Tolnaftate 1% Cream 30gm
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 antifungal medicine used to treat skin infections like athlete's foot, jock itch, and ringworm. It works by stopping the growth of the fungus that causes these infections.
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 dry it thoroughly.
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, make sure to apply the medication between your toes.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms and areas with high heat.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
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 dry it thoroughly.
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, make sure to apply the medication between your toes.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms and areas with high heat.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
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 and allow air circulation.
- Avoid sharing towels, clothing, or footwear to prevent spreading the infection.
- Continue treatment for the full recommended duration, even if symptoms improve, to prevent recurrence.
- For athlete's foot, sprinkle antifungal powder in shoes and socks daily.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected area and surrounding skin twice daily (morning and evening)
Condition-Specific Dosing:
tineaPedis:
Continue for 4 weeks or as directed by a doctor.
tineaCruris:
Continue for 2 weeks or as directed by a doctor.
tineaCorporis:
Continue for 2 weeks or as directed by a doctor.
Pediatric Dosing
Neonatal:
Not established (consult physician)
Infant:
Not established (consult physician)
Child:
Children 2 years and older: Apply a thin layer to affected area and surrounding skin twice daily (morning and evening). Consult a doctor for use in children under 2 years.
Adolescent:
Apply a thin layer to affected area and surrounding skin twice daily (morning and evening).
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 exert its antifungal activity by inhibiting 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 systemic absorption (<0.5%)
Tmax:
Not significant systemically
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not significant systemically
ProteinBinding:
Not significant systemically
CnssPenetration:
No
Elimination:
HalfLife:
Not significant systemically
Clearance:
Not significant systemically
ExcretionRoute:
Not significant systemically
Unchanged:
Not significant systemically
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Full therapeutic effect may take 2-4 weeks
DurationOfAction:
Maintained with continued application until infection clears
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening side effect:
- 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. 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 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, consult your doctor. 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 immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening side effect:
- 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. 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 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, consult 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 or irritation at the application site
- Severe itching or burning
- Rash or hives developing
- 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 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.
Additionally, 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 currently taking
Any natural products or vitamins you are using
* Any existing health problems you have
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or change the dosage 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.
Additionally, 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 currently taking
Any natural products or vitamins you are using
* Any existing health problems you have
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or change the dosage 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 of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If this drug is ingested, it may cause harm, 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, as it is necessary to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Ingestion of topical tolnaftate is unlikely to cause systemic toxicity due to poor absorption. Symptoms might include mild gastrointestinal upset if a large amount is swallowed.
What to Do:
If swallowed, call a Poison Control Center immediately (1-800-222-1222). For skin irritation, discontinue use and wash the area with soap and water. Seek medical attention if irritation persists or worsens.
Drug Interactions
Monitoring
Routine Monitoring
Clinical symptoms of fungal infection (e.g., itching, redness, scaling)
Frequency: Daily
Target: Resolution of symptoms
Action Threshold: Worsening symptoms, no improvement after 2-4 weeks, or signs of allergic reaction/irritation
Skin integrity at application site
Frequency: Daily
Target: No irritation, redness, or rash
Action Threshold: Development of severe irritation, burning, stinging, or rash
Symptom Monitoring
- Resolution of itching
- Reduction in redness
- Decrease in scaling
- Healing of skin lesions
- Absence of burning or stinging at application site
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Due to minimal systemic absorption, risk is generally considered low for topical use.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but use with caution.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
It is not known whether tolnaftate is excreted in human milk. Due to minimal systemic absorption, risk to a nursing infant is considered low. Use with caution and 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 doctor. Ensure proper diagnosis as other skin conditions can mimic fungal infections.
Geriatric Use
No specific dosage adjustments or precautions are necessary 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 application for the full duration is crucial for successful treatment.
- It is generally effective for superficial dermatophyte infections (tinea pedis, cruris, corporis) but less effective for yeast infections (e.g., Candida) or nail infections (onychomycosis).
- Patients should be advised to keep the affected area clean and dry to aid in treatment and prevent recurrence.
- If no improvement is seen after 2-4 weeks of consistent use, re-evaluate the diagnosis or consider an alternative antifungal agent.
Alternative Therapies
- Clotrimazole (topical)
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Undecylenic acid (topical)
Cost & Coverage
Average Cost:
$5 - $20 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
OTC (Over-The-Counter), generally not covered by insurance unless prescribed and submitted for FSA/HSA reimbursement.
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.