Econazole Nitrate 1% Cream 85gm
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 medicine 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 closely.
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.
Administration
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 Instructions
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 moisture and heat. Do not refrigerate or freeze.
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 make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
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.
Administration
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 Instructions
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 moisture and heat. Do not refrigerate or freeze.
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 make up for a missed dose.
Lifestyle & Tips
- Wash hands before and after applying the cream.
- Clean and dry the affected skin area thoroughly before application.
- Apply a thin layer of cream to the affected area and surrounding skin.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Keep the affected area clean and dry to prevent fungal growth.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a sufficient amount to cover affected areas once daily.
Condition-Specific Dosing:
Tinea Cruris, Tinea Corporis, Tinea Versicolor, Cutaneous Candidiasis:
Once daily for 2 weeks.
Tinea Pedis:
Once daily for 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, consult pediatrician
Child:
Apply once daily for 2-4 weeks, similar to adult dosing, under medical supervision.
Adolescent:
Apply once daily for 2-4 weeks, similar to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical use, minimal systemic absorption)
Moderate:
No adjustment needed (topical use, minimal systemic absorption)
Severe:
No adjustment needed (topical use, minimal systemic absorption)
Dialysis:
No specific considerations (topical use, minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (topical use, minimal systemic absorption)
Moderate:
No adjustment needed (topical use, minimal systemic absorption)
Severe:
No adjustment needed (topical use, minimal systemic absorption)
Pharmacology
Mechanism of Action
Econazole nitrate is an azole antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. It does this by inhibiting 14-alpha demethylase, a cytochrome P450-dependent enzyme. This inhibition leads to structural and functional damage to the fungal cell membrane, increasing its permeability and ultimately leading to cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<10% of applied dose systemically)
Tmax:
Not well-defined for topical systemic absorption, but peak plasma concentrations are very low.
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not well-defined due to minimal systemic absorption
ProteinBinding:
Not well-defined due to minimal systemic absorption
CnssPenetration:
No
Elimination:
HalfLife:
Variable (due to minimal systemic absorption, not clinically relevant for topical use)
Clearance:
Not clinically relevant for topical use
ExcretionRoute:
Renal and fecal (for systemically absorbed portion)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Symptomatic improvement typically within a few days; mycological cure requires full course of treatment.
PeakEffect:
Achieved with completion of full treatment course.
DurationOfAction:
Effect persists as long as treatment continues and for a period after cessation, depending on the infection.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening 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, or 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 discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the drug was applied.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening 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, or 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 discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the drug was applied.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. 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 irritation at the application site
- Development of new rash or worsening of existing rash
- Signs of an allergic reaction (e.g., swelling, severe rash, difficulty breathing)
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with your other medications and health conditions.
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 quantities may cause gastrointestinal upset (nausea, vomiting).
What to Do:
For accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222). Management is generally supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical diagnosis of fungal infection
Rationale: To confirm the need for antifungal therapy
Timing: Prior to initiation of treatment
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily/Weekly
Target: Complete resolution
Action Threshold: If symptoms worsen or do not improve after 2-4 weeks, re-evaluate diagnosis or treatment.
Skin irritation at application site
Frequency: Daily
Target: Minimal to none
Action Threshold: If severe irritation, burning, or allergic reaction occurs, discontinue use and consult healthcare provider.
Symptom Monitoring
- Redness
- Itching
- Scaling
- Burning sensation
- Blistering
- Swelling
- Worsening of rash
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 following topical application is minimal, which reduces the risk.
Trimester-Specific Risks:
First Trimester:
Potential risk, but minimal systemic absorption limits exposure.
Second Trimester:
Potential risk, but minimal systemic absorption limits exposure.
Third Trimester:
Potential risk, but minimal systemic absorption limits exposure.
Lactation
Econazole nitrate is considered L3 (moderately safe) for use during lactation. Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. Caution should be exercised to avoid direct contact of the infant with the treated skin area, especially if applied to the breast.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption.
Pediatric Use
Econazole nitrate cream can be used in pediatric patients, including infants and children, for appropriate indications. Dosing is generally similar to adults, but treatment duration may vary. Always consult a pediatrician for use in very young children.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is similar to that in younger adults.
Clinical Information
Clinical Pearls
- Advise patients to complete the full prescribed course of treatment, even if symptoms improve, to ensure complete eradication of the fungal infection and prevent recurrence.
- Emphasize the importance of good hygiene, keeping the affected area clean and dry, and wearing breathable clothing to aid in treatment and prevent reinfection.
- Instruct patients to avoid contact with eyes, mouth, and other mucous membranes. If accidental contact occurs, rinse thoroughly with water.
- Topical econazole nitrate is generally well-tolerated; however, advise patients to report any signs of severe irritation, burning, or allergic reaction.
Alternative Therapies
- Clotrimazole (topical)
- Miconazole (topical)
- Ketoconazole (topical)
- Terbinafine (topical)
- Naftifine (topical)
- Ciclopirox (topical)
Cost & Coverage
Average Cost:
$15 - $50 per 85gm 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, including the amount taken and the time it happened, to ensure you receive the best possible care.