"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.
The following adverse reactions have been identified during post approval use of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .
Gastrointestinal Disorders: vomiting
Injury, Poisoning and Procedural Complications: accidental exposure
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) Side Effects Center for a complete guide to possible side effects
Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a miconazole intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is unknown.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/27/2010
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