Ammonium Lactate 12% Cream 385gm
It is used to treat dry, scaly skin.It is used to treat itching caused by dry skin.
Drug Class
Keratolytic; Emollient
Pharmacologic Class
Alpha-hydroxy acid (AHA); Humectant
Pregnancy Category
Category C
FDA Approved
Jun 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ammonium Lactate 12% Cream is a moisturizer and skin softener used to treat dry, scaly skin conditions like xerosis (dry skin) and ichthyosis (fish-scale disease). It works by helping your skin hold onto water and by gently removing dead skin cells, making your skin smoother and softer.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
- Do not apply the medication to open wounds, cuts, or irritated skin.
- Avoid touching your eyes, nose, or mouth after handling the medication.
- If you accidentally get the medication in your eyes, nose, or mouth, rinse the affected area with water and seek medical attention if irritation persists.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from direct sunlight and heat sources. Keep all medications in a secure location, out of the reach of children and pets. When your medication is expired or no longer needed, dispose of it properly. Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your local pharmacist for guidance on medication disposal and to see if there are any drug take-back programs available in your area.
Missing a Dose
If you forget to apply a dose of your medication, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply extra doses or double doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
- Do not apply the medication to open wounds, cuts, or irritated skin.
- Avoid touching your eyes, nose, or mouth after handling the medication.
- If you accidentally get the medication in your eyes, nose, or mouth, rinse the affected area with water and seek medical attention if irritation persists.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from direct sunlight and heat sources. Keep all medications in a secure location, out of the reach of children and pets. When your medication is expired or no longer needed, dispose of it properly. Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your local pharmacist for guidance on medication disposal and to see if there are any drug take-back programs available in your area.
Missing a Dose
If you forget to apply a dose of your medication, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply extra doses or double doses to make up for a missed dose.
Lifestyle & Tips
- For external use only. Avoid contact with eyes, lips, and mucous membranes.
- May cause stinging or burning, especially on broken or inflamed skin. This usually lessens with continued use.
- Alpha-hydroxy acids (AHAs) can increase your skin's sensitivity to the sun. Use sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week after stopping treatment.
- Do not apply to acutely inflamed, broken, or open skin.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily
Condition-Specific Dosing:
xerosis:
Apply to dry, scaly skin areas twice daily.
ichthyosis:
Apply to affected areas twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, thinner skin)
Child:
Apply to affected areas twice daily (generally safe for older children, consult pediatrician)
Adolescent:
Apply to affected areas twice daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Ammonium lactate is a topical alpha-hydroxy acid (AHA). Lactic acid acts as a humectant, attracting and holding water in the stratum corneum, thereby increasing skin hydration. It also has mild keratolytic properties, promoting desquamation of hyperkeratotic skin by interfering with corneocyte cohesion, leading to a smoother, softer skin texture.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<5% of applied dose)
Tmax:
Not applicable (topical, local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (localized to skin)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not significant systemically
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin texture and hydration
PeakEffect:
Several weeks of consistent use
DurationOfAction:
Maintained with continued use
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Irritation at the site where the medication was applied
Burning or stinging sensations
Itching
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Irritation at the site where the medication was applied
Burning or stinging sensations
Itching
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning
- Stinging that does not subside
- Intense redness
- Swelling
- Blistering
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To minimize potential side effects, avoid exposing the treated area to sunlight. Additionally, be aware that applying this drug after shaving or on sensitive, irritated, or broken skin may cause burning or stinging sensations.
If you use this medication on your face, you may have a higher risk of experiencing skin irritation. It is also important to use this drug as directed, as using it too frequently can worsen your skin condition.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
To minimize potential side effects, avoid exposing the treated area to sunlight. Additionally, be aware that applying this drug after shaving or on sensitive, irritated, or broken skin may cause burning or stinging sensations.
If you use this medication on your face, you may have a higher risk of experiencing skin irritation. It is also important to use this drug as directed, as using it too frequently can worsen your skin condition.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose may lead to severe local irritation, redness, burning, and peeling.
What to Do:
Wash the affected area thoroughly with water. Discontinue use. If irritation persists or is severe, seek medical attention. Systemic overdose is highly unlikely due to minimal absorption. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Other topical keratolytics (e.g., salicylic acid, urea in high concentrations) - may increase irritation
Monitoring
Baseline Monitoring
Skin condition (dryness, scaling, hyperkeratosis)
Rationale: To assess baseline severity and guide treatment
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, burning, stinging, itching)
Frequency: Daily, especially during initial use
Target: Minimal to no irritation
Action Threshold: Discontinue use if severe irritation persists
Efficacy (improvement in skin hydration, texture, reduction in scaling)
Frequency: Weekly to monthly
Target: Patient-reported improvement and visual assessment
Action Threshold: Re-evaluate treatment if no improvement after 2-4 weeks
Symptom Monitoring
- Severe burning
- Stinging
- Redness
- Itching
- Peeling
- Swelling
- Rash
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected.
Trimester-Specific Risks:
First Trimester:
Limited data, but minimal systemic absorption suggests low risk.
Second Trimester:
Limited data, but minimal systemic absorption suggests low risk.
Third Trimester:
Limited data, but minimal systemic absorption suggests low risk.
Lactation
Considered compatible with breastfeeding. Minimal systemic absorption means negligible amounts are expected to be excreted in breast milk. Apply to skin areas away from the breast to avoid direct infant exposure.
Infant Risk:
Low risk (L2)
Pediatric Use
Safety and effectiveness in children younger than 2 years have not been established. Use with caution in young children due to thinner skin and potentially increased absorption. Consult a pediatrician.
Geriatric Use
No specific dosage adjustments are necessary. Generally well-tolerated in elderly patients, similar to adults.
Clinical Information
Clinical Pearls
- Ammonium lactate cream is particularly effective for conditions characterized by dry, scaly, and thickened skin.
- Patients should be advised that initial stinging or burning is common, especially on very dry or fissured skin, but usually subsides with continued use.
- Emphasize the importance of sun protection due to increased photosensitivity caused by AHAs.
- Advise patients to avoid applying the cream to open wounds, inflamed skin, or mucous membranes.
- Consistent, regular application is key to achieving and maintaining therapeutic benefits.
Alternative Therapies
- Other emollients and humectants (e.g., petrolatum, mineral oil, glycerin-based creams)
- Topical corticosteroids (for inflammatory components, but not for primary dryness/scaling)
- Retinoids (topical, for certain hyperkeratotic conditions)
Cost & Coverage
Average Cost:
$40 - $100 per 385gm cream
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered by most prescription plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.