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AVYCAZ

CEFTAZIDIME, AVIBACTAM

Manufacturer: Allergan, Inc.

Score: 141.0

Quick Summary

AVYCAZ is a combination antibiotic consisting of ceftazidime and avibactam, used to treat complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia. It is administered intravenously and has shown effectiveness in clinical trials. However, it is contraindicated in patients with known hypersensitivity to ceftazidime, avibactam, or other cephalosporins, and caution should be exercised in patients with renal impairment. The recommended dosage varies based on the infection being treated and the patient's renal function, with dose adjustments recommended for patients with moderate to severe renal impairment.

Key Clinical Findings and Indications

  • Complicated intra-abdominal infections
  • Complicated urinary tract infections
  • Hospital-acquired bacterial pneumonia

Important Safety Information

Warning

AVYCAZ is contraindicated in patients with known hypersensitivity to ceftazidime, avibactam, or other cephalosporins

Contraindications

  • Hypersensitivity to ceftazidime, avibactam, or other cephalosporins

Adverse Reactions

  • Diarrhea
  • Nausea
  • Vomiting
  • Rash
  • Infusion site phlebitis

Dosing Recommendations

General Guidance

Dose adjustments are recommended for patients with moderate to severe renal impairment

Complicated intra-abdominal infections

Adult Dose

2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) every 8 hours

Pediatric Dose

62.5 mg/kg to a maximum of 2.5 grams (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg to a maximum dose of ceftazidime 2 grams and avibactam 0.5 grams) every 8 hours

Complicated urinary tract infections

Adult Dose

2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) every 8 hours

Pediatric Dose

62.5 mg/kg to a maximum of 2.5 grams (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg to a maximum dose of ceftazidime 2 grams and avibactam 0.5 grams) every 8 hours

Hospital-acquired bacterial pneumonia

Adult Dose

2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) every 8 hours

Pediatric Dose

62.5 mg/kg to a maximum of 2.5 grams (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg to a maximum dose of ceftazidime 2 grams and avibactam 0.5 grams) every 8 hours

Special Population Considerations

Pregnancy

  • There are no adequate and well-controlled studies of AVYCAZ in pregnant women

Nursing Mothers

  • It is not known whether AVYCAZ is excreted in human milk

Pediatric Use

  • The safety and effectiveness of AVYCAZ have been established in pediatric patients at least 31 weeks gestational age and older

Geriatric Use

  • Of the 1809 patients treated with AVYCAZ in the Phase 2 and Phase 3 clinical trials, 621 (34.5%) were 65 years of age and older