Biafine Emulsion 90gm
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
Wound healing agent; Topical protectant
Pharmacologic Class
Topical skin protectant; Emollient; Trolamine
Pregnancy Category
Not available
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Biafine Emulsion is a soothing, protective cream used to help heal and relieve pain from minor burns (like sunburns), skin irritation, and skin reactions from radiation therapy. It works by keeping the skin moist and creating a protective barrier, which helps your skin heal naturally.
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 thoroughly 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 use and dry it well.
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 this medication at room temperature, avoiding freezing.
Be aware of the storage duration for this medication and discard it when expired. Refer to the storage information provided with the medication or consult 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 advised 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 thoroughly 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 use and dry it well.
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 this medication at room temperature, avoiding freezing.
Be aware of the storage duration for this medication and discard it when expired. Refer to the storage information provided with the medication or consult 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 advised by your doctor.
Lifestyle & Tips
- Clean the affected area gently before applying Biafine.
- Apply a thick layer of the emulsion to the affected skin without rubbing it in. Allow it to absorb naturally.
- Do not apply Biafine to bleeding wounds, deep wounds, or infected wounds without specific medical advice.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Wash your hands thoroughly before and after applying the emulsion.
- Protect treated areas from excessive sun exposure, especially if the skin is already sensitive or damaged.
- Do not use if you are allergic to any of the ingredients.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thick layer 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. Repeat 2-4 times daily.
Superficial wounds and abrasions:
Apply a thick layer to cover the wound. Repeat 2-4 times daily.
Radiation dermatitis:
Apply 3 times daily, including immediately after each radiation treatment session.
Pediatric Dosing
Neonatal:
Apply a thin layer to the affected area 2-4 times daily, or as directed. Use with caution on large body surface areas due to potential for increased absorption through immature skin.
Infant:
Apply a thin layer to the affected area 2-4 times daily, or as directed. Use with caution on large body surface areas due to potential for increased absorption through immature skin.
Child:
Apply a thin layer to the affected area 2-4 times daily, or as directed.
Adolescent:
Apply a thick layer to the affected area 2-4 times daily, or as directed.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Biafine Emulsion is a water-based emulsion that provides a moist environment conducive to healing. Its primary active ingredient, Trolamine (Triethanolamine), helps to restore physiological pH, promote fibroblast activity, and facilitate the removal of necrotic tissue. The emulsion forms a protective barrier, reduces transepidermal water loss, and provides a soothing effect, aiding in the management of superficial wounds, burns, and radiation-induced skin reactions. It is thought to promote angiogenesis and collagen synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption.
Tmax:
Not applicable (minimal systemic absorption).
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
No (minimal systemic absorption).
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 and protective effect; therapeutic effects (e.g., wound healing, reduction in inflammation) develop over days to weeks with continued use.
PeakEffect:
Not applicable for acute systemic effect; peak skin healing observed over time with consistent application.
DurationOfAction:
Maintains a moist and protective environment until the next application, typically 8-12 hours.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor 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, 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
+ 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. 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:
* Skin irritation
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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, 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
+ 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. 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:
* Skin irritation
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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 pain, redness, swelling, or warmth at the application site.
- Pus or foul odor coming from the wound.
- Fever or chills.
- Signs of an allergic reaction, such as a widespread rash, hives, severe itching, difficulty breathing, or swelling of the face, lips, tongue, or throat.
- Worsening of the skin condition despite regular 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.
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.
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.
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, it is crucial to inform your doctor about this medication. You may need to remove the product before the procedure to ensure your safety.
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, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision about 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, it is crucial to inform your doctor about this medication. You may need to remove the product before the procedure to ensure your safety.
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, inform your doctor. It is necessary 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:
- Overdose with topical application is not expected due to minimal systemic absorption. Excessive application might lead to skin maceration (softening and breakdown of skin due to prolonged moisture) or local irritation.
What to Do:
Discontinue use of the product. Gently wash off any excess product from the skin. If local irritation persists or worsens, seek medical attention. For accidental ingestion, contact a poison control center (1-800-222-1222) or emergency services, although systemic toxicity from ingestion is highly unlikely given the product's composition.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of skin integrity and wound characteristics (e.g., size, depth, presence of infection, pain level, erythema, blistering).
Rationale: To establish baseline for evaluating treatment efficacy, identifying potential complications, and guiding initial application.
Timing: Prior to initiation of therapy.
Routine Monitoring
Visual inspection of treated area for signs of healing (e.g., re-epithelialization, reduced erythema), infection (e.g., pus, increased pain, warmth, spreading redness), or adverse reactions (e.g., severe irritation, allergic reaction).
Frequency: Daily or with each dressing change/application.
Target: Improvement in skin condition, reduction in pain, absence of infection, progression of wound healing.
Action Threshold: Worsening of condition, signs of infection (pus, fever, spreading redness), severe local irritation, allergic reaction, or lack of expected improvement.
Symptom Monitoring
- Pain relief
- Reduction in redness/inflammation
- Signs of healing (e.g., re-epithelialization, granulation tissue formation)
- Absence of itching or burning
- Signs of allergic reaction (rash, hives, swelling)
- Signs of infection (increased pain, pus, fever, warmth, spreading redness, foul odor)
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, as with any medication, consult a healthcare professional before use.
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 use during lactation due to minimal systemic absorption. Avoid applying the emulsion to areas where the infant may directly ingest the product (e.g., breast area).
Infant Risk:
Low risk.
Pediatric Use
Biafine Emulsion can be used in pediatric patients. However, use with caution on large body surface areas, especially in infants and young children, due to the potential for increased absorption through immature or compromised skin, although systemic effects are still unlikely.
Geriatric Use
No specific dose adjustments or precautions are needed for geriatric patients beyond general skin care considerations for elderly individuals (e.g., thinner, more fragile skin, increased susceptibility to skin tears).
Clinical Information
Clinical Pearls
- Biafine is particularly well-regarded for its efficacy in managing radiation dermatitis, providing significant relief and promoting healing for patients undergoing radiation therapy.
- The product is designed to be applied in a thick layer, not rubbed in, to create an occlusive, moist healing environment. Patients should be instructed not to rub it into the skin.
- While effective for superficial burns and wounds, Biafine should not be used on deep, bleeding, or heavily infected wounds without direct medical supervision.
- Patients should be advised that the emulsion may feel somewhat greasy or leave a visible residue on the skin, which is normal and part of its protective function.
- It can be used as a primary dressing or as a component of a multi-layered dressing system.
Alternative Therapies
- Topical corticosteroids (for inflammatory skin conditions, but not for wound healing)
- Silver sulfadiazine (for burns, but with different indications and side effect profile)
- Other advanced wound care products (e.g., hydrocolloids, alginates, foam dressings, depending on wound type and exudate level)
Cost & Coverage
Average Cost:
Typically $50-$150 per 90gm tube
Insurance Coverage:
Often not covered by standard prescription drug plans unless specifically prescribed for a medical condition (e.g., radiation dermatitis) and prior authorization is obtained. May be covered under medical benefits for wound care or as a medical device in some cases. Patient out-of-pocket cost can be significant.
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 this 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.