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  • CLASSES

    Humectants

    DEA CLASS

    OTC, Rx

    DESCRIPTION

    Moisturizing agent; contains lactic acid neutralized with ammonium hydroxide (i.e., ammonium lactate); 12% cream and lotion are available Rx-only for the treatment of ichthyosis vulgaris and mild to severe xerosis. Five-percent strength is an OTC, fragrance-free lotion used to relieve dry skin.

    COMMON BRAND NAMES

    AL-12, Amlactin, Amlactin Ultra, LAC-cream, Lac-Hydrin, Lac-Hydrin Five, LAC-lotion, Moist Skin

    HOW SUPPLIED

    AL-12/Amlactin/Ammonium Lactate/Lac-Hydrin/Lac-Hydrin Five/LAC-lotion/Moist Skin Topical Lotion: 5%, 12%
    Amlactin/Amlactin Ultra/Ammonium Lactate/Ammonium Lactate, Potassium Lactate, Sodium Lactate/LAC-cream/Lac-Hydrin Topical Cream: 12%

    DOSAGE & INDICATIONS

    For the treatment of ichthyosis vulgaris.
    Topical dosage (12% lotion or cream)
    Adults, Adolescents, and Children >= 2 years

    Apply twice daily to the affected skin areas and rub in thoroughly. Clinical improvement may not be evident for several weeks. If the skin condition worsens with treatment, the medication should be discontinued promptly.

    For the treatment of xerosis.
    Topical dosage
    Adults, Adolescents, and Children >= 2 years

    Apply twice daily to the affected skin areas and rub in thoroughly. Clinical improvement may not be evident for several weeks. If the skin condition worsens with treatment, the medication should be discontinued promptly.

    MAXIMUM DOSAGE

    Adults

    No maximum dosage information available.

    Elderly

    No maximum dosage information available.

    Adolescents

    No maximum dosage information available.

    Children

    No maximum dosage information available.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment is needed.

    Renal Impairment

    No dosage adjustment is needed.

    ADMINISTRATION

    Topical Administration
    Cream/Ointment/Lotion Formulations

    Ammonium lactate cream or lotion is applied topically to the skin (for external use only). Before applying the cream or lotion, the affected areas should be clean and dry.
    Wash hands before and after application of the cream or the lotion.
    Do not apply the cream or lotion to the eye; avoid contact with the eyes, mouth, lips, and other mucous membranes.
    Cream: To apply the cream, massage gently and thoroughly into the affected skin areas.
    Lotion: Shake well before application to the skin. To apply the lotion, massage gently and thoroughly into the affected skin areas.

    STORAGE

    AL-12:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Amlactin:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Amlactin Ultra:
    - Avoid excessive heat (above 104 degrees F)
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Amlactin XL:
    - Store at room temperature (between 59 to 86 degrees F)
    LAC-cream :
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Lac-Hydrin:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Lac-Hydrin Five:
    - Storage information not listed
    LAC-lotion:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Moist Skin:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Skin abrasion, sunlight (UV) exposure

    Ammonium lactate is for external use only. Contact with eyes, lips, or mucous membranes should be avoided. Ammonium lactate may cause irritation when applied to the face, especially in patients with fair or sensitive skin. A mild, transient stinging may occur when ammonium lactate is applied to a skin abrasion or inflamed areas. Patients should be cautioned to avoid artificial or natural sunlight to treated areas of skin, including the face, which may be more sensitive to the effects of sunlight (UV) exposure.

    Children, infants, neonates

    The safety and efficacy of ammonium lactate have not been established in neonates, infants, or children less than 2 years old. Potential systemic toxicity from percutaneous absorption of lactic acid has not been studied, but may be a potential concern because of the increased surface area to body weight ratio in young children.

    Pregnancy

    Ammonium lactate is classified as FDA pregnancy category B. There are no adequate and well-controlled studies in pregnant women. According to the manufacturer, it should be used during pregnancy only if clearly needed.

    Breast-feeding

    Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent ammonium lactate affects normal lactic acid levels in human milk. According to the manufacturer, caution should be exercised when the cream or lotion is administered to breast-feeding women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    exfoliative dermatitis / Delayed / Incidence not known

    Moderate

    erythema / Early / 2.0-2.0

    Mild

    skin irritation / Early / 10.0-15.0
    pruritus / Rapid / 5.0-5.0
    xerosis / Delayed / 2.0-2.0
    petechiae / Delayed / Incidence not known
    skin hyperpigmentation / Delayed / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Ammonium Lactate products.

    PREGNANCY AND LACTATION

    Pregnancy

    Ammonium lactate is classified as FDA pregnancy category B. There are no adequate and well-controlled studies in pregnant women. According to the manufacturer, it should be used during pregnancy only if clearly needed.

    Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent ammonium lactate affects normal lactic acid levels in human milk. According to the manufacturer, caution should be exercised when the cream or lotion is administered to breast-feeding women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Lactic acid is an alpha-hydroxy acid that acts as a keratin-softening agent by increasing the hydration of human skin and reducing epidermal keratinization. Lactic acid is reported to be one of the most effective naturally occurring humectants in the skin. Glycerin and propylene glycol are also humectants. Humectants draw water into the stratum corneum to hydrate the epidermis, while emollients retain water that is already present. Mineral oil and petrolatum are emollients; they act as occlusive agents and moisturizers, helping to relieve pruritus and other symptoms of dry skin. Urea is a mild keratolytic. Urea also increases water uptake in the stratum corneum and has a direct effect on the stratum corneum elasticity by binding to epidermal protein. Cetyl alcohol acts as an emulsion stabilizer and thickening agent.

    PHARMACOKINETICS

    Ammonium lactate is applied topically to the skin.

    Topical Route

    Absorption of Lac-Hydrin 12% cream into human cadaver skin was approximately 5.8% of the topically applied dose after 68 hours.