Pronunciation:

sef-TAZ-i-deem, a-vi-BAK-tam

Brand Names:

• Avycaz

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic Combination

Pharmacologic—

3rd Generation Cephalosporin

Uses of This Medicine:

Ceftazidime and avibactam combination injection is used alone or together with other medicines (eg, metronidazole) to treat complicated infections in many different parts of the body (eg, stomach, kidneys). It is also used to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Ceftazidime and avibactam combination injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or 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 ceftazidime and avibactam combination injection in children younger than 31 weeks gestational age. 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 ceftazidime and avibactam 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.

• Cholera Vaccine, Live
• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Furosemide
• Gestodene
• Levonorgestrel
• Mestranol
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Probenecid
• Warfarin

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.

• Chloramphenicol

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 penicillin, history of—May increase risk of an allergic reaction to occur again.

• Brain disease (eg, encephalopathy) or
• Diarrhea, severe, history of or
• Myoclonus (muscle twitching or jerking) or
• Seizures—Use with caution. May make these conditions worse.

• 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 hospital. It is given through an IV catheter that is 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:

Your doctor will check your or your child's progress closely while receiving this medicine. This will allow your doctor to see if it is working properly and to decide if you should continue to receive it and 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 or your child have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while receiving this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while receiving this medicine.

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

Check with your doctor right away if you have confusion, loss of consciousness, jerking or twitching of the muscles, seizures, seeing, hearing, or feeling things that are not there, or severe sleepiness while receiving this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests 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:

More common

Diarrhea

Less common

Headache

Rare

Agitation

black, tarry stools

bleeding gums

blood in the urine or stools

bluish color

changes in skin color

chest pain

chills

confusion

cough

decreased awareness or responsiveness

decreased urine

dizziness

dry mouth

fever

hostility

increased thirst

irregular heartbeat

irritability

loss of appetite

loss of consciousness

mood changes

muscle pain, cramps, or twitching

nausea

numbness or tingling in the hands, feet, or lips

painful or difficult urination

pinpoint red spots on the skin

rapid weight gain

seizures

severe sleepiness

sore throat

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

swelling of the face, ankles, hands, foot, or leg

swollen glands

tenderness

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

vomiting

white patches in the mouth or throat or on the tongue

Incidence not known

Back, leg, or stomach pains

blistering, peeling, or loosening of the skin

bloody or cloudy urine

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest tightness

cough

dark urine

difficulty breathing

difficulty swallowing

fast heartbeat

general body swelling

general feeling of tiredness or weakness

hives, itching, skin rash

hoarseness

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

lower back or side pain

nosebleeds

painful or difficult urination

pale skin

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

unusual weight gain

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:

More common

Difficulty having a bowel movement

stomach pain

Rare

Anxiety

change in taste

loss of taste

redness of the skin

Incidence not known

Collection of blood under the skin, deep, dark purple bruise, or itching, pain, or swelling of the skin at the injection site

dry, red, hot, or irritated skin

itching of the vagina or genital area

pain during sexual intercourse

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site

thick, white vaginal discharge with no odor or with a mild odor

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.