Avar-E Green 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
Acne and Rosacea Agent
Pharmacologic Class
Keratolytic; Sulfonamide Antibacterial
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 away dead skin cells, which can unclog pores. Sulfacetamide is an antibiotic that helps to stop the growth of bacteria on the skin that can cause acne and worsen rosacea. Together, they work to reduce breakouts, redness, and inflammation.
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 topically, directly 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.
Clean the affected area before application and ensure it is completely dry.
Apply a thin layer of the medication to the affected area and gently rub it in.
Continue using the medication as instructed by your doctor, even if your symptoms improve.
Important Usage Precautions
Unless instructed to do so by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep the container lid tightly closed at all times.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing 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 the information provided. It is essential to use this medication only as directed.
Apply this medication topically, directly 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.
Clean the affected area before application and ensure it is completely dry.
Apply a thin layer of the medication to the affected area and gently rub it in.
Continue using the medication as instructed by your doctor, even if your symptoms improve.
Important Usage Precautions
Unless instructed to do so by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep the container lid tightly closed at all times.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Cleanse skin gently before applying the cream.
- Apply a thin layer to the affected areas, avoiding eyes, mouth, and mucous membranes.
- Wash hands thoroughly after application.
- Avoid using abrasive cleansers, harsh soaps, or other irritating topical products unless directed by your doctor.
- Use a non-comedogenic moisturizer if skin dryness occurs.
- Protect treated areas from sun exposure, as sulfacetamide can increase sun sensitivity. Use sunscreen and wear protective clothing.
- Do not use if you have a known allergy to sulfonamides (sulfa drugs) or sulfur.
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 a thin layer to affected areas 1 to 3 times daily.
rosacea:
Apply a thin layer to affected areas 1 to 3 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution; safety and efficacy not fully established for children under 12 years. Consult physician.
Adolescent:
Apply a thin layer to affected areas 1 to 3 times daily, similar to adult dosing, under physician supervision.
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
Sulfur acts as a keratolytic agent, promoting the shedding of dead skin cells and preventing pore clogging. It also has mild antibacterial and antifungal properties. Sulfacetamide is a sulfonamide antibiotic that inhibits the growth of susceptible bacteria (e.g., Propionibacterium acnes) by interfering with the synthesis of folic acid (a necessary growth factor for bacteria). The combination provides both antibacterial and keratolytic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 4% for sulfacetamide, negligible for sulfur)
Tmax:
Not applicable (topical, minimal systemic absorption)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (primarily local action)
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:
Days to weeks for noticeable improvement
PeakEffect:
Several weeks of consistent use
DurationOfAction:
Maintained with continued use
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately or seek emergency 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
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
+ New or worsening cough
+ 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
- Vomiting
- Yellow skin or eyes
A health problem called lupus has been reported with drugs like this one, resulting in one death. Seek medical attention immediately if you experience:
+ A rash on your cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have concerns or questions, 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.
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 immediately or seek emergency 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
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
+ New or worsening cough
+ 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
- Vomiting
- Yellow skin or eyes
A health problem called lupus has been reported with drugs like this one, resulting in one death. Seek medical attention immediately if you experience:
+ A rash on your cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have concerns or questions, 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.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation, redness, burning, or peeling that does not subside.
- Signs of an allergic reaction such as rash, hives, itching, swelling of the face/lips/tongue, or difficulty breathing (seek immediate medical attention).
- Worsening of skin condition or no improvement after several weeks 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 symptoms you experienced.
If you have a known sulfa allergy.
If you are currently using any medications that contain silver.
If you have been diagnosed with 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 whether it is safe to take this medication in conjunction with your other medications and health issues. 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 symptoms you experienced.
If you have a known sulfa allergy.
If you are currently using any medications that contain silver.
If you have been diagnosed with 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 whether it is safe to take this medication in conjunction with your other medications and health issues. 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 using it on cuts, scrapes, or damaged skin, as this may exacerbate skin irritation. Additionally, using other skin products concurrently with this medication may increase the risk of irritation. Therefore, consult 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 may worsen your skin condition.
