Tolnaftate 1% Cream 14.18gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Thiocarbamate Antifungal
Pregnancy Category
Category C
FDA Approved
Jan 1965
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tolnaftate is an antifungal medicine used on the skin to treat common fungal 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
This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use 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 otherwise 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 this medication at room temperature in a dry place, avoiding storage in a bathroom. 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 scheduled dose, skip the missed dose and continue with your regular application 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 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
This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use 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 otherwise 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 this medication at room temperature in a dry place, avoiding storage in a bathroom. 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 scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Clean and dry the affected area thoroughly before applying the cream.
- Wash hands before and after applying the cream.
- Do not use on nails or scalp infections.
- Wear loose-fitting clothing and breathable footwear (e.g., cotton socks) to keep the affected area dry.
- Change socks and underwear daily.
- Avoid sharing towels, clothing, or footwear to prevent spreading the infection.
- Continue using the cream for the full recommended duration, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected skin areas twice daily
Condition-Specific Dosing:
tineaPedis:
Apply for 4 weeks
tineaCruris:
Apply for 2 weeks
tineaCorporis:
Apply for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Apply a thin layer to affected skin areas twice daily (consult physician for children under 2 years)
Adolescent:
Apply a thin layer to affected skin areas twice daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed due to minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Tolnaftate is a synthetic thiocarbamate antifungal agent. It is thought to exert its antifungal effect 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 (<1%)
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (localized action)
ProteinBinding:
Not applicable (minimal systemic)
CnssPenetration:
No
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:
Clinical improvement typically seen within a few days
PeakEffect:
Within 2-4 weeks of consistent use
DurationOfAction:
Maintained as long as treatment continues and infection is resolved
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
- 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.
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
- 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, itching, or irritation at the application site
- Development of a rash or hives
- Swelling or blistering of the skin
- No improvement in symptoms after 2-4 weeks of use
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 safe use, it is crucial to disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
Your doctor and pharmacist need this information to assess potential interactions and determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 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 safe use, it is crucial to disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
Your doctor and pharmacist need this information to assess potential interactions and determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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 breastfeeding, 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:
- Topical overdose is unlikely due to minimal systemic absorption. Ingestion may cause mild gastrointestinal upset.
What to Do:
If accidentally ingested, contact a poison control center or seek medical attention. For topical irritation, discontinue use and wash the area. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of affected skin area
Rationale: To establish baseline severity and extent of fungal infection
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (itching, redness, scaling)
Frequency: Daily by patient, weekly by clinician if follow-up is needed
Target: Complete resolution
Action Threshold: If no improvement after 2 weeks (tinea cruris/corporis) or 4 weeks (tinea pedis), re-evaluate diagnosis or treatment
Skin irritation or allergic reaction
Frequency: Daily by patient
Target: Absence of new or worsening irritation
Action Threshold: Discontinue use if irritation, burning, or rash occurs
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
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected.
Trimester-Specific Risks:
First Trimester:
Limited data, generally considered low risk due to minimal absorption.
Second Trimester:
Limited data, generally considered low risk due to minimal absorption.
Third Trimester:
Limited data, generally considered low risk due to minimal 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.
Infant Risk:
Low risk (L3)
Pediatric Use
Safety and efficacy in children under 2 years of age have not been established; consult a physician. For children 2 years and older, use as directed by a healthcare professional.
Geriatric Use
No specific dosage adjustments are necessary. 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). Consistent application for the full duration is crucial for successful treatment.
- It is most effective for superficial fungal infections (tinea pedis, tinea cruris, tinea corporis) and generally not effective for yeast infections (e.g., Candida) or nail/scalp infections.
- Advise patients to keep the affected area clean and dry to aid in treatment and prevent recurrence.
- If symptoms do not improve after the recommended treatment period, re-evaluate the diagnosis, as it may not be a fungal infection or may require a different antifungal agent.
Alternative Therapies
- Clotrimazole (topical)
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Undecylenic acid (topical)
Cost & Coverage
Average Cost:
$5 - $20 per 14.18gm tube
Generic Available:
Yes
Insurance Coverage:
Often OTC, may not be covered by prescription plans unless prescribed. Some HSA/FSA eligible.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 medication taken, the amount, and the time it occurred.