Cefepime and Zidebactam Injection

Cefepime and zidebactam injection is used to treat urinary tract infections (UTI) caused by specific bacteria. Cefepime is in a class of antibiotics called cephalosporins. It works by killing bacteria. Zidebactam is in a class called beta-lactamase inhibitors. It works by preventing bacteria from destroying cefepime.

Antibiotics such as cefepime and zidebactam injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Cefepime and zidebactam injection comes as a powder to be mixed with liquid and injected intravenously (into a vein). It is infused (injected slowly) every 8 hours over 1 hour. The length of your treatment depends on the type of infection that you have and how well you respond to the medication.

You may receive cefepime and zidebactam injection in a hospital or you may administer the medication at home. If you will be receiving cefepime and zidebactam 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.

Use cefepime and zidebactam injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You should begin to feel better during the first few days of treatment with cefepime and zidebactam injection. If your symptoms do not improve or get worse, call your doctor. If you still have symptoms of infection after you finish cefepime and zidebactam injection, tell your doctor.

Use cefepime and zidebactam injection until you finish the prescription, even if you feel better. If you stop using cefepime and zidebactam injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using cefepime and zidebactam injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using cefepime and zidebactam injection. 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 or liver disease, problems with your digestive system especially colitis (inflammation of the large intestine), malnutrition (you do not eat or cannot digest the nutrients needed for good health), or problems with your vitamin K levels.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using cefepime and zidebactam injection, call your doctor.
• you should know that your blood pressure may increase during your treatment with cefepime and zidebactam injection. Your doctor will probably monitor your blood pressure during your treatment.

Unless your doctor tells you otherwise, continue your normal diet.

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

Cefepime and zidebactam injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea

Some side effects can be serious. If you experience any of these symptoms stop taking cefepime and zidebactam injection and call your doctor immediately or get emergency medical treatment:

• severe diarrhea (watery or bloody stools) that may occur with stomach cramps (may occur up to 2 months or more after your treatment)
• rash; itching; hives; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, and eyes
• agitation, confusion; loss of consciousness; seeing things or hearing voices that do not exist
• fever and other signs of new or worsening infection
• fatigue; weakness; dizziness; shortness of breath; yellowing of the skin or eyes; lower abdominal pain; clay-colored stools; dark urine; feeling of fest heart beat

Cefepime and zidebactam injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• confusion
• seizures
• jerking movements

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to cefepime and zidebactam injection.

If you have diabetes, cefepime and zidebactam injection can cause false results with certain urine glucose tests. Talk to your doctor about using other glucose tests while using cefepime and zidebactam injection.

If you still have symptoms of infection after you finish the cefepime and zidebactam injection, call your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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