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

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Ammonium Lactate - Ammonium Lactate cream prescribing information

Indications & Usage

INDICATIONS AND USAGE

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

Dosage & Administration

DOSAGE AND ADMINISTRATION

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

Contraindications

CONTRAINDICATIONS

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

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, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 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, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

Description
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) 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.

How Supplied/Storage & Handling
Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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