Lac-Hydrin

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Lac-Hydrin

Classes

Humectants

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.

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

Common Brand Names

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

Dea Class

Rx, OTC

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

Dosage And 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.

Dosing Considerations
Hepatic Impairment

No dosage adjustment is needed.

Renal Impairment

No dosage adjustment is needed.

Drug Interactions

There are no drug interactions associated with Ammonium Lactate products.

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%

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.

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.

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.