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TOLNAFTATE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Tolnaftate is a topical antifungal agent.

Specific Substances

    1) Tolnaftate
    2) Naphthiomate-T
    3) Tolnaftat
    4) SCH-10144
    5) TOLNAPHTHATE
    6) TOLSANIL
    7) TONOFTAL

Available Forms Sources

    A) USES
    1) Tolnaftate is available in foot care preparations for the treatment of athlete's foot (Prod Info tolnaftate topical cream, 2005). It is not active against Candida spp. or bacteria.

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Tolnaftate is used in the treatment and prevention of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
    B) PHARMACOLOGY: Tolnaftate is an antifungal. It inhibits the growth of dermatophytes epidermophyton, microsporum, trichophyton spp. and malassezia furfur; however, it is not active against candida spp.
    C) EPIDEMIOLOGY: Exposure can occur. Acute toxicity is unlikely.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: There are minimal reports of adverse reactions to tolnaftate. Skin irritation and local hypersensitivity reactions have been the primary adverse effects reported.
    E) WITH POISONING/EXPOSURE
    1) OVERDOSE: No reports of exposure. Overdose events are anticipated to be similar to adverse events. A minor or inadvertent ingestion is not anticipated to result in significant toxicity.
    0.2.20) REPRODUCTIVE
    A) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.
    0.2.21) CARCINOGENICITY
    A) At the time of this review, no data were available to assess the carcinogenic potential of this agent.

Laboratory Monitoring

    A) No specific laboratory studies are indicated and are unlikely to be needed.
    B) Obtain a baseline CBC and assess electrolytes and liver and renal function as indicated following a significant ingestion.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF TOXICITY
    1) Treatment is symptomatic and supportive. Topical irritation may occur; discontinue the product and cleanse the skin with soap and water. Significant toxicity is not anticipated following a taste or minor inadvertent ingestion of tolnaftate cream or solution.
    B) DECONTAMINATION
    1) Gastrointestinal decontamination is unlikely to be necessary.
    C) ENHANCED ELIMINATION
    1) No studies have addressed the utilization of enhanced elimination techniques following tolnaftate oral exposure, but are unlikely to be necessary.
    D) PATIENT DISPOSITION
    1) HOME CRITERIA: Following an inadvertent dermal exposure with a topical product, cleanse the area with soap and water. Following an inadvertent ocular exposure, the eyes should be flushed copiously with water. An asymptomatic child that has inadvertently had a taste or minor ingestion of a topical product (ie, cream, solution) can be monitored at home with adult supervision. Children that develop more than mild symptoms (ie recurrent vomiting, difficulty breathing) should be sent to a healthcare center.
    2) OBSERVATION CRITERIA: Patients with a deliberate overdose, and those who are symptomatic, may need to be monitored for several hours. Due to limited experience, treatment is symptomatic and supportive. Patients that remain asymptomatic or are clearly improving and clinically stable can be discharged.
    3) CONSULT CRITERIA: Consult a poison center or medical toxicologist for assistance in managing patients that develop severe toxicity or in whom the diagnosis is not clear.
    0.4.4) EYE EXPOSURE
    A) DECONTAMINATION: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, the patient should be seen in a healthcare facility.
    0.4.5) DERMAL EXPOSURE
    A) OVERVIEW
    1) DECONTAMINATION: Remove contaminated clothing and jewelry and place them in plastic bags. Wash exposed areas with soap and water for 10 to 15 minutes with gentle sponging to avoid skin breakdown. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).

Range Of Toxicity

    A) TOXICITY: A toxic dose has not been established. At the time of this review, there are no reports of acute oral ingestion with tolnaftate. THERAPEUTIC DOSE: ADULT and CHILDREN 2 YEARS OF AGE AND OLDER: Apply or spray a thin layer to the infected area once or twice daily (twice for treatment of athlete's foot and ringworm) for 4 weeks.

