Cefepime Injection

Brand Name(s):

• Maxipime®

IMPORTANT WARNING:

[Posted 6/26/2012]ISSUE:There have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of cefepime (Maxipime), primarily in patients with renal impairment who did not receive appropriate dosage adjustments of cefepime. The Warnings and Precautions and Adverse Reactions sections of the cefepime label are being revised to highlight this risk.

BACKGROUND:Cases of nonconvulsive status epilepticus associated with cefepime are documented in the medical literature and have been identified in FDA's Adverse Event Reporting System (AERS) database. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment; however, some cases occurred in patients receiving dosage adjustment appropriate for their degree of renal impairment. In the majority of cases, the seizures were reversible and resolved after discontinuing cefepime and/or after hemodialysis. See the Drug Safety Communication at: Web Sitefor additional information.

RECOMMENDATIONS:Health care professionals should adjust the dosage of cefepime in patients with creatinine clearance less than or equal to 60 mL/min. If seizures associated with cefepime therapy occur, consider discontinuing cefepime or making appropriate dosage adjustments in patients with renal impairment.

Caregivers who notice symptoms of nonconvulsive status epilepticus in a patient receiving cefepime should seek medical attention right away. Symptoms of nonconvulsive status epilepticus could include altered mental status, confusion, and decreased responsiveness. For more information visit the FDA website at: Web Siteand Web Site.

WHY is this medicine prescribed?

Your doctor has ordered cefepime, an antibiotic, to help treat your infection. The drug will be either injected into a large muscle (such as your buttock or hip) or added to an intravenous fluid that will drip through a needle or catheter placed in your vein for 30 minutes, one or two times a day.

Cefepime eliminates bacteria that cause many infections, including pneumonia and skin and urinary tract infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Your health care provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations. It is important to keep all appointments with your doctor and the laboratory. The length of treatment depends on how your infection and symptoms respond to the medication.

What SPECIAL PRECAUTIONS should I follow?

Before administering cefepime,

• tell your doctor and pharmacist if you are allergic to cefepime, penicillin, cephalosporins [cefaclor (Ceclor), cefadroxil (Duricef), or cephalexin (Keflex)], or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins.
• tell your doctor if you have or have ever had kidney, liver, or gastrointestinal disease (especially colitis).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cefepime, call your doctor.
• if you have diabetes and regularly check your urine for sugar, use Clinistix or Tes-Tape. Do not use Clinitest tablets, because cefepime may cause false positive results.

HOW should this medicine be used?

Before you administer cefepime, look at the solution closely. It should be clear and free of floating material. Gently squeeze the bag or observe the solution container to make sure there are no leaks. Do not use the solution if it is discolored, if it contains particles, or if the bag or container leaks. Use a new solution, but show the damaged one to your health care provider.

It is important that you use your medication exactly as directed. Do not stop your therapy on your own for any reason because your infection could worsen and result in hospitalization. Do not change your dosing schedule without talking to your health care provider. Your health care provider may tell you to stop your infusion if you have a mechanical problem (such as a blockage in the tubing, needle, or catheter); if you have to stop an infusion, call your health care provider immediately so your therapy can continue.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

• Your health care provider probably will give you a several-day supply of cefepime at a time. If you are receiving cefepime intravenously (in your vein), you probably will be told to store it in the refrigerator.
• Take your next dose from the refrigerator 1 hour before using it; place it in a clean, dry area to allow it to warm to room temperature.

If you are receiving cefepime intramuscularly (in your muscle), your health care provider will tell you how to store it properly.

Store your medication only as directed. Make sure you understand what you need to store your medication properly.

Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of reach of children. Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury.

What should I do in case of 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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 18, 2012.