Sodium Sulfacetamide 10% Wash Liq

Manufacturer BIOCOMP Active Ingredient Sulfacetamide Gel and Wash(sul fa SEE ta mide) Pronunciation SUL-fa-SEE-ta-mide
It is used to treat bacterial infections.It is used to control seborrheic dermatitis.It is used to treat dandruff.
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Drug Class
Anti-acne agent; Antibacterial
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Pharmacologic Class
Sulfonamide antibiotic
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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?

Sodium Sulfacetamide 10% Wash is a medicated liquid used on the skin to treat conditions like acne and seborrheic dermatitis. It works by stopping the growth of certain bacteria that can cause these skin problems.
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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 the information provided. It is essential to use this medication as directed, even if your symptoms improve.

Application Instructions

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, do not wash your hand after application.
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 skin and gently rub it in.

Storage and Disposal

Store this medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the lid tightly closed when not in use.

Missed Dose

If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Cleanse skin thoroughly before applying the wash.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on broken or irritated skin.
  • Use a non-comedogenic moisturizer if skin dryness occurs.
  • Avoid using PABA-containing sunscreens, as they may reduce the effectiveness of this medication. Use PABA-free sunscreens.
  • Continue using as directed, even if symptoms improve, to maintain results.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected areas 1-2 times daily, or as directed by physician. Wash thoroughly and rinse.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

acne vulgaris: Apply a thin layer to affected areas after cleansing, usually once or twice daily.
seborrheic dermatitis: Apply to affected areas once or twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Use with caution; generally similar adult dosing for children >12 years. Consult physician for younger children.
Adolescent: Apply to affected areas 1-2 times daily, or as directed by physician. Wash thoroughly and rinse.
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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 is a sulfonamide antibiotic. It exerts its antibacterial effect by competitive antagonism of para-aminobenzoic acid (PABA), an essential component for bacterial synthesis of dihydrofolic acid. Dihydrofolic acid is then converted to tetrahydrofolic acid, which is necessary for the synthesis of purines and thymidylate, and thus for DNA and RNA synthesis. By inhibiting this process, sulfacetamide prevents bacterial growth and reproduction (bacteriostatic action).
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <4% of applied dose)
Tmax: Not applicable for topical wash (systemic Tmax not clinically relevant)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not clinically relevant (minimal systemic absorption)
ProteinBinding: Not clinically relevant (minimal systemic absorption)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not clinically relevant (minimal systemic absorption)
Clearance: Not clinically relevant (minimal systemic absorption)
ExcretionRoute: Primarily local action; any absorbed drug is renally excreted.
Unchanged: Not clinically relevant (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically seen within several weeks (e.g., 2-4 weeks for acne).
PeakEffect: Varies with condition and individual response, often after several weeks of consistent use.
DurationOfAction: Requires continued application for sustained effect.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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
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. If you experience any of the following symptoms, contact your doctor right away:
+ 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 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 attention:

* Skin irritation

Reporting Side Effects

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, itching, or stinging that does not subside
  • Excessive redness or swelling of the treated area
  • Worsening of skin condition
  • Signs of a severe allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/throat) - seek immediate medical attention.
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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 allergic reaction you experienced, including any symptoms that occurred.
A known sulfa allergy, as this may affect your ability to take this medication.
The use of any medications containing silver, as this may interact with this drug.
The presence of kidney disease, as this may impact the safety and effectiveness of this medication.

This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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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.

To avoid staining, take precautions to protect your clothing and fabrics when using this drug, as it may cause discoloration.

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

Do not use this medication for an extended period beyond the recommended duration, as this may lead to a secondary infection. Additionally, excessive use of this drug can worsen your skin condition.

Note that different brands of this medication may be suitable for children of various ages, so it is crucial to consult with your doctor before administering this drug to a child.

Exercise caution when applying this medication to large areas of skin or near open wounds, and discuss any concerns with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive skin irritation
  • Redness
  • Swelling
  • Burning

What to Do:

Discontinue use and wash the area thoroughly with water. If irritation persists, seek medical advice. For accidental ingestion, call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • PABA-containing sunscreens (may inactivate sulfacetamide)
  • Topical preparations containing silver (e.g., silver sulfadiazine, may cause discoloration)

Monitoring

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Routine Monitoring

Skin irritation (redness, itching, burning, scaling)

Frequency: Daily, with each application

Target: Minimal to no irritation

Action Threshold: Discontinue use and consult physician if severe or persistent irritation occurs.

Clinical improvement of acne/seborrhea

Frequency: Weekly to monthly

Target: Reduction in lesions, inflammation, or scaling

Action Threshold: Re-evaluate treatment if no improvement after 4-6 weeks.

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Symptom Monitoring

  • Skin redness
  • Itching
  • Burning sensation
  • Scaling
  • Dryness
  • Swelling
  • Allergic reactions (rash, hives, difficulty breathing - rare but serious)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, sulfonamides can cross the placenta. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Theoretical risk of teratogenicity, though low with topical use.
Second Trimester: Generally considered safer than first or third, but still Category C.
Third Trimester: Avoid use near term due to theoretical risk of kernicterus in neonates (though extremely low with topical application due to minimal absorption).
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Lactation

L3 (Moderately Safe). Minimal systemic absorption makes significant transfer into breast milk unlikely. However, caution is advised. Avoid applying to areas where the infant may ingest the medication.

Infant Risk: Low risk of adverse effects due to minimal systemic absorption. Monitor infant for diarrhea or rash.
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Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been fully established. Use in children should be under the guidance of a physician. Generally well-tolerated in adolescents.

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Geriatric Use

No specific dosage adjustments or precautions are generally required for geriatric patients. Minimal systemic absorption reduces the risk of age-related systemic adverse effects.

Clinical Information

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Clinical Pearls

  • This wash is often used as part of a multi-therapy regimen for acne or seborrheic dermatitis.
  • Patients should be advised that improvement may take several weeks of consistent use.
  • Warn patients about potential for local irritation, especially during the initial phase of treatment.
  • Emphasize the importance of avoiding contact with eyes and mucous membranes.
  • Advise patients to use PABA-free sunscreens to avoid inactivation of the drug.
  • Cross-sensitivity with other sulfonamides (e.g., sulfonylureas, thiazide diuretics, carbonic anhydrase inhibitors) is possible, though rare with topical use due to minimal systemic absorption.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene)
  • Benzoyl peroxide
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Azelaic acid
  • Oral antibiotics (for more severe cases)
  • Oral isotretinoin (for severe, recalcitrant acne)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 per 170g bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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 taken, the amount, and the time it happened.