DESCRIPTION
A formulation of lactic acid neutralized with ammonium hydroxide
Indicated for the treatment of mild to severe xerosis (dry skin) and ichthyosis vulgaris (hyperkeratotic disorder) and for temporary relief of itching
Generic versions are classified as a cosmetic and has not been shown to be bioequivalent or therapeutically equivalent to the prescription
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/LAC-cream/Lac-Hydrin Topical Cream: 12%
DOSAGE & INDICATIONS
For the treatment of ichthyosis vulgaris.
Topical dosage (12% lotion or cream)
Adults
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.
Children and Adolescent 2 to 17 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
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.
Children and Adolescents 2 to 17 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.
Geriatric
No maximum dosage information available.
Adolescents
No maximum dosage information available.
Children
Children 2 and older: No maximum dosage information available.
Children under 2 years old: Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
Neonates
Safety and efficacy have not been established.
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:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 77 degrees F
Amlactin:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 77 degrees F
Amlactin Ultra:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 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:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 77 degrees F
Lac-Hydrin Five:
- Storage information not provided in labeling
LAC-lotion:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 77 degrees F
Moist Skin:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 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
skin hyperpigmentation / Delayed / Incidence not known
petechiae / 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.
Affected cytochrome P450 isoenzymes: none
Topical Route
Absorption of Lac-Hydrin 12% cream into human cadaver skin was approximately 6.1% of the topically applied dose after 68 hours.