Description and Brand Names

US Brand Name

  1. Avycaz

Descriptions


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.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ceftazidime and avibactam combination injection in children younger than 3 months of age to treat infections in the stomach or kidneys or in children to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Safety and efficacy have not been established.

Geriatric

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.

Breastfeeding

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.

Drug Interactions

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
  • 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

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

Precautions

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 any of the following symptoms while receiving this medicine: confusion, loss of consciousness, jerking or twitching of the muscles, seizures, seeing, hearing, or feeling things that are not there, or severe sleepiness.

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

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

  1. Diarrhea

Less common

  1. Headache

Rare

  1. Agitation
  2. black, tarry stools
  3. bleeding gums
  4. blood in the urine or stools
  5. bluish color
  6. changes in skin color
  7. chest pain
  8. chills
  9. confusion
  10. cough
  11. decreased awareness or responsiveness
  12. decreased urine
  13. dizziness
  14. dry mouth
  15. fever
  16. hostility
  17. increased thirst
  18. irregular heartbeat
  19. irritability
  20. loss of appetite
  21. loss of consciousness
  22. mood changes
  23. muscle pain, cramps, or twitching
  24. nausea
  25. numbness or tingling in the hands, feet, or lips
  26. painful or difficult urination
  27. pinpoint red spots on the skin
  28. rapid weight gain
  29. seizures
  30. severe sleepiness
  31. sore throat
  32. sores, ulcers, or white spots on the lips or in the mouth
  33. swelling of the face, ankles, hands, foot, or leg
  34. swollen glands
  35. tenderness
  36. unusual bleeding or bruising
  37. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  38. vomiting
  39. white patches in the mouth or throat or on the tongue

Incidence not known

  1. Back, leg, or stomach pains
  2. blistering, peeling, or loosening of the skin
  3. bloody or cloudy urine
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. cough
  6. dark urine
  7. difficulty breathing
  8. difficulty swallowing
  9. fast heartbeat
  10. general body swelling
  11. general feeling of tiredness or weakness
  12. hives, itching, skin rash
  13. hoarseness
  14. joint pain
  15. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  16. lower back or side pain
  17. nosebleeds
  18. painful or difficult urination
  19. pale skin
  20. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  21. red, irritated eyes red skin lesions, often with a purple center
  22. tightness in the chest
  23. unusual weight gain
  24. 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

  1. Difficulty having a bowel movement
  2. stomach pain

Rare

  1. Anxiety
  2. change in taste
  3. loss of taste
  4. redness of the skin

Incidence not known

  1. Collection of blood under the skin, deep, dark purple bruise, or itching, pain, or swelling of the skin at the injection site
  2. dry, red, hot, or irritated skin
  3. itching of the vagina or genital area
  4. pain during sexual intercourse
  5. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site
  6. 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.