AUDIENCE: Infectious Disease, Pharmacy
ISSUE: FDA is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug ceftazidime-avibactam (Avycaz) due to confusion about the drug strength displayed on the vial and carton labels. Ceftazidime-avibactam was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, FDA revised the labels to indicate that each vial contains ceftazidime-avibactam 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
Since ceftazidime-avibactam's approval in February 2015, FDA received reports of three medication error cases related to confusion on how the strength was displayed on the ceftazidime-avibactam vial and carton labels. Two cases stated that the errors occurred during preparation of the dose in the pharmacy. The third case described concern about the potential for confusion because the strength displayed for ceftazidime-avibactam differs from how the strength is displayed for other beta-lactam/beta-lactamase drugs. Based on the information provided in the reports, FDA is aware that at least one of the patients received a higher-than-intended dose of ceftazidime-avibactam. No adverse events were reported.
BACKGROUND: Ceftazidime-avibactam is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options.
RECOMMENDATION: Due to reports of medication errors associated with ceftazidime-avibactam, the vial and carton labels have been revised to indicate that each vial contains ceftazidime-avibactam 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
The combination of ceftazidime and avibactam injection is used with metronidazole (Flagyl) to treat abdominal (stomach area) infections. It is also used to treat kidney and urinary tract infections. Ceftazidime is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Avibactam is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from breaking down ceftazidime. Antibiotics will not work for colds, flu, or other viral infections.
How should this medicine be used?
The combination of ceftazidime and avibactam injection comes as a powder to be added to fluid and injected intravenously (into a vein). It is usually infused (injected slowly) intravenously over a period of 2 hours every 8 hours. The length of your treatment depends on your general health, the type of infection you have and how well you respond to the medication. Your doctor will tell you how long to use ceftazidime and avibactam injection. You may receive ceftazidime and avibactam injection in a hospital or you may administer the medication at home. If you will be receiving ceftazidime and avibactam injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions.
You should begin to feel better during the first few days of treatment with ceftazidime and avibactam injection. If your symptoms do not improve or get worse, tell your doctor. If you still have symptoms of infection after you finish ceftazidime and avibactam injection, tell your doctor.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using ceftazidime and avibactam injection,
- tell your doctor and pharmacist if you are allergic to ceftazidime and avibactam injection, carbapenem antibiotics such as doripenem (Doribax), imipenem and cilastatin (Primaxin), or meropenem (Merrem); cephalosporin antibiotics such as cefaclor, cefadroxil, cefazolin (Ancef, Kefzol), cefdinir, cefditoren (Spectracef), cefepime (Maxipime), cefixime (Suprax), cefotaxime (Claforan), cefoxitin, cefpodoxime, cefprozil, ceftazidime (Fortaz, Tazicef, in Avycaz), ceftibuten (Cedax), ceftriaxone (Rocephin), cefuroxime (Ceftin, Zinacef), and cephalexin (Keflex); penicillin; any other medications, or any of the ingredients in ceftazidime and avibactam injection. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: probenecid (Probalan, in Col-Probenecid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using ceftazidime and avibactam injection, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medication cause?
Ceftazidime and avibactam injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- difficulty breathing or swallowing
- severe diarrhea with watery or bloody stools (up to 2 months after your treatment)
- sudden muscle twitching or jerking that you cannot control
- hand tremor
- seeing things or hearing voices that do not exist
- coma (loss of consciousness for a period of time)
Ceftazidime and avibactam injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ceftazidime and avibactam injection.
If you have diabetes, ceftazidime and avibactam injection can cause false results with certain urine glucose tests. Talk to your doctor about using other glucose tests while using ceftazidime and avibactam injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.