Get your patient on Ammonium Lactate - Ammonium Lactate lotion (Ammonium Lactate)

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Ammonium Lactate - Ammonium Lactate lotion prescribing information

Indications & Usage

INDICATIONS AND USAGE

Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

Dosage & Administration

DOSAGE AND ADMINISTRATION

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

Contraindications

CONTRAINDICATIONS

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

Adverse Reactions

ADVERSE REACTIONS

The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

Description

DESCRIPTION

•Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5 - 5.5. It also contains cetyl alcohol, fragrance, 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:

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Pharmacology

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) may 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 lotion, 12% using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

How Supplied/Storage & Handling

HOW SUPPLIED

Ammonium Lactate Lotion, 12% is available as follows:

225 g bottle (NDC 45802- 419 -54)

400 g bottle (NDC 45802- 419 -26)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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