Drug Reference
Lactate
Rx only
Fact box
- Habit forming
- No
- Availability
- Prescription (Rx)
Brand names
4XLA ActivatorAmLactin APAmlactinAstri-UCAtrac-TainDermaplexDianeal Low Calcium 1.5Dianeal Low Calcium 2.5Dianeal Low Calcium 4.25Dianeal PD-2/1.5Dianeal PD-2/2.5Dianeal PD-2/4.25EncoreExtranealGeri-HydrolacIonosol-MBLac-HydrinLacticareLactinolOxy GardPhexxPhexxiPur-OxyU-LactinValiant BarrierValiant Shield
Available as
100 MG/ML · Topical Cream50 MG/ML · Topical Cream0.25 MG/MG · Topical Ointment16 MG/ML · Topical Solution0.00232 MEQ/ML · Injectable Solution5 MG/ML · Topical Solution26.4 MG/ML · Topical Solution50 MG/ML · Topical Solution120 MG/ML · Topical Cream50 MG/ML2.5 MG/ML · Topical Solution3 MG/ML · Topical Solution25 MG/ML · Topical Solution5 MG/ML22 MG/ML · Topical Solution100 MG/ML · Topical Solution0.2 MG/ML · Injectable Solution120 MG/ML20 MG/ML0.01 MG/MG0.167 MG/MG · Topical Gel0.04 MG/MG · Topical Gel140 MG/ML · Topical Solution100 MG/ML
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
How it works
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 in vitro 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.
How to use / dosing
DOSAGE AND ADMINISTRATION Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Side effects
ADVERSE REACTIONS 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.
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyUnsafe
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.
BreastfeedingCaution
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, 12% is administered to a nursing woman.
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
WARNING 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.
Contraindications
CONTRAINDICATIONS Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Pediatric use
Pediatric Use The safety and effectiveness of Ammonium Lactate Cream, 12% have been established in pediatric patients as young as 2 years old.
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Current FDA labels (DailyMed)
- DEXTROSE AND ELECTROLYTE NO. 48 (SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE) INJECTION [BAXTER HEALTHCARE COMPANY]
- IONOSOL MB AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) INJECTION, SOLUTION [ICU MEDICAL INC.]
- POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [ICU MEDICAL INC.]
- LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [ICU MEDICAL INC.]
- LACTATED RINGERS AND DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.]
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.