Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Germany, Japan , Malaysia, India, China, U.S., U.K
Tolnaftate is an Antifungal agent belonging to the pharmacological class of Topical Antifungals.
Tolnaftate has been approved to relieve symptoms and also for the treatment and maintenance of Tinea Infections.
Tolnaftate is administered as a topical application, and there is a lack of available information regarding its pharmacokinetics. It remains uncertain whether tolnaftate is absorbed through the epidermis and whether it attains measurable systemic concentrations in the bloodstream.
After subcutaneous administration, the parent compound and its metabolites exhibit high concentrations in the intestinal contents and are primarily distributed to organs such as the liver, adrenals, pancreas, and fat. The excretion of butenafine HCl occurs mainly through the feces and urine in the form of conjugated metabolites. Additionally, the drug is found in high concentrations in breast milk, indicating its potential transfer to nursing infants.
The common side effects involved in using Tolnaftate are Skin irritation (redness, itching, or burning sensation), Allergic reactions (hives, rash, swelling, or difficulty breathing), Skin dryness, Peeling or blistering of the treated skin, Changes in skin color at the application site, Worsening of the condition being treated.
Tolnaftate is available in the form of Cream, Spray, Powder, Solution, Gel.
Tolnaftate is approved in Germany, Japan, Malaysia, India, the U.K., the U.S., and China.
Tolnaftate, belonging to the pharmacological class of Topical Antifungal, acts as an Antifungal agent.
Tolnaftate, similar to naftifine and terbinafine, acts as a reversible and noncompetitive inhibitor of fungal squalene epoxidase. This enzyme, located in the cell membrane, plays a crucial role in the biosynthetic pathway leading from acetate to sterols. When this enzyme is blocked, squalene accumulates, leading to a deficiency of ergosterol.
Studies have shown that tolnaftate can cause distortions in hyphae and inhibit the growth of mycelium in fungi that are susceptible to its action. Cases of resistance to tolnaftate are very rare, but there is a potential for resistance to develop due to the action of multidrug efflux transporters.
Depending on its concentration at the site of infection and the specific susceptibility of the fungus, tolnaftate exhibits either fungistatic (slowing down fungal growth) or fungicidal (killing the fungus) effects.
Tolnaftate has been approved to relieve symptoms and also for the treatment and maintenance of Tinea infections.
Tolnaftate is found to be available in the form of Cream, Spray, Powder, Solution, Gel.
Tolnaftate can be used in the following treatment:
● Tinea Infections
Tolnaftate can help to relieve symptoms and also for the treatment and maintenance of Tinea Infections.
Tolnaftate is approved for use in the following clinical indications:
● Tinea Infections
Tinea Infections:
Tinea Corporis/Tinea Cruris:
● Topical Treatment: Apply the medication to the affected and surrounding areas twice daily until clinical resolution, usually lasting 1 to 4 weeks.
Tinea Pedis (labeled use)/Tinea Manuum (off-label use):
● Topical Treatment: Apply the medication to the affected and surrounding areas twice daily until one week after clinical resolution, typically for a total treatment duration of 4 weeks.
Tinea Pedis (Prevention):
● Topical Prevention: Apply the medication once or twice daily to prevent tinea pedis infection.
Tolnaftate is available in the following dosage forms and strengths:
- Cream:
- Tolnaftate Cream 1%: This is the most common strength for tolnaftate creams, where 1 gram of cream contains 10 mg of tolnaftate.
- Spray:
- Tolnaftate Spray 1%: Similar to the cream, 1% strength is standard for tolnaftate sprays, with 10 mg of tolnaftate per gram of spray.
- Powder:
- Tolnaftate Powder 1%: Powder formulations usually have a 1% concentration of tolnaftate, containing 10 mg of the active ingredient per gram of powder.
- Solution:
- Tolnaftate Solution 1%: For otitis externa treatment, the solution typically has a 1% concentration, containing 10 mg of tolnaftate per milliliter of solution.
- Gel:
- Tolnaftate Gel 1%: Gels also come in a 1% strength, containing 10 mg of tolnaftate per gram of gel.
Cream, Spray, Powder, Solution, Gel.
Dosage Adjustments in Kidney Patients:
There are found to be no dosage adjustments in the manufacturer's labeling.
Dosage Adjustments in Hepatic Impairment Patients:
There are found to be no dosage adjustments in the manufacturer's labeling.
Dosage Adjustments in Pediatric Patients:
Tinea Pedis (Athlete's Foot):
● Treatment for Children ≥2 years and Adolescents: Apply the topical medication twice daily for 4 weeks.
● Prevention for Children ≥2 years and Adolescents: Apply the topical medication once or twice daily.
Tinea Corporis (Ringworm) Treatment:
● Treatment for Children ≥2 years and Adolescents: Apply the topical medication twice daily for 4 weeks.
Tinea Cruris (Jock Itch) Treatment:
● Treatment for Children ≥2 years and Adolescents: Apply the topical medication twice daily for 2 weeks.
When taking Tolnaftate, there are certain dietary restrictions that should be followed to ensure the medication's effectiveness and safety:
● There are no specific food warnings associated with the use of tolnaftate. It is a topical antifungal agent meant for external use on the skin. Since it is not ingested or absorbed systemically, there is generally no interaction with food.
