Hylatopic Plus Cream 450gm

Manufacturer BAUSCH HEALTH Active Ingredient Emollient Cream, Emulsion, Gel, Lotion, and Ointment(ee MOL ee ents) Pronunciation Hy-la-TOP-ik Plus
It is used to treat or prevent certain skin problems.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Dermatological Agent, Emollient
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Pharmacologic Class
Skin Barrier Repair Agent, Humectant, Lipid Replenisher
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Pregnancy Category
Not applicable (generally considered safe for topical use)
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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?

Hylatopic Plus Cream is a moisturizing cream designed to help hydrate very dry, irritated, or compromised skin. It works by replenishing the skin's natural moisture and protective barrier, making it smoother and more comfortable. It's often used for conditions like eczema, atopic dermatitis, or general severe dryness.
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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.

Application Instructions

Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause burning.
If your medication requires shaking before use, make sure you understand the instructions before applying it.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply the medication to the affected area as instructed by your doctor. You may need to cover the treated area with a bandage or dressing; consult with your doctor for guidance.

Storage and Disposal

Store the medication at room temperature and do not freeze it.
Check the storage information provided with the medication to determine how long you can store it before disposing of it. If you have questions, consult with your pharmacist.

Missed Dose

If you miss a dose, apply it as soon as you remember.
Since this medication is often used as needed, do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Apply to damp skin immediately after bathing or showering to lock in moisture.
  • Use regularly, even when skin appears healthy, to maintain barrier function.
  • Avoid harsh soaps, hot water, and prolonged baths that can strip skin oils.
  • Wear loose, breathable clothing to prevent skin irritation.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply liberally to affected areas as needed or as directed by a healthcare professional.

Condition-Specific Dosing:

dryness: Apply multiple times daily, especially after bathing or hand washing.
eczema: Apply liberally to affected areas, often in conjunction with other prescribed treatments.
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Pediatric Dosing

Neonatal: Apply liberally to affected areas as needed or as directed by a healthcare professional.
Infant: Apply liberally to affected areas as needed or as directed by a healthcare professional.
Child: Apply liberally to affected areas as needed or as directed by a healthcare professional.
Adolescent: Apply liberally to affected areas as needed or as directed by a healthcare professional.
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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

Hylatopic Plus Cream functions as an emollient, humectant, and skin barrier repair agent. It forms an occlusive layer on the skin surface, reducing transepidermal water loss (TEWL) and increasing skin hydration. Ingredients like hyaluronic acid act as humectants, drawing and retaining moisture in the skin. Ceramides and other lipids help replenish the skin's natural lipid barrier, improving its integrity and protective function. This combined action helps to soothe dry, irritated skin and restore its natural protective barrier.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (primarily local action)
Tmax: Not applicable (local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (primarily localized to stratum corneum)
ProteinBinding: Not applicable
CnssPenetration: No

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable
ExcretionRoute: Not applicable
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Immediate (for skin hydration and softening)
PeakEffect: Within minutes to hours (for initial hydration and barrier improvement)
DurationOfAction: Hours (depends on environmental factors and skin condition, requires reapplication)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Abnormal bleeding from the affected area
Fever

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

* Skin irritation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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:

  • Increased redness or irritation after application
  • Swelling
  • Intense itching or burning
  • Development of a new rash
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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 allergic reaction and its symptoms.
If you have a skin rash caused by an allergic reaction to a food or medication.
* If you have a bleeding wound.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change 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.

Before using sunscreen with this drug, consult with your doctor to determine the best approach. Additionally, discuss with your doctor the use of other medications or products on your skin, including soaps, to ensure safe and effective treatment.

Certain brands of this medication may not be suitable for application on open sores, broken skin, or severe burns. Be sure to check with your doctor or pharmacist for specific guidance on using this medication.

Some products containing this drug may include metal components. If you have an upcoming procedure such as an MRI, cardioversion, radiation, or other medical procedure, inform your doctor beforehand, as these products may need to be removed to ensure your safety.

In the event that this medication is swallowed, it can cause harm. If ingestion occurs, immediately contact a doctor or a poison control center for assistance.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision about treatment.
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Overdose Information

Overdose Symptoms:

  • Not applicable for topical use. Accidental ingestion is unlikely to cause systemic toxicity due to minimal absorption.

What to Do:

If ingested, seek medical advice. For topical irritation, discontinue use and wash affected area. If symptoms persist, consult a healthcare professional. For severe reactions or large ingestions, call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (dryness, redness, itching, integrity)

Rationale: To establish baseline severity of skin issues.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Skin hydration and comfort

Frequency: Daily or as needed

Target: Improved hydration, reduced dryness/itching

Action Threshold: If dryness or irritation worsens, reassess treatment plan.

Signs of irritation or allergic reaction

Frequency: Daily

Target: Absence of new redness, swelling, rash

Action Threshold: Discontinue use if irritation or allergic reaction occurs.

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Symptom Monitoring

  • Increased dryness
  • Redness
  • Itching
  • Burning sensation
  • Rash
  • Swelling

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy. Minimal systemic absorption is expected.

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Generally considered safe for topical use during lactation. Minimal systemic absorption is expected. Avoid applying to areas where infants may ingest the product (e.g., nipples) without wiping off first.

Infant Risk: Low risk
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Pediatric Use

Safe and commonly used in pediatric populations, including infants, for dry skin conditions like eczema. Dosing is similar to adults: apply liberally as needed.

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Geriatric Use

Safe and often beneficial for geriatric populations, who frequently experience age-related skin dryness and barrier dysfunction. Dosing is similar to adults: apply liberally as needed.

Clinical Information

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Clinical Pearls

  • Emollients are the cornerstone of therapy for dry skin conditions; consistent and liberal application is crucial.
  • Applying emollients within 3 minutes of bathing helps to trap moisture in the skin.
  • Hylatopic Plus is steroid-free, making it suitable for long-term use and on sensitive areas.
  • Can be used in conjunction with prescription topical medications (e.g., corticosteroids) to enhance their efficacy and reduce their frequency of use.
  • Patients should be advised to use their fingertips to scoop out the cream rather than dipping their whole hand to maintain hygiene, especially for large tubs.
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Alternative Therapies

  • Petroleum jelly (e.g., Vaseline)
  • Mineral oil
  • Other over-the-counter moisturizers
  • Prescription topical corticosteroids (for inflammatory flares, not as a daily emollient)
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Cost & Coverage

Average Cost: Not available (retail product, price varies) per 450gm
Generic Available: Yes
Insurance Coverage: Often Over-The-Counter (OTC), may be covered by some prescription drug plans or Flexible Spending Accounts (FSAs)/Health Savings Accounts (HSAs) with a prescription.
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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, including the amount taken and the time it happened, to ensure you receive the best possible care.