"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
(oritavancin) for Injection
ORBACTIV (oritavancin) for injection contains oritavancin diphosphate, a semisynthetic lipoglycopeptide antibacterial drug.
The chemical name for oritavancin is [4”R]-22-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-arabinohexopyranosyl)- N3''-[(4'-chloro[1,1'-biphenyl]-4-yl)methyl] vancomycin phosphate [1:2] [salt]. The empirical formula of oritavancin diphosphate is C86H97N10O26Cl3•2H3PO4 and the molecular weight is 1989.09. The chemical structure is represented below:
ORBACTIV is supplied as a sterile white to off-white lyophilized powder for intravenous infusion that contains oritavancin diphosphate, mannitol (an inactive ingredient) and phosphoric acid (to adjust pH 3.1 to 4.3). Each 50 ml capacity glass vial contains 449 mg oritavancin diphosphate (equivalent to 405 mg of oritavancin, 5 mg excess is to ensure withdrawal of 400 mg oritavancin), 400 mg oritavancin (free base equivalent).
Each vial is reconstituted with sterile water for injection and further diluted with 5% Dextrose in sterile Water for intravenous infusion. Both the reconstituted solution and the diluted solution for infusion should be clear, colorless to pale yellow solution [see DOSAGE AND ADMINISTRATION].
Last reviewed on RxList: 8/15/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Orbactiv Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.