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Vabomere
Generic Name: Meropenem/Vaborbactam
Drug Category: Penem Antibacterial/Beta-Lactamase Inhibitor
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 14 days.
| Approved Uses |
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Indicated for: Complicated Urinary Tract Infections (cUTI), including Pyelonephritis: • Indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. The duration of treatment is for up to 14 days. Dosage adjustment is recommended in patients with renal impairment who have an eGFR less than 50 mL/min/1.73m2. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including VABOMERE, and may range in severity from mild diarrhea to fatal colitis. In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported. Alert patients receiving VABOMERE on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Co-administration of probenecid with VABOMERE is not recommended. Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Fetal malformations were observed in vaborbactam-treated rabbits, therefore advise pregnant women of the potential risks to the fetus. Meropenem has been reported to be excreted in human milk. It is unknown whether vaborbactam is excreted in human milk. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource |
| Adverse Events |
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Headache, infusion site reactions, allergic reactions, diarrhea and seizures. GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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