Be cautious when handling this drug, as it may stain clothing or fabric. Take necessary precautions to protect your clothing and fabrics from potential staining.
In the event of accidental ingestion, this drug may cause harm. If swallowed, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication to ensure the well-being of both you and your baby.
When applying this drug, avoid using it on cuts, scrapes, or damaged skin, as this may exacerbate skin irritation. Additionally, using other skin products concurrently with this medication may increase the risk of irritation. Therefore, consult 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 may worsen your skin condition.
Be cautious when handling this drug, as it may stain clothing or fabric. Take necessary precautions to protect your clothing and fabrics from potential staining.
In the event of accidental ingestion, this drug may cause harm. If swallowed, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication to ensure the well-being of both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to increased local irritation, redness, and peeling.
What to Do:
If excessive local irritation occurs, discontinue use and wash the area with water. If ingested, contact a poison control center (1-800-222-1222) or seek emergency medical attention, though systemic toxicity from ingestion of a small amount is unlikely.
Drug Interactions
Moderate Interactions
- PABA-containing sunscreens (may inactivate sulfacetamide)
- Silver sulfadiazine (concurrent use with sulfacetamide may increase risk of systemic sulfonamide effects, though unlikely with topical use)
Monitoring
Baseline Monitoring
Skin assessment (type, severity of condition, presence of irritation)
Rationale: To establish baseline for efficacy and adverse effects monitoring.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in lesions, redness)
Frequency: Weekly to monthly
Target: Improvement in skin condition
Action Threshold: Lack of improvement after 6-8 weeks, or worsening of condition, warrants re-evaluation.
Local skin irritation (redness, dryness, peeling, itching, burning)
Frequency: Daily to weekly
Target: Minimal to no irritation
Action Threshold: Moderate to severe irritation, persistent discomfort, or signs of allergic reaction (e.g., rash, swelling) warrants discontinuation and medical evaluation.
Symptom Monitoring
- Excessive dryness or peeling of skin
- Redness or irritation at application site
- Itching or burning sensation
- Unusual odor (sulfur smell)
- Signs of allergic reaction (e.g., hives, swelling, difficulty breathing - rare but serious)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, sulfacetamide is a sulfonamide, and systemic sulfonamides are associated with risks in pregnancy (e.g., kernicterus in neonates if used near term). Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential risk, but minimal systemic absorption limits concern.
Second Trimester:
Potential risk, but minimal systemic absorption limits concern.
Third Trimester:
Avoid use near term due to theoretical risk of kernicterus in the neonate from systemic absorption of sulfacetamide, though unlikely with topical use.
Lactation
L3 (Moderately Safe). Minimal systemic absorption of both sulfur and sulfacetamide is expected, making infant exposure low. However, caution is advised. Avoid applying to areas where the infant may ingest the medication (e.g., breast area). Monitor infant for potential adverse effects (e.g., diarrhea, rash).
Infant Risk:
Low risk of adverse effects due to minimal maternal systemic absorption and transfer into breast milk.
Pediatric Use
Safety and efficacy have not been fully established for children under 12 years of age. Use in this population should be under the direct supervision of a physician, weighing potential benefits against risks.
Geriatric Use
No specific dosage adjustments are typically required. However, older patients may have more fragile or sensitive skin, so monitor closely for irritation or excessive dryness.
Clinical Information
Clinical Pearls
- Patients should be advised that the product may have a characteristic sulfur odor.
- Initial dryness or peeling is common; advise patients to start with once-daily application and gradually increase frequency as tolerated.
- This product may bleach fabrics; advise patients to allow the cream to dry completely before contact with clothing or bedding.
- Emphasize the importance of consistent use for optimal results, which may take several weeks.
- Remind patients to avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical azelaic acid
- Topical dapsone
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Other topical sulfur-only products
Cost & Coverage
Average Cost:
$50 - $200+ per 57gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization for brand-name products)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.