Tolnaftate 1% Powder 45gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Thiocarbamate Antifungal
Pregnancy Category
C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tolnaftate 1% powder 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, helping to relieve symptoms like itching, burning, and scaling.
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 treated area.
Clean the affected area before applying the medication and dry it thoroughly.
Shake the container well before use.
Sprinkle the powder evenly over the affected skin area.
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 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 treated area.
Clean the affected area before applying the medication and dry it thoroughly.
Shake the container well before use.
Sprinkle the powder evenly over the affected skin area.
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 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 the affected area and dry thoroughly before applying the powder.
- Wear well-ventilated shoes and change shoes and socks daily if treating athlete's foot.
- Keep feet and groin area dry, especially after showering or sweating.
- Avoid sharing towels, clothing, or shoes to prevent spreading the infection.
- Wash hands thoroughly after applying the powder to prevent spreading the infection to other body parts or to others.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of powder to the affected area and surrounding skin twice daily (morning and evening).
Condition-Specific Dosing:
tineaPedis:
Apply twice daily for 4 weeks or as directed by a physician.
tineaCruris:
Apply twice daily for 2 weeks or as directed by a physician.
tineaCorporis:
Apply twice daily for 4 weeks or as directed by a physician.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (consult physician for children under 2 years of age)
Child:
Apply twice daily for 2-4 weeks, or as directed by a physician (consult physician for children under 2 years of age).
Adolescent:
Apply twice daily for 2-4 weeks, or as directed by a physician.
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 fungicidal action by inhibiting the enzyme squalene epoxidase, which is essential for the biosynthesis of ergosterol, a critical component of the fungal cell membrane. This inhibition leads to a deficiency of ergosterol and an accumulation of squalene within the fungal cell, disrupting cell membrane integrity and function, ultimately leading to fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1%)
Tmax:
Not clinically significant for topical use
FoodEffect:
Not applicable for topical use
Distribution:
Vd:
Not clinically significant for topical use
ProteinBinding:
Not clinically significant for topical use
CnssPenetration:
Limited
Elimination:
HalfLife:
Not clinically significant for topical use
Clearance:
Not clinically significant for topical use
ExcretionRoute:
Not clinically significant for topical use
Unchanged:
Not clinically significant for topical use
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within a few days to 1 week.
PeakEffect:
Full therapeutic effect usually observed after 2-4 weeks of consistent use.
DurationOfAction:
Maintained as long as treatment continues and for a period after cessation, depending on the fungal load and patient hygiene.
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
Not all possible side effects are listed here. 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
Not all possible side effects are listed here. 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:
- If the condition worsens or does not improve within 2 weeks (for jock itch/ringworm) or 4 weeks (for athlete's foot).
- If severe irritation, redness, itching, or burning occurs after application.
- Signs of an allergic reaction (e.g., rash, hives, swelling, difficulty breathing), though rare.
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 treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems you have.
This information will help your doctor determine if 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 treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems you have.
This information will help your doctor determine if 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 swallowed, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately. If you are pregnant, planning to become pregnant, or are breast-feeding, you must discuss this with your doctor to carefully 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) or seek medical attention. For topical overuse, wash the area with soap and water. Symptomatic and supportive care if needed.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection (e.g., redness, scaling, itching)
Rationale: To establish baseline severity and confirm diagnosis (if not already confirmed).
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of symptoms (e.g., itching, burning, scaling)
Frequency: Daily to weekly
Target: Progressive improvement
Action Threshold: If no improvement after 2 weeks (jock itch/ringworm) or 4 weeks (athlete's foot), or if condition worsens, discontinue use and consult a physician.
Skin irritation or allergic reaction
Frequency: Daily
Target: Absence of new or worsening irritation
Action Threshold: If irritation, redness, or itching occurs or worsens, discontinue use and consult a physician.
Symptom Monitoring
- Itching
- Burning
- Redness
- Scaling
- Cracking
- Soreness
- Blistering
- Unusual skin irritation
Special Patient Groups
Pregnancy
Tolnaftate is generally considered to have minimal systemic absorption when applied topically. While animal reproduction studies have not been conducted, the risk to a fetus is considered low due to limited systemic exposure. Use during pregnancy should be done with caution and only if clearly needed, after consulting a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but consult physician.
Second Trimester:
Low risk due to minimal systemic absorption, but consult physician.
Third Trimester:
Low risk due to minimal systemic absorption, but consult physician.
Lactation
It is not known whether topical tolnaftate is excreted in human milk. However, due to minimal systemic absorption, it is considered unlikely to pose a significant risk to a nursing infant. Caution should be exercised, and direct application to the breast area should be avoided to prevent accidental ingestion by the infant.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Safety and efficacy in children under 2 years of age have not been established. Consult a physician before use in children under 2 years of age. For children 2 years and older, use as directed for adults, ensuring proper application and monitoring for irritation.
Geriatric Use
No specific dosage adjustments or precautions are generally necessary for geriatric patients. The safety profile is similar to that in younger adults due to minimal systemic absorption.
Clinical Information
Clinical Pearls
- Tolnaftate is effective for dermatophyte infections (tinea) but generally not for yeast infections (e.g., Candida).
- Consistency is key: patients should be advised to use the product for the full recommended duration, even if symptoms improve, to prevent recurrence.
- Powder formulations are particularly useful for moist or sweaty areas, helping to keep the area dry and inhibit fungal growth.
- Advise patients on proper hygiene, such as keeping the affected area clean and dry, wearing breathable fabrics, and changing socks/underwear frequently, to aid treatment and prevent reinfection.
- If the infection is severe, widespread, or does not respond to topical treatment, an oral antifungal may be necessary, and the patient should be referred to a healthcare provider.
Alternative Therapies
- Clotrimazole (topical)
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Undecylenic acid (topical)
Cost & Coverage
Average Cost:
$5 - $15 per 45gm powder
Generic Available:
Yes
Insurance Coverage:
Over-the-counter (OTC) products are generally not covered by prescription insurance plans unless specifically prescribed by a physician and covered under a flexible spending account (FSA) or health savings account (HSA).
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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.