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VIBATIV
Bacterial infections
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Drug Name:

VIBATIV Rx

Generic Name and Formulations:
Telavancin (as HCl) 250mg, 750mg; per vial; pwd for IV infusion after reconstitution and dilution; preservative-free.

Company:
Theravance, Inc.



Therapeutic Use:

Indications for VIBATIV:

Complicated skin and skin structure infections due to susceptible gram (+) bacteria. Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) due to Staphylococcus aureus.

Adult Dose for VIBATIV:

≥18yrs: Give by IV infusion over 60 minutes. Complicated skin and skin structure: 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's Dose for VIBATIV:

<18yrs: not studied.

Pharmacological Class:

Lipoglycopeptide.

Rems:

YES

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. Diabetes. CHF. Hypertension. Obtain (–) pregnancy test before treatment for women of childbearing potential; use appropriate effective contraception during treatment. Discontinue at first signs of hypersensitivity reaction. Known hypersensitivity to vancomycin. Congenital long QT syndrome, uncompensated heart failure, severe left ventricular hypertrophy: avoid. Pregnancy (Cat.C): not recommended, may cause fetal harm. Nursing mothers.

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.

Adverse Reactions:

Dysgeusia, GI upset, foamy urine; nephrotoxicity (reevaluate if occurs), infusion reactions ("red man syndrome"), superinfection (eg, antibiotic-associated colitis), QT prolongation, C.difficile-associated diarrhea.

How Supplied:

Single-use vials—10

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