Avar-E Emollient 10-5% Cream 57gm
It is used to treat pimples (acne).It is used to treat rosacea.It is used to control seborrheic dermatitis.
Drug Class
Anti-acne agent; Antiseborrheic agent
Pharmacologic Class
Keratolytic; Sulfonamide antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream contains two active ingredients: sulfur and sulfacetamide. Sulfur helps to dry out and peel the skin, which can clear up blemishes and reduce oiliness. Sulfacetamide is an antibiotic that helps to stop the growth of bacteria on the skin that can cause acne and other skin conditions. Together, they work to treat conditions like acne, rosacea, and seborrheic dermatitis.
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 as directed to ensure safe and effective treatment.
Application Instructions
Apply this medication only to the affected area of your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause irritation or burning.
If the medication accidentally comes into contact with your lips or eyelids, rinse the area with water immediately.
Before and after applying the medication, wash your hands thoroughly to prevent the spread of infection.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected area and gently rub it in.
Continued Use and Precautions
Continue using the medication as directed, even if your symptoms improve.
Avoid covering the treated area with bandages, dressings, or makeup unless your doctor instructs you to do so.
Storage and Disposal
Store the medication at room temperature, away from heat sources and freezing temperatures.
Keep the container tightly closed to maintain the medication's potency.
Missed Dose Instructions
If you miss a dose, apply it 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 application schedule.
Do not apply two doses at once or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed to ensure safe and effective treatment.
Application Instructions
Apply this medication only to the affected area of your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause irritation or burning.
If the medication accidentally comes into contact with your lips or eyelids, rinse the area with water immediately.
Before and after applying the medication, wash your hands thoroughly to prevent the spread of infection.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected area and gently rub it in.
Continued Use and Precautions
Continue using the medication as directed, even if your symptoms improve.
Avoid covering the treated area with bandages, dressings, or makeup unless your doctor instructs you to do so.
Storage and Disposal
Store the medication at room temperature, away from heat sources and freezing temperatures.
Keep the container tightly closed to maintain the medication's potency.
Missed Dose Instructions
If you miss a dose, apply it 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 application schedule.
Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the cream.
- Apply a thin layer to clean, dry affected areas. Do not apply to broken or irritated skin.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- This medication may cause increased sensitivity to sunlight. Use sunscreen (non-PABA containing) and wear protective clothing when outdoors.
- Sulfur can have a distinct odor and may stain certain fabrics (e.g., silver jewelry, light-colored clothing).
- Do not use occlusive dressings or bandages over the treated area unless directed by your doctor.
- Be patient; it may take several weeks to see significant improvement.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas 1 to 3 times daily, or as directed by physician.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
Acne Vulgaris:
Apply to affected areas 1-3 times daily.
Rosacea:
Apply to affected areas 1-3 times daily.
Seborrheic Dermatitis:
Apply to affected areas 1-3 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children under 12 years due to lack of studies, unless specifically directed by a physician)
Adolescent:
Apply a thin layer to affected areas 1 to 3 times daily, or as directed by physician.
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
Sulfacetamide is a sulfonamide antibiotic that inhibits bacterial growth by interfering with the synthesis of folic acid (para-aminobenzoic acid antagonism), which is essential for bacterial growth. It is active against *Cutibacterium acnes* (formerly *Propionibacterium acnes*). Sulfur acts as a keratolytic agent, promoting the shedding of dead skin cells and helping to unclog pores. It also has mild antiseptic, antifungal, and antiparasitic properties, and helps to dry and peel the skin.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 4% for sulfacetamide, negligible for sulfur) when applied topically.
Tmax:
Not applicable for topical local action; systemic Tmax not well-defined due to minimal 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 for topical local action; systemic half-life not well-defined due to minimal absorption.
Clearance:
Not applicable for topical local action; systemic clearance not well-defined due to minimal absorption.
ExcretionRoute:
If systemically absorbed, sulfacetamide is primarily excreted renally. Sulfur is not significantly excreted systemically.
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin conditions.
PeakEffect:
Weeks to months for maximal therapeutic effect.
DurationOfAction:
Dependent on continued application.
Safety & Warnings
Side Effects
Serious 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 signs or 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
Skin irritation
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
+ If you experience any of the following, call your doctor right away:
- Rash
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes
- Fever, chills, or sore throat
- Cough that is new or worse
- Feeling very tired or weak
- Any bruising or bleeding
- Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Throwing up
- Yellow skin or eyes
A health problem called lupus has been reported with drugs like this one, resulting in one death. If you experience any of the following signs of lupus, contact your doctor right away:
+ Rash on your cheeks or other body parts
+ Sunburn easy
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Other Side Effects
Most people do not experience serious side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects or any other unusual effects, contact your doctor or seek medical help:
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns 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 signs or 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
Skin irritation
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
+ If you experience any of the following, call your doctor right away:
- Rash
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes
- Fever, chills, or sore throat
- Cough that is new or worse
- Feeling very tired or weak
- Any bruising or bleeding
- Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Throwing up
- Yellow skin or eyes
A health problem called lupus has been reported with drugs like this one, resulting in one death. If you experience any of the following signs of lupus, contact your doctor right away:
+ Rash on your cheeks or other body parts
+ Sunburn easy
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Other Side Effects
Most people do not experience serious side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects or any other unusual effects, contact your doctor or seek medical help:
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns 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:
- Severe burning, stinging, or itching that does not subside
- Excessive redness, swelling, or peeling of the skin
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Worsening of skin condition
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 you experienced.
