Oxistat 1% Cream 60gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category B
FDA Approved
Sep 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxistat 1% Cream is a medicine applied to the skin to treat fungal infections like athlete's foot, jock itch, ringworm, and tinea versicolor. 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 to do so 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
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 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. 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 to do so 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
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 application 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 daily and keep feet dry.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
- Continue using the cream for the full prescribed duration, 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:
Tinea pedis:
Apply once daily for 4 weeks
Tinea corporis/cruris:
Apply once daily for 2 weeks
Tinea versicolor:
Apply once daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established in children under 12 years; use with caution and under medical supervision if prescribed.
Adolescent:
Apply to affected areas once daily (similar to adult dosing, generally for ages 12 and older)
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
Oxiconazole is an imidazole antifungal agent that inhibits the biosynthesis of ergosterol, an essential component of the fungal cell membrane. It achieves this by inhibiting cytochrome P450-dependent 14-alpha-demethylase, an enzyme necessary for the conversion of lanosterol to ergosterol. This inhibition leads to an accumulation of 14-alpha-methyl sterols and a depletion of ergosterol, resulting in increased fungal cell membrane permeability, leakage of cellular contents, and ultimately, fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<0.3% of applied dose)
Tmax:
Not clinically significant (topical application)
FoodEffect:
Not applicable (topical application)
Distribution:
Vd:
Not clinically significant (minimal systemic absorption)
ProteinBinding:
Not clinically significant (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically significant (minimal systemic absorption)
Clearance:
Not clinically significant (minimal systemic absorption)
ExcretionRoute:
Not clinically significant (minimal systemic absorption)
Unchanged:
Not clinically significant (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks (clinical improvement typically seen within 1-2 weeks)
PeakEffect:
2-4 weeks (for full therapeutic effect)
DurationOfAction:
Not applicable (requires continued application for duration of treatment)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, 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 is not exhaustive, and you may have questions about side effects. If so, 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, 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 is not exhaustive, and you may have questions about side effects. If so, 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 or irritation at the application site
- Severe burning or stinging
- Swelling or blistering
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat - 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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose 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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of 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, you must discuss this with your doctor. This conversation will help you understand the potential benefits and risks of taking this drug, both for you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Ingestion may cause gastrointestinal upset.
What to Do:
If accidentally ingested, contact a poison control center immediately. For the U.S., call 1-800-222-1222. Treatment is generally supportive.
Drug Interactions
Monitoring
Routine Monitoring
Clinical response (resolution of symptoms, skin appearance)
Frequency: Daily by patient, periodically by clinician
Target: Improvement in redness, itching, scaling; eventual clearing of lesion
Action Threshold: Lack of improvement after 2-4 weeks, worsening symptoms, or development of new adverse reactions
Local skin reactions (e.g., irritation, burning, itching, erythema)
Frequency: Daily by patient
Target: Minimal to no irritation
Action Threshold: Severe or persistent irritation, allergic reaction
Symptom Monitoring
- Resolution of itching
- Reduction in redness
- Decrease in scaling
- Improvement in skin appearance
- Absence of new lesions
Special Patient Groups
Pregnancy
Oxiconazole is Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
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
It is not known whether oxiconazole is excreted in human milk. Due to minimal systemic absorption, the risk to a nursing infant is considered low. Use with caution and only if clearly needed. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low (L3 - Moderately Safe, or L2 - Safer, due to minimal systemic absorption)
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children should be under medical supervision and only if the potential benefit justifies the potential risk.
Geriatric Use
No specific dosage adjustments are required for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, no age-related differences in safety or efficacy are expected.
Clinical Information
Clinical Pearls
- Oxistat Cream is for external use only. Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use occlusive dressings unless specifically instructed by a healthcare professional.
- Patients should be advised to use the medication for the full prescribed treatment period, even if symptoms improve, to prevent relapse.
- If no improvement is seen after the recommended treatment period (e.g., 2 weeks for tinea corporis/cruris, 4 weeks for tinea pedis), the diagnosis should be re-evaluated.
- Proper hygiene, such as keeping the affected area clean and dry, is crucial for successful treatment and prevention of recurrence.
Alternative Therapies
- Clotrimazole cream/lotion
- Miconazole cream/powder
- Terbinafine cream
- Ketoconazole cream
- Econazole cream
Cost & Coverage
Average Cost:
Varies widely per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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's a good idea 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.