From the FDA Drug Label
DIRECTIONS FOR USE Intramuscular Administration Reconstitute ceftriaxone for injection powder with the appropriate diluent (see COMPATIBILITY AND STABILITY) Inject diluent into vial, shake vial thoroughly to form solution. Withdraw entire contents of vial into syringe to equal total labeled dose. After reconstitution, each 1 mL of solution contains approximately 250 mg or 350 mg equivalent of ceftriaxone for injection according to the amount of diluent indicated below.
- Intramuscular Reconstitution:
- Reconstitute with the appropriate diluent.
- Inject diluent into vial and shake thoroughly.
- The amount of diluent to be added is as follows:
- 250 mg: 0.9 mL (for 250 mg/mL)
- 500 mg: 1.8 mL (for 250 mg/mL) or 1 mL (for 350 mg/mL)
- 1 gram: 3.6 mL (for 250 mg/mL) or 2.1 mL (for 350 mg/mL)
- 2 gram: 7.2 mL (for 250 mg/mL) or 4.2 mL (for 350 mg/mL)
- Intravenous Reconstitution:
- Reconstitute vials with an appropriate IV diluent.
- The amount of diluent to be added is as follows:
- 250 mg: 2.4 mL
- 500 mg: 4.8 mL
- 1 gram: 9.6 mL
- 2 gram: 19.2 mL
- After reconstitution, each 1 mL of solution contains approximately 100 mg equivalent of ceftriaxone for injection.
- Withdraw entire contents and dilute to the desired concentration with the appropriate IV diluent. 1
From the Research
Ceftriaxone should be reconstituted by adding an appropriate diluent to the powder in the vial and shaking gently until completely dissolved, with the recommended concentrations being 250-350 mg/mL for intramuscular (IM) injection and not exceeding 40 mg/mL for IV push or 100 mg/mL for IV infusion, as supported by the most recent and highest quality studies 2, 3.
Reconstitution Guidelines
To ensure proper reconstitution, the following guidelines should be followed:
- For IM injection, add 1% lidocaine, sterile water, or 0.9% sodium chloride to achieve a concentration of 250-350 mg/mL.
- For IV administration, reconstitute with sterile water or 0.9% sodium chloride to a concentration not exceeding 40 mg/mL for IV push or 100 mg/mL for IV infusion.
Solution Stability and Inspection
After reconstitution, the solution should be:
- Clear and yellow to amber in color.
- Inspected for particles or discoloration before administration, and discarded if present.
- Used within the recommended timeframe, with IV solutions remaining stable for 24 hours at room temperature or 3-4 days if refrigerated, and IM solutions used within 24 hours.
Clinical Considerations
Proper reconstitution is essential to ensure appropriate drug delivery and prevent administration issues, as incorrect concentration can affect both efficacy and patient comfort, as noted in studies such as 4, which highlights the potential risks of incorrect diluent use.
Key Points
- Reconstitute ceftriaxone with the recommended diluent and concentration.
- Inspect the solution for particles or discoloration before administration.
- Use the reconstituted solution within the recommended timeframe.
- Be aware of potential risks associated with incorrect diluent use, as reported in studies such as 4.