Ammonium Lac 12% Lotion 400gm
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
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This lotion contains lactic acid, which is a natural moisturizer and exfoliant. It helps to soften and smooth rough, dry, or scaly skin by gently removing dead skin cells and increasing the skin's moisture. It's commonly used for conditions like dry skin, ichthyosis, and keratosis pilaris.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read the information provided carefully. 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 place, 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 way to dispose of your medication. You may also want to explore drug take-back programs in your area.
What to Do If You Miss 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 use extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions and read the information provided carefully. 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 place, 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 way to dispose of your medication. You may also want to explore drug take-back programs in your area.
What to Do If You Miss 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 use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply to clean, dry skin.
- Avoid contact with eyes, lips, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to irritated, broken, or inflamed skin.
- Lactic acid can increase sensitivity to the sun. Use sunscreen and wear protective clothing when outdoors, especially during the initial weeks of treatment.
- Some mild stinging or burning may occur, especially during the first few applications. This usually subsides with continued use. If severe or persistent, discontinue use and consult a doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily or as directed by a physician.
Condition-Specific Dosing:
dry skin:
Apply to affected areas twice daily.
ichthyosis:
Apply to affected areas twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution and physician consultation)
Child:
Not established (use with caution and physician consultation)
Adolescent:
Apply to affected areas twice daily or as directed by a physician.
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
Lactic acid is an alpha-hydroxy acid that acts as a humectant, attracting and retaining moisture in the skin. It also has keratolytic properties, promoting the desquamation (shedding) of hyperkeratotic stratum corneum cells, thereby softening and smoothing rough, dry skin. Ammonium hydroxide is used to adjust the pH of the lotion to optimize the activity of lactic acid and enhance its stability.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (minimal systemic absorption)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable
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:
Gradual (days to weeks for noticeable improvement)
PeakEffect:
Weeks of consistent use
DurationOfAction:
Continues with regular 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 reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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
Note: 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 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 reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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
Note: 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 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
- Development of a rash or hives
- Swelling of the face, lips, or tongue (signs of allergic reaction)
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 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 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 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:
- Severe skin irritation
- Redness
- Peeling
- Burning sensation
What to Do:
Topical overdose is unlikely to cause systemic effects. If excessive irritation occurs, wash the area thoroughly with water and discontinue use. If ingested, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (dryness, scaling, roughness)
Rationale: To assess the severity of the condition and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, stinging, burning, peeling)
Frequency: Daily, especially during initial use
Target: Minimal to no irritation
Action Threshold: Discontinue use if severe irritation occurs; reduce frequency if mild irritation persists.
Improvement in skin texture and hydration
Frequency: Weekly to monthly
Target: Softer, smoother, less dry skin
Action Threshold: Re-evaluate treatment if no improvement after several weeks of consistent use.
Symptom Monitoring
- Excessive redness
- Persistent stinging or burning
- Severe itching
- Increased peeling or flaking
- Development of rash or allergic reaction
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, use only if clearly needed and after consulting with a healthcare provider.
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
Generally considered safe for topical use during lactation due to minimal systemic absorption. Avoid applying to areas where the infant may ingest the lotion (e.g., breast area).
Infant Risk:
Low risk
Pediatric Use
Use with caution in young children, especially infants, as their skin may be more sensitive and prone to irritation. Not recommended for infants unless specifically directed by a physician. For older children and adolescents, use as directed by a physician.
Geriatric Use
Generally safe for use in geriatric patients. No specific dose adjustments are typically required. Monitor for skin sensitivity or irritation, which may be more pronounced in older skin.
Clinical Information
Clinical Pearls
- Initial stinging or burning is common and usually resolves with continued use.
- Emphasize the importance of consistent use for optimal results.
- Advise patients to use sunscreen daily due to increased sun sensitivity.
- Not for use on open wounds, broken, or acutely inflamed skin.
- Can be very effective for conditions like keratosis pilaris and severe dry, scaly skin.
Alternative Therapies
- Emollients (e.g., petroleum jelly, mineral oil-based creams)
- Humectants (e.g., glycerin, hyaluronic acid-based products)
- Topical corticosteroids (for inflammatory skin conditions, not for simple dryness)
- Retinoids (topical, for certain skin conditions)
Cost & Coverage
Average Cost:
Price range varies (typically $15-$30) per 400gm bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often OTC, may not be covered by prescription 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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 information about the medication taken, the amount, and the time it happened.