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Vibativ Generic Name & Formulations
Legal Class
Rx
General Description
Telavancin (as HCl) 750mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Lipoglycopeptide.
How Supplied
Single-use vials—10
Manufacturer
Generic Availability
NO
Vibativ Indications
Indications
Complicated skin and skin structure infections (cSSSI) due to susceptible gram (+) bacteria. Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) due to Staphylococcus aureus (reserve use when no alternatives).
Vibativ Dosage and Administration
Adult
≥18yrs: Give by IV infusion over 60mins. cSSSI: treat for 7–14 days. HABP/VABP: treat for 7–21 days. Normal renal function: 10mg/kg once every 24hrs. Renal impairment: CrCl 30–50mL/min: 7.5mg/kg every 24hrs; CrCl 10–<30mL/min: 10mg/kg every 48hrs; CrCl<10mL/min or dialysis: not recommended.
Children
<18yrs: not established.
Vibativ Contraindications
Contraindications
Concomitant IV unfractionated heparin sodium.
Vibativ Boxed Warnings
Boxed Warning
Increased mortality in HABP/VABP patients with pre-existing moderate or severe renal impairment. Nephrotoxicity. Potential adverse developmental outcomes.
Vibativ Warnings/Precautions
Warnings/Precautions
Increased mortality in patients with pre-existing moderate/severe renal impairment who were treated for HABP/VABP. Baseline CrCl≤50mL/min. Risk of nephrotoxicity; monitor renal function. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 2 days after last dose. Diabetes. CHF. Hypertension. Discontinue at first sign of rash or any other sign of hypersensitivity reaction. Known hypersensitivity to vancomycin. Congenital long QT syndrome, uncompensated heart failure, severe left ventricular hypertrophy: avoid. Pregnancy: exclude status prior to initiation. Nursing mothers.
Vibativ Pharmacokinetics
See Literature
Vibativ Interactions
Interactions
Caution with other drugs that can cause QT prolongation. Increased risk of renal toxicity with NSAIDs, ACE inhibitors, loop diuretics. May interfere with coagulation tests (eg, PT/INR, aPPT, activated clotting time, coagulation-based factor Xa tests) and some urine protein tests.
Vibativ Adverse Reactions
Adverse Reactions
Dysgeusia, nausea, vomiting, foamy urine, diarrhea; nephrotoxicity, infusion reactions ("red man syndrome"), superinfection, QT prolongation, C.difficile-associated diarrhea.
Vibativ Clinical Trials
See Literature
Vibativ Note
Not Applicable
Vibativ Patient Counseling
See Literature
