Biafine Emulsion 45gm
It is used to treat or prevent certain skin problems.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Skin Protectant; Wound Healing Agent
Pharmacologic Class
Topical Emollient; Trolamine-based Emulsion
Pregnancy Category
Not available
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Biafine Emulsion is a soothing cream that helps heal and protect irritated or damaged skin, such as from burns, sunburns, or skin reactions from radiation therapy. It works by keeping the skin moist and helping it repair itself.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed by your healthcare provider.
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 to do so before applying it to the affected area.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this 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, avoiding freezing.
Be aware of the medication's expiration date or storage duration. Check the packaging or consult with your pharmacist if you have questions.
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 prescribed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed by your healthcare provider.
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 to do so before applying it to the affected area.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this 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, avoiding freezing.
Be aware of the medication's expiration date or storage duration. Check the packaging or consult with your pharmacist if you have questions.
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 prescribed by your doctor.
Lifestyle & Tips
- Keep the affected skin clean before applying Biafine.
- Avoid harsh soaps or irritants on the treated area.
- Protect treated skin from excessive sun exposure.
- Follow your healthcare provider's instructions for wound care and dressing changes.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply liberally to the affected area 2-4 times daily, or as directed by a healthcare professional.
Condition-Specific Dosing:
First-degree burns:
Apply a thick layer until the skin no longer absorbs the product. Reapply 2-4 times daily.
Second-degree burns and other skin wounds:
After cleansing the wound, apply a thick layer. Reapply to maintain a moist environment. Cover with a sterile dressing if necessary.
Radiation dermatitis:
Apply 2-3 times daily to the irradiated area, including during the course of radiation therapy and for several weeks post-treatment.
Pediatric Dosing
Neonatal:
Not established (consult pediatrician)
Infant:
Apply sparingly as directed by a healthcare professional.
Child:
Apply sparingly as directed by a healthcare professional.
Adolescent:
Apply liberally to the affected area 2-4 times daily, or as directed by a healthcare professional.
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 adjustment needed (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
Biafine Emulsion, with its active ingredient Trolamine (Triethanolamine), is a water-based emulsion designed to promote wound healing and provide symptomatic relief for various skin irritations. It works by maintaining a moist wound environment, which is crucial for optimal cellular activity and tissue repair. Trolamine itself is a mild alkaline substance that may contribute to the emulsion's ability to soothe and protect the skin. The emulsion helps to rehydrate damaged skin, facilitate the removal of necrotic tissue, and promote granulation and re-epithelialization. It forms a protective barrier that helps to reduce pain and inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible 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:
Immediate soothing effect upon application
PeakEffect:
Not applicable for systemic effect; local effects are continuous with application
DurationOfAction:
Varies with application frequency and severity of condition; generally lasts until next application
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Signs of skin infection, including oozing, heat, swelling, redness, or pain
- Abnormal bleeding from the affected area
- Fever
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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Skin irritation
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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Signs of skin infection, including oozing, heat, swelling, redness, or pain
- Abnormal bleeding from the affected area
- Fever
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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Skin irritation
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.
Seek Immediate Medical Attention If You Experience:
- Increased redness, swelling, or pain at the application site
- Pus or foul odor from the wound
- Fever or chills
- Allergic reaction (rash, itching, hives, difficulty breathing)
- No improvement or worsening of the skin condition after several days of use
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.
A skin rash caused by an allergic reaction to a food or drug.
* Any bleeding wounds you may have.
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 existing treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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.
A skin rash caused by an allergic reaction to a food or drug.
* Any bleeding wounds you may have.
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 existing treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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, which can interfere with certain medical procedures such as MRI, cardioversion, or radiation therapy. Before undergoing any procedure, inform your doctor about your use of this medication to determine if any special precautions are necessary.
If this medication is accidentally swallowed, it can cause harm. In such cases, 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.
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, which can interfere with certain medical procedures such as MRI, cardioversion, or radiation therapy. Before undergoing any procedure, inform your doctor about your use of this medication to determine if any special precautions are necessary.
If this medication is accidentally swallowed, it can cause harm. In such cases, 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.
Overdose Information
Overdose Symptoms:
- Not applicable for topical overdose due to minimal systemic absorption. Ingestion of large quantities may cause gastrointestinal upset.
What to Do:
For accidental ingestion, seek medical advice. For topical overuse, simply wipe off excess product. If irritation occurs, discontinue use and consult a healthcare professional.
Drug Interactions
Monitoring
Routine Monitoring
Skin condition (redness, irritation, signs of infection)
Frequency: Daily or with each application
Target: Improvement in symptoms, absence of adverse reactions
Action Threshold: Worsening condition, increased pain, signs of infection (pus, fever, spreading redness) warrant medical evaluation.
Symptom Monitoring
- Pain relief
- Reduction in redness and inflammation
- Healing progression (e.g., re-epithelialization, reduction in wound size)
- Absence of itching or burning at application site
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, use should be under the guidance of a healthcare professional.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Generally considered safe for use during lactation due to minimal systemic absorption. Avoid applying to areas where the infant may ingest the product (e.g., nipples).
Infant Risk:
Low risk
Pediatric Use
Generally considered safe for use in children, but specific dosing and application frequency should be guided by a pediatrician, especially for infants and very young children. Avoid use on large body surface areas or broken skin in infants without medical supervision.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. Use as directed for adults.
Clinical Information
Clinical Pearls
- Biafine is particularly effective for superficial burns (first and second-degree) and for managing skin reactions associated with radiation therapy (radiation dermatitis).
- It is a hydrophilic emulsion, meaning it helps to draw moisture to the skin, which is beneficial for healing.
- Can be used as a soothing agent for sunburns, minor cuts, abrasions, and post-procedure skin irritation (e.g., after laser treatments or chemical peels, if approved by the practitioner).
- Apply a thick layer and allow the skin to absorb it. Do not rub it in completely if treating a burn or wound, as a protective layer is desired.
- Ensure the skin is clean before application to prevent trapping bacteria.
Alternative Therapies
- Silver sulfadiazine (for burns, but different mechanism and indications)
- Topical corticosteroids (for inflammatory skin conditions, but not for wound healing)
- Specific wound care dressings (e.g., hydrocolloids, alginates)
Cost & Coverage
Average Cost:
$20 - $40 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Often OTC; may be covered by some prescription plans for specific indications (e.g., radiation dermatitis) with prior authorization or as a medical necessity.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.