Pronunciation:

im-i-PEN-em, sye-la-STAT-in, rel-e-BAK-tam

Brand Names:

• Recarbrio

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Pharmacologic—

Beta-Lactam

Chemical—

Carbapenem

Uses of This Medicine:

Imipenem, cilastatin, and relebactam combination injection is used to treat complicated bacterial infections in many different parts of the body (eg, kidneys, stomach). This medicine is also used to treat hospital-acquired and ventilator-associated bacterial pneumonia.

This medicine is an antibiotic that works by killing bacteria or preventing their growth. It 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 imipenem, cilastatin, and relebactam 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 imipenem, cilastatin, and relebactam combination injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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.

• Bupropion
• Cholera Vaccine, Live
• Ganciclovir
• Theophylline
• Valganciclovir
• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine

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

• Brain disease (eg, lesions) or
• Seizures, history of or
• Stroke, history of—May increase risk of developing seizures.

• Kidney disease—Use with caution. The effects may be increased because of 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. It must be given slowly, so the needle will have to stay in place for at least 30 minutes every 6 hours.

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 types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse 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.

Some patients may develop seizures while receiving this medicine. If you already have had stroke or a history of seizures and you are taking anticonvulsants, you should continue to take them unless otherwise directed by your doctor. Tell your doctor if you are also using divalproex sodium (Depakote®) or valproic acid (Depakene®).

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 thy 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

Confusion

decreased urine output

diarrhea

dizziness

dry mouth

fast or irregular heartbeat

headache

increased thirst

loss of appetite

mood changes

muscle pain or cramps

nausea or vomiting

numbness or tingling in the hands, feet, or lips

pale skin

seizures

swelling of the face, ankles, or hands

troubled breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Agitation

black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

fever

hallucinations

lack of feeling or emotion

nervousness

pain, redness, or swelling at the injection site

pinpoint red spots on the skin

pounding in the ears

sleepiness or unusual drowsiness

slow heartbeat

slow speech

unusual excitement, nervousness, or restlessness

Incidence not known

Back or leg pains

chest pain or tightness

chills

clay-colored stools

cough or hoarseness

dark urine

difficulty swallowing

general body swelling

hives, itching, or skin rash

light-colored stools

lower back or side pain

nosebleeds

painful or difficult urination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

reddening of the skin, especially around the ears

sores, ulcers, or white spots on the lips or in the mouth

sore throat

stomach cramps, pain, and tenderness

swollen glands

unpleasant breath odor

vomiting of blood

watery and severe diarrhea, which may also be bloody

yellow eyes or skin

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:

Less common

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.