Ammonium Lac 12% Lotion 400gm (otc)
It is used to treat dry, scaly skin.It is used to treat itching caused by dry skin.
Drug Class
Emollient; Keratolytic
Pharmacologic Class
Alpha-hydroxy acid (AHA)
Pregnancy Category
Category C
FDA Approved
Mar 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ammonium Lactate Lotion is a skin moisturizer and softener. It works by helping your skin hold onto water and by gently removing dead skin cells, making dry, rough, or scaly skin feel 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 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.
Before and after applying the medication, wash your hands thoroughly, unless your hand is the area being treated.
Clean the affected area before applying the medication and dry it well.
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 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 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.
If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs 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 dosing schedule.
Do not apply two doses at the same time or take extra doses.
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.
Before and after applying the medication, wash your hands thoroughly, unless your hand is the area being treated.
Clean the affected area before applying the medication and dry it well.
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 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 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.
If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs 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 dosing schedule.
Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply to clean, dry skin.
- Avoid contact with eyes, lips, and other mucous membranes.
- Avoid applying to open wounds or irritated skin.
- Use sunscreen and protective clothing, as this product may increase sun sensitivity.
- Do not use on children under 2 years of age unless directed by a doctor.
Available Forms & Alternatives
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
Infant:
Not established (use with caution, consult pediatrician)
Child:
Apply to affected areas twice daily (use with caution, may cause stinging)
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
Lactic acid is an alpha-hydroxy acid that acts as a humectant, 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 hyperkeratotic areas. Ammonium hydroxide is used to neutralize lactic acid to form ammonium lactate, which is less irritating than free lactic acid at the same concentration.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption (<5% of applied dose)
Tmax:
Not clinically relevant for topical application
FoodEffect:
Not applicable
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Not clinically relevant for topical application
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant for topical application
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Not clinically relevant for topical application
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin texture and hydration
PeakEffect:
Weeks to months with consistent use
DurationOfAction:
Dependent on continued application
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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. 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 medication was applied
- Burning or stinging sensations
- Itching
Reporting Side Effects
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 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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. 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 medication was applied
- Burning or stinging sensations
- Itching
Reporting Side Effects
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 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 stinging or burning that does not subside
- Excessive redness or irritation
- Swelling
- Blistering
- Signs of allergic reaction (rash, itching, 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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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, it is crucial to discuss the benefits and risks of 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 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, it is crucial to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe local irritation (burning, stinging, redness, peeling)
- If ingested: Nausea, vomiting, abdominal pain, diarrhea (unlikely with topical product)
What to Do:
If severe local irritation occurs, wash the area thoroughly with water and discontinue use. If ingested, seek immediate medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Moderate Interactions
- Other topical exfoliants (e.g., retinoids, salicylic acid, benzoyl peroxide): May increase skin irritation, dryness, or peeling.
Minor Interactions
- Topical corticosteroids: May alter absorption or efficacy if applied concurrently to the same area (separate application times).
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dryness, scaling, or hyperkeratosis.
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: Persistent or severe irritation warrants reduction in frequency or discontinuation.
Improvement in skin hydration and texture
Frequency: Weekly to monthly
Target: Softer, smoother, less scaly skin
Action Threshold: Lack of improvement after several weeks may indicate need for alternative therapy.
Symptom Monitoring
- Stinging
- Burning
- Redness (erythema)
- Peeling
- Dryness
- Itching (pruritus)
- Irritation
Special Patient Groups
Pregnancy
Use with caution. While systemic absorption is minimal, human data are limited. Benefits should outweigh potential risks. Category C.
Trimester-Specific Risks:
First Trimester:
Minimal risk due to low systemic absorption, but caution advised.
Second Trimester:
Minimal risk due to low systemic absorption.
Third Trimester:
Minimal risk due to low systemic absorption.
Lactation
Considered low risk. Minimal systemic absorption makes transfer to breast milk unlikely. L2.
Infant Risk:
Low risk of adverse effects on a nursing infant due to minimal maternal systemic absorption.
Pediatric Use
Generally safe for children over 2 years, but use with caution as their skin may be more sensitive and prone to stinging or irritation. Not recommended for infants under 2 years unless directed by a healthcare professional.
Geriatric Use
Generally safe for elderly patients. No specific dose adjustments are typically needed. May be beneficial for age-related dry skin (xerosis).
Clinical Information
Clinical Pearls
- Patients may experience mild stinging or burning, especially during the first few applications or on very dry/cracked skin. This usually subsides with continued use.
- Advise patients to apply to damp skin after bathing for better absorption and hydration.
- Emphasize the importance of consistent, twice-daily application for optimal results.
- Warn patients about increased sun sensitivity and recommend daily sunscreen use.
- Not for use on the face unless specifically directed by a dermatologist, due to potential for irritation.
Alternative Therapies
- Urea-containing creams/lotions (e.g., Ureacin, Kerasal)
- Salicylic acid-containing products (for keratolytic effect)
- Alpha-hydroxy acid (AHA) creams (e.g., glycolic acid)
- Emollients and moisturizers (e.g., petrolatum, mineral oil, dimethicone, ceramides)
- Topical corticosteroids (for inflammatory skin conditions, not just dryness)
Cost & Coverage
Average Cost:
$15 - $40 per 400gm lotion
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as it is an OTC product, but some plans may cover with a prescription.
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, including the amount taken and the time it happened, to ensure you receive the best possible care.