Ovace Plus 10% Wash Liquid 473ml
It is used to treat bacterial infections.It is used to control seborrheic dermatitis.It is used to treat dandruff.
Drug Class
Anti-acne agent; Antibacterial
Pharmacologic Class
Sulfonamide antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sulfacetamide is an antibiotic medicine applied to the skin, usually as a wash or lotion. It works by stopping the growth of certain bacteria that can cause skin problems like acne. It also helps reduce 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 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 dry it thoroughly.
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 to maintain the medication's effectiveness.
Missed Dose
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 continue with your regular application schedule.
* Do not apply two doses at the same time 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 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 dry it thoroughly.
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 to maintain the medication's effectiveness.
Missed Dose
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 continue with your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Use as directed by your doctor. Do not use more often or for longer than prescribed.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Some people may experience temporary stinging, burning, or dryness when first starting treatment. This usually lessens with continued use.
- Protect treated skin from excessive sun exposure, as sulfonamides can increase sun sensitivity. Use sunscreen and wear protective clothing.
- Do not use on broken or irritated skin.
- If you are also using topical dapsone, be aware that a temporary yellow or orange discoloration of the skin and facial hair may occur.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas 1-2 times daily, or as directed by physician. Wet skin and apply a generous amount to areas to be treated. Work into a lather and rinse thoroughly. Pat dry.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for very young children; consult physician. For older children/adolescents, similar to adult dosing under medical supervision.
Adolescent:
Apply to affected areas 1-2 times daily, or as directed by physician. Wet skin and apply a generous amount to areas to be treated. Work into a lather and rinse thoroughly. Pat dry.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed due to minimal systemic absorption.
Moderate:
No adjustment typically needed due to minimal systemic absorption.
Severe:
No adjustment typically needed due to minimal systemic absorption.
Dialysis:
No specific considerations for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically needed due to minimal systemic absorption.
Moderate:
No adjustment typically needed due to minimal systemic absorption.
Severe:
No adjustment typically needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Sulfacetamide is a sulfonamide antibiotic that exerts its antibacterial effect by inhibiting the growth of bacteria that are susceptible to sulfonamides. It competitively inhibits dihydropteroate synthase, an enzyme involved in the synthesis of folic acid (pteroylglutamic acid) from para-aminobenzoic acid (PABA). Since bacteria require folic acid for growth, this inhibition leads to bacteriostasis. In the context of acne, it helps control the growth of Propionibacterium acnes (now Cutibacterium acnes) and reduces inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <4%) after topical application.
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application.
ProteinBinding:
Not well-defined for topical application; systemically, sulfonamides are highly protein bound.
CnssPenetration:
Limited (not relevant for topical application).
Elimination:
HalfLife:
Not well-defined for topical application; systemically, sulfonamides have varying half-lives.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal (primarily unchanged or as acetylated metabolites) if systemically absorbed, but minimal for topical.
Unchanged:
Not well-defined for topical application.
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin conditions.
PeakEffect:
Several weeks of consistent use.
DurationOfAction:
Requires continuous application for sustained effect.
Confidence:
Medium
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 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
+ 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
- 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 immediately:
+ 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. Many people do not experience any side effects or only have minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, 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.
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 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
+ 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
- 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 immediately:
+ 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. Many people do not experience any side effects or only have minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, 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.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (e.g., blistering, peeling, severe redness, swelling, oozing)
- Signs of a serious allergic reaction (e.g., rash, hives, itching, swelling of the face/tongue/throat, severe dizziness, trouble breathing)
- Unusual or persistent skin discoloration
- No improvement in skin condition 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.
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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and other drugs. 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.
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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and other drugs. 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.
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, frequent or 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. 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 are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you, considering both your health and the baby's well-being.
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, frequent or 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. 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 are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you, considering both your health and the baby's well-being.
Overdose Information
Overdose Symptoms:
- Overdose with topical sulfacetamide is unlikely due to minimal systemic absorption. However, excessive application may lead to increased local irritation.
What to Do:
If accidental ingestion occurs or severe local reaction, seek medical attention. For ingestion, call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Major Interactions
- Topical dapsone (may cause temporary yellow/orange discoloration of skin and facial hair)
Moderate Interactions
- Products containing PABA (para-aminobenzoic acid) or its derivatives (e.g., some sunscreens) may inactivate sulfacetamide.
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., acne severity, presence of lesions, inflammation)
Rationale: To establish baseline for treatment efficacy and identify potential contraindications (e.g., severe irritation).
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, itching, burning, dryness)
Frequency: Daily, with each application.
Target: Minimal to no irritation.
Action Threshold: Persistent or severe irritation warrants discontinuation and medical evaluation.
Therapeutic response (reduction in acne lesions, inflammation)
Frequency: Weekly to monthly.
Target: Gradual improvement in skin condition.
Action Threshold: Lack of improvement after 6-8 weeks may indicate need for alternative therapy.
Symptom Monitoring
- Severe skin irritation (e.g., blistering, peeling, severe redness, swelling)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Unusual skin discoloration (especially if used with dapsone)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, sulfonamides can cross the placenta. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for 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 the newborn (due to displacement of bilirubin from albumin binding sites), although this risk is very low with minimal topical absorption.
Lactation
L3 (Moderately Safe). Sulfonamides are excreted in breast milk. While systemic absorption from topical application is minimal, caution is advised. Monitor the infant for diarrhea, candidiasis, or rash. Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
Low risk of adverse effects due to minimal maternal systemic absorption, but theoretical risk of sulfonamide-related effects in the infant (e.g., jaundice, hemolytic anemia in G6PD deficient infants).
Pediatric Use
Safety and efficacy have not been fully established in children under 12 years of age. Use in adolescents is generally similar to adults. Consult a pediatrician for use in younger children.
Geriatric Use
No specific dosage adjustments are typically 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 for topical use.
Clinical Information
Clinical Pearls
- Sulfacetamide wash is often used for acne vulgaris and rosacea, particularly for its anti-inflammatory and antibacterial properties.
- Patients should be instructed to wet the skin before applying the wash and to work it into a lather before rinsing thoroughly.
- Advise patients to avoid contact with eyes, mouth, and mucous membranes, as it can cause irritation.
- Remind patients that improvement may take several weeks of consistent use.
- Warn patients about potential temporary skin discoloration if used concurrently with topical dapsone.
- Sun protection is important due to potential photosensitivity.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Benzoyl peroxide
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline, erythromycin) for more severe cases
- Isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Average Cost:
Price varies widely by pharmacy and formulation (e.g., $50 - $200+) per 473ml bottle
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3 for brand, Tier 1 for generic formulations.
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.