Generic name: CEFTAZIDIME 2g, AVIBACTAM SODIUM 0.5g
Dosage form: powder, for solution
Medically reviewed by Drugs.com. Last updated on Oct 10, 2019.
2.1 Recommended Dosage in Adult Patients
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 with CrCl greater than 50 mL/min. 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.
|Table 1. Dosage of AVYCAZ 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) by Indication|
|Duration of Treatment|
Infections [used in combination with
||Every 8 hours
||cIAI: 5 to 14 days
cUTI: 7 to 14 days
HABP/VABP: 7 to 14 days
|Complicated Urinary Tract
Infections including Pyelonephritis (cUTI)
Pneumonia and Ventilator-associated
Bacterial Pneumonia (HABP/VABP)
2.2 Recommended Dosage in Pediatric Patients with cIAI or cUTI
The recommended dosage of AVYCAZ in pediatric patients aged 2 to < 18 years with cIAI or cUTI and an estimated glomerular filtration rate (eGFR) greater than 50 mL/min/1.73 m2 and in pediatric patients aged 3 months to < 2 years without renal impairment is described in Table 2. AVYCAZ is administered every 8 hours by intravenous infusion over 2 hours. For treatment of cIAI, metronidazole should be given concurrently.
There is insufficient information to recommend a dosing regimen for pediatric patients with HABP/VABP.
|Table 2. Dosage of AVYCAZ (ceftazidime and avibactam) in Patients 3 months to < 18 years|
|Infection||Age Range||Dose||Frequency||Infusion Time (hours)||Duration of treatment|
|cIAI* and cUTI including Pyelonephritis||2 years to less than18 yearsa||AVYCAZ 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||2
||cIAI: 5 to 14 days
cUTI: 7 to14 days
|6 months to less than 2 years||AVYCAZ 62.5 mg/kg (Ceftazidime 50 mg/kg and avibactam 12.5 mg/kg)|
|3 months to less than 6 months||AVYCAZ 50 mg/kg (Ceftazidime 40 mg/kg and avibactam 10 mg/kg)|
|a For pediatric patients (2 years or older) with eGFR less than or equal to 50 mL/min/1.73m2, dosage adjustments are recommended [see Dosage and Administration (2.3)].
* AVYCAZ was used in combination with metronidazole in cIAI pediatric patients [see Clinical Studies (14.1)]
2.3 Dosage Adjustments in Adult and Pediatric Patients (2 Years and Older) with Renal Impairment
The recommended AVYCAZ dosage in adult and pediatric patients 2 years and older with varying degrees of renal function is presented in Table 3 and Table 4, respectively. For patients with changing renal function, monitor CrCl in adults or eGFR in pediatric patients 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)]. There is insufficient information to recommend a dosing regimen for pediatric patients less than 2 years of age with renal impairment.
|Table 3. Dosage of AVYCAZ in Adult Patients with Renal Impairment|
|Estimated Creatinine Clearance (mL/minute)a||Dose for AVYCAZ (ceftazidime and avibactam)b||Frequency|
|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|
|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
|Table 4. Dosage of AVYCAZ for cUTI and cIAI in Pediatric Patients 2 years and older with Renal Impairmenta|
|Estimated eGFRb (mL/min/1.73m2)||Dose for AVYCAZ (ceftazidime and avibactam)c||Frequency|
|31 to 50||AVYCAZ 31.25 mg/kg to a maximum of 1.25 grams (Ceftazidime 25 mg/kg and avibactam 6.25 mg/kg to a maximum dose of ceftazidime 1 gram and avibactam 0.25 grams)||Every 8 hours|
|16 to 30||AVYCAZ 23.75 mg/kg to a maximum of 0.94 grams (Ceftazidime 19 mg/kg and avibactam 4.75 mg/kg to a maximum dose of ceftazidime 0.75 grams and avibactam 0.19 grams)||Every 12 hours|
|6 to 15||AVYCAZ 23.75 mg/kg to a maximum of 0.94 grams (Ceftazidime 19 mg/kg and avibactam 4.75 mg/kg to a maximum dose of ceftazidime 0.75 grams and avibactam 0.19 grams)||Every 24 hours|
|Less than or equal to 5d||AVYCAZ 23.75 mg/kg to a maximum of 0.94 grams (Ceftazidime 19 mg/kg and avibactam 4.75 mg/kg to a maximum dose of ceftazidime 0.75 grams and avibactam 0.19 grams)||Every 48 hours|
|a Dosing was derived based on the population PK modeling, which assumed similar proportional effects of renal impairment in adults and pediatric patients 2 years and older [see Clinical Pharmacology (12.3)]
b As calculated using the Schwartz bedside formula
c All doses of AVYCAZ are administered over 2 hours
d Both ceftazidime and avibactam are hemodialyzable; thus, administer AVYCAZ after hemodialysis on hemodialysis days
2.4 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.
