Ceftazidime/Avibactam

Ceftazidime/Avibactam is a prescription medication used to treat Intra-abdominal infections, Urinary Tract Infections, and Bacterial Pneumonia

• Ceftazidime/Avibactam is available under the following different brand names: Avycaz.

Adult and pediatric dosage

Injection, powder of reconstitution

• (2g/0.5g) vial: 2.5g
• Equivalent to 2.635 grams of ceftazidime pentahydrate/sodium carbonate powder and 0.551 grams of avibactam sodium

Intra-abdominal infections

Adult dosage

2.5 g (2g/0.5g) IV every 8 hours infused over 2 hours for 5-14 days

Pediatric dosage

• Children younger than 3 months: Safety and efficacy not established
• Children 3 months-2 years of age: 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg) IV every 8 hours for 5-14 days
• Children 2 years-18 years of age: 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg IV every 8 hours for 5-14 days; not to exceed 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams)

Urinary Tract Infections

Adult dosage

• 2.5 g (2g/0.5g) IV every 8 hours infused over 2 hour for 7-14 days

Pediatric dosage

• Children younger than 3 months: Safety and efficacy not established
• Children 3 months-2 years of age: 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg) IV every 8 hours for 7-14 days
• Children 2 years-18 years of age: 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg IV every 8 hours for 7-14 days; not to exceed 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams)

Bacterial Pneumonia

Adult dosage

• 2.5 g (2g/0.5g) IV every 8 hours infused over 2 hours for 7-14 day

Dosage Considerations – Should be Given as Follows: 

See "Dosages."

Common side effects of Ceftazidime/Avibactam include:

• nausea, 
• vomiting, 
• diarrhea, and
• bruising where the IV needle is placed

Serious side effects of Ceftazidime/Avibactam include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• severe stomach pain, 
• watery or bloody diarrhea, 
• seizure, 
• rigid muscles, 
• overactive reflexes, 
• confusion, 
• hallucination, and
• change in mental state

Rare side effects of Ceftazidime/Avibactam include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Ceftazidime/Avibactam has severe interactions with no other drugs. 
• Ceftazidime/Avibactam has serious interactions with the following drug:
  • cholera vaccine
• Ceftazidime/Avibactam has moderate interactions with the following drugs:
  • probenecid
  • voclosporin
• Ceftazidime/Avibactam has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Known serious hypersensitivity to avibactam, ceftazidime, or other cephalosporins

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ceftazidime/Avibactam?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ceftazidime/Avibactam?”

Cautions

• In clinical trials, cure rates were lower in patients with baseline moderate renal impairment (CrCl 30-50 mL/min) who were treated for cIAI with ceftazidime/avibactam plus metronidazole (45% cure rate) compared with meropenem (74% cure rate); during the clinical trial, the ceftazidime/avibactam dose was 33% lower than what is currently recommended for patients with moderate renal impairment (see Dosage Modifications); follow current dosage adjustment recommendations for renal impairment
• Serious and occasionally fatal anaphylactic reactions and serious skin reactions have been reported with beta-lactam antibacterials; caution in patients with history of allergy to cephalosporins, penicillins, or carbapenems
• Clostridium difficile associated diarrhea (CDAD) has been associated with nearly all systemic antibacterials; severity may range from mild diarrhea to fatal colitis; may occur over 2 months following antibacterial use; if CDAD suspected, manage fluid and electrolytes levels and monitor antibacterial treatment for CDAD
• Seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported with ceftazidime, especially in the setting of renal impairment; adjust dose according to CrCl (see Dosage Modifications)
• Confirm suspected bacterial infection when prescribing ceftazidime/avibactam to avoid the risk of developing drug-resistant bacteria
• Drug interactions overview
  • Avibactam is an OAT1/OAT3 substrate; probenecid, a potent OAT inhibitor, inhibits OAT uptake of avibactam by 56-70% and potentially decrease the elimination of avibactam when coadministered; therefore, coadministration of ceftazidime/avibactam with probenecid is not recommended
  • Ceftazidime administration may result in a false-positive reaction for glucose in the urine with certain methods; glucose tests based on enzymatic glucose oxidase reactions be used

Pregnancy and Lactation

• There are no adequate and well-controlled studies of ceftazidime/avibactam, ceftazidime, or avibactam in pregnant women
• Neither ceftazidime nor avibactam were teratogenic in rats at doses 40 and 9 times the recommended human clinical dose; in the rabbit, at twice the exposure as seen at the human clinical dose, there were no effects on embryofetal development with avibactam
• Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed
• Ceftazidime is excreted in human milk in low concentrations
• Unknown whether avibactam is excreted into human milk, although avibactam was shown to be excreted in the milk of rats
• No information is available on the effects of ceftazidime and avibactam on the breastfed child or on milk production