A known sulfa allergy.
Current use of medications containing silver.
Presence of kidney disease.
This list is not exhaustive, and it is crucial to discuss all your medications (including 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 status. Never start, stop, or adjust 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 you experienced.
A known sulfa allergy.
Current use of medications containing silver.
Presence of kidney disease.
This list is not exhaustive, and it is crucial to discuss all your medications (including 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 status. Never start, stop, or adjust 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.
When applying this drug, avoid putting it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, using other skin products concurrently with this medication may increase the risk of irritation. Therefore, it is crucial to consult with your doctor before using any other drugs or products on your skin, including soaps.
Adhere to your doctor's instructions regarding the duration of use, as using this drug for an extended period beyond the recommended timeframe can worsen your skin condition.
To prevent staining, take precautions to protect your clothing and fabrics, as this drug may cause discoloration.
In the event of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center, as this drug can be harmful if swallowed.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
When applying this drug, avoid putting it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, using other skin products concurrently with this medication may increase the risk of irritation. Therefore, it is crucial to consult with your doctor before using any other drugs or products on your skin, including soaps.
Adhere to your doctor's instructions regarding the duration of use, as using this drug for an extended period beyond the recommended timeframe can worsen your skin condition.
To prevent staining, take precautions to protect your clothing and fabrics, as this drug may cause discoloration.
In the event of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center, as this drug can be harmful if swallowed.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive local irritation (severe redness, peeling, burning) may occur.
What to Do:
Discontinue use and wash the area thoroughly with water. For severe local reactions, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or emergency services immediately.
Drug Interactions
Moderate Interactions
- Silver-containing products (e.g., silver sulfadiazine): Sulfacetamide can react with silver, potentially causing discoloration or inactivation.
- Para-aminobenzoic acid (PABA) containing sunscreens: PABA can antagonize the antibacterial action of sulfacetamide.
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., lesion count, inflammation)
Rationale: To establish baseline severity and track treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin irritation (redness, dryness, peeling, itching)
Frequency: Daily, during initial treatment phase, then as needed.
Target: Minimal to no irritation.
Action Threshold: Moderate to severe irritation; discontinue use and consult physician.
Efficacy (improvement in acne, rosacea, or seborrheic dermatitis)
Frequency: Weekly to monthly.
Target: Reduction in lesion count, inflammation, or scaling.
Action Threshold: No improvement after 6-8 weeks, or worsening of condition; re-evaluate treatment.
Symptom Monitoring
- Excessive dryness or peeling
- Severe redness or burning
- Itching or stinging
- Swelling
- Allergic reactions (e.g., rash, hives, difficulty breathing, facial swelling)
- Yellowing or discoloration of skin/hair (rare, due to sulfur)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with topical use, reducing systemic exposure.
Trimester-Specific Risks:
First Trimester:
Risk cannot be ruled out. Minimal systemic absorption is expected.
Second Trimester:
Risk cannot be ruled out. Minimal systemic absorption is expected.
Third Trimester:
Risk cannot be ruled out. Minimal systemic absorption is expected. Sulfonamides, if absorbed systemically, may cause kernicterus in neonates if used near term, but this risk is extremely low with topical application.
Lactation
L3 (Moderately Safe). Minimal systemic absorption is expected, making infant exposure unlikely. Caution is advised to avoid direct contact of the infant with treated skin areas.
Infant Risk:
Low risk of adverse effects to the infant due to minimal maternal systemic absorption and subsequent excretion into breast milk. Avoid applying to areas where the infant may ingest the product.
Pediatric Use
Safety and efficacy have not been established in children under 12 years of age. Use in adolescents is common and generally considered safe under medical supervision.
Geriatric Use
No specific dosage adjustments are typically required. Elderly patients may have more sensitive skin and may be more prone to irritation; monitor closely.
Clinical Information
Clinical Pearls
- This combination product is effective for inflammatory acne, rosacea, and seborrheic dermatitis due to its antibacterial and keratolytic properties.
- Patients should be advised about the characteristic sulfur odor, which can be noticeable.
- Warn patients about potential staining of jewelry (especially silver) and light-colored fabrics.
- Emphasize the importance of sun protection due to potential photosensitivity with sulfacetamide.
- For best results, apply to clean, dry skin. Avoid excessive application, as it does not increase efficacy but may increase irritation.
- If irritation occurs, advise patients to reduce frequency of application or temporarily discontinue use and consult their physician.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin, dapsone)
- Benzoyl peroxide
- Salicylic acid
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline, erythromycin) for more severe cases
- Isotretinoin (for severe, recalcitrant acne)
- Metronidazole (for rosacea)
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $200+ per 57gm cream
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to 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 detailed information about the medication taken, the amount, and the time it occurred.