTRO with 0.9% Sodium Chloride Injection, USP.

Incompatibilities SIVEXTRO for Injection is incompatible with any solution containing divalent cations (e.g., Ca 2+ , Mg 2+ ), including Lactated Ringer’s Injection and Hartmann’s Solution.