Ammonium Lac 12% Lotion 225gm
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
C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This lotion contains lactic acid, which is an ingredient that helps to soften and moisturize very dry, rough, or scaly skin. It works by helping your skin hold onto water and by gently removing dead skin cells.
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 medication. It is essential to use this medication only as directed.
Apply this medication to your skin only, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the medication to open wounds, cuts, or irritated skin.
Before each use, shake the medication well.
Storing and Disposing of Your Medication
To ensure the safety and efficacy of your medication, follow these storage and disposal guidelines:
Store the medication at room temperature.
Keep all medications in a safe and 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 or healthcare provider. 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.
Missing a Dose
If you miss a dose of your medication, follow these steps:
Apply the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or take 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 medication. It is essential to use this medication only as directed.
Apply this medication to your skin only, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the medication to open wounds, cuts, or irritated skin.
Before each use, shake the medication well.
Storing and Disposing of Your Medication
To ensure the safety and efficacy of your medication, follow these storage and disposal guidelines:
Store the medication at room temperature.
Keep all medications in a safe and 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 or healthcare provider. 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.
Missing a Dose
If you miss a dose of your medication, follow these steps:
Apply the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer to the affected skin areas and rub in thoroughly.
- Wash hands immediately after applying the lotion.
- Avoid contact with eyes, lips, and mucous membranes (e.g., inside the nose or mouth). If contact occurs, rinse thoroughly with water.
- Do not apply to irritated, inflamed, or broken skin.
- This product may 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.
- For external use only. Do not swallow.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily
Condition-Specific Dosing:
xerosis:
Apply to affected areas twice daily
ichthyosis:
Apply to affected areas twice daily
hyperkeratosis:
Apply to affected areas twice daily
Pediatric Dosing
Neonatal:
Not established (generally not recommended due to skin sensitivity)
Infant:
Not established (generally not recommended due to skin sensitivity)
Child:
Use with caution; generally not recommended for children under 12 years unless directed by physician. If used, apply sparingly to affected areas twice daily.
Adolescent:
Apply to affected areas twice daily, similar to adult dosing, with caution for irritation.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Dialysis:
No specific considerations (topical application, minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Pharmacology
Mechanism of Action
Lactic acid, an alpha-hydroxy acid, acts as a humectant by attracting and holding water in the stratum corneum, thereby increasing skin hydration. It also has keratolytic properties, promoting the shedding of dead skin cells and softening rough, scaly skin. Ammonium hydroxide is included to adjust the pH of the formulation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 5% of applied dose)
Tmax:
Not applicable (primarily local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (primarily localized to skin)
ProteinBinding:
Not applicable (primarily localized to skin)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (primarily local action)
Clearance:
Not applicable (primarily local action)
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 of consistent use for optimal results.
DurationOfAction:
Dependent on continued application.
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 attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you and do not go away:
- 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. 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 attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you and do not go away:
- 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. 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 irritation
- Swelling or blistering of the skin
- Signs of allergic reaction (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 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 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 identify potential interactions between this medication and other substances.
* 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 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. You may experience burning or stinging if you apply this drug after shaving or on skin that is sensitive, irritated, or broken.
Using this medication on your face may increase your risk of skin irritation. Additionally, using this drug 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 this medication to both you and your baby.
To minimize potential side effects, avoid exposing the treated area to sunlight. You may experience burning or stinging if you apply this drug after shaving or on skin that is sensitive, irritated, or broken.
Using this medication on your face may increase your risk of skin irritation. Additionally, using this drug 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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe local skin irritation (intense burning, redness, peeling, blistering)
- Systemic effects are highly unlikely due to minimal absorption.
What to Do:
Discontinue use immediately. Wash the affected area with soap and water. Apply a cool compress. If irritation persists or is severe, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical help, though systemic toxicity from ingestion is rare due to low concentration and poor absorption.
Drug Interactions
Moderate Interactions
- Other topical keratolytics (e.g., salicylic acid, urea, retinoids) - may increase irritation or peeling.
Monitoring
Baseline Monitoring
Skin condition assessment (dryness, scaling, hyperkeratosis)
Rationale: To establish baseline severity and identify areas for treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin irritation (redness, burning, stinging, peeling)
Frequency: Daily, especially during initial use
Target: Minimal to no irritation
Action Threshold: Persistent or severe irritation; discontinue use and consult healthcare provider.
Improvement in skin hydration and texture
Frequency: Weekly to monthly
Target: Softer, smoother, less scaly skin
Action Threshold: No improvement after several weeks of consistent use; re-evaluate diagnosis or treatment.
Symptom Monitoring
- Burning sensation
- Stinging sensation
- Redness (erythema)
- Itching (pruritus)
- Peeling or flaking of skin
- Dryness (paradoxical worsening)
- Swelling
- Blistering
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but controlled studies in pregnant women are lacking.
Trimester-Specific Risks:
First Trimester:
Minimal risk expected due to low systemic absorption, but caution advised.
Second Trimester:
Minimal risk expected due to low systemic absorption.
Third Trimester:
Minimal risk expected due to low systemic absorption.
Lactation
L3 (Moderately safe). Minimal systemic absorption is expected, making it unlikely to be excreted in breast milk in clinically significant amounts. Use with caution, and avoid applying to areas where the infant may ingest the product (e.g., breasts).
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal maternal systemic absorption.
Pediatric Use
Generally not recommended for infants and young children (under 12 years) due to increased skin sensitivity and potential for irritation. If used in older children/adolescents, apply with caution and monitor closely for irritation. Consult a pediatrician before use.
Geriatric Use
Generally safe for use in geriatric patients. No specific dose adjustments are typically required. Monitor for increased skin fragility or sensitivity that may occur with aging.
Clinical Information
Clinical Pearls
- Ammonium lactate lotion is highly effective for conditions characterized by dry, scaly, or rough skin, such as xerosis, ichthyosis vulgaris, and hyperkeratosis.
- Patients should be counseled on the potential for transient stinging or burning, especially during the initial applications or if applied to abraded skin.
- Emphasize the importance of sun protection (sunscreen, protective clothing) due to increased photosensitivity caused by alpha-hydroxy acids.
- For best results, apply immediately after bathing or showering to damp skin to help seal in moisture.
- Avoid using on the face unless specifically directed by a healthcare professional, as facial skin can be more sensitive to AHAs.
Alternative Therapies
- Emollients (e.g., petrolatum, mineral oil, dimethicone-based creams)
- Humectants (e.g., glycerin, hyaluronic acid)
- Topical corticosteroids (for inflammatory skin conditions)
- Retinoids (topical or oral, for severe hyperkeratotic conditions)
- Other alpha-hydroxy acids (e.g., glycolic acid)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and specific product/brand per 225gm lotion
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, but may require prior authorization or be subject to tiered co-pays. Some formulations are OTC.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.