Oxiconazole Nitrate 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
Sep 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxiconazole is an antifungal cream used to treat skin infections like athlete's foot, jock itch, and ringworm. It works by stopping the growth of the fungus that causes these infections.
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 doctor or 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 doctor or 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 the 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.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas once daily
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
tinea_pedis:
Apply once daily for 4 weeks
tinea_cruris:
Apply once daily for 2 weeks
tinea_corporis:
Apply once daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established; use with caution and under medical supervision. Dosing typically similar to adults for affected areas.
Adolescent:
Apply to affected areas once daily for 2-4 weeks, similar to adult dosing.
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 adjustment needed (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 nitrate is an azole antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. It does this by inhibiting the fungal cytochrome P450 14Îą-demethylase enzyme, which is responsible for the demethylation of lanosterol to ergosterol. This inhibition leads to structural and functional damage to the fungal cell membrane, increasing its permeability and ultimately leading to fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
<0.3% (systemic after topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
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:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Full therapeutic effect observed at completion of 2-4 week treatment course
DurationOfAction:
Duration of effect after cessation of treatment depends on complete eradication of infection
Safety & Warnings
Side Effects
Urgent 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. If you experience any of the following side effects or any other unusual effects that bother you or do not go away, contact your doctor for advice:
- Irritation at the site where the drug was applied
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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. If you experience any of the following side effects or any other unusual effects that bother you or do not go away, contact your doctor for advice:
- Irritation at the site where the drug was applied
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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
- Swelling or blistering of the skin
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing - rare for topical)
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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 immediately. 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:
- Ingestion of topical cream is unlikely to cause systemic toxicity due to minimal absorption. Local irritation may occur if applied excessively.
What to Do:
If ingested, seek medical attention. For excessive topical application, wash off with soap and water. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection
Rationale: To confirm diagnosis and establish baseline severity
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily by patient, weekly by clinician if follow-up is needed
Target: Progressive improvement
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks may indicate treatment failure or incorrect diagnosis.
Local skin reactions (e.g., burning, stinging, irritation, erythema)
Frequency: Daily by patient
Target: Minimal to none
Action Threshold: Severe or persistent irritation may require discontinuation.
Symptom Monitoring
- Reduction in itching
- Decrease in redness (erythema)
- Reduction in scaling or flaking of skin
- Improvement in skin appearance
- Absence of new lesions
Special Patient Groups
Pregnancy
Oxiconazole nitrate is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, and systemic absorption in humans after topical application is minimal. Generally considered safe for use during pregnancy when indicated.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Minimal systemic absorption of oxiconazole nitrate is expected after topical application, making it unlikely to be excreted in breast milk in clinically significant amounts. Generally considered compatible with breastfeeding (L3).
Infant Risk:
Low risk to nursing infant due to minimal maternal systemic absorption. Avoid applying to areas where the infant may ingest the cream (e.g., breast/nipple area).
Pediatric Use
Safety and efficacy have not been fully established in pediatric patients. Use with caution and under medical supervision. Dosing is typically similar to adults for affected areas, but treatment duration may vary. Avoid use in neonates and infants unless specifically directed by a physician.
Geriatric Use
No specific dose adjustments or precautions are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact safety or efficacy.
Clinical Information
Clinical Pearls
- Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent relapse.
- Advise patients to apply the cream to the entire affected area and a small border of healthy skin around it.
- Remind patients that topical antifungals are for external use only and should not be used in the eyes, mouth, or vagina.
- If no improvement is seen after the recommended treatment duration, re-evaluate the diagnosis or consider alternative therapies.
- Patients should maintain good hygiene practices (e.g., keeping skin dry, wearing breathable fabrics) to prevent reinfection.
Alternative Therapies
- Clotrimazole topical
- Miconazole topical
- Terbinafine topical
- Ketoconazole topical
- Econazole topical
- Sertaconazole topical
- Naftifine topical
Cost & Coverage
Average Cost:
$30 - $60 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.