Ammonium Lac 12% Cream 280gm
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); pH modifier
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream helps to soften and moisturize very dry, rough, or scaly skin. It works by helping the skin shed dead cells and hold onto moisture, making your skin feel smoother and softer.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication topically, directly to the affected area of your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause irritation or burning.
Before and after applying the medication, wash your hands thoroughly, unless the treated area is on your hand. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and ensure it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.
Avoid applying the medication to open wounds, cuts, or irritated skin.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature.
Keep all medications in a secure location, out of the reach of children and pets.
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. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs if available.
Missed Dose
If you miss a dose:
Apply the missed dose as soon as you remember.
If the next scheduled dose is near, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at once or use extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication topically, directly to the affected area of your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause irritation or burning.
Before and after applying the medication, wash your hands thoroughly, unless the treated area is on your hand. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and ensure it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.
Avoid applying the medication to open wounds, cuts, or irritated skin.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature.
Keep all medications in a secure location, out of the reach of children and pets.
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. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs if available.
Missed Dose
If you miss a dose:
Apply the missed dose as soon as you remember.
If the next scheduled dose is near, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at once or use extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid applying to irritated, broken, or inflamed skin.
- Avoid contact with eyes, lips, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Lactic acid can increase sensitivity to the sun. Use sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week after stopping.
- For external use only. Do not ingest.
- Wash hands thoroughly after application.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily or as directed by physician. Rub in thoroughly.
Condition-Specific Dosing:
dry, scaly skin:
Apply to affected areas twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Consult physician; use with caution due to thinner skin and potential for increased absorption.
Child:
Consult physician; use with caution due to thinner skin and potential for increased absorption.
Adolescent:
Apply to affected areas twice daily or as directed by physician.
Dose Adjustments
Renal Impairment:
Mild:
Not applicable (topical product with minimal systemic absorption)
Moderate:
Not applicable (topical product with minimal systemic absorption)
Severe:
Not applicable (topical product with minimal systemic absorption)
Dialysis:
Not applicable (topical product with minimal systemic absorption)
Hepatic Impairment:
Mild:
Not applicable (topical product with minimal systemic absorption)
Moderate:
Not applicable (topical product with minimal systemic absorption)
Severe:
Not applicable (topical product with minimal systemic absorption)
Pharmacology
Mechanism of Action
Lactic acid, an alpha-hydroxy acid, acts as a keratolytic by promoting desquamation of hyperkeratotic stratum corneum. It also has humectant properties, increasing the water content of the skin and improving skin hydration. Ammonium hydroxide is used to adjust the pH of the cream, optimizing the activity and stability of lactic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 6% of applied dose)
Tmax:
Not clinically significant for topical use
FoodEffect:
Not applicable (topical product)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin texture and hydration
PeakEffect:
Weeks to months with consistent use
DurationOfAction:
Continues as long as product is used regularly
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical help immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the drug was applied
- Burning or stinging sensations
- Itching
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical help immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the drug was applied
- Burning or stinging sensations
- Itching
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. 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, or itching that does not subside
- Excessive redness or swelling
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/throat) - seek immediate medical attention
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 assess potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This precaution will help prevent potential interactions or adverse effects.
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 assess potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This precaution will help prevent potential interactions or adverse effects.
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 at a higher risk of experiencing skin irritation. Overusing this drug can worsen your skin condition, so it is crucial to follow the recommended dosage and usage instructions.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss the benefits and risks of using this medication with your doctor to ensure the best possible outcome 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 are at a higher risk of experiencing skin irritation. Overusing this drug can worsen your skin condition, so it is crucial to follow the recommended dosage and usage instructions.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss the benefits and risks of using this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe local skin irritation (redness, burning, peeling)
- If ingested (highly unlikely for topical cream): gastrointestinal upset, nausea, vomiting
What to Do:
For topical overdose, wash affected area with soap and water. Discontinue use. For accidental ingestion, seek immediate medical attention or call Poison Control at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Other topical keratolytics (e.g., salicylic acid, urea, retinoids): May increase skin irritation or excessive peeling.
Monitoring
Baseline Monitoring
Skin condition (dryness, scaling, irritation)
Rationale: To establish baseline for assessing treatment efficacy and adverse effects.
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: Discontinue use if severe irritation, burning, or stinging occurs.
Improvement in skin hydration and texture
Frequency: Weekly to monthly
Target: Reduced dryness, flaking, and roughness
Action Threshold: Re-evaluate treatment if no improvement after several weeks of consistent use.
Symptom Monitoring
- Skin redness
- Burning sensation
- Stinging sensation
- Peeling or flaking
- Itching
- Swelling
- Signs of allergic reaction (rash, hives)
Special Patient Groups
Pregnancy
Generally considered low risk for topical use due to minimal systemic absorption. However, consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Low risk, but consult physician.
Second Trimester:
Low risk, but consult physician.
Third Trimester:
Low risk, but consult physician.
Lactation
Considered low risk for topical use. Minimal systemic absorption makes transfer to breast milk unlikely. Avoid applying to areas where infant may ingest the cream.
Infant Risk:
Low risk
Pediatric Use
Use with caution, especially in infants and young children, as their skin is thinner and more permeable, potentially leading to increased absorption and irritation. Consult a physician.
Geriatric Use
No specific dose adjustments needed. Monitor for increased skin fragility or sensitivity, which may be more common in older adults.
Clinical Information
Clinical Pearls
- This cream is particularly effective for conditions like xerosis (dry skin), ichthyosis, and keratosis pilaris.
- Initial application may cause mild stinging or burning, which usually subsides with continued use.
- Patients should be advised about increased sun sensitivity and the importance of sun protection.
- For best results, apply to damp skin after bathing or showering to lock in moisture.
Alternative Therapies
- Urea cream (e.g., Ureacin, Keralac)
- Salicylic acid topical (e.g., for keratosis pilaris)
- Alpha-hydroxy acid lotions (other concentrations or types)
- Emollients and moisturizers (e.g., petrolatum, mineral oil, ceramides)
- Topical corticosteroids (for inflammatory skin conditions, not primary dry skin)
Cost & Coverage
Average Cost:
$20 - $50 per 280gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often OTC, may not be covered by all plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, including the dosage, time of ingestion, and any other relevant information.