AVYCAZ (ceftazidime/avibactam sodium)

There are 0 contraindications.

There are 6 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Clostridioides difficile infection
Colitis

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Hypoprothrombinemia
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Lower seizure threshold
Myoclonus
Seizure disorder

There are 29 severe adverse reactions.

More Frequent	Less Frequent
None.	Hemolytic anemia Hypokalemia

Rare/Very Rare

Abnormal hepatic function tests Agranulocytosis Anaphylaxis Angioedema Aplastic anemia Candidiasis Clostridioides difficile infection Colitis Encephalopathy Eosinophilia Erythema multiforme Hemorrhage Interstitial nephritis Jaundice Kidney disease with reduction in glomerular filtration rate (GFr) Kidney stone Kounis syndrome Leukopenia Lymphocytosis Neutropenic disorder Nonconvulsive status epilepticus Renal failure Seizure disorder Stevens-johnson syndrome Thrombocytopenic disorder Thrombocytosis Toxic epidermal necrolysis

There are 17 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Nausea Vomiting	Acute abdominal pain Constipation Phlebitis after infusion Skin rash

Rare/Very Rare
Dysgeusia Injection site sequelae Maculopapular rash Myoclonus Paresthesia Prolonged activated partial thromboplastin time Pruritus of skin Symptoms of anxiety Urticaria Vaginitis

Reproduction studies in mice and rats using ceftazidime dosages up to 40 times the usual human dose have not revealed evidence of harm to the fetus. Avibactam was not teratogenic in rats or rabbits. In rats, there was no evidence of embryofetal toxicity at an avibactam dosage of 1 g/kg daily (approximately 9 times the human dosage based on area under the concentration-time curve (AUC)) and no effects on pup growth and viability at a dosage of 825 mg/kg daily.

In rabbits, there was no evidence of embryofetal toxicity at an avibactam dosage of 100 mg/kg, but increased implantation loss, lower mean fetal weights, delayed ossification of bones, and other anomalies were observed at higher dosages. There are no adequate and controlled studies using ceftazidime and avibactam in pregnant women, and the drug should be used during pregnancy only if clearly needed.

Ceftazidime is distributed into human milk in low concentrations. It is not known whether avibactam is distributed into human milk. (See Pharmacokinetics: Distribution.) Ceftazidime and avibactam should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.