Clinical Effects

Summary Of Exposure

    A) USES: Tolnaftate is used in the treatment and prevention of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
    B) PHARMACOLOGY: Tolnaftate is an antifungal. It inhibits the growth of dermatophytes epidermophyton, microsporum, trichophyton spp. and malassezia furfur; however, it is not active against candida spp.
    C) EPIDEMIOLOGY: Exposure can occur. Acute toxicity is unlikely.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: There are minimal reports of adverse reactions to tolnaftate. Skin irritation and local hypersensitivity reactions have been the primary adverse effects reported.
    E) WITH POISONING/EXPOSURE
    1) OVERDOSE: No reports of exposure. Overdose events are anticipated to be similar to adverse events. A minor or inadvertent ingestion is not anticipated to result in significant toxicity.

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) HYPERSENSITIVITY REACTION
    1) WITH THERAPEUTIC USE
    a) Hypersensitivity reactions have occurred which have been confirmed by patch testing to be due to tolnaftate. The reactions have been limited to the local area only with no reports of systemic activity (Gellin et al, 1972; Emmett & Marrs, 1973).
    b) Patch testing has also confirmed allergic reactions to monoamylamine, an ingredient in tolnaftate cream (Tharp, 1973).
    B) SKIN IRRITATION
    1) WITH THERAPEUTIC USE
    a) Skin irritation may occur with therapeutic use (Prod Info tolnaftate topical cream, 2005).

Reproductive

    3.20.1) SUMMARY
    A) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.
    3.20.2) TERATOGENICITY
    A) LACK OF EFFECT
    1) No problems with the use of topical tolnaftate during pregnancy have been documented (USPDI, 1988).
    3.20.3) EFFECTS IN PREGNANCY
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.

Carcinogenicity

    3.21.2) SUMMARY/HUMAN
    A) At the time of this review, no data were available to assess the carcinogenic potential of this agent.
    3.21.3) HUMAN STUDIES
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the carcinogenic potential of this agent.

Genotoxicity

    A) At the time of this review, no data were available to assess the mutagenic or genotoxic potential of this agent.

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) No specific laboratory studies are indicated and are unlikely to be needed.
    B) Obtain a baseline CBC and assess electrolytes and liver and renal function as indicated following a significant ingestion.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) No specific laboratory studies are indicated and are unlikely to be needed.
    2) Obtain a baseline CBC and assess electrolytes and liver and renal function as indicated following a significant ingestion.
    4.1.3) URINE
    A) URINALYSIS
    1) Monitoring urinalysis as indicated following a significant exposure.

Methods

    A) CHROMATOGRAPHY
    1) Tolnaftate has been determined in commercial products via reverse-phase liquid chromatography (Thompson & Carlson, 1991).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.2) HOME CRITERIA/ORAL
    A) Following an inadvertent dermal exposure with a topical product, cleanse the area with soap and water. Following an inadvertent ocular exposure, the eyes should be flushed copiously with water. An asymptomatic child that has inadvertently had a taste or minor ingestion of a topical product (ie, cream, solution) can be monitored at home with adult supervision. Children that develop more than mild symptoms (ie recurrent vomiting, difficulty breathing) should be sent to a healthcare center.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Consult a poison center or medical toxicologist for assistance in managing patients that develop severe toxicity or in whom the diagnosis is not clear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) Patients with a deliberate overdose, and those who are symptomatic, may need to be monitored for several hours. Due to limited experience, treatment is symptomatic and supportive. Patients that remain asymptomatic or are clearly improving and clinically stable can be discharged.

Monitoring

    A) No specific laboratory studies are indicated and are unlikely to be needed.
    B) Obtain a baseline CBC and assess electrolytes and liver and renal function as indicated following a significant ingestion.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) SUMMARY
    1) Gastrointestinal decontamination is unlikely to be necessary.
    6.5.2) PREVENTION OF ABSORPTION
    A) SUMMARY
    1) Gastrointestinal decontamination is unlikely to be necessary.
    6.5.3) TREATMENT
    A) SUPPORT
    1) Treatment is symptomatic and supportive.
    B) MONITORING OF PATIENT
    1) No specific laboratory studies are indicated and are unlikely to be needed. Obtain a baseline CBC and assess electrolytes and liver and renal function as indicated following a significant ingestion.

