Ammonium Lactate

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Overview

What is Ammonium Lactate?

*Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water.

Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:

What does Ammonium Lactate look like?

What are the available doses of Ammonium Lactate?

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What should I talk to my health care provider before I take Ammonium Lactate?

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How should I use Ammonium Lactate?

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

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

What interacts with Ammonium Lactate?

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

What are the warnings of Ammonium Lactate?

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What are the precautions of Ammonium Lactate?

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

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Patients using Ammonium Lactate Cream, 12% should receive the following information and instructions:

Carcinogenesis, Mutagenesis, Impairment of Fertility -

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Pregnancy:

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 ammonium lactate cream is administered to a nursing woman.

Pediatric Use -

The safety and efficacy of Ammonium Lactate Cream, 12% has been established in patients as young as 2 years old.

Geriatric Use -

Clinical studies of 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.

What are the side effects of Ammonium Lactate?

In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with ammonium lactate cream were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% 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 were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

What should I look out for while using Ammonium Lactate?

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

Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see ). Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted.

What might happen if I take too much Ammonium Lactate?

Sorry No Records found

How should I store and handle Ammonium Lactate?

Ammonium Lactate Cream, 12% is available as follows:385 g bottle (NDC 45802--26)280 g carton (NDC 45802--83) containing two 140 g tubes (NDC 45802--98)Ammonium Lactate Cream, 12% is available as follows:385 g bottle (NDC 45802--26)280 g carton (NDC 45802--83) containing two 140 g tubes (NDC 45802--98)Ammonium Lactate Cream, 12% is available as follows:385 g bottle (NDC 45802--26)280 g carton (NDC 45802--83) containing two 140 g tubes (NDC 45802--98)

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Clinical Information

Chemical Structure

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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 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.

Non-Clinical Toxicology

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

Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see ). Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted.

Since cilostazol is extensively metabolized by cytochrome P-450 isoenzymes, caution should be exercised when cilostazol is coadministered with inhibitors of CYP3A4 such as ketoconazole and erythromycin or inhibitors of CYP2C19 such as omeprazole. Pharmacokinetic studies have demonstrated that omeprazole and erythromycin significantly increased the systemic exposure of cilostazol and/or its major metabolites. Population pharmacokinetic studies showed higher concentrations of cilostazol among patients concurrently treated with diltiazem, an inhibitor of CYP3A4 (see , ). Cilostazol does not, however, appear to cause increased blood levels of drugs metabolized by CYP3A4, as it had no effect on lovastatin, a drug with metabolism very sensitive to CYP3A4 inhibition.

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.

In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with ammonium lactate cream were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% 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 were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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