Oxistat 1% Cream 30gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal, Topical
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category B
FDA Approved
Dec 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxiconazole cream is an antifungal medication used to treat skin infections caused by fungi, such as athlete's foot, jock itch, ringworm, and yeast infections of the skin. It works by stopping the growth of the fungus.
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. Continue using the 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.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.
Missed Dose
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.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the 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.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.
Missed Dose
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
- Wash hands before and after applying the cream.
- Clean and dry the affected area thoroughly before application.
- Apply a thin layer of cream to the affected skin and surrounding area.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Change socks and underwear daily.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas once daily
Condition-Specific Dosing:
tineaPedis:
Apply once daily for 1 month
tineaCorporisCruris:
Apply once daily for 2 weeks
tineaVersicolor:
Apply once daily for 2 weeks
cutaneousCandidiasis:
Apply once daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Apply once daily to affected areas; duration depends on infection type (similar to adults)
Adolescent:
Apply once daily to affected areas; duration depends on infection type (similar to adults)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Dialysis:
No specific considerations (topical application, minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Pharmacology
Mechanism of Action
Oxiconazole is an imidazole antifungal agent that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to structural and functional damage to the fungal cell membrane, increasing its permeability and causing leakage of essential intracellular components, ultimately leading to fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 0.3% (systemic absorption after topical application)
Tmax:
Not clinically relevant for topical application
FoodEffect:
Not applicable (topical application)
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Not clinically relevant for topical application
CnssPenetration:
Limited (due to minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for topical application
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Primarily urine and feces for the small absorbed amount
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within a few days to a week
PeakEffect:
Not precisely defined for topical antifungals; full therapeutic effect achieved after completing the prescribed course
DurationOfAction:
Maintained as long as the cream is applied; residual antifungal activity may persist for a short period after discontinuation
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat
- Blistering
- Swelling
- Oozing or bleeding
- Burning
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Irritation at the site where the drug was applied
- Any other side effects that bother you or do not go away
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat
- Blistering
- Swelling
- Oozing or bleeding
- Burning
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Irritation at the site where the drug was applied
- Any other side effects that bother you or do not go away
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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:
- Increased redness, itching, or irritation at the application site
- Development of blisters or oozing
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing - seek immediate medical attention)
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. 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. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts may cause gastrointestinal upset.
What to Do:
If ingested, contact a poison control center immediately (Call 1-800-222-1222). For topical overdose, wash the area with soap and water.
Drug Interactions
Monitoring
Routine Monitoring
Resolution of fungal infection symptoms (e.g., itching, redness, scaling)
Frequency: Daily by patient, periodically by clinician
Target: Complete resolution
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks of treatment
Local skin irritation (e.g., burning, stinging, erythema)
Frequency: Daily by patient
Target: Minimal to none
Action Threshold: Severe or persistent irritation, blistering, or signs of allergic reaction
Symptom Monitoring
- Itching
- Redness
- Scaling
- Burning sensation
- Stinging sensation
- Blistering
- Swelling
Special Patient Groups
Pregnancy
Oxiconazole is Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data and minimal systemic absorption.
Second Trimester:
Low risk based on animal data and minimal systemic absorption.
Third Trimester:
Low risk based on animal data and minimal systemic absorption.
Lactation
Oxiconazole is Lactation Risk L3 (Moderately Safe). Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. Use with caution; avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption.
Pediatric Use
Safety and efficacy have been established in pediatric patients 12 years of age and older. For younger children, use should be under medical supervision. Dosing is generally similar to adults for topical application.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is similar to that in younger adults.
Clinical Information
Clinical Pearls
- Oxiconazole cream is for external use only. Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use for ophthalmic, oral, or intravaginal infections.
- Patients should be advised to complete the full course of therapy, even if symptoms improve, to prevent relapse.
- If no improvement is seen after the recommended treatment period, the diagnosis should be re-evaluated.
- For tinea pedis, advise patients to wear well-ventilated shoes and change socks frequently.
Alternative Therapies
- Clotrimazole cream
- Miconazole cream
- Terbinafine cream
- Ketoconazole cream
- Econazole cream
- Sertaconazole cream
Cost & Coverage
Average Cost:
Varies, typically $50-$150 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it is a good idea to check 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 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.