Sivextro Dosage
Generic name: tedizolid phosphate 200mg
Dosage forms: tablet, film coated, lyophilized powder for injection
Drug class: Oxazolidinone antibiotics
Medically reviewed by Drugs.com. Last updated on Apr 4, 2025.
2.1 Important Administration Instructions for Pediatric Patients Weighing Less than 35 kg
Do not administer SIVEXTRO Tablets to pediatric patients weighing less than 35 kg.
2.2 Recommended Dosage for Adult Patients
The recommended dosage of SIVEXTRO is 200 mg administered once daily for six (6) days either as an oral tablet (with or without food) or as an intravenous (IV) infusion in adult patients.
The recommended dosage and administration of SIVEXTRO in adult patients are described in Table 1.
Infection | Route | Dose | Frequency | Infusion Time | Duration of Treatment |
---|---|---|---|---|---|
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) |
Intravenous | 200 mg | Once daily | 1 hour | 6 days |
Oral | 200 mg | Once daily | Not Applicable |
No dose adjustment is necessary when changing from intravenous to oral SIVEXTRO.
2.3 Recommended Dosage for Pediatric Patients
Recommended Dosage of SIVEXTRO for Injection for Pediatric Patients: Intravenous Dosage
The recommended intravenous dosage of SIVEXTRO for Injection for pediatric patients (at least 26 weeks gestational age and weighing at least 1 kg) is presented in Table 2.
Weight Band (kg) | Dose | Frequency | Infusion Time | Duration of Treatment |
---|---|---|---|---|
|
||||
Pediatric Patients Weighing Less than 2 kg | ||||
1 to less than 2* | 3 mg/kg | Twice daily | 1 hour | 6 days |
Pediatric Patients Weighing at Least 2 kg | ||||
2 to less than 3 | 6 mg | Twice daily | 1 hour | 6 days |
3 to less than 6 | 12 mg | |||
6 to less than 10 | 20 mg | |||
10 to less than 14 | 30 mg | |||
14 to less than 20 | 40 mg | |||
20 to less than 35 | 60 mg | |||
Pediatric Patients Weighing at Least 35 kg | ||||
Greater than or equal to 35 | 200 mg | Once daily | 1 hour | 6 days |
Recommended Dosage of SIVEXTRO Tablets for Pediatric Patients: Oral Dosage
The recommended oral dosage of SIVEXTRO Tablets for pediatric patients is presented in Table 3. SIVEXTRO Tablets can be administered with or without food. Do not administer SIVEXTRO Tablets to pediatric patients weighing less than 35 kg.
Weight Band (kg) | Dose | Frequency | Duration of Treatment |
---|---|---|---|
Greater than or equal to 35 | 200 mg | Once daily | 6 days |
No dose adjustment is necessary when changing from intravenous to oral SIVEXTRO.
2.4 Recommendations Regarding Missed Doses(s)
For Once Daily Oral Dosing of SIVEXTRO Tablets
If patients miss a dose, administer the dose as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, instruct the patients to wait until their next scheduled dose.
2.5 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).
Body Weight (kg) | Amount of SIVEXTRO per dose (given twice daily) |
Volume of stock solution (0.8 mg/mL) to be transferred to an adequately sized infusion bag or infusion syringe |
---|---|---|
Pediatric Patients Weighing Less than 2 kg | ||
1 to less than 2 | 3 mg/kg | Volume (mL) = Weight (kg) x 3.75 mL/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.
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