"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"...
If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
Eurax (crotamiton cream, lotion) should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until the acute inflammation has subsided.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals have not been conducted.
Pregnancy (Category C)
Animal reproduction studies have not been conducted with Eurax (crotamiton cream, lotion) . It is also not known whether Eurax (crotamiton cream, lotion) can cause fetal harm when applied topically to a pregnant woman or can affect reproduction capacity. Eurax (crotamiton cream, lotion) should be given to a pregnant woman only if clearly needed.
Safety and effectiveness in children have not been established.
Clinical studies with Eurax (crotamiton USP) Lotion/Cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/12/2008
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