CloudRx - Avycef – Ceftazidime + Avibactam

Indications

This combination IV Infusion is indicated in-

Complicated Intra-abdominal Infections (cIAI)
Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)

Pharmacology

Ceftazidime inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins (PBPs), which leads to bacterial cell lysis and death. Avibactam is a non β-lactam, β-lactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis. It inhibits both Ambler class A and class C β-lactamases and some class D enzymes, including extended-spectrum β-lactamases (ESBLs), KPC and OXA-48 carbapenemases, and AmpC enzymes. Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many class D enzymes.

Dosage & Administration

Important:
Do not take any medication without a doctor's prescription. Self-medication can be dangerous.

Dosage in Adult Patients with Creatinine Clearance (CrCl) greater than 50 mL/min-

Infection	Dose	Frequency	Infusion Time	Duration of Treatment
Complicated Intra-abdominalnInfections [used in combination with metronidazole] (cIAI)	2.5 grams	Every 8 hours	2 hours	cIAI: 5 to 14 days cUTI: 7 to 14 days HABP/VABP: 7 to 14 days
Complicated Urinary Tract Infections including Pyelonephritis (cUTI)
Hospital-acquired Bacterial Pneumonia and Ventilator- associated Bacterial Pneumonia (HABP/VABP)

Dosage in Adult Patients with Creatinine Clearance (CrCl) less than 50 mL/min-

Estimated CrCl (mL/minute)	Dose	Frequency
31 to 50	1.25 grams (ceftazidime 1 gram and avibactam 0.25 grams) intravenously	Every 8 hours
16 to 30	0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously	Every 12 hours
6 to 15	0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously	Every 24 hours
Less than or equal to 5	0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously	Every 48 hours

Dosage in Patients 3 months to < 18 years

Infection	Age Range	Dose	Frequency	Infusion Time	Duration of Treatment
cIAI and cUTI including Pyelonephritis	2 years to less than18 years	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 Hours	cIAI: 5 to 14 days cUTI: 7 to14 days
	6 months to less than 2 years	62.5 mg/kg (Ceftazidime 50 mg/kg and avibactam 12.5 mg/kg)
	3 months to less than 6 months	50 mg/kg (Ceftazidime 40 mg/kg and avibactam 10 mg/kg)

In Pediatric Patients 2 to < 18 years with Renal Impairment-

Estimated eGFR (mL/min/1.73m2)	Dose	Frequency
31 to 50	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	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	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 5	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

Interaction

Clinical interaction study of this IV infusion or avibactam alone with probenecid has not been conducted, co-administration of this IV infusion with probenecid is not recommended.

Contraindications

This is contraindicated in patients with known serious hypersensitivity to the components of (ceftazidime and avibactam), avibactam-containing products or other members of the cephalosporin class.

Side Effects

Adult cIAI, cUTI and HABP/VABP Patients: The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting. The most common adverse reactions (3%) in cUTI patients are diarrhea and nausea. The most common adverse reactions (≥5%) in HABP/VABP patients were diarrhea and vomiting. Pediatric cIAI and cUTI Patients: The most common adverse reactions (>3%) in pediatric patients were vomiting, diarrhea, rash, and infusion site phlebitis

Pregnancy & Lactation

There are no adequate and well-controlled studies of this IV infusion, ceftazidime, or avibactam in pregnant women. No information is available on the effects of ceftazidime and avibactam on the breast-fed child or on milk production.

Precautions & Warnings

Decreased efficacy in adult cIAI patients with baseline CrCl of 30 to less than or equal to 50 mL/ min: Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dose of this IV infusion accordingly.

Hypersensitivity reactions: Includes anaphylaxis and serious skin reactions. Cross-hypersensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue this IV infusion.

Clostridium difficile-associated diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including this IV infusion. Evaluate if diarrhea occurs.

Central Nervous System Reactions: Seizures and other neurologic events may occur, especially in patients with renal impairment. Adjust dose in patients with renal impairment.

Storage Conditions

Store at temperature not exceeding 25°C in a dry place. Protect from light & moisture.

Brand	Strength	৳
Avitaz Square Pharmaceuticals PLC	(2 gm+0.5 gm)/vial	-
Ceftazim AV Aristopharma Ltd.	(2 gm+0.5 gm)/vial	-
Zavicefta Radiant Pharmaceuticals Ltd.	(2 gm+0.5 gm)/vial	-
Ziditam Incepta Pharmaceuticals Ltd.	(2 gm+0.5 gm)/vial	-

Avycef – Ceftazidime + Avibactam

Avycef