Tolnaftate 1% Cream 15gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Thiocarbamate Antifungal
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tolnaftate is an over-the-counter (OTC) medicine used to treat common fungal infections of the skin, such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). 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.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
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 instructed by your doctor, do not cover the treated area with bandages or dressings.
For athlete's foot, be sure to apply the medication between the toes.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms.
Protect the medication from heat sources.
Keep all medications in a safe location, out of the reach of children and pets.
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.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
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 instructed by your doctor, do not cover the treated area with bandages or dressings.
For athlete's foot, be sure to apply the medication between the toes.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms.
Protect the medication from heat sources.
Keep all medications in a safe location, out of the reach of children and pets.
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
- Clean and dry the affected area thoroughly before applying the cream.
- Wash hands before and after applying the cream.
- Wear loose-fitting clothing and breathable footwear (e.g., cotton socks) to keep the affected area dry.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
- Continue treatment for the full recommended duration, even if symptoms improve, to prevent recurrence.
- For athlete's foot, change socks and shoes daily.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected area twice daily
Condition-Specific Dosing:
tineaPedis:
Apply twice daily for 4 weeks
tineaCruris:
Apply twice daily for 2 weeks
tineaCorporis:
Apply twice daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (consult physician for children under 2 years)
Child:
Apply a thin layer to affected area twice daily (for children 2 years and older)
Adolescent:
Apply a thin layer to affected area twice daily
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
Tolnaftate is a synthetic thiocarbamate antifungal agent. It is believed to inhibit the enzyme squalene epoxidase, which is essential for the biosynthesis of ergosterol, a critical component of fungal cell membranes. This inhibition leads to a deficiency of ergosterol and an accumulation of squalene within the fungal cell, disrupting membrane integrity and function, ultimately leading to fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<1%)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Symptom improvement typically within a few days to a week
PeakEffect:
Full therapeutic effect usually seen after 2-4 weeks of consistent use
DurationOfAction:
Maintained as long as treatment continues; recurrence possible if treatment is stopped prematurely
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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with 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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with 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 a worsening infection (e.g., pus, severe pain)
- No improvement in symptoms after 2 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 allergic reaction you experienced, including any symptoms that occurred.
If you have nail or scalp infections, as this medication is not effective in treating these types of infections.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your overall health status, including any existing medical conditions
This information will help your doctor determine whether it is safe for you to take this medication, and if so, what dosage is appropriate. Never start, stop, or adjust the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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 allergic reaction you experienced, including any symptoms that occurred.
If you have nail or scalp infections, as this medication is not effective in treating these types of infections.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your overall health status, including any existing medical conditions
This information will help your doctor determine whether it is safe for you to take this medication, and if so, what dosage is appropriate. Never start, stop, or adjust the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If this drug is accidentally ingested, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately if swallowing occurs. If you are pregnant, planning to become pregnant, or are currently breast-feeding, you must discuss this with your doctor. This discussion will help you understand the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely due to minimal systemic absorption. Ingestion may cause mild gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
For accidental ingestion, seek medical attention or call a poison control center. For topical irritation, discontinue use and wash the area. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection (e.g., lesion size, erythema, pruritus, scaling)
Rationale: To establish baseline severity and guide treatment duration.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment of fungal infection (e.g., resolution of symptoms, skin appearance)
Frequency: Weekly or as needed
Target: Complete resolution of signs and symptoms
Action Threshold: Lack of improvement after 2 weeks, worsening symptoms, or signs of irritation/allergic reaction
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
Tolnaftate is generally considered low risk during pregnancy due to minimal systemic absorption. However, use only if clearly needed and after consulting a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk, but caution advised.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Tolnaftate is considered low risk during lactation due to minimal systemic absorption. It is unlikely to be excreted in breast milk in clinically significant amounts. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk
Pediatric Use
Safe for use in children 2 years of age and older. For children under 2 years, consult a physician. Dosing is similar to adults, applying a thin layer twice daily. Ensure proper diagnosis as other skin conditions can mimic fungal infections.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. Efficacy and safety are similar to those in younger adults.
Clinical Information
Clinical Pearls
- Tolnaftate is fungistatic, meaning it inhibits fungal growth, rather than fungicidal (killing the fungus). This means consistent and complete treatment duration is crucial for efficacy.
- It is most effective for superficial skin infections caused by dermatophytes (tinea infections) and generally not effective for yeast infections (e.g., Candida) or nail fungus (onychomycosis).
- Advise patients to continue treatment for the full recommended period (e.g., 2-4 weeks), even if symptoms improve, to prevent relapse.
- Emphasize good hygiene practices, such as keeping the affected area clean and dry, and wearing breathable clothing, to aid in treatment and prevent recurrence.
- If no improvement is seen after 2 weeks of treatment, or if the condition worsens, advise the patient to consult a healthcare professional for re-evaluation and potential alternative diagnosis or treatment.
Alternative Therapies
- Clotrimazole (topical)
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Undecylenic acid (topical)
Cost & Coverage
Average Cost:
$5 - $20 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Generally not covered by prescription insurance as it is an OTC product; may be eligible for FSA/HSA reimbursement.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.