pharmacopeia

Lactate

US-FDASourced from openFDA
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Indications

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

Contraindications

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

Dosage & administration

Sourced from openFDA

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

Warnings & precautions

Sourced from openFDA

Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Cream, 12% should be discontinued if any hypersensitivity is observed.

Adverse reactions

Sourced from openFDA

In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 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, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic effects 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/m 2 /day in the rat and 7200 mg/m 2 /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, Ammonium Lactate Cream, 12% should be used during pregnancy only if clearly needed.

Approval history

Sourced from openFDA
  • Mar 22, 1971NDANDA016679Baxter Hlthcare
  • Mar 22, 1971NDANDA016682Baxter Hlthcare
  • Aug 13, 1975NDANDA017608Otsuka Icu Medcl
  • Jan 26, 1976NDANDA017641Otsuka Icu Medcl
  • Sep 27, 1978NDANDA017512Vantive Us Hlthcare
  • Feb 2, 1979NDANDA017484Baxter Hlthcare
  • Feb 19, 1982NDANDA018494Baxter Hlthcare
  • Dec 27, 1982NDANDA018681B Braun

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
73,863 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Death8,36111%
  2. 2Peritonitis3,8925.3%
  3. 3Peritonitis Bacterial2,5293.4%
  4. 4Drug Ineffective2,4263.3%
  5. 5Hypotension2,2423.0%
  6. 6Pneumonia1,9462.6%
  7. 7Dyspnoea1,8142.5%
  8. 8Vomiting1,7682.4%
  9. 9Peritoneal Dialysis Complication1,7482.4%
  10. 10Drug Interaction1,7312.3%
  11. 11Weight Increased1,6892.3%
  12. 12Neuroleptic Malignant Syndrome1,6532.2%
  13. 13Myocardial Infarction1,6192.2%
  14. 14Infection1,5402.1%
  15. 15Sepsis1,5352.1%

Literature

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Recent PubMed references pinned to Lactate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,402 ClinicalTrials.gov registrations naming Lactate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Lactate used for?
According to FDA labeling, Lactate carries indications including: Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the brand names for Lactate?
Lactate is marketed under brand names including 4XLA Activator, AmLactin AP, Amlactin, Astri-UC, Atrac-Tain, Dermaplex, Dianeal Low Calcium 1.5, Dianeal Low Calcium 2.5.
What are the contraindications for Lactate?
Lactate labeling lists contraindications including: Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for lactate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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