Ovace Plus 9.8% Lotion 57gm
It is used to treat bacterial infections.It is used to control seborrheic dermatitis.It is used to treat dandruff.
Drug Class
Topical anti-infective, anti-acne agent
Pharmacologic Class
Sulfonamide antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ovace Plus is a lotion containing an antibiotic called sulfacetamide. It's used on the skin to treat conditions like acne, rosacea, and seborrheic dermatitis by helping to control bacteria and reduce inflammation.
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, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash your hand after use.
Clean the affected area before applying the medication and ensure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Some brands of this medication require shaking before use; be sure to check if this applies to your specific brand.
Storage and Disposal
Store this medication at room temperature, avoiding freezing and excessive heat.
Keep the lid 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 the same time or use extra doses to make up for a missed application.
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, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash your hand after use.
Clean the affected area before applying the medication and ensure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Some brands of this medication require shaking before use; be sure to check if this applies to your specific brand.
Storage and Disposal
Store this medication at room temperature, avoiding freezing and excessive heat.
Keep the lid 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 the same time or use extra doses to make up for a missed application.
Lifestyle & Tips
- Cleanse affected skin thoroughly before applying the lotion.
- Apply a thin layer to the affected areas, gently rubbing it in.
- Wash hands immediately after applying the lotion.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Avoid using PABA-containing sunscreens, as they may reduce the effectiveness of sulfacetamide.
- Use sunscreen and protective clothing, as some skin conditions treated by this medication (e.g., rosacea) can be exacerbated by sun exposure.
- Do not use on broken or irritated skin without consulting a healthcare professional.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to affected areas 1-3 times daily, or as directed by physician.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin film to affected areas 1-3 times daily after cleansing.
rosacea:
Apply a thin film to affected areas 1-3 times daily after cleansing.
seborrheic_dermatitis:
Apply a thin film to affected areas 1-3 times daily after cleansing.
Pediatric Dosing
Neonatal:
Not established (use with caution due to potential for systemic absorption and kernicterus risk in neonates)
Infant:
Not established (use with caution due to potential for systemic absorption)
Child:
Apply a thin film to affected areas 1-3 times daily, or as directed by physician. Use with caution.
Adolescent:
Apply a thin film to affected areas 1-3 times daily, or as directed by physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific considerations for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Sulfacetamide is a sulfonamide antibiotic that exerts its antibacterial effect by inhibiting the growth of susceptible bacteria. It competitively inhibits dihydropteroate synthase, an enzyme involved in the synthesis of folic acid (pteroylglutamic acid) from para-aminobenzoic acid (PABA). Folic acid is essential for bacterial growth. This action is bacteriostatic.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <4%) after topical application to intact skin.
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 due to minimal systemic absorption.
ProteinBinding:
Not well-defined for topical application due to minimal systemic absorption.
CnssPenetration:
Limited (not relevant for topical use).
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption.
Clearance:
Not well-defined for topical application due to minimal systemic absorption.
ExcretionRoute:
Primarily renal if systemically absorbed.
Unchanged:
High percentage if systemically absorbed.
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical improvement.
PeakEffect:
Weeks to months for maximal effect.
DurationOfAction:
Maintained with continued application.
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 when taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek immediate 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
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 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. While many people experience no side effects or only minor ones, some may be more bothersome. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
* 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 when taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek immediate 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
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 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. While many people experience no side effects or only minor ones, some may be more bothersome. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
* 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 rash, blistering, or peeling (signs of serious skin reactions like Stevens-Johnson syndrome)
- Swelling of the face, lips, tongue, or throat (signs of severe allergic reaction)
- Difficulty breathing or swallowing
- Persistent or worsening redness, itching, burning, or irritation at the application site
- Unusual bruising or bleeding (rare, but report if occurs)
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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health status. 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health status. 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, 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 have a sulfite allergy, inform your doctor, as some products may contain sulfites.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
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. 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 have a sulfite allergy, inform your doctor, as some products may contain sulfites.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication to ensure the best outcome for 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, burning, stinging).
What to Do:
If excessive application occurs, wash the area with water. In case of accidental ingestion or severe systemic symptoms, seek immediate medical attention or call a poison control center (1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- Hypersensitivity to sulfonamides or any component of the formulation.
Major Interactions
- Silver-containing products (e.g., silver sulfadiazine, silver nitrate): Sulfonamides can react with silver, leading to inactivation of both agents.
Moderate Interactions
- PABA-containing sunscreens: Para-aminobenzoic acid (PABA) can antagonize the antibacterial activity of sulfonamides.
Monitoring
Baseline Monitoring
Skin assessment (type, severity, extent of condition)
Rationale: To establish baseline for efficacy and adverse reaction monitoring.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in lesions, inflammation)
Frequency: Weekly to monthly, or as clinically indicated.
Target: Improvement in skin condition.
Action Threshold: Lack of improvement or worsening may indicate need for alternative therapy.
Local adverse reactions (erythema, irritation, dryness, pruritus, scaling)
Frequency: At each follow-up visit, or as reported by patient.
Target: Minimal to no irritation.
Action Threshold: Significant or persistent irritation may require dose reduction, temporary discontinuation, or discontinuation.
Symptom Monitoring
- Severe skin rash (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Signs of systemic allergic reaction (e.g., swelling of face/lips/tongue, difficulty breathing)
- Unusual bruising or bleeding (rare, but possible with systemic absorption)
- Persistent or worsening skin irritation/redness/dryness
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. Avoid use near term due to theoretical risk of kernicterus in the neonate.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of teratogenicity with systemic sulfonamides, but minimal absorption with topical.
Second Trimester:
Generally considered low risk due to minimal systemic absorption.
Third Trimester:
Avoid use near term (last trimester) due to theoretical risk of kernicterus in the neonate if significant systemic absorption occurs, as sulfonamides can displace bilirubin from albumin binding sites.
Lactation
L3 (Moderately Safe). Sulfonamides are excreted in breast milk. However, systemic absorption from topical application is minimal, making infant exposure low. Use with caution. Avoid applying to areas where the infant may ingest the medication (e.g., breast area).
Infant Risk:
Low risk of adverse effects in breastfed infants due to minimal maternal systemic absorption. Monitor infant for diarrhea, rash, or jaundice.
Pediatric Use
Use with caution, especially in infants and young children, due to the potential for greater systemic absorption through immature or compromised skin barrier, and theoretical risk of kernicterus in neonates. Safety and efficacy in children under 12 years have not been fully established.
Geriatric Use
No specific dosage adjustments are typically required. Use with caution in elderly patients with very fragile or compromised skin, as they may be more susceptible to local irritation.
Clinical Information
Clinical Pearls
- Sulfacetamide topical is often used for inflammatory acne, rosacea, and seborrheic dermatitis, particularly when patients cannot tolerate or respond to other topical agents.
- Patients should be advised that improvement may take several weeks.
- The lotion should be applied to clean, dry skin.
- Advise patients to avoid contact with eyes and mucous membranes, as it can cause irritation.
- Patients with a history of hypersensitivity to sulfonamides, sulfonylureas, thiazide diuretics, or carbonic anhydrase inhibitors may have cross-sensitivity.
- Some formulations may contain sodium sulfacetamide and sulfur, which can have a distinct odor. Ovace Plus is specifically sulfacetamide sodium.
- Discontinue use if severe irritation or signs of systemic reaction occur.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Azelaic acid
- Metronidazole (for rosacea)
- Oral antibiotics (e.g., doxycycline, minocycline for severe cases)
Cost & Coverage
Average Cost:
Varies widely, check current pharmacy pricing per 57gm lotion
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often covered by most plans, especially generic)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.