000223 Ammonium Lactate

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 cream also contains water, light mineral oil, glyceryl stearate, polyoxyl 100 stearate, propylene glycol, polyoxyl 40 stearate, glycerin, cetyl alcohol, magnesium aluminum silicate, laureth-4, methyl and propyl parabens, and methylcellulose. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid.

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 ammonium lactate cream using human cadaver skin indicates that approximately 6.1% of the material was absorbed after 68 hours.

INDICATIONS AND USAGE

Ammonium lactate cream is indicated for the treatment of ichthyosis vulgaris and xerosis.

CONTRAINDICATIONS

None known.

WARNINGS

Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted. Sun exposure (natural or artificial sunlight) to areas of the skin treated with ammonium lactate cream should be minimized or avoided (see PRECAUTIONS).

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 hyperpigmentation has not been studied.

Information for the Patient

Patients using ammonium lactate cream should receive the following information and instructions:

1.

This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. Caution is advised when used on the face because of the potential for irritation. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.

2.

Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.

3.

This medication may cause stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).

4.

If the skin condition worsens with treatment, the medication should be promptly discontinued.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

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. Although the biologic significance of these results to humans is not clear, patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. Long-term dermal carcinogenicity studies in animals have not been conducted to evaluate the carcinogenic potential of ammonium lactate.

Pregnancy, Teratogenic Effects, Pregnancy Category C

Animal reproduction studies have not been conducted with ammonium lactate cream. It is also not known whether ammonium lactate cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ammonium lactate cream should be given to a pregnant woman 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 ammonium lactate cream is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of ammonium lactate cream have not been established in pediatric patients less than 12 years old. Potential systemic toxicity from percutaneous absorption has not been studied. Because of the increased surface area to body weight ratio in pediatric patients, the systemic burden of lactic acid may be increased.

ADVERSE REACTIONS

In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with 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.

In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with ammonium lactate cream were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

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 Cream 12% is available in 140 g plastic tubes and 385 g plastic bottle.

Storage: