Ovace Plus 10% Shampoo 237ml
It is used to control seborrheic dermatitis.It is used to treat dandruff.
Drug Class
Dermatological agent, Anti-infective
Pharmacologic Class
Sulfonamide antibiotic
Pregnancy Category
Category C (for systemic sulfonamides, but topical absorption is minimal)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sulfacetamide shampoo is a medicine used on the skin or scalp to treat conditions like seborrheic dermatitis (a flaky, itchy rash) and acne. It works by stopping the growth of certain bacteria and reducing 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
Do not take this medication by mouth. It is for use on your scalp and hair only.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause burning.
Before applying, shake the medication well.
Wash your hands before and after use.
Apply the medication to wet hair and scalp, gently working it in.
Rinse your hair and scalp thoroughly after application.
Storage and Disposal
Store the 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 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 the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Do not take this medication by mouth. It is for use on your scalp and hair only.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause burning.
Before applying, shake the medication well.
Wash your hands before and after use.
Apply the medication to wet hair and scalp, gently working it in.
Rinse your hair and scalp thoroughly after application.
Storage and Disposal
Store the 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 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
- Use exactly 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.
- For external use only. Do not swallow.
- Wash hands thoroughly after applying the shampoo.
- Some people may experience temporary stinging or burning when first applying. This usually subsides.
- Protect treated areas from sunlight or artificial UV light if photosensitivity occurs, although this is rare with topical sulfacetamide.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area (e.g., scalp, face, trunk) once or twice daily. Lather well, leave on for 5-10 minutes, then rinse thoroughly. Frequency may be reduced as condition improves.
Condition-Specific Dosing:
seborrheicDermatitis:
Apply to affected areas of the scalp or skin, lather, leave on for 5-10 minutes, then rinse. Use once daily initially, then reduce to 2-3 times per week as directed by physician.
acneVulgaris:
Apply to affected skin areas, lather, leave on for 5-10 minutes, then rinse. Use once or twice daily.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult pediatrician)
Infant:
Not established (use with caution, consult pediatrician)
Child:
Dosing similar to adults for children >12 years; for younger children, use with caution and under medical supervision. Apply to affected area, lather, leave on for 5-10 minutes, then rinse thoroughly.
Adolescent:
Dosing similar to adults. Apply to affected area, lather, leave on for 5-10 minutes, then rinse thoroughly.
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
Mechanism of Action
Sulfacetamide is a sulfonamide antibiotic that exerts its antibacterial effect by inhibiting the synthesis of dihydrofolic acid, an essential precursor in the folic acid pathway of susceptible bacteria. This competitive inhibition of para-aminobenzoic acid (PABA) prevents bacterial growth and replication. It also has keratolytic and antifungal properties, which contribute to its efficacy in conditions like seborrheic dermatitis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<10%)
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Primarily local action, minimal systemic excretion
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical improvement
PeakEffect:
Weeks of consistent use
DurationOfAction:
Dependent on continued application and underlying condition
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, 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 experience no side effects or only minor ones, it's 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 or seek medical help:
* Skin irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, 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 experience no side effects or only minor ones, it's 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 or seek medical help:
* Skin irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 burning, stinging, or irritation that does not go away
- New or worsening rash, hives, or itching
- Swelling of the face, lips, or tongue (signs of allergic reaction)
- Difficulty breathing
- Signs of systemic absorption (very rare): fever, sore throat, unusual bleeding or bruising, yellowing of skin/eyes.
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 safely.
The use of any medications containing silver, as this may interact with this drug.
The presence of kidney disease, as this may impact the safe use 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 conjunction with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 safely.
The use of any medications containing silver, as this may interact with this drug.
The presence of kidney disease, as this may impact the safe use 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 conjunction with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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.
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 are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You will need to have a discussion about the potential benefits and risks of using this medication 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 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.
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 are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You will need to have a discussion about the potential benefits and risks of using this medication to 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, peeling).
- If ingested: Nausea, vomiting, abdominal pain, dizziness, headache. In large amounts, systemic sulfonamide toxicity could occur (e.g., crystalluria, blood dyscrasias), but this is highly unlikely with a shampoo formulation.
