Generic name: ceftazidime 2g, avibactam sodium 0.5g
Dosage form: powder, for solution
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The recommended dosage of AVYCAZ is 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) administered every 8 hours by intravenous (IV) infusion over 2 hours in patients 18 years of age and older in patients with normal renal function. For treatment of cIAI, metronidazole should be given concurrently. The guidelines for dosage of AVYCAZ in patients with creatinine clearance [CrCl] greater than 50 mL/min are listed in Table 1.
|Duration of Treatment|
|Complicated Intra-abdominal Infections [used in combination with metronidazole]||2.5 grams||Every 8 hours||2||5 to 14 days|
|Complicated Urinary Tract Infections including Pyelonephritis||2.5 grams||Every 8 hours||2||7 to 14 days|
Dosage Adjustments in Patients with Renal Impairment
The recommended AVYCAZ dosage in patients with varying degrees of renal function is presented in Table 2. For patients with changing renal function, monitor CrCl at least daily and adjust the dosage of AVYCAZ accordingly [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
a As calculated using the Cockcroft-Gault formula.
b All doses of AVYCAZ are administered over 2 hours
c Both ceftazidime and avibactam are hemodialyzable; thus, administer AVYCAZ after hemodialysis on hemodialysis days.
|Estimated Creatinine Clearance (mL/minute)a||Recommended Dosage Regimen for AVYCAZ (ceftazidime and avibactam)b|
|31 to 50||AVYCAZ 1.25 grams (ceftazidime 1 gram and avibactam 0.25 grams) intravenously every 8 hours|
|16 to 30||AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously every 12 hours|
|6 to 15c||AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously every 24 hours|
|Less than or equal to 5c||AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously every 48 hours|
Preparation of the AVYCAZ Solution for Administration
AVYCAZ is supplied as a dry powder, which must be constituted and subsequently diluted, using aseptic technique prior to intravenous infusion.
- Constitute the powder in the AVYCAZ vial with 10 mL of one of the following solutions:
- sterile water for injection, USP
- 0.9% of sodium chloride injection, USP (normal saline)
- 5% of dextrose injection, USP
- all combinations of dextrose injection and sodium chloride injection, USP, containing up to 2.5% dextrose, USP, and 0.45% sodium chloride, USP, or
- lactated Ringer's injection, USP
- Mix gently. The constituted AVYCAZ solution will have an approximate ceftazidime concentration of 0.167 grams/mL and an approximate avibactam concentration of 0.042 grams/mL. The final volume is approximately 12 mL. The constituted solution is not for direct injection. The constituted solution must be diluted before intravenous infusion.
- Prepare the required dose for intravenous infusion by withdrawing the appropriate volume determined from Table 3 from the constituted vial.
Table 3. Preparation of AVYCAZ Doses AVYCAZ (ceftazidime and avibactam) Dose Volume to Withdraw from Constituted Vial for Further Dilution to 50 to 250 mL 2.5 grams (2 grams and 0.5 grams) 12 mL (entire contents) 1.25 grams (1 gram and 0.25 grams) 6 mL 0.94 grams (0.75 grams and 0.19 grams) 4.5 mL
- Before infusion, dilute the withdrawn volume of the constituted AVYCAZ solution further with the same diluent used for constitution of the powder (except sterile water for injection), to achieve a total volume between 50 mL (ceftazidime 0.04 grams/mL and avibactam 0.01 grams/mL) to 250 mL (ceftazidime 0.008 grams/mL and avibactam 0.002 grams/mL) in an infusion bag. If sterile water for injection was used for constitution, use any of the other appropriate constitution diluents for dilution.
- Mix gently and ensure that the contents are dissolved completely. Visually inspect the diluted AVYCAZ solution (for administration) for particulate matter and discoloration prior to administration (the color of the AVYCAZ infusion solution for administration ranges from clear to light yellow).
- Use the diluted AVYCAZ solution in the infusion bags within 12 hours when stored at room temperature.
- The diluted AVYCAZ solution in the infusion bags may be stored under refrigeration at 2 to 8°C (36 to 46°F) up to 24 hours following dilution and used within 12 hours of subsequent storage at room temperature.
The AVYCAZ solution for administration at the range of diluted concentrations of ceftazidime 0.008 g/mL and avibactam 0.002 g/mL to ceftazidime 0.04 g/mL and avibactam 0.01 g/mL is compatible with the more commonly used intravenous infusion fluids in infusion bags (including Baxter® Mini-Bag Plus™) such as:
- 0.9% sodium chloride injection, USP
- 5% dextrose injection, USP
- all combinations of dextrose injection and sodium chloride injection, USP, containing up to 2.5% dextrose, USP, and 0.45% sodium chloride, USP
- lactated ringer's injection, USP, and
- Baxter® Mini-Bag Plus™ containing 0.9% sodium chloride injection or 5% dextrose injection.
Compatibility of AVYCAZ solution for administration with other drugs has not been established.
Storage of Constituted Solutions
Upon constitution with appropriate diluent, the constituted AVYCAZ solution may be held for no longer than 30 minutes prior to transfer and dilution in a suitable infusion bag.
Following dilution of the constituted solutions with the appropriate diluents, AVYCAZ solutions in the infusion bags are stable for 12 hours when stored at room temperature.
Following dilution of the constituted solutions with the appropriate diluents, AVYCAZ solutions in the infusion bags may also be refrigerated at 2 to 8°C (36 to 46°F) for up to 24 hours; and then should be used within 12 hours of subsequent storage at room temperature.