Lac-Hydrin

Lac-Hydrin (lactic acid) is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

Ammonium lactate is a combination of lactic acid and ammonium hydroxide. Ammonium lactate is a moisturizer.

Ammonium lactate is used to treat dry, scaly, itchy skin.

Ammonium lactate may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ammonium lactate topical and call your doctor at once if you have:

• severe redness or stinging where the medicine was applied.

Common side effects may include:

• mild dryness or skin irritation after use; or

• bruising of discoloration of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 Lac-Hydrin Cream using human cadaver skin indicates that approximately 6.1% of the material was absorbed after 68 hours.

Lac-Hydrin Cream is indicated for the treatment of ichthyosis vulgaris and xerosis.

General

For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded (for example, after shaving the legs).Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.

Information For Patients

Patients using Lac-Hydrin Cream should receive the following information and instructions:

1. This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
2. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure isunavoidable, clothing should be worn to protect the skin.
3. This medication may cause stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
4. If the skin condition worsens with treatment, the medication should be promptly discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate cream enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of ammonium lactate cream was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.

In dermal Segment I and III studies with ammonium lactate cream there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m2/day), approximately 0.4 times the human topical dose.

Pregnancy

Teratogenic effects: Pregnancy Category B.

Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m2/day in the rat and 7200 mg/m2/day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Lac-Hydrin Cream should be used during pregnancy only if clearly needed.

Nursing Mothers

Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lac-Hydrin is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Lac-Hydrin Cream have been established in pediatric patients as young as 2 years old.

Geriatric Use

Clinical studies of Lac-Hydrin® (ammonium lactate) Cream, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Lac-Hydrin® 12%* (ammonium lactate) Cream is available in cartons of 280 g (two 140 g plastic tubes) (NDC # 10631-099-28) and 385 g plastic bottle (NDC # 10631-099-38). Store at controlled room temperature, 15° C-30° C (59° F-86° F).

RANBAXY

Jacksonville, FL 32257 USA

Revised July 2009

Applies to ammonium lactate topical: external cream, external lotion

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where this drug is used.

Applies to ammonium lactate topical: compounding solution, topical cream, topical lotion

Dermatologic

Dermatologic side effects have been reported in patients with xerosis including transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Irritation, eczema, petechiae, dryness, and hyperpigmentation have been reported less frequently.

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).[Ref]

Some side effects of Lac-Hydrin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.