Ammonium Lac 12% Lotion 225gm (otc)

Manufacturer NNODUM CORPORATION Active Ingredient Lactic Acid and Ammonium Hydroxide Lotion(LAK tik AS id & a MOE nee um hye DROKS ide) Pronunciation LAK tik AS id & a MOE nee um hye DROKS ide
It is used to treat dry, scaly skin.It is used to treat itching caused by dry skin.
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Drug Class
Keratolytic, Emollient, Moisturizer
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Pharmacologic Class
Alpha-hydroxy acid (AHA), Humectant
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Pregnancy Category
Not available
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This lotion contains lactic acid, an alpha-hydroxy acid. It works by helping your skin attract and hold moisture, making it feel smoother and less dry. It also gently exfoliates dead skin cells, which can improve rough or scaly skin conditions.
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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 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 that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
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.

Storage and Disposal

To store and dispose of this medication properly:

Keep it at room temperature.
Store all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications. Do not flush them down the toilet or pour them down the drain unless instructed to do so.
If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missed Dose

If you miss a dose, follow these steps:

Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Apply to clean, dry skin.
  • Avoid contact with eyes, lips, and mucous membranes.
  • Do not apply to open wounds, broken, or severely irritated skin.
  • Use sunscreen daily, as lactic acid can increase sun sensitivity.
  • Wash hands after application.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected areas as directed, usually once or twice daily.
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Pediatric Dosing

Neonatal: Not established, consult physician
Infant: Not established, consult physician
Child: Not established, consult physician
Adolescent: Apply to affected areas as directed, usually once or twice daily, consult physician for younger adolescents.
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Dose Adjustments

Renal Impairment:

Mild: Not applicable (minimal systemic absorption)
Moderate: Not applicable (minimal systemic absorption)
Severe: Not applicable (minimal systemic absorption)
Dialysis: Not applicable (minimal systemic absorption)

Hepatic Impairment:

Mild: Not applicable (minimal systemic absorption)
Moderate: Not applicable (minimal systemic absorption)
Severe: Not applicable (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Lactic acid, an alpha-hydroxy acid (AHA), acts as a humectant by attracting and holding water in the stratum corneum, thereby increasing skin hydration. It also functions as a keratolytic agent, promoting the loosening and shedding of dead skin cells from the skin's surface, which helps to smooth rough skin and reduce scaling. Ammonium hydroxide is used to adjust the pH of the lotion to optimize the activity of lactic acid and ensure product stability.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from topical application
Tmax: Not available (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)
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Pharmacodynamics

OnsetOfAction: Days to weeks for noticeable improvement in skin texture and hydration
PeakEffect: Weeks of consistent use
DurationOfAction: Continuous with regular application

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help 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 attention 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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning
  • Intense stinging
  • Excessive redness
  • Persistent itching
  • Swelling
  • Rash
  • Worsening of skin condition
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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.
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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.
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Overdose Information

Overdose Symptoms:

  • Severe local irritation
  • Intense burning sensation
  • Significant redness
  • Excessive peeling or flaking of skin
  • Blistering (rare)

What to Do:

Wash the affected area thoroughly with water. Discontinue use immediately. If irritation persists or is severe, seek medical attention. For accidental ingestion, contact a Poison Control Center (1-800-222-1222) or emergency services.

Drug Interactions

Monitoring

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Symptom Monitoring

  • Skin irritation
  • Redness
  • Burning
  • Stinging
  • Itching
  • Peeling
  • Dryness
  • Improvement in skin texture
  • Improvement in skin hydration

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, it is always advisable to consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Minimal risk due to topical application and low systemic absorption.
Second Trimester: Minimal risk due to topical application and low systemic absorption.
Third Trimester: Minimal risk due to topical application and low systemic absorption.
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Lactation

Likely safe for topical use during lactation due to minimal systemic absorption. Avoid applying to areas where the infant might come into direct contact with or ingest the lotion (e.g., breasts).

Infant Risk: Low risk
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Pediatric Use

Use with caution in young children, as their skin may be more sensitive. Consult a pediatrician before use, especially for infants and toddlers.

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Geriatric Use

Generally safe for use in geriatric patients. No specific dose adjustments are typically needed. May be particularly beneficial for age-related dry skin (xerosis).

Clinical Information

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Clinical Pearls

  • This lotion is commonly used for conditions characterized by dry, rough, or scaly skin, such as xerosis (dry skin), ichthyosis, and keratosis pilaris.
  • Patients may experience mild stinging or burning, especially during the initial applications or on very dry/cracked skin. This usually subsides with continued use.
  • Emphasize the critical importance of daily sunscreen use, as lactic acid can increase the skin's sensitivity to sun exposure.
  • Not intended for use on inflamed, broken, or acutely irritated skin, as it can exacerbate irritation.
  • Consistent, long-term use is often necessary to maintain therapeutic benefits for chronic skin conditions.
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Alternative Therapies

  • Other emollients and moisturizers (e.g., petrolatum, ceramides)
  • Topical corticosteroids (for inflammatory skin conditions)
  • Topical retinoids (for exfoliation and skin turnover)
  • Prescription-strength keratolytics
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Cost & Coverage

Average Cost: $15-$30 per 225gm bottle
Generic Available: Yes
Insurance Coverage: Usually not covered by insurance as it is an OTC product.
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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 taken, the amount, and the time it happened.