Ovace Plus 10% Cream 57gm
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?
Ovace Plus Cream contains sulfacetamide, an antibiotic that helps treat skin conditions like acne, rosacea, and seborrheic dermatitis by stopping the growth of certain bacteria and reducing inflammation. It's applied directly to the skin.
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, 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.
Important Preparation Instructions
Some brands of this medication require shaking before each use. Be sure to check whether your brand needs to be shaken before application.
Storage and Disposal
Store this medication at room temperature, away from heat sources.
Keep the lid tightly closed to maintain the medication's effectiveness.
Do not freeze this medication.
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 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 dose.
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, 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.
Important Preparation Instructions
Some brands of this medication require shaking before each use. Be sure to check whether your brand needs to be shaken before application.
Storage and Disposal
Store this medication at room temperature, away from heat sources.
Keep the lid tightly closed to maintain the medication's effectiveness.
Do not freeze this medication.
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 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 dose.
Lifestyle & Tips
- Cleanse the affected skin area thoroughly before applying the cream.
- Apply a thin film of the cream to the entire affected area, not just individual lesions.
- Wash hands before and after applying the cream.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use on broken or irritated skin.
- Avoid using PABA-containing sunscreens, as they may reduce the effectiveness of sulfacetamide.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to affected areas 1 to 3 times daily.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
acne vulgaris:
Apply to affected areas 1-3 times daily.
seborrheic dermatitis:
Apply to affected areas 1-3 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Consult physician; generally similar to adult dosing for children over 12 years, but use with caution in younger children.
Adolescent:
Apply a thin film to affected areas 1 to 3 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Sulfacetamide is a sulfonamide antibiotic that exerts its antibacterial effect by competitive inhibition of para-aminobenzoic acid (PABA), an essential component for bacterial synthesis of folic acid. This interferes with bacterial growth by inhibiting the synthesis of nucleic acids and proteins. It also has anti-inflammatory properties, which may contribute to its efficacy in conditions like acne and seborrheic dermatitis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<4% of applied dose)
Tmax:
Not clinically relevant for topical application
FoodEffect:
Not applicable
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
High (if systemically absorbed)
CnssPenetration:
Limited/No
Elimination:
HalfLife:
Not clinically relevant for topical application
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Renal (if systemically absorbed)
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical improvement
PeakEffect:
Weeks to months
DurationOfAction:
Maintained with continued application
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention 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
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
+ 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, with one reported death. If you experience any of the following symptoms, tell 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
Like all medications, this drug may cause side effects. Many people experience no side effects or only minor ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, call your doctor or seek medical attention:
* Skin irritation
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, talk to 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 experience any of the following symptoms, seek medical attention 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
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
+ 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, with one reported death. If you experience any of the following symptoms, tell 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
Like all medications, this drug may cause side effects. Many people experience no side effects or only minor ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, call your doctor or seek medical attention:
* Skin irritation
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, talk to 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, redness, burning, or peeling that worsens or does not improve.
- Signs of an allergic reaction: rash, itching, hives, swelling (especially of the face, lips, or tongue), severe dizziness, trouble breathing.
- Yellowing of the skin or eyes (jaundice), unusual tiredness, or dark urine (signs of liver problems, rare with topical 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 allergic reaction you experienced, including any symptoms.
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. They will help you determine if 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 ensure your safety.
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.
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. They will help you determine if 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 ensure your safety.
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, excessive use can worsen your skin condition.
When considering use in children, note that different brands of this medication may be suitable for different age groups. Therefore, 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. It is recommended that you discuss this 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 to 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 a longer duration than prescribed, as this may lead to a second infection. Additionally, excessive use can worsen your skin condition.
When considering use in children, note that different brands of this medication may be suitable for different age groups. Therefore, 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. It is recommended that you discuss this 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 to you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- If accidentally ingested, symptoms could include nausea, vomiting, abdominal pain, dizziness, headache, and in severe cases, blood dyscrasias or kidney damage (similar to systemic sulfonamide overdose).
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately. For topical overdose, wash off excess cream. For accidental ingestion, seek immediate medical attention.
Drug Interactions
Major Interactions
- Silver-containing products (e.g., silver sulfadiazine): May inactivate sulfacetamide.
- PABA-containing sunscreens: May inhibit the antibacterial activity of sulfacetamide.
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To document baseline condition and identify areas for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin irritation (e.g., redness, itching, burning, peeling)
Frequency: Daily, during application
Target: Minimal to no irritation
Action Threshold: Discontinue if severe irritation or hypersensitivity occurs.
Signs of clinical improvement
Frequency: Weekly to monthly
Target: Reduction in lesions, inflammation, or scaling
Action Threshold: Re-evaluate diagnosis or treatment if no improvement after 6-8 weeks.
Symptom Monitoring
- Local irritation (redness, itching, burning, stinging)
- Dryness or peeling of skin
- Rash or hives (signs of hypersensitivity)
- Swelling of face, lips, or tongue (signs of severe allergic reaction)
- Difficulty breathing (signs of severe allergic reaction)
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 are generally avoided in late pregnancy due to theoretical risks of kernicterus in the neonate.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but use with caution.
Second Trimester:
Low risk due to minimal systemic absorption, but use with caution.
Third Trimester:
Avoid use near term due to theoretical risk of kernicterus in the neonate, although systemic absorption is minimal.
Lactation
L3 (Moderately Safe). Minimal systemic absorption makes significant infant exposure unlikely. Use with caution, and 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.
Pediatric Use
Generally considered safe for topical use in children, but specific age recommendations may vary by product. Consult a physician for use in infants and young children. Avoid extensive application to large body surface areas in infants due to potentially higher absorption.
Geriatric Use
No specific dose adjustments are necessary. Use with caution in patients with a history of sulfonamide hypersensitivity.
Clinical Information
Clinical Pearls
- Sulfacetamide topical preparations may cause a yellow discoloration of the skin, hair, or fabric, especially if left on for prolonged periods or if used with certain other topical products (e.g., those containing silver).
- Patients with a history of hypersensitivity to sulfonamides, sulfonylureas, thiazide diuretics, or carbonic anhydrase inhibitors may have cross-sensitivity to sulfacetamide.
- Discontinue use if signs of irritation, hypersensitivity, or systemic adverse reactions occur.
- This product is for external use only. Do not ingest.
Alternative Therapies
- Topical clindamycin
- Topical erythromycin
- Benzoyl peroxide
- Topical retinoids (e.g., tretinoin, adapalene)
- Azelaic acid
- Salicylic acid
Cost & Coverage
Average Cost:
Varies, typically $50-$200 per 57gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.