Cefepime-zidebactam
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Zaynich · Reconstitution and dilution
- Preparation
- Reconstitute with 10 mL of the labeled bag fluid or sterile water for injection. Further dilute in a 100 mL bag of 0.9% sodium chloride, 5% dextrose or lactated Ringer's.
- Administration and handling
- Section 2.3 specifies how to adjust the bag volume when using sterile water and how much to withdraw for each dose. The vial concentrate cannot be given directly.
- Manufacturer's storage limits
- Reconstituted vial: up to 6 hours at 20-25 C or 12 hours at 2-8 C. Administer the diluted infusion within 12 hours at 20-25 C or within 24 hours at 2-8 C. A compounding beyond-use date requires a separate assessment.
| Prescribed combination dose | Volume from the reconstituted vial | Labeled bag |
|---|---|---|
| 3 g (2 g cefepime + 1 g zidebactam) | 13 mL | 100 mL |
| 1.5 g (1 g cefepime + 0.5 g zidebactam) | 6.5 mL | 100 mL |
Table 2 permits starting with a 250 mL bag after discarding 150 mL. Also follow the adjustment in section 2.3 if sterile water was used in the vial.
Product and source details
Wockhardt Suisse USA LLC · NDA220787
Product NDC: 87706-866
SPL effective 2026-10-16 | SPL version 3. Checked 2026-11-13.
Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.
Product identifiers and clinical review status
U.S. label preparation available. Full monograph review pending.
Exact formulation, concentration, container, manufacturer, regulatory identifiers, and a reproducible label snapshot have not all been reconciled.
What remains to be completed
- Obtain independent corroboration of the label preparation where available.
- Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
- Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.