The dietary restriction should be individualized as per patient requirements.
Tolnaftate may be contraindicated under the following conditions:
● Hypersensitivity to the active substance or to any of the excipients
The treating physician must closely monitor the patient and keep pharmacovigilance as follows:
Usage Warnings for Tolnaftate Once-A-DayTM Cream:
Avoid Eye Application:
- Tolnaftate Once-A-DayTM Cream should never be used for treating eye infections. Keep the cream away from the eyes.
PRECAUTIONS:
Sensitivity or Irritation:
- If you experience any signs of sensitivity or chemical irritation while using Tolnaftate Once-A-DayTM Cream, discontinue its use promptly, and seek appropriate medical treatment.
Pregnancy and Nursing:
- Tolnaftate Once-A-DayTM Cream should not be used during pregnancy or by nursing mothers unless advised by a physician.
Not Suitable for Nail or Scalp Infections:
- Tolnaftate Once-A-DayTM Cream is not intended for treating fungal infections of the nails or scalp.
Avoid Occlusive Dressings:
- Unless directed by a physician, do not apply occlusive dressings over Tolnaftate Once-A-DayTM Cream.
Usage Guidelines:
For Adults and Children Over 12:
- Tolnaftate Once-A-DayTM Cream is suitable for use in adults and children above the age of 12 years.
Use in Children Under 12:
- For children under 12 years of age, Tolnaftate Once-A-DayTM Cream should only be used under the advice of a physician.
Breast Feeding Warning
There is limited available data concerning the use of tolnaftate during breastfeeding, and its excretion in human milk remains unknown. However, after topical application, it is poorly absorbed, suggesting a low risk to nursing infants. To reduce the possibility of exposing the infant, advise patients to avoid applying tolnaftate topically to the breast. It is essential to consider the advantages of breastfeeding, the potential risk of drug exposure to the infant, and the consequences of an untreated or inadequately treated condition. If a breastfeeding infant experiences any adverse effects related to a drug administered to the mother, healthcare providers are encouraged to report such incidents to the FDA.
Pregnancy Warning
Pregnancy:
Pregnancy Category B
Data on the use of tolnaftate in pregnant women is currently unavailable, and there is uncertainty about its absorption through the epidermis and potential effects on the fetus and reproductive capacity. As with any medication during pregnancy, it should only be used under the guidance of a physician.
Food Warning
There are certain food-related warnings and precautions to consider when using Tolnaftate:
● There are no specific food warnings associated with the use of tolnaftate. It is a topical antifungal agent meant for external use on the skin. Since it is not ingested or absorbed systemically, there is generally no interaction with food.
The adverse reactions related to Tolnaftate can be categorized as follows:
Common:
● Skin irritation (redness, itching, or burning sensation) at the application site.
Less common :
● Allergic reactions (hives, rash, swelling, or difficulty breathing).
Rare :
● Changes in skin color at the application site.
● Peeling or blistering of the treated skin.
No drug interactions have been reported in the product monograph.
The following are the side effects involving Tolnaftate:
● Skin irritation (redness, itching, or burning sensation)
● Allergic reactions (hives, rash, swelling, or difficulty breathing)
● Skin dryness
● Peeling or blistering of the treated skin
● Changes in skin color at the application site
● Worsening of the condition being treated
The use of Tolnaftate should be prudent in the following group of special populations:
Pregnancy:
Pregnancy Category B
Data on the use of tolnaftate in pregnant women is currently unavailable, and there is uncertainty about its absorption through the epidermis and potential effects on the fetus and reproductive capacity. As with any medication during pregnancy, it should only be used under the guidance of a physician.
Lactation
There is limited available data concerning the use of tolnaftate during breastfeeding, and its excretion in human milk remains unknown. However, after topical application, it is poorly absorbed, suggesting a low risk to nursing infants. To reduce the possibility of exposing the infant, advise patients to avoid applying tolnaftate topically to the breast. It is essential to consider the advantages of breastfeeding, the potential risk of drug exposure to the infant, and the consequences of an untreated or inadequately treated condition. If a breastfeeding infant experiences any adverse effects related to a drug administered to the mother, healthcare providers are encouraged to report such incidents to the FDA.
Pediatric:
No information pertaining to use of drugs in the pediatric population has been found to be available.
Geriatric Use:
No information pertaining to use of drug in geriartic population has been found to be available.
The physician should be vigilant about the knowledge pertaining to the identification and treatment of overdosage of Tolnaftate.
No information pertaining to the overdose maintenance or treatment has been found in the product monographs.
Pharmacodynamics:
Tolnaftate is an OTC (over-the-counter) synthetic antifungal agent.
Pharmacokinetics:
Tolnaftate is administered as a topical application, and there is a lack of available information regarding its pharmacokinetics. It remains uncertain whether tolnaftate is absorbed through the epidermis and whether it attains measurable systemic concentrations in the bloodstream.
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2. https://go.drugbank.com/drugs/DB00525
3. https://reference.medscape.com/drug/tinactin-ting-tolnaftate-topical-343495
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6. https://www.rxlist.com/tolnaftate/generic-drug.htm
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