For external use only. Not for ophthalmic use.
If irritation or sensitivity occurs, or infection appears, discontinue treatment and institute appropriate therapy. LidaMantle® should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.
Carcinogenesis, mutagenesis, and impairment Of fertility
Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.
Use In Pregnancy
Teratogenic Effects: Pregnancy Category B Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and wellcontrolled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.
Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.
Last reviewed on RxList: 9/22/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional LidaMantle Information
Report Problems to the Food and Drug Administration
Find out what women really need.