Ceftazidime compatibility and stability

Ceftazidime
FORATZ®,TAZICEF®,CEFTAZIDIME® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
Compatibility and stability
Directions for use
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

Intramuscular

FORTAZ, when constituted as directed with Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection, maintains satisfactory potency for 12 hours at room temperature or for 3 days under refrigeration. Solutions in Sterile Water for Injection that are frozen immediately after constitution in the original container are stable for 3 months when stored at -20°C. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 3 hours at room temperature or for 3 days in a refrigerator.

Tazicef (ceftazidime for injection, USP) when reconstituted as directed with Sterile Water for Injection, maintains satisfactory potency for 24 hours at room temperature or for 7 days under refrigeration (5°C). Solutions in Sterile Water for Injection that are frozen immediately after reconstitution in the original container are stable for 3 months when stored at -20°C. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 8 hours at room temperature or for 4 days in a refrigerator (5°C).

Intravenous

FORTAZ, when constituted as directed with Sterile Water for Injection, maintains satisfactory potency for 12 hours at room temperature or for 3 days under refrigeration. Solutions in 0.9% Sodium Chloride Injection in VIAFLEX® small-volume containers that are frozen immediately after constitution are stable for 3 months when stored at -20°C. Do not force thaw by immersion in water baths or by microwave irradiation. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 12 hours at room temperature or for 3 days in a refrigerator. More concentrated solutions in Sterile Water for Injection in the original container that are frozen immediately after constitution are stable for 3 months when stored at -20°C. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 8 hours at room temperature or for 3 days in a refrigerator.

FORTAZ is compatible with the more commonly used IV infusion fluids. Solutions at concentrations between 1 and 40 mg/mL in 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; 5% Dextrose Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose Injection; Ringer's Injection, USP; Lactated Ringer's Injection, USP; 10% Invert Sugar in Water for Injection; and NORMOSOL®-M in 5% Dextrose Injection may be stored for up to 12 hours at room temperature or for 3 days if refrigerated.

The 1- and 2-g FORTAZ ADD-Vantage vials, when diluted in 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 0.45% Sodium Chloride Injection, may be stored for up to 12 hours at room temperature or for 3 days under refrigeration.

FORTAZ is less stable in Sodium Bicarbonate Injection than in other IV fluids. It is not recommended as a diluent. Solutions of FORTAZ in 5% Dextrose Injection and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers, and volume control devices of common IV infusion sets.

Ceftazidime at a concentration of 4 mg/mL has been found compatible for 12 hours at room temperature or for 3 days under refrigeration in 0.9% Sodium Chloride Injection or 5% Dextrose Injection when admixed with: cefuroxime sodium (ZINACEF®) 3 mg/mL, heparin 10 or 50 U/mL, or potassium chloride 10 or 40 mEq/L.

Tazicef (ceftazidime for injection, USP) when reconstituted as directed with Sterile Water for Injection, maintains satisfactory potency for 24 hours at room temperature or for 7 days under refrigeration. Solutions in Sterile Water for Injection in the original container or in 0.9% Sodium Chloride Injection in Viaflex® small volume containers that are frozen immediately after reconstitution are stable for 3 months when stored at -20°C. For larger volumes where it may be necessary to warm the frozen product (to a maximum of 40°C), care should be taken to avoid heating after thawing is complete. Do not force thaw by immersion in water baths or by microwave irradiation. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 8 hours at room temperature or for 4 days in a refrigerator (5°C).

Tazicef is compatible with the more commonly used IV infusion fluids. Solutions at concentrations between 1 mg/mL and 40 mg/mL in the following infusion fluids may be stored for up to 24 hours at room temperature or 7 days if refrigerated: 0.9% Sodium Chloride Injection; Ringer’s Injection USP; Lactated Ringer’s Injection USP; 5% Dextrose Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose Injection.

Tazicef is less stable in Sodium Bicarbonate Injection than in other IV fluids. It is not recommended as a diluent. Solutions of Tazicef in 5% Dextrose and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers and volume control devices of common IV infusion sets.

Ceftazidime at a concentration of 20 mg/mL has been found physically compatible for 24 hours at room temperature or 7 days under refrigeration in Sterile Water for Injection when admixed with: cefazolin sodium 330 mg/mL; heparin 1000 units/mL; and cimetidine HCl 150 mg/mL.

Ceftazidime at a concentration of 20 mg/mL has been found physically compatible for 24 hours at room temperature or 7 days under refrigeration in 5% Dextrose Injection when admixed with potassium chloride 40 mEq/L.

Ceftazidime for injection, when constituted as directed with Sterile Water for Injection should have the contents withdrawn within 4 hours. Solutions in Sterile Water for Injection in the infusion vial or in 0.9% Sodium Chloride Injection in VIAFLEX® small-volume containers that are frozen immediately after constitution are stable for 6 months when stored at -20°C. Do not force thaw by immersion in water baths or by microwave irradiation. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 24 hours at room temperature or for 7 days in a refrigerator.

Ceftazidime is compatible with the more commonly used IV infusion fluids. Solutions at concentrations between 1 and 40 mg/mL in 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; 5% Dextrose Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose Injection; Ringer's Injection, USP; Lactated Ringer’s Injection, USP; 10% Invert Sugar in Water for Injection; and NORMOSOL®-M in 5% Dextrose Injection may be stored for up to 24 hours at room temperature or for 7 days if refrigerated.

Ceftazidime for injection is less stable in Sodium Bicarbonate Injection than in other IV fluids. It is not recommended as a diluent. Solutions of ceftazidime for injection in 5% Dextrose Injection and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers, and volume control devices of common IV infusion sets.

Ceftazidime at a concentration of 4 mg/mL has been found compatible for 24 hours at room temperature or for 7 days under refrigeration in 0.9% Sodium Chloride Injection or 5% Dextrose Injection when admixed with: cefuroxime sodium 3 mg/mL, heparin 10 or 50 U/mL, or potassium chloride 10 or 40 mEq/L. Vancomycin solution exhibits a physical incompatibility when mixed with a number of drugs, including ceftazidime. The likelihood of precipitation with ceftazidime is dependent on the concentrations of vancomycin and ceftazidime present. It is therefore recommended, when both drugs are to be administered by intermittent IV infusion, that they be given separately, flushing the IV lines (with 1 of the compatible IV fluids) between the administration of these 2 agents.

Note: Parenteral drug products should be inspected visually for particulate matter before administration whenever solution and container permit.

As with other cephalosporins, FORTAZ powder, as well as solutions, tend to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf