Pronunciation:

sul-BAK-tam, dur-loe-BAK-tam

Brand Names:

• Xacduro

Dosage Forms:

• Powder for Solution

Uses of This Medicine:

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 belong to the group of medicines known as beta-lactamase inhibitors. They work by killing bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sulbactam and durlobactam combination injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulbactam and durlobactam combination injection in the elderly. However, elderly patients are more likely to have unwanted effects and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving sulbactam and durlobactam combination injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Nitisinone
• Probenecid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to cephalosporins, beta-lactams, or penicillins, history of or
• Diarrhea—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 cleared up completely. 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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.