a) 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,
● lactated Ringer’s injection, USP
b) Mix gently and ensure that the contents are dissolved completely. The constituted AVYCAZ solution will have an approximate ceftazidime concentration of 167 mg/mL and an approximate avibactam concentration of 42 mg/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.
c) Prepare the required dose for intravenous infusion by withdrawing the appropriate volume determined from Table 5 from the constituted vial. To prepare doses for pediatric patients weighing less than 40 kg, follow the constitution instruction above to yield a solution with a final AVYCAZ concentration of approximately 209 mg/mL (ceftazidime concentration of 167 mg/mL and an avibactam concentration of 42 mg/mL). Use these concentrations to calculate the volume of AVYCAZ required to prepare the prescribed dose.
|Table 5. Preparation of AVYCAZ Doses for Adult and Pediatric Patients (Weighing 40 kg or More)|
|AVYCAZ (ceftazidime and avibactam) Dose||Volume to Withdraw from Constituted Vial for Further Dilution to
50 to 250a 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|
|a. Dilution to 250 mL should only be used for the 2.5 gram dose|
d) 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 ceftazidime concentration of 8 to 40 mg/mL and an avibactam concentration of 2 to 10 mg/mL in an infusion bag. If sterile water for injection was used for constitution, use any of the other appropriate constitution diluents for dilution.
e) 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).
f) Use the diluted AVYCAZ solution in the infusion bags within 12 hours when stored at room temperature.
g) 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.
2.5 Drug Compatibility
The AVYCAZ solution for administration at the range of diluted concentrations of ceftazidime 8 mg/mL and avibactam 2 mg/mL to ceftazidime 40 mg/mL and avibactam 10 mg/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
Intravenous Line Compatibility
Simulated Y-site compatibility of AVYCAZ admixed with other drug products in a 1:1 volume ratio at room temperature was evaluated by visual inspection, and measurement of turbidity and particulate matter at 0, 1 and 4 hours after mixing. Ceftazidime and avibactam were tested at concentrations of 20 mg/mL and 5 mg/mL, respectively, which can be obtained by dilution of constituted AVYCAZ solution in a 100 mL intravenous infusion bag. The highest recommended concentration (40 mg/mL of ceftazidime and 10 mg/mL of avibactam) was not tested in this study and should not be used during co-administration of AVYCAZ with other drugs through the same intravenous line. Compatible drugs with the corresponding compatible diluent (i.e., 0.9% Sodium Chloride Injection, 5 % Dextrose Injection or Lactated Ringer’s Injection) are listed in Tables 6, 7, 8 and 9 below.
Any drug products not listed in the tables below should not be co-administered with AVYCAZ through the same intravenous line (or cannula).
|Table 6. Compatible Drugs for use with 0.9% Sodium Chloride, 5% Dextrose or Lactated Ringer’s Injection as Diluents|
|Dopamine Hydrochloride Injection|
|Imipenem and Cilastatin for Injection|
|Magnesium Sulfate Injection|
|Norepinephrine Bitartrate Injection|
|Phenylephrine Hydrochloride Injection|
|Aztreonam Injection or Aztreonam for Injection|
|Colistimethate for Injection|
|Amikacin Sulfate Injection|
|Azithromycin for Injection|
|Ceftaroline fosamil for Injection|
|Table 7. Compatible Drugs for use with 0.9% Sodium Chloride or 5% Dextrose Injection as Diluents|
|Potassium Phosphates Injection|
|Table 8. Compatible Drugs for use with 5% Dextrose or Lactated Ringer’s Injection as Diluents|
|Heparin Sodium Injection|
|Tobramycin Injection or Tobramycin for Injection|
|Table 9. Compatible Drugs for use with One Compatible Diluent only|
|Meropenem for Injection (0.9% Sodium Chloride Injection diluent only)|
|Sodium Bicarbonate Injection (5% Dextrose Injection diluent only|
|Tedizolid Phosphate for Injection (5% Dextrose Injection diluent only)|
|Potassium Chloride in Water for Injection (40 mEq/100 mL) (Lactated Ringer’s Injection diluent only)|
2.6 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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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