Avar-E Ls 10-2% Cream 57gm

Manufacturer MISSION Active Ingredient Sulfur and Sulfacetamide Cream(SUL fur & sul fa SEE ta mide) Pronunciation SUL-fur & sul-fa-SEE-ta-mide
It is used to treat pimples (acne).It is used to treat rosacea.It is used to control seborrheic dermatitis.
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Drug Class
Anti-acne agent; Antiseborrheic agent
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Pharmacologic Class
Sulfonamide antibiotic (Sulfacetamide); Keratolytic/Antifungal/Antiparasitic (Sulfur)
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Pregnancy Category
Category C
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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?

This cream contains two active ingredients, sulfur and sulfacetamide, which work together to treat skin conditions like acne, rosacea, and seborrheic dermatitis. Sulfacetamide helps stop the growth of bacteria on the skin, while sulfur helps to dry and peel the skin, reducing oiliness and promoting skin cell turnover.
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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 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 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 dry it completely.
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 instructed by your doctor, even if your symptoms improve.
Avoid covering the treated area with bandages, dressings, or makeup unless specifically advised to do so by your doctor.

Storage and Disposal

Store the medication at room temperature, away from freezing temperatures and heat sources.
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 the missed dose 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 application.
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Lifestyle & Tips

  • Cleanse skin thoroughly before application.
  • Apply a thin layer to affected areas, avoiding eyes, mouth, and mucous membranes.
  • Wash hands thoroughly after application.
  • Avoid excessive sun exposure and use sunscreen, as sulfur can increase sun sensitivity.
  • Avoid using other topical irritants or abrasive cleansers unless directed by your doctor.
  • Be aware that sulfur can have a distinct odor and may stain certain fabrics.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to affected areas 1 to 2 times daily, or as directed by physician.

Condition-Specific Dosing:

acne_vulgaris: Apply to affected areas after cleansing, once or twice daily.
rosacea: Apply to affected areas after cleansing, once or twice daily.
seborrheic_dermatitis: Apply to affected areas after cleansing, once or twice daily.
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Pediatric Dosing

Neonatal: Not established (use with caution due to sulfonamide component)
Infant: Not established (use with caution due to sulfonamide component)
Child: Dosing generally similar to adults for children >12 years; consult physician for younger children.
Adolescent: Apply a thin layer to affected areas 1 to 2 times daily, or as directed by physician.
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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

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Mechanism of Action

Sulfacetamide: A sulfonamide antibiotic that competitively inhibits bacterial dihydropteroate synthase, an enzyme essential for the synthesis of folic acid. This action prevents bacterial growth. Sulfur: Possesses keratolytic, antibacterial, antifungal, and antiparasitic properties. It promotes the shedding of dead skin cells, helps to dry and peel the skin, and has a mild antiseptic effect.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Not applicable (primarily local action)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (primarily local action)
Clearance: Not applicable (primarily local action)
ExcretionRoute: Not applicable (primarily local action)
Unchanged: Not applicable (primarily local action)
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Pharmacodynamics

OnsetOfAction: Days to weeks for noticeable improvement
PeakEffect: Weeks to months of consistent use
DurationOfAction: Dependent on continued application

Safety & Warnings

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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 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
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. If you experience any of the following symptoms, 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 Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning, stinging, or itching that does not subside
  • Excessive redness or swelling
  • Worsening of skin condition
  • Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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 symptoms 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 (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 issues. Never start, stop, or adjust 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.

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. Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.

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.

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 can be harmful. 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, it is crucial to discuss the benefits and risks associated with this medication with your doctor, as this will help determine the best course of action for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
  • Excessive application may lead to severe local irritation, redness, and peeling.

What to Do:

If excessive application occurs, wash the area thoroughly with water. If severe irritation persists, discontinue use and consult a healthcare professional. For accidental ingestion, contact a poison control center (Call 1-800-222-1222 in the US).

Drug Interactions

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Major Interactions

  • Silver-containing preparations (e.g., silver sulfadiazine): May cause discoloration of the skin due to precipitation of silver sulfide when used concomitantly with sulfacetamide.
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Moderate Interactions

  • Other topical acne medications (e.g., retinoids, benzoyl peroxide, salicylic acid): May increase skin irritation, dryness, or peeling if used concurrently. Use with caution and consider alternating application times.

Monitoring

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Baseline Monitoring

Skin assessment (type, severity of condition, presence of irritation)

Rationale: To establish baseline for efficacy and adverse reaction monitoring.

Timing: Prior to initiation of therapy

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Routine Monitoring

Skin irritation (redness, dryness, peeling, itching)

Frequency: Daily, or as symptoms arise

Target: Minimal to no irritation

Action Threshold: If severe or persistent irritation occurs, reduce frequency of application or discontinue use and consult physician.

Efficacy (improvement in acne, rosacea, or seborrheic dermatitis symptoms)

Frequency: Weekly to monthly

Target: Reduction in lesions, inflammation, or scaling

Action Threshold: If no improvement after 6-8 weeks, re-evaluate diagnosis or treatment plan.

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Symptom Monitoring

  • Excessive dryness
  • Peeling
  • Redness
  • Itching
  • Burning sensation
  • Stinging
  • Allergic reactions (rash, hives, swelling)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. Sulfacetamide is Pregnancy Category C due to potential for kernicterus in neonates if absorbed systemically, especially near term. Sulfur is Category B. Systemic absorption from topical use is minimal, but risks should be weighed against benefits.

Trimester-Specific Risks:

First Trimester: Minimal risk from topical use, but generally avoid unnecessary medications.
Second Trimester: Minimal risk from topical use.
Third Trimester: Increased caution, especially near term, due to theoretical risk of kernicterus with sulfonamides if significant systemic absorption occurs.
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Lactation

Use with caution during breastfeeding. Sulfonamides are excreted in breast milk and may pose a risk of kernicterus in jaundiced or G6PD-deficient infants. While systemic absorption from topical use is minimal, consider alternative treatments or avoid application to areas where the infant may ingest the cream.

Infant Risk: Low risk with minimal topical absorption, but theoretical risk for jaundiced or G6PD-deficient infants.
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Pediatric Use

Safety and efficacy in children younger than 12 years have not been fully established. Use in infants and neonates is generally not recommended due to the sulfonamide component and potential for systemic absorption leading to kernicterus.

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Geriatric Use

No specific dosage adjustments are typically required for geriatric patients. Use with caution in patients with sensitive skin, as older adults may have thinner or more fragile skin prone to irritation.

Clinical Information

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Clinical Pearls

  • Patients should be advised that the cream may have a sulfurous odor and can potentially stain clothing or bedding.
  • Instruct patients to avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Sun protection is important as sulfur can increase photosensitivity.
  • Initial irritation (redness, dryness, peeling) is common and often resolves with continued use or by reducing application frequency. If severe, discontinue use.
  • This combination is often effective for inflammatory acne, rosacea, and seborrheic dermatitis due to its antibacterial and anti-inflammatory properties.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene)
  • Topical benzoyl peroxide
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Topical azelaic acid
  • Oral antibiotics (e.g., doxycycline, minocycline)
  • Oral isotretinoin (for severe acne)
  • Other topical antifungals (for seborrheic dermatitis)
  • Metronidazole topical (for rosacea)
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Cost & Coverage

Average Cost: Varies widely (e.g., $50 - $300+) per 57gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (may require prior authorization for brand, generics often covered)
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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.