Table 2: Dosage of ZERBAXA in Adult Patients with CrCl 50 mL/min or lessĬomplicated Intra-abdominal Infections and Complicated Urinary Tract Infections, Including Pyelonephritisħ50 mg (500 mg and 250 mg) intravenously every 8 hoursġ.5 g (1 g and 0.5 g) intravenously every 8 hoursģ75 mg (250 mg and 125 mg) intravenously every 8 hoursĪ single loading dose of 750 mg (500 mg and 250 mg) followed by a 150 mg (100 mg and 50 mg) maintenance dose administered every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis)Ī single loading dose of 2.25 g (1.5 g and 0.75 g) followed by a 450 mg (300 mg and 150 mg) maintenance dose administered every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis)
AZTREONAM IC50 PSEUDOMONAS AERUGINOSA PBP3 FULL
ZERBAXA 375 mg (250 mg and 125 mg) intravenously every 8 hoursĮnd-stage renal disease (ESRD) on hemodialysis (HD)Ī single loading dose of ZERBAXA 750 mg (500 mg and 250 mg) followed by a ZERBAXA 150 mg (100 mg and 50 mg) maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis)Ī single loading dose of ZERBAXA 2.25 g (1.5 g and 0.75 g) followed by a ZERBAXA 450 mg (300 mg and 150 mg) maintenance dose administered every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis)įULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1Ĝomplicated Intra-abdominal Infections 1.2Ĝomplicated Urinary Tract Infections, Including Pyelonephritis 1.3 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) 1.4 Usage 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2ĝosage Adjustments in Patients with Renal Impairment 2.3 Preparation of Solutions 2.4Ĝompatibility 2.5 Storage of Constituted Solutions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1ĝecreased Efficacy in Patients with Baseline Creatinine Clearance of 30 to 50 mL/min 5.2 Hypersensitivity Reactions 5.3 Clostridioides difficile-associated Diarrhea 5.4ĝevelopment of Drug-resistant Bacteria 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Patients with Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 12.4 Microbiology 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1Ĝomplicated Intra-abdominal Infections 14.2Ĝomplicated Urinary Tract Infections, Including Pyelonephritis 14.3 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.
ZERBAXA 1.5 g (1 g and 0.5 g) intravenously every 8 hours ZERBAXA 750 mg (500 mg and 250 mg) intravenously every 8 hours * CrCl estimated using Cockcroft-Gault formula
Recommended Dosage of ZERBAXA in Adult Patients with CrCl 50 mL/min or less ( 2.2) Estimated CrCl (mL/min) * Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) * Used in conjunction with metronidazole 500 mg intravenously every 8 hoursĬomplicated Intra-abdominal Infections (cIAI) *Ĭomplicated Urinary Tract Infections (cUTI), Including Pyelonephritis Recommended Dosage of ZERBAXA by Infection in Patients with Creatinine Clearance (CrCl) Greater than 50 mL/min ( 2.1) Infection
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