Prescription Drugs

CLINICAL PHARMACOLOGY Lactic acid is an alpha-hydroxy acid.It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) are felt to act as humectants when applied to the skin. This property may influence hydration of the stratum corneum.In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known. An in vitro study of percutaneous absorption of Lac-Hydrin Cream (ammonium lactate cream) using human cadaver skin indicates that approximately 6.1% of the material was absorbed after 68 hours.

Lac-Hydrin® 12% (ammonium lactate) Cream For Dermatologic use only. Not for Ophthalmic, Oral or Intravaginal use. DESCRIPTION Lac-Hydrin is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4.Lac-Hydrin® 12% (ammonium lactate) Cream also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methyl and propyl parabens, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:

INDICATIONS Lac-Hydrin Cream (ammonium lactate cream) is indicated for the treatment of ichthyosis vulgaris and xerosis. DOSAGE AND ADMINISTRATION Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician. HOW SUPPLIED Lac-Hydrin® 12% (ammonium lactate) Cream is available in cartons of 280 g (two 140 g plastic tubes) (NDC # 0072-5730-28) and 385 g plastic bottle (NDC # 0072-5730-38). Store at controlled room temperature, 15° C-30° C (59° F-86° F). Bristol-Myers Squibb Company, Princeton, NJ 08543, USA. Revised August 2003. FDA Rev date: 12/13/2004

OVERDOSE No information provided. CONTRAINDICATIONS Lac-Hydrin Cream (ammonium lactate cream) is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

SIDE EFFECTS In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Lac-Hydrin Cream (ammonium lactate cream) were rash (including erythema and irritation) and burning/stinging.Each was reported in approximately 10-15% of patients.In addition, itching was reported in approximately 5% of patients. DRUG INTERACTIONS No information provided.

WARNINGS 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. PRECAUTIONS General 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. The mutagenic potential of ammonium lactate cream was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative. 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. Pregnancy 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. Nursing Mothers 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. Pediatric Use The safety and effectiveness of Lac-Hydrin Cream (ammonium lactate cream) have been established in pediatric patients as young as 2 years old. Geriatric Use 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.