Durlobactam Injection and Sulbactam Injection

The combination of durlobactam injection and sulbactam injection is used to treat certain types of pneumonia that developed in adults who are on ventilators or who were already in a hospital. Sulbactam is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of certain bacteria. Durlobactam is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from destroying sulbactam.

Antibiotics such as durlobactam and sulbactam injection will not work for colds, flu, or other viral infections. It works by stopping the growth of bacteria. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

The combination of durlobactam and sulbactam injection comes as a powder to be mixed with liquid and injected intravenously (into a vein). It is usually infused (injected slowly) intravenously over a period of 3 hours every 6 hours for 7 to 14 days. The length of treatment depends on your general health and how well you respond to the medication.

You may receive durlobactam and sulbactam injection in a hospital, or you may administer the medication at home. If you will be using durlobactam and sulbactam 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 durlobactam and sulbactam injection.

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

Use durlobactam and sulbactam injection until you finish the prescription, even if you feel better. If you stop using durlobactam and sulbactam injection too soon or if you 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 durlobactam and sulbactam injection,

• tell your doctor and pharmacist if you are allergic to durlobactam; sulbactam; carbapenem antibiotics such as ertapenem (Invanz), imipenem and cilastatin (Primaxin), or meropenem (Merrem, in Vabomere); penicillin antibiotics; cephalosporin antibiotics such as cefaclor, cefadroxil, cefazolin, cefdinir, cefepime (Maxipime), cefixime (Suprax), cefotetan, cefoxitin, cefpodoxime, cefprozil, ceftaroline (Teflaro), ceftazidime (Tazicef, in Avycaz), ceftriaxone, cefuroxime, and cephalexin; any other medications; or any of the ingredients in durlobactam and sulbactam 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. 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 durlobactam and sulbactam injection, call your doctor.

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

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

• constipation

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

• rash; hives; itching; swelling of the face, throat, tongue, lips, and eyes; or difficulty breathing or swallowing
• 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)
• irregular, fast, or pounding heartbeat
• pale skin, dizziness, weakness, or excessive tiredness
• decreased urination
• swelling of your legs, ankles, or feet
• shortness of breath

Durlobactam and sulbactam 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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:

• seizures

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

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