Ammonium lactate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Ammonium lactate is an antipruritic that is FDA approved for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris. Common adverse reactions include burning sensation, erythema, skin peeling disorder, stinging of skin.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Ammonium Lactate Cream is indicated for the treatment of dry, scaly skin(xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.
- Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ammonium lactate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ammonium lactate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ammonium lactate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ammonium lactate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ammonium lactate in pediatric patients.
Contraindications
Ammonium Lactate Cream is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Warnings
- Sun exposure to areas of the skin treated with Ammonium lactate Cream, 12% should be minimized or avoided. The use of Ammonium Lactate Cream should be discontinued if any hypersensitivity is observed.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Ammonium lactate Clinical Trials Experience in the drug label.
Postmarketing Experience
- The most frequent adverse experiences in patients with xeroxis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation.
- Due to 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).
Drug Interactions
There is limited information regarding Ammonium lactate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- 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 formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ammonium Lactate Cream should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ammonium lactate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ammonium lactate during labor and delivery.
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
Safety and effectiveness of Ammonium Lactate Cream have been demonstrated in infants and children. No unusual toxic effects were reported.
Geriatic 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.
Gender
There is no FDA guidance on the use of Ammonium lactate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ammonium lactate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ammonium lactate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ammonium lactate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ammonium lactate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ammonium lactate in patients who are immunocompromised.
Administration and Monitoring
Administration
Monitoring
There is limited information regarding Ammonium lactate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ammonium lactate and IV administrations.
Overdosage
There is limited information regarding Ammonium lactate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ammonium lactate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ammonium lactate Mechanism of Action in the drug label.
Structure
There is limited information regarding Ammonium lactate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ammonium lactate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ammonium lactate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ammonium lactate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ammonium lactate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ammonium lactate How Supplied in the drug label.
Storage
There is limited information regarding Ammonium lactate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Ammonium lactate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ammonium lactate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- AMMONIUM LACTATE ®[1]
Look-Alike Drug Names
There is limited information regarding Ammonium lactate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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