Ammonium Lactate 12% Cream 2x140gm
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)
Pregnancy Category
Category B
FDA Approved
Aug 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ammonium Lactate 12% Cream is a medication used to treat dry, scaly skin conditions like xerosis (dry skin) and ichthyosis (fish-scale skin disease). It works by helping your skin hold onto moisture and by gently removing dead skin cells, making your skin softer and smoother.
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.
Application Instructions
1. Wash your hands before applying the medication, unless your hand is the area being treated.
2. Clean the affected area before applying the medication and make sure it is completely dry.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. Avoid applying the medication to open wounds, cuts, or irritated skin, as this can cause further irritation.
5. Keep the medication out of your mouth, nose, and eyes, as it may cause burning.
Storage and Disposal
To ensure the safety and efficacy of your medication:
1. Store it at room temperature.
2. Keep all medications in a secure location, out of the reach of children and pets.
3. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
4. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
Missed Dose Instructions
If you miss a dose of your medication:
1. Apply the missed dose as soon as you remember.
2. If it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule.
3. Do not apply two doses at the same time or use extra 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.
Application Instructions
1. Wash your hands before applying the medication, unless your hand is the area being treated.
2. Clean the affected area before applying the medication and make sure it is completely dry.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. Avoid applying the medication to open wounds, cuts, or irritated skin, as this can cause further irritation.
5. Keep the medication out of your mouth, nose, and eyes, as it may cause burning.
Storage and Disposal
To ensure the safety and efficacy of your medication:
1. Store it at room temperature.
2. Keep all medications in a secure location, out of the reach of children and pets.
3. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
4. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
Missed Dose Instructions
If you miss a dose of your medication:
1. Apply the missed dose as soon as you remember.
2. If it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule.
3. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer to affected areas and rub in thoroughly. Do not use on eyes, lips, or mucous membranes.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- This medication can make your skin more sensitive to the sun. Use sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week after stopping treatment.
- For external use only. Do not swallow.
- May cause stinging or burning, especially on broken or irritated skin. This usually lessens with continued use.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily
Condition-Specific Dosing:
dry skin:
Apply a thin layer to affected areas twice daily
ichthyosis:
Apply a thin layer to affected areas twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established; use with caution and under medical supervision due to potential for increased absorption and irritation in very young skin.
Child:
Apply to affected areas twice daily, or as directed by physician. Use with caution.
Adolescent:
Apply to affected areas twice daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use
Moderate:
No adjustment needed for topical use
Severe:
No adjustment needed for topical use
Dialysis:
No specific considerations for topical use
Hepatic Impairment:
Mild:
No adjustment needed for topical use
Moderate:
No adjustment needed for topical use
Severe:
No adjustment needed for topical use
Pharmacology
Mechanism of Action
Ammonium lactate is a compound of lactic acid and ammonium hydroxide. Lactic acid is an alpha-hydroxy acid (AHA) that acts as a humectant, attracting and holding moisture in the skin. It also has keratolytic properties, promoting the shedding of dead skin cells and softening hyperkeratotic areas. The ammonium hydroxide neutralizes the lactic acid to form ammonium lactate, which is less irritating than free lactic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 6% of applied dose)
Tmax:
Not applicable for systemic Tmax; local effect
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable for systemic distribution; primarily local skin effect
ProteinBinding:
Not applicable for systemic distribution; primarily local skin effect
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable for systemic half-life; primarily local skin effect
Clearance:
Not applicable for systemic clearance; primarily local skin effect
ExcretionRoute:
Not applicable for systemic excretion; primarily local skin effect
Unchanged:
Not applicable for systemic excretion
Pharmacodynamics
OnsetOfAction:
Within days for softening and hydration, full effect may take weeks
PeakEffect:
Weeks of consistent use
DurationOfAction:
Maintained with continued use
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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, contact your doctor or seek immediate medical attention:
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. If you have questions or concerns about side effects, consult your doctor for medical advice. 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, contact your doctor or seek immediate medical attention:
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. If you have questions or concerns about side effects, consult your doctor for medical advice. 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
- Excessive redness
- Swelling
- Blistering
- Signs of allergic reaction (rash, itching/swelling, severe dizziness, trouble 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 assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage 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 assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage 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 are more likely to experience skin irritation. Furthermore, using this drug too frequently can exacerbate your skin condition.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the benefits and risks of this medication with your doctor, as this will help determine the best course of treatment for both 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 are more likely to experience skin irritation. Furthermore, using this drug too frequently can exacerbate your skin condition.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the benefits and risks of this medication with your doctor, as this will help determine the best course of treatment for both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic effects due to minimal absorption. Local symptoms may include severe skin irritation, redness, burning, and peeling.
What to Do:
If ingested, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). For severe topical irritation, wash the area thoroughly with water and discontinue use. Symptomatic and supportive care.
Drug Interactions
Moderate Interactions
- Other topical products with keratolytic or exfoliating properties (e.g., salicylic acid, retinoids, benzoyl peroxide) - may increase irritation.
Monitoring
Baseline Monitoring
Skin condition (dryness, scaling, irritation)
Rationale: To assess baseline severity and identify areas for treatment
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, burning, stinging, peeling)
Frequency: Daily, especially during initial use
Target: Minimal to no irritation
Action Threshold: If severe or persistent irritation occurs, reduce frequency or discontinue use and consult physician.
Therapeutic response (skin hydration, reduction in scaling/roughness)
Frequency: Weekly to monthly
Target: Improved skin texture and hydration
Action Threshold: If no improvement after 2-4 weeks, re-evaluate diagnosis or treatment.
Symptom Monitoring
- Skin redness
- Burning sensation
- Stinging
- Peeling
- Itching
- Dryness (paradoxical)
Special Patient Groups
Pregnancy
Ammonium lactate cream is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Systemic absorption is minimal with topical use, making risk to the fetus low.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
It is not known whether ammonium lactate is excreted in human milk. However, systemic absorption is minimal, so significant exposure to the infant is unlikely. Use with caution; avoid applying to areas where the infant may ingest the cream.
Infant Risk:
Low risk (L3)
Pediatric Use
Safety and effectiveness in children under 2 years of age have not been established. Use with caution in children, especially infants, due to potentially increased systemic absorption through immature skin and higher risk of irritation. Consult a physician.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Elderly patients may have more fragile skin, so monitor for irritation.
Clinical Information
Clinical Pearls
- Ammonium lactate cream is particularly effective for very dry, rough, or scaly skin conditions like xerosis and ichthyosis.
- Patients should be advised about increased sun sensitivity and the importance of sun protection (sunscreen, protective clothing) while using this product.
- Initial application may cause mild stinging or burning, especially on broken or very dry skin. This usually subsides with continued use as the skin barrier improves.
- Avoid applying to open wounds, inflamed skin, or mucous membranes.
- Consistent, regular use is key for optimal results.
Alternative Therapies
- Urea cream (e.g., Ureacin, Keralac)
- Salicylic acid topical (for keratolytic effect)
- Alpha-hydroxy acid (AHA) lotions (other types)
- Emollients and moisturizers (e.g., petrolatum, mineral oil, ceramides)
- Topical corticosteroids (for inflammatory conditions with dryness, but not for primary dryness/ichthyosis)
Cost & Coverage
Average Cost:
$30 - $60 per 140gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 details. 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 information about the medication taken, the amount, and the time it happened.