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Ammonium lactate (topical): Pediatric drug information

Ammonium lactate (topical): Pediatric drug information
(For additional information see "Ammonium lactate (topical): Drug information" and see "Ammonium lactate (topical): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • AL12 [OTC];
  • AmLactin [OTC];
  • Geri-Hydrolac [OTC];
  • Geri-Hydrolac-12 [OTC];
  • Lac-Hydrin Five [OTC];
  • Lac-Hydrin Twelve [OTC] [DSC];
  • Lac-Hydrin [DSC]
Therapeutic Category
  • Topical Skin Product
Dosing: Pediatric
Dermatologic conditions

Dermatologic conditions:

Lotion: Infants, Children, and Adolescents: Topical: Apply to the affected area(s) twice daily; rub in well

Cream: Children ≥2 years and Adolescents: Topical: Apply to the affected area(s) twice daily; rub in well

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Dosing: Adult

(For additional information see "Ammonium lactate (topical): Drug information")

Dermatologic conditions

Dermatologic conditions: Topical: Cream, lotion: Apply twice daily to affected area; rub in well

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Dermatologic: Burning/stinging (3% to 15%), rash (2% to 15%; includes erythema and irritation)

1% to 10%: Dermatologic: Itching (5%), dry skin (2%)

Contraindications

Hypersensitivity to lactic acid, ammonium hydroxide, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Burning/stinging: May cause burning or stinging upon application to abraded skin.

• Photosensitivity: May cause photosensitivity; minimize exposure to the sun of areas being treated.

Other warnings/precautions:

• Appropriate use: For external use only; not for use on eyes, lips, or mucous membranes; use with caution to facial area (may be more sensitive to irritation).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product.

Cream, topical:

Lac-Hydrin: Lactic acid 12% with ammonium hydroxide (140 g [DSC], 385 g[DSC])

Geri-Hydrolac 12: Lactic acid 12% with ammonium hydroxide (140 g)

Generic: Lactic acid 12% with ammonium hydroxide (140 g, 385 g)

Lotion, topical:

AL12: Lactic acid 12% with ammonium hydroxide (225 g, 400 g)

AmLactin: Lactic acid 12% with ammonium hydroxide (57 g, 225 g [DSC], 400 g [DSC], 500 g, 567 g)

Geri-Hydrolac 5: Lactic acid 5% with ammonium hydroxide (222 mL)

Geri-Hydrolac 12: Lactic acid 12% with ammonium hydroxide (225 g, 400 g)

Lac-Hydrin Five: Lactic acid 5% with ammonium hydroxide (226 g)

Lac-Hydrin Twelve: Lactic acid 12% with ammonium hydroxide (400 g [DSC])

Generic: Lactic acid 10% with ammonium hydroxide (355 mL, 473 mL); Lactic acid 12% with ammonium hydroxide (225 g, 400 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Ammonium Lactate External)

12% (per gram): $0.05 - $0.20

Lotion (Amlactin Daily External)

12% (per gram): $0.07

Lotion (Ammonium Lactate External)

12% (per gram): $0.02 - $0.19

Lotion (Lac-Hydrin Five External)

5% (per gram): $0.06

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

Topical: For external use only; avoid contact with eyes, lips, or mucous membranes. Shake lotion well before use. Apply a small amount to the affected area(s) and rub in thoroughly.

Administration: Adult

For topical use only; rub in well; shake lotion well before application. Avoid use on eyes, lips, or mucous membranes.

Storage/Stability

Lac-Hydrin cream/lotion: Store at 15°C to 30°C (59°F to 86°F).

Use

Prescription products: Treatment of ichthyosis vulgaris and xerosis (dry, scaly skin) (Lotion: FDA approved in infants, children, adolescents, and adults; Cream: FDA approved in ages ≥2 years and adults)

OTC products: Treatment of dry, scaly, itchy skin (OTC products: FDA approved in pediatric patients [age not specified] and adults)

Note: Approved ages may vary by product; see product labeling for details.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Calcipotriene: Lactic Acid may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with lactic acid. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

Pregnancy Considerations

Lactic acid is a normal component in blood and tissues. Topical application in animals has not shown fetal harm.

Monitoring Parameters

Physical examination of skin condition

Mechanism of Action

Exact mechanism of action unknown; lactic acid is a normal component in blood and tissues. When applied topically to the skin, acts as a humectant.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Ichthyosis xerosis: 3 to 7 days

Absorption: 6%

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Lactocev | Nutrafilm;
  • (AU) Australia: Lanate;
  • (BR) Brazil: Lac-hydrin;
  • (CO) Colombia: Alfacare | Lac-hydrin;
  • (EC) Ecuador: Lac-hydrin;
  • (HK) Hong Kong: Lanate;
  • (IN) India: Hydralac | Lak Am Lact;
  • (KR) Korea, Republic of: Lac-hydrin | Lactcare | Taro ammonium lactate;
  • (LT) Lithuania: Kerapil;
  • (MX) Mexico: Kerapil | Lac-hydrin;
  • (MY) Malaysia: Lanate;
  • (NZ) New Zealand: Lac-hydrin | Lanate;
  • (PR) Puerto Rico: Amlactin | Geri-Hydrolac | Kerasal al | Laclotion;
  • (SG) Singapore: Lac-hydrin | Lanate
  1. Amlactin Daily Lotion (ammonium lactate) [prescribing information]. Princeton, NJ: Sandoz; received May 2020.
  2. Ammonium Lactate Cream 12% (lactic acid and ammonium hydroxide) [prescribing information]. Allegan, MI: Perrigo; received December 2019.
  3. Ammonium Lactate Lotion 12% (lactic acid and ammonium hydroxide) [prescribing information]. Allegan, MI: Perrigo; received December 2019.
  4. Geri-Hydrolac cream (lactic acid and ammonium hydroxide) [prescribing information]. Mount Vernon, NY: Geritrex Corporation; June 2013.
  5. Lac-Hydrin (ammonium lactate cream) [prescribing information]. Jacksonville, FL: Ranbaxy Laboratories Inc; July 2009.
  6. Lac-Hydrin Five (lactic acid and ammonium hydroxide) [prescribing information]. Jacksonville, FL: Ranbaxy Laboratories, Inc; received July 2017.
  7. Lac-Hydrin lotion (lactic acid and ammonium hydroxide) [prescribing information]. Jacksonville, FL: Ranbaxy Laboratories, Inc; September 2009.
Topic 13280 Version 98.0

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