Oxiconazole Nitrate 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
Jan 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxiconazole is an antifungal cream 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.
Using Dressings or Bandages
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
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 medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medication, and consider participating in a drug take-back program 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 schedule.
* Do not apply two doses at the same time or use extra doses.
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.
Using Dressings or Bandages
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
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 medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medication, and consider participating in a drug take-back program 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 schedule.
* Do not apply two doses at the same time or use extra doses.
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.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas once daily (tinea pedis, tinea corporis, tinea cruris) or twice daily (cutaneous candidiasis).
Condition-Specific Dosing:
tineaPedis:
Apply once daily for 4 weeks.
tineaCorporis:
Apply once daily for 2 weeks.
tineaCruris:
Apply once daily for 2 weeks.
cutaneousCandidiasis:
Apply twice daily for 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Apply to affected areas once daily or twice daily, similar to adult dosing, under medical supervision.
Adolescent:
Apply to affected areas once daily or twice daily, 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 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 nitrate is an imidazole antifungal agent that inhibits the biosynthesis of ergosterol, an essential component of the fungal cell membrane. This inhibition leads to structural and functional damage to the fungal cell membrane, increasing its permeability and causing leakage of cellular contents, ultimately leading to fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
<0.3% (systemic after topical application)
Tmax:
Not clinically relevant for topical application
FoodEffect:
Not applicable
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Not clinically relevant for topical application
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant for topical application
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Not clinically relevant for topical application
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Days to weeks (clinical improvement)
PeakEffect:
Weeks (full resolution of symptoms)
DurationOfAction:
Maintained as long as treatment continues, with sustained effect after completion of full course.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious 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
+ 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. Although 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 any of the following side effects or if they persist or bother you:
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of potential 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious 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
+ 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. Although 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 any of the following side effects or if they persist or bother you:
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of potential 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:
- Severe burning, itching, or stinging at the application site
- Increased redness or irritation
- Swelling or blistering of the skin
- 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 symptoms you experienced.
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.
* Any existing health problems, as this medication may interact with other medical conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current 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.
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.
* Any existing health problems, as this medication may interact with other medical conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current 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 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 of large amounts may cause gastrointestinal upset.
What to Do:
If ingested, contact a poison control center immediately. For topical overdose, wash the area with soap and water. Call 1-800-222-1222
Drug Interactions
Monitoring
Routine Monitoring
Clinical improvement of fungal infection (e.g., reduction in redness, itching, scaling)
Frequency: Daily by patient, weekly by clinician if needed
Target: Progressive resolution of symptoms
Action Threshold: Lack of improvement after 1-2 weeks, or worsening symptoms, warrants re-evaluation.
Local skin reactions (e.g., irritation, burning, itching, erythema)
Frequency: Daily
Target: Minimal to no reaction
Action Threshold: Severe or persistent irritation, or signs of allergic reaction, warrants discontinuation.
Symptom Monitoring
- Resolution of itching
- Reduction in redness
- Decrease in scaling
- Healing of skin lesions
- Absence of burning sensation
Special Patient Groups
Pregnancy
Oxiconazole is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. It is generally considered safe for use during pregnancy when applied topically, as systemic absorption is minimal. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk, minimal systemic absorption.
Second Trimester:
Low risk, minimal systemic absorption.
Third Trimester:
Low risk, minimal systemic absorption.
Lactation
It is not known whether oxiconazole is excreted in human milk. However, due to minimal systemic absorption after topical application, it is considered unlikely to pose a significant risk to a nursing infant. Use with caution; consider applying after feeding or avoiding application to areas that may come into direct contact with the infant.
Infant Risk:
Low risk (L3)
Pediatric Use
Oxiconazole cream has been used safely in pediatric patients for superficial fungal infections. Dosing is generally similar to adults, but use under medical supervision, especially in very young children. Ensure proper application and avoid accidental ingestion.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is similar to that in younger adults. Use with caution in patients with fragile skin.
Clinical Information
Clinical Pearls
- Emphasize the importance of completing the full course of treatment, even if symptoms improve, to prevent relapse.
- Advise patients to keep the affected area clean and dry to aid in treatment and prevent recurrence.
- For tinea pedis, recommend wearing cotton socks and well-ventilated shoes, and changing them frequently.
- Inform patients that temporary burning, stinging, or itching may occur upon application, but severe reactions warrant discontinuation.
- Oxiconazole is for external use only; avoid contact with eyes, mouth, and vagina.
Alternative Therapies
- Clotrimazole cream
- Miconazole cream
- Terbinafine cream
- Ketoconazole cream
- Econazole cream
- Sertaconazole cream
Cost & Coverage
Average Cost:
$50 - $150 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.