Pronunciation:

SEF-e-peem hye-droe-KLOR-ide, en-me-taz-oh-BAK-tam

Brand Names:

• Exblifep

Classifications:

Pharmacologic—

Cefepime

Uses of This Medicine:

Cefepime and enmetazobactam combination injection is used to treat complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection).

Cefepime and enmetazobactam are antibiotics that belong to the group of medicines known as cephalosporin antibiotics and beta-lactamase inhibitors. They work by killing the bacteria and preventing their growth. However, these medicines 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 cefepime and enmetazobactam 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 cefepime and enmetazobactam combination injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in the dose for patients receiving this medicine.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

• Cholera Vaccine, Live
• Furosemide
• Warfarin

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 or beta-lactams, known or history of—Should not be used in patients with this condition.

• Kidney disease or
• Liver disease or
• Poor nutrition status—Use with caution. May increase the risk for serious side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through an IV catheter placed into one of your veins. This medicine must be given slowly, so the IV will have to stay in place for at least 2 hours.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are receiving this medicine to see if the medicine is working properly and to decide if you should continue to receive it. 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. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Check with your doctor right away if you have agitation, back pain, blurred vision, coma, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, muscle twitching or jerking, problems with speech or speaking, rhythmic movement of the muscles, seizures, stiff neck, unusual tiredness or weakness, or vomiting. These may be symptoms of serious nervous system problems (eg, encephalopathy, aphasia, myoclonus, and seizures).

Cefepime and enmetazobactam combination injection may cause diarrhea, and in some cases it can be severe. It may occur 2 or more months 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.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests (eg, urine glucose test) may be affected by this medicine.

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:

Less common

Diarrhea

pale skin

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Black, tarry stools

bleeding gums

blood in the urine or stools

chest pain

chills

confusion

cough

dizziness

fever

irregular heartbeat

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

nausea or vomiting

numbness and tingling around the mouth, fingertips, or feet

painful or difficult urination

pinpoint red spots on the skin

restlessness

seizures

sore throat

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

stomach cramps

swollen glands

tenderness

tremor

watery or bloody diarrhea

weakness or heaviness of the legs

Incidence not known

Agitation

back or leg pain

blistering, peeling, or loosening of the skin

bloody or cloudy urine

chest tightness

clay-colored stools

coma

cough or hoarseness

dark urine

difficulty swallowing

drowsiness

hallucinations

headache

hives, itching, skin rash

increased menstrual flow or vaginal bleeding

irritability

joint or muscle pain

loss of appetite

lower back or side pain

muscle twitching or jerking

nosebleeds

paralysis

problems with speech or speaking

prolonged bleeding from cuts

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

red irritated eyes

red skin lesions, often with a purple center

rhythmic movement of the muscles

stiff neck

sudden decrease in amount of urine

unpleasant breath odor

vomiting of blood

yellowing of the 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:

More common

Bluish color

changes in skin color

dry, red, hot, or irritated skin

swelling of the foot or leg

Rare

Belching

bloated, full feeling

excess air or gas in the stomach

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.