Ammonium Lactate

Description

DESCRIPTION *Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:

What Is Ammonium Lactate Used For?

INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.

Dosage and Administration

DOSAGE AND ADMINISTRATION Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

Side Effects (Adverse Reactions)

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.

Contraindications

CONTRAINDICATIONS Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Pregnancy and Breastfeeding

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/m 2 /day in the rat and 7200 mg/m 2 /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, 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 ammonium lactate cream is administered to a nursing woman.

How Supplied

HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: 280 g carton (NDC 72162-1413-2) containing two 140 g tubes STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].