Econazole Nitrate 1% Cream 30gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category C
FDA Approved
Dec 1978
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 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 make sure it is completely dry.
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 take 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 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 make sure it is completely dry.
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 take extra doses.
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 cover the entire affected area and surrounding skin.
- 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 area dry.
- Change socks and underwear daily if treating foot or groin infections.
- Continue using the cream for the full prescribed duration, 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 a thin layer to affected areas once daily for tinea cruris, tinea corporis, and tinea pedis; twice daily (morning and evening) for cutaneous candidiasis and tinea versicolor.
Condition-Specific Dosing:
tineaCruris:
Once daily for 2 weeks
tineaCorporis:
Once daily for 2 weeks
tineaPedis:
Once daily for 1 month
cutaneousCandidiasis:
Twice daily for 2 weeks
tineaVersicolor:
Twice daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established (use with caution, consult pediatrician)
Infant:
Not established (use with caution, consult pediatrician)
Child:
Apply a thin layer to affected areas once daily for tinea cruris, tinea corporis, and tinea pedis; twice daily (morning and evening) for cutaneous candidiasis and tinea versicolor. Dosing duration similar to adults.
Adolescent:
Apply a thin layer to affected areas once daily for tinea cruris, tinea corporis, and tinea pedis; twice daily (morning and evening) for cutaneous candidiasis and tinea versicolor. Dosing duration similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
Not applicable (minimal systemic absorption)
Moderate:
Not applicable (minimal systemic absorption)
Severe:
Not applicable (minimal systemic absorption)
Dialysis:
Not applicable (minimal systemic absorption)
Hepatic Impairment:
Mild:
Not applicable (minimal systemic absorption)
Moderate:
Not applicable (minimal systemic absorption)
Severe:
Not applicable (minimal systemic absorption)
Pharmacology
Mechanism of Action
Econazole nitrate inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This leads to structural and functional impairment of the cytoplasmic membrane, resulting in leakage of essential intracellular components and ultimately fungal cell death. It also inhibits the synthesis of triglycerides and phospholipids by fungi.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<10%) after topical application to intact skin.
Tmax:
Not clinically relevant for systemic absorption from topical application.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not clinically relevant for systemic distribution from topical application.
ProteinBinding:
Not clinically relevant for systemic protein binding from topical application.
CnssPenetration:
Limited (not clinically relevant for topical use).
Elimination:
HalfLife:
Not clinically relevant for systemic elimination from topical application.
Clearance:
Not clinically relevant for systemic clearance from topical application.
ExcretionRoute:
Primarily renal and fecal if absorbed systemically.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within a few days to a week.
PeakEffect:
Full therapeutic effect observed after completing the recommended course of therapy (2-4 weeks depending on condition).
DurationOfAction:
Effect persists as long as treatment is continued and for a period after cessation, depending on the eradication of the fungal infection.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention right away:
- Signs of an allergic reaction, including 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 or seek medical help if you experience:
- Irritation at the site where the medication 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 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 attention right away:
- Signs of an allergic reaction, including 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 or seek medical help if you experience:
- Irritation at the site where the medication 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 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 if these occur
- No improvement in symptoms after 2-4 weeks of treatment
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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication 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 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication 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, 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 during pregnancy or breast-feeding to make an informed decision about its use.
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 (1-800-222-1222) or seek medical attention. For topical overdose, wash the area with soap and water. Symptomatic and supportive care if needed.
Drug Interactions
Moderate Interactions
- Warfarin (potential for enhanced anticoagulant effect, though rare with topical use due to minimal systemic absorption)
Confidence Interactions
Monitoring
Routine Monitoring
Clinical improvement of skin lesions
Frequency: Daily observation by patient
Target: Reduction in redness, itching, scaling
Action Threshold: If no improvement after 2-4 weeks, or worsening of symptoms, re-evaluate diagnosis.
Local skin reactions (e.g., irritation, burning, itching)
Frequency: Daily observation by patient
Target: Absence or mild, transient reactions
Action Threshold: If severe irritation, burning, or signs of allergic reaction occur, discontinue use and consult healthcare provider.
Symptom Monitoring
- Resolution of itching
- Reduction in redness
- Decrease in scaling or flaking
- Healing of skin lesions
- Absence of new lesions
Special Patient Groups
Pregnancy
Econazole nitrate is classified as Pregnancy Category C. While systemic absorption is minimal, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Limited data, use with caution.
Second Trimester:
Limited data, use with caution.
Third Trimester:
Limited data, use with caution.
Lactation
Econazole nitrate is considered L2 (Safer) during lactation. Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. However, avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Generally considered safe for use in pediatric patients, including infants, when used as directed. Dosing and duration are similar to adults. Always consult a pediatrician for use in very young children.
Geriatric Use
No specific dosage adjustments are required for geriatric patients. Efficacy and safety profiles are similar to those in younger adults.
Clinical Information
Clinical Pearls
- Emphasize the importance of completing the full course of treatment, even if symptoms improve, to prevent recurrence of the infection.
- Advise patients to keep the affected area clean and dry to aid in healing and prevent reinfection.
- For tinea pedis (athlete's foot), recommend wearing cotton socks and changing them frequently, and wearing well-ventilated shoes.
- Inform patients that a mild burning or stinging sensation may occur upon application, which is usually temporary.
- If the infection does not improve after the recommended treatment period, or if it worsens, advise the patient to contact their healthcare provider for re-evaluation.
Alternative Therapies
- Clotrimazole topical
- Miconazole topical
- Terbinafine topical
- Ketoconazole topical
- Nystatin topical (for candidiasis only)
Cost & Coverage
Average Cost:
$15 - $40 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.