Econazole Nitrate 1% Cream 15gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category C
FDA Approved
Mar 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Econazole nitrate cream is an antifungal medication used to treat various 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
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Do not apply the medication to the vagina.
Application Instructions
Use the medication as directed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Guidelines
Do not cover the treated area with bandages, dressings, or makeup unless instructed to do so by your doctor.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from refrigeration and freezing.
Keep the medication in a dry place, avoiding storage in a bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Missing a 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 safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Do not apply the medication to the vagina.
Application Instructions
Use the medication as directed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Guidelines
Do not cover the treated area with bandages, dressings, or makeup unless instructed to do so by your doctor.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from refrigeration and freezing.
Keep the medication in a dry place, avoiding storage in a bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Missing a 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
- Clean and dry the affected area thoroughly before applying the cream.
- Wash hands before and after applying the cream.
- Apply a thin layer of cream to the affected skin and surrounding area, rubbing it in gently.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Wear loose-fitting clothing and breathable fabrics (e.g., cotton) to help keep the affected area dry.
- Change socks and underwear daily if treating foot or groin infections.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily or twice daily.
Condition-Specific Dosing:
tineaPedis:
Apply once daily for 4 weeks.
tineaCruris:
Apply once daily for 2 weeks.
tineaCorporis:
Apply once daily for 2 weeks.
cutaneousCandidiasis:
Apply twice daily for 2 weeks.
tineaVersicolor:
Apply once daily for 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Generally same as adult dosing for children 2 years of age and older, under medical supervision.
Adolescent:
Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application).
Moderate:
No adjustment needed (topical application).
Severe:
No adjustment needed (topical application).
Dialysis:
No specific considerations for topical application.
Hepatic Impairment:
Mild:
No adjustment needed (topical application).
Moderate:
No adjustment needed (topical application).
Severe:
No adjustment needed (topical application).
Pharmacology
Mechanism of Action
Econazole nitrate inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This leads to structural and functional damage to the fungal cell membrane, increasing its permeability and ultimately causing cell death. It also inhibits the synthesis of triglycerides and phospholipids by fungi.
Pharmacokinetics
Absorption:
Bioavailability:
Very low (<10% systemic absorption after topical application)
Tmax:
Not well defined for systemic absorption from topical application; peak concentrations in stratum corneum within hours.
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable for topical use with minimal systemic absorption.
ProteinBinding:
Approximately 98% (if systemically absorbed)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well defined for topical systemic absorption; prolonged retention in skin.
Clearance:
Not well defined for topical systemic absorption.
ExcretionRoute:
Primarily urine and feces (if systemically absorbed).
Unchanged:
<1% (systemically)
Pharmacodynamics
OnsetOfAction:
Symptomatic relief typically within a few days; mycological cure may take 2-4 weeks.
PeakEffect:
Not applicable for topical antifungal effect; sustained concentrations in skin.
DurationOfAction:
Sustained due to retention in the stratum corneum.
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
- Swelling of the mouth, face, lips, tongue, or throat
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 monitor your response to the medication. If you notice any of the following side effects or any other unusual effects, contact your doctor for advice:
- Irritation at the site where the drug was applied
Important Note
This list does not include all possible side effects. If you have 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.
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
- Swelling of the mouth, face, lips, tongue, or throat
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 monitor your response to the medication. If you notice any of the following side effects or any other unusual effects, contact your doctor for advice:
- Irritation at the site where the drug was applied
Important Note
This list does not include all possible side effects. If you have 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
- 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.
- No improvement in symptoms after the recommended treatment period.
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 drug may interact with other prescription or over-the-counter (OTC) medications, 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 ensure your safety, 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 with all 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, 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 drug may interact with other prescription or over-the-counter (OTC) medications, 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 ensure your safety, 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 with all 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, you must discuss this with your doctor. This conversation will help you understand the benefits and risks of taking this drug, both for you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Not expected with topical use due to minimal systemic absorption. Ingestion of large amounts may cause gastrointestinal upset (nausea, vomiting).
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection (e.g., extent of rash, itching, scaling)
Rationale: To establish baseline severity and type of infection.
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily by patient, weekly by clinician if needed.
Target: Progressive improvement leading to complete resolution.
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks of therapy may indicate treatment failure, incorrect diagnosis, or adverse reaction.
Skin irritation or allergic reaction
Frequency: Daily by patient.
Target: Absence of new or worsening irritation.
Action Threshold: Development of severe itching, burning, blistering, or swelling requires discontinuation and medical evaluation.
Symptom Monitoring
- Reduction in itching
- Decrease in redness and inflammation
- Resolution of scaling or flaking
- Clearing of skin lesions
- Absence of new lesions
Special Patient Groups
Pregnancy
Econazole nitrate is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal after topical application.
Trimester-Specific Risks:
First Trimester:
Limited data; use with caution and only if clearly needed.
Second Trimester:
Limited data; use with caution and only if clearly needed.
Third Trimester:
Limited data; use with caution and only if clearly needed.
Lactation
It is not known whether econazole nitrate is excreted in human milk. Due to minimal systemic absorption, risk to a nursing infant is considered low. Use with caution; avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk (L3)
Pediatric Use
Safety and efficacy have not been fully established in children younger than 2 years of age. For children 2 years and older, dosing is generally similar to adults, but use under medical supervision.
Geriatric Use
No specific dose adjustments are necessary for elderly patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are unlikely to affect safety or efficacy.
Clinical Information
Clinical Pearls
- Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent recurrence.
- Advise patients to keep the affected area clean and dry to aid in treatment and prevent reinfection.
- Econazole nitrate cream is for external use only. Avoid contact with eyes, mouth, and other mucous membranes.
- Not effective for nail or scalp fungal infections, which often require oral antifungal therapy.
- If irritation or sensitivity develops, discontinue use and consult a healthcare professional.
Alternative Therapies
- Clotrimazole (topical)
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Nystatin (topical, primarily for Candida)
Cost & Coverage
Average Cost:
$10 - $30 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred 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 this medication, don't 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.