Ovace 10% Wash Liquid 180ml

Manufacturer MISSION 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.
đŸˇī¸
Drug Class
Anti-acne agent, Topical antibiotic
đŸ§Ŧ
Pharmacologic Class
Sulfonamide antibiotic
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Ovace 10% Wash Liquid is a topical medication containing sulfacetamide, an antibiotic that helps treat skin conditions like acne by stopping the growth of certain bacteria on the skin. It comes as a wash that you apply to your skin.
📋

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.
Wash your hands 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 applying the medication and make sure it is 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 Instructions

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 resume your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
💡

Lifestyle & Tips

  • Cleanse skin gently before applying the wash.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Avoid using PABA-containing sunscreens, as they can make this medication less effective. Use PABA-free sunscreens.
  • Protect treated areas from sunlight and artificial UV light (tanning beds) as sulfacetamide can increase sun sensitivity. Use protective clothing and sunscreen.
  • Do not use on broken, irritated, or severely inflamed skin.
  • Be patient; it may take several weeks to see significant improvement in your skin condition.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

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

Condition-Specific Dosing:

Acne Vulgaris: Apply a thin layer to affected areas, lather gently, and rinse thoroughly after 10-20 seconds. Use 1-2 times daily.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (contraindicated in infants < 2 months due to risk of kernicterus)
Infant: Not established (contraindicated in infants < 2 months)
Child: Not established (use with caution in children due to potential for increased systemic absorption)
Adolescent: Apply to affected areas 1-2 times daily, or as directed by physician. Lather and rinse thoroughly.
âš•ī¸

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

đŸ”Ŧ

Mechanism of Action

Sulfacetamide is a sulfonamide antibiotic. It exerts its antibacterial effect by competing with para-aminobenzoic acid (PABA), an essential component for bacterial synthesis of folic acid. This inhibition of folic acid synthesis prevents bacterial growth and proliferation. It is active against a wide range of gram-positive and gram-negative bacteria, including Propionibacterium acnes (now Cutibacterium acnes), which is implicated in acne vulgaris.
📊

Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically < 4%) through intact skin. Absorption may be increased with extensive application, prolonged contact, or compromised skin barrier.
Tmax: Not applicable (for systemic absorption, variable and low)
FoodEffect: Not applicable (topical administration)

Distribution:

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

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Primarily local elimination; any systemically absorbed drug is excreted renally.
Unchanged: Not applicable (minimal systemic absorption)
âąī¸

Pharmacodynamics

OnsetOfAction: Antibacterial effect begins rapidly, but clinical improvement for acne may take several weeks (e.g., 8-12 weeks).
PeakEffect: Clinical peak effect for acne typically seen after several weeks of consistent use.
DurationOfAction: Duration of effect is dependent on continued application.
Confidence: Medium

Safety & Warnings

âš ī¸

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
+ Difficulty 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 symptoms, 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 extremely tired or weak
+ 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

Like all medications, this drug may cause side effects. While many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

* Skin irritation

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 (e.g., excessive redness, burning, itching, peeling, swelling)
  • Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • Unusual skin discoloration (e.g., yellowing of skin or hair, though rare)
  • 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, including any symptoms that occurred.
A known sulfa allergy, as this may affect your ability to take this medication.
Current use of medications containing silver, as this may interact with this drug.
Presence of kidney disease, as this may impact the safety and effectiveness of this medication.

Additionally, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, to your doctor and pharmacist. This comprehensive list will help identify potential interactions between this medication and other substances you are taking.

Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
âš ī¸

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 a longer duration than prescribed, as this may lead to a second infection. Additionally, using this drug too frequently can worsen your skin condition.

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

When applying this medication to a large area of skin or near open wounds, exercise caution and discuss any concerns with your doctor.

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

Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive local irritation may occur.

What to Do:

Discontinue use and wash affected area thoroughly. For accidental ingestion or severe local reaction, call a poison control center (1-800-222-1222) or seek immediate medical attention.

Drug Interactions

🟡

Moderate Interactions

  • PABA-containing sunscreens (may inactivate sulfacetamide)
âš ī¸

Confidence Interactions

Monitoring

đŸ”Ŧ

Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of acne or other skin conditions and identify any pre-existing irritation or hypersensitivity.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Skin irritation (e.g., redness, dryness, peeling, itching)

Frequency: Daily, during initial weeks of therapy and as needed thereafter

Target: Minimal to no irritation

Action Threshold: Persistent or severe irritation; discontinue use and consult physician.

Clinical response (improvement in acne lesions)

Frequency: Monthly, or as clinically indicated

Target: Reduction in number and severity of lesions

Action Threshold: No improvement after 8-12 weeks, or worsening of condition.

đŸ‘ī¸

Symptom Monitoring

  • Skin irritation (redness, itching, burning, stinging, dryness, peeling)
  • Allergic reactions (rash, hives, swelling, difficulty breathing - rare but serious)
  • Photosensitivity (increased sensitivity to sunlight)
  • Discoloration of skin or hair (rare, usually temporary)

Special Patient Groups

🤰

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.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though low with topical use.
Second Trimester: Generally considered safer than first or third trimester, but still Category C.
Third Trimester: Avoid use near term (last trimester) due to theoretical risk of kernicterus in the newborn, especially if applied to large areas or broken skin.
🤱

Lactation

L3 (Moderately safe). Caution is advised. While systemic absorption is minimal, sulfonamides are excreted in breast milk. Risk of kernicterus in jaundiced, premature, or G6PD-deficient infants. Use with caution and monitor infant for adverse effects.

Infant Risk: Low risk for healthy, full-term infants with limited topical application. Higher risk for jaundiced, premature, or G6PD-deficient infants due to theoretical risk of kernicterus.
đŸ‘ļ

Pediatric Use

Contraindicated in infants less than 2 months of age due to the risk of kernicterus. Use with caution in older children due to potential for increased systemic absorption compared to adults, especially if applied to large surface areas or broken skin.

👴

Geriatric Use

No specific dosage adjustments or precautions are generally required for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are unlikely to significantly impact safety or efficacy.

Clinical Information

💎

Clinical Pearls

  • Instruct patients to lather the wash gently and rinse thoroughly to minimize irritation.
  • Emphasize the importance of consistent use for several weeks to see optimal results for acne.
  • Advise patients to avoid contact with eyes and mucous membranes, as it can cause irritation.
  • Remind patients about sun sensitivity and the need for sun protection (PABA-free sunscreen, protective clothing).
  • Patients with a history of hypersensitivity to sulfonamides or furosemide, thiazide diuretics, sulfonylureas, or carbonic anhydrase inhibitors should use with caution due to potential cross-reactivity.
  • Discoloration of skin or hair (e.g., yellowing) is a rare but possible side effect, usually temporary and reversible upon discontinuation.
🔄

Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene)
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Benzoyl peroxide
  • Azelaic acid
  • Salicylic acid
  • Oral antibiotics (for severe acne, e.g., doxycycline, minocycline)
  • Oral isotretinoin (for severe, recalcitrant acne)
💰

Cost & Coverage

Average Cost: Varies widely, typically $50 - $200+ per 180ml bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (for brand); Tier 1 (for generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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's a good idea 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 for clarification. 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.