Sulbactam and durlobactam (Intravenous)

Sulbactam and durlobactam combination injection is used to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Sulbactam and durlobactam are antibiotics that are part of a group called beta-lactamase inhibitors. They kill bacteria and stop their growth. However, this medicine will not work for colds, flu, or other viral infections.

This medicine should only be given by or under the direct supervision of your doctor.

It is very important that your doctor check your progress closely while you are receiving this medicine. This is to make sure that the medicine is working properly and that the infection is completely cleared up. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may cause diarrhea, and in some cases, it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how age affects the use of sulbactam and durlobactam combination injection in children. Safety and effectiveness have not been determined.

Geriatric

So far, studies have not shown specific problems in older adults that would limit the use of sulbactam and durlobactam combination injection. However, older patients are more likely to experience unwanted effects and age-related kidney issues, which may require caution and adjustments in the dose for those receiving sulbactam and durlobactam combination injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

While some medicines should not be used together, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. When using this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are noted for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency for one or both medicines.

• Nitisinone
• Probenecid

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around mealtime, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how this medicine works. Be sure to tell your doctor about any other medical issues you have, especially:

• Allergy to cephalosporins, beta-lactams, or penicillins, history of or
• Diarrhea—Use with caution. This may worsen these conditions.

• Kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Agitation
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• coma
• confusion
• dark urine
• decreased urine
• depression
• dizziness
• dry mouth
• diarrhea
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• headache
• hostility
• increased thirst
• irregular heartbeat
• irritability
• lethargy
• loss of appetite
• mood changes
• muscle pain, cramps, or twitching
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• stomach pain
• stupor
• swelling of the face, ankles, or hands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• constipation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Xacduro

Available Dosage Forms:

• Powder for Solution

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 3 hours for 7 to 14 days.