Zidebactam (1 brand name, 1 dosage form, 1 route)
Available dosage forms: POWDER.
Routes of administration: INTRAVENOUS.
Brand Names
- ZAYNICH
Contraindications
ZAYNICH is contraindicated in patients with a known history of serious hypersensitivity to the components of ZAYNICH (cefepime and zidebactam) or other beta-lactam antibacterial drugs [ see Warnings and Precautions ( 5.1) ].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1) ] Neurotoxicity [ see Warnings and Precautions ( 5.2) ] Clostridiodes difficileInfection [ see Warnings and Precautions ( 5.3) ]
Mechanism of Action
Cefepime and zidebactam, components of ZAYNICH, are antibacterial drugs [see Microbiology ( 12.4)] .
Overdosage
There is no experience with overdose of ZAYNICH. Patients who receive an overdose should be carefully observed and given supportive treatment. Cefepime and zidebactam can be removed by hemodialysis [see Clinical Pharmacology ( 12.3)] . No clinical information is available on the use of hemodialysis to treat ZAYNICH overdosage. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability and nonconvulsive status epilepticus [see Warnings and Precautions ( 5.2), Adverse Reactions ( 6.2), and Dosage and Administration ( 2.2)] .