What to Do:
For topical irritation, discontinue use and rinse thoroughly. For accidental ingestion, seek immediate medical attention. Call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Contraindicated Interactions
- Patients with known hypersensitivity to sulfonamides or any component of the formulation.
- Patients with kidney disease (rare, due to minimal systemic absorption, but caution advised for severe cases if any systemic absorption is a concern).
Major Interactions
- Silver-containing products (e.g., silver sulfadiazine): Concurrent use with topical sulfacetamide may lead to inactivation of sulfacetamide or formation of insoluble precipitates.
Moderate Interactions
- Topical PABA-containing sunscreens: May interfere with the antibacterial action of sulfacetamide if applied simultaneously to the same area.
Monitoring
Baseline Monitoring
Skin/Scalp condition assessment
Rationale: To establish baseline severity of seborrheic dermatitis, acne, or other treated conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in scaling, redness, lesions)
Frequency: Weekly to bi-weekly during initial treatment phase
Target: Visible improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms after 2-4 weeks may indicate need for alternative therapy or re-evaluation.
Local skin irritation (redness, itching, burning, dryness)
Frequency: Daily during initial treatment, then as needed
Target: Minimal to no irritation
Action Threshold: Persistent or severe irritation may require reduction in frequency, temporary discontinuation, or change in therapy.
Symptom Monitoring
- Redness
- Itching
- Burning sensation
- Dryness
- Peeling
- Worsening of lesions
- Signs of allergic reaction (rash, hives, swelling)
Special Patient Groups
Pregnancy
Category C. While systemic sulfonamides are Category C (and D near term), topical absorption of sulfacetamide is minimal. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption suggests low risk, but caution advised.
Second Trimester:
Minimal systemic absorption suggests low risk, but caution advised.
Third Trimester:
Avoid near term if significant systemic absorption is a concern due to theoretical risk of kernicterus in neonates (extremely unlikely with topical use).
Lactation
L3. Minimal systemic absorption is expected, making transfer into breast milk unlikely to be clinically significant. However, caution is advised. Avoid applying to areas where the infant may ingest the product (e.g., breast). Consult with a healthcare provider.
Infant Risk:
Low (due to minimal maternal systemic absorption)
Pediatric Use
Generally considered safe for topical use in children, but specific age recommendations vary by product. Use with caution in infants and young children, and under medical supervision. Avoid use in neonates due to theoretical risk of kernicterus (extremely unlikely with topical use).
Geriatric Use
No specific dose adjustments or precautions are generally required for geriatric patients. Use with caution in patients with very sensitive or fragile skin, as they may be more prone to irritation.
Clinical Information
Clinical Pearls
- Sulfacetamide shampoo is often used as a maintenance therapy after initial control of seborrheic dermatitis or acne.
- Patients should be instructed to leave the shampoo on the affected area for the recommended duration (typically 5-10 minutes) to allow for adequate contact time and efficacy.
- Rinse thoroughly after use to prevent residue buildup, which can cause dryness or irritation.
- Advise patients that improvement may not be immediate and consistent use is key for best results.
- Rarely, systemic absorption can occur, leading to sulfonamide-related adverse effects, especially in patients with extensive skin breakdown or prolonged use over large surface areas. Monitor for signs of systemic toxicity (e.g., fever, rash, blood dyscrasias).
- Patients with a history of hypersensitivity to sulfonamides, sulfonylureas, thiazide diuretics, or carbonic anhydrase inhibitors may have cross-reactivity.
Alternative Therapies
- Ketoconazole shampoo (for seborrheic dermatitis)
- Selenium sulfide shampoo (for seborrheic dermatitis)
- Zinc pyrithione shampoo (for seborrheic dermatitis)
- Topical retinoids (for acne)
- Benzoyl peroxide (for acne)
- Topical antibiotics (e.g., clindamycin, erythromycin for acne)
- Topical corticosteroids (for inflammatory skin conditions, but not for long-term use in seborrheic dermatitis due to side effects)
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $200+ per 237ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (may require prior authorization for brand, generic often covered)
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.