Oxiconazole Nitrate 1% Cream 90gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category B
FDA Approved
Jan 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxiconazole is a cream used to treat skin infections caused by fungi, such as 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 directed 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. You may also want to check with your pharmacist about 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 directed 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. You may also want to check with your pharmacist about 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 and underwear daily.
- Avoid sharing towels, clothing, or personal items.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas once daily.
Condition-Specific Dosing:
tineaPedis:
Apply once daily for 4 weeks.
tineaCorporis:
Apply once daily for 2 weeks.
tineaCruris:
Apply once daily for 2 weeks.
tineaVersicolor:
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 topical application if indicated.
Adolescent:
Apply to affected areas once daily, similar to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Oxiconazole nitrate is an imidazole antifungal agent that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. It achieves this by inhibiting the enzyme lanosterol 14-alpha-demethylase. This inhibition leads to increased cell membrane permeability, leakage of essential cellular contents, and ultimately, fungal cell death. It exhibits fungicidal activity against a broad spectrum of dermatophytes, yeasts, and other pathogenic fungi.
Pharmacokinetics
Absorption:
Bioavailability:
<0.3% (systemic absorption after topical application)
Tmax:
Not clinically relevant for topical application
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Not clinically relevant for topical application
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for topical application (systemic half-life not well-defined due to minimal absorption)
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Not clinically relevant for topical application (minimal systemic excretion)
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks.
PeakEffect:
Full therapeutic effect observed at completion of treatment course (2-4 weeks).
DurationOfAction:
Sustained as long as treatment is continued and for a period after cessation, depending on the infection type.
Confidence:
Medium
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 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, any of 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 prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To minimize potential risks, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To minimize potential risks, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
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, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both 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.
What to Do:
If accidentally ingested, contact a poison control center immediately (e.g., 1-800-222-1222). For excessive topical application, wash the area with soap and water. Symptomatic and supportive care if needed.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical diagnosis of fungal infection
Rationale: To confirm the presence of a susceptible fungal infection before initiating treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of signs and symptoms (e.g., itching, redness, scaling)
Frequency: Daily/Weekly
Target: Progressive improvement leading to complete resolution
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks of treatment may indicate incorrect diagnosis, resistant organism, or non-compliance; re-evaluate patient.
Local adverse reactions (e.g., burning, stinging, irritation, pruritus)
Frequency: Daily
Target: Minimal to no local irritation
Action Threshold: Severe or persistent local reactions may require discontinuation of therapy.
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Reduction in scaling or flaking
- Healing of skin lesions
- Absence of new lesions
Special Patient Groups
Pregnancy
Oxiconazole is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Due to minimal systemic absorption after topical application, the risk to the fetus is considered low. Use only if clearly needed and potential benefits outweigh potential risks.
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
It is not known whether oxiconazole is excreted in human milk. However, due to minimal systemic absorption, it is unlikely to be present in breast milk in significant amounts. Caution should be exercised when administered to a nursing mother. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk (L3 - Moderately safe) due to minimal systemic absorption, but potential for direct exposure if applied to breast area.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been fully established. Use in children should be under medical supervision and only if clearly indicated. Dosing for children over 12 years is generally similar to adults for topical application.
Geriatric Use
No specific dosage adjustments are necessary 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, no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Clinical Information
Clinical Pearls
- Ensure the affected skin area is clean and dry before applying the cream to maximize efficacy.
- Advise patients to complete the full prescribed course of treatment, even if symptoms improve, to prevent relapse and ensure complete eradication of the fungal infection.
- For tinea pedis, recommend wearing cotton socks and well-ventilated shoes, and changing them frequently.
- Counsel patients on good hygiene practices to prevent reinfection and spread of the fungus.
- If no improvement is seen after the recommended treatment duration, re-evaluate the diagnosis or consider alternative antifungal agents.
Alternative Therapies
- Clotrimazole (topical)
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Econazole (topical)
- Sertaconazole (topical)
- Naftifine (topical)
- Ciclopirox (topical)
Cost & Coverage
Average Cost:
Varies, typically $30-$100+ per 90gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.