Sun exposure to areas of the skin treated with Lac-Hydrin Cream (ammonium lactate cream) should be minimized or avoided (see PRECAUTIONS section). The use of Lac-Hydrin Cream (ammonium lactate cream) should be discontinued if any hypersensitivity is observed.
For external use only.Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded (for example, after shaving the legs). Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyper-pigmentation has not been studied.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation.The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans.However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate cream enhanced the rate of ultraviolet light-induced skin tumor formation.
In dermal Segment I and III studies with ammonium lactate cream there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m2/day), approximately 0.4 times the human topical dose.
Teratogenic effects: Pregnancy Category B.
Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m2/day in the rat and 7200 mg/m2/day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Lac-Hydrin Cream (ammonium lactate cream) should be used during pregnancy only if clearly needed.
Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk.Because many drugs are excreted in human milk, caution should be exercised when Lac-Hydrin is administered to a nursing woman.
The safety and effectiveness of Lac-Hydrin Cream (ammonium lactate cream) have been established in pediatric patients as young as 2 years old.
Clinical studies of Lac-Hydrin® (ammonium lactate) Cream, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.Other reported clinical experience has not identified differences in responses between elderly and younger patients.In general, dose selection for an elderly patient should be cautious.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/18/2008
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