Imipenem, Cilastatin, and Relebactam Injection

Imipenem, cilastatin, and relebactam injection is used to treat adults with certain serious urinary tract infections including kidney infections, and certain serious abdominal (stomach) infections when there are few or no other treatment options. It is also used to treat certain types of pneumonia that developed in adults who are on ventilators or who were already in a hospital. Imipenem is in a class of medications called carbapenem antibiotics. It works by killing bacteria. Cilastatin is in a class of medications called dehydropeptidase inhibitors. It works by helping imipenem stay active in your body for a longer period of time. Relebactam is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from destroying imipenem.

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

Imipenem, cilastatin, and relebactam injection comes as a powder to be mixed with liquid and injected intravenously (into a vein) over a period of 30 minutes. It is usually given every 6 hours for 4 to 14 days, or as long your doctor recommends treatment.

You may receive imipenem, cilastatin, and relebactam injection in a hospital, or you may administer the medication at home. If you will be using imipenem, cilastatin, and relebactam 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. Ask your healthcare provider what to do if you have any problems injecting imipenem, cilastatin, and relebactam injection.

You should begin to feel better during the first few days of treatment with imipenem, cilastatin, and relebactam. If your symptoms do not improve or get worse, tell your doctor.

Use imipenem, cilastatin, and relebactam injection until you finish the prescription, even if you feel better. If you stop using imipenem, cilastatin, and relebactam 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 receiving imipenem, cilastatin, and relebactam injection,

• tell your doctor and pharmacist if you are allergic to imipenem, cilastatin, relebactam, any other medications especially carbapenems such as ertapenem (Invanz) or meropenem (Merrem), penicillins such as amoxicillin (Amoxil, in Augmentin), ampicillin, or penicillin V potassium (Penicillin VK), cephalosporins such as cefaclor, cefadroxil, or cephalexin (Keflex), or any of the ingredients in imipenem, cilastatin, and relebactiam injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what 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: divalproex sodium (Depakote), ganciclovir (Cytovene, Valcyte), or valproic acid (Depakene). 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 seizures, a stroke, brain lesions, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving imipenem, cilastatin, and relebactam, call your doctor.

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

• Imipenem, cilastatin, and relebactam injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea

  • vomiting

  • diarrhea

  • headache

  • swelling, pain, or redness near the spot where the medication was injected

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)

  • seizures

  • confusion

  • muscle jerks, shakes, or spasms that you can't control

  • rash; hives; swelling of the eyes, face, lips or throat; difficulty swallowing or breathing

• Imipenem, cilastatin, and relebactam injection may cause other side effects. Call your doctor if you have any unusual problems while receiving 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).

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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 the following:

• seizures

• confusion

• muscle jerks, shakes, or spasms

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to imipenem, cilastatin, and relebactam 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.