Eye Exposure

    6.8.1) DECONTAMINATION
    A) EYE IRRIGATION, ROUTINE: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, an ophthalmologic examination should be performed (Peate, 2007; Naradzay & Barish, 2006).

Dermal Exposure

    6.9.1) DECONTAMINATION
    A) DERMAL DECONTAMINATION
    1) DECONTAMINATION: Remove contaminated clothing and wash exposed area thoroughly with soap and water for 10 to 15 minutes. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).

Enhanced Elimination

    A) SUMMARY
    1) No studies have addressed the utilization of enhanced elimination techniques following tolnaftate oral exposure, but are unlikely to be necessary.

Range Of Toxicity

Summary

    A) TOXICITY: A toxic dose has not been established. At the time of this review, there are no reports of acute oral ingestion with tolnaftate. THERAPEUTIC DOSE: ADULT and CHILDREN 2 YEARS OF AGE AND OLDER: Apply or spray a thin layer to the infected area once or twice daily (twice for treatment of athlete's foot and ringworm) for 4 weeks.

Therapeutic Dose

    7.2.1) ADULT
    A) TOPICAL SOLUTION, POWDER, SPRAY, OR CREAM
    1) Apply or spray a thin layer to the infected area once or twice daily (twice for treatment of athlete's foot and ringworm) for 4 weeks (OTC Product Information, as posted to the DailyMed site 01/2014; OTC Product Information, as posted to the DailyMed site 09/2014; OTC Product Information, as posted to the DailyMed site 11/2014; OTC Product Information, as posted to the DailyMed site 10/2014).
    7.2.2) PEDIATRIC
    A) TOPICAL SOLUTION, POWDER, SPRAY, OR CREAM
    1) 2 YEARS OF AGE OR OLDER: Apply or spray a thin layer to the infected area once or twice daily (twice for treatment of athlete's foot and ringworm) for 4 weeks (OTC Product Information, as posted to the DailyMed site 01/2014; OTC Product Information, as posted to the DailyMed site 09/2014; OTC Product Information, as posted to the DailyMed site 11/2014; OTC Product Information, as posted to the DailyMed site 10/2014).
    2) UNDER 2 YEARS OLD: Not for use unless advised by a doctor (OTC Product Information, as posted to the DailyMed site 01/2014; OTC Product Information, as posted to the DailyMed site 09/2014; OTC Product Information, as posted to the DailyMed site 11/2014; OTC Product Information, as posted to the DailyMed site 10/2014).

Minimum Lethal Exposure

    A) SUMMARY
    1) The minimum lethal human dose of this agent has not been delineated.

Maximum Tolerated Exposure

    A) SUMMARY
    1) A toxic dose has not been established.
    2) At the time of this review, there are no reports of acute oral ingestion with tolnaftate.

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) LD50- (ORAL)RAT:
    1) Greater than 6 g/kg ((RTECS, 2000))
    B) LD50- (SUBCUTANEOUS)RAT:
    1) Greater than 4 g/kg ((RTECS, 2000))
    C) LD50- (ORAL)MOUSE:
    1) 10 g/kg ((RTECS, 2000))
    D) LD50- (SUBCUTANEOUS)MOUSE:
    1) Greater than 6 g/kg ((RTECS, 2000))

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Tolnaftate is known to distort the hyphae and stunts mycelial growth in susceptible fungi (USPDI, 1991). It inhibits the growth of dermatophytes epidermophyton, microsporum, trichophyton spp., and malassezia furfur; however, it is not active against candida spp. or bacteria (JEF Reynolds , 2000).

Physicochemical

Physical Characteristics

    A) A white to creamy-white fine powder, odorless to a slight odor (JEF Reynolds , 2000)

Molecular Weight

    A) 307.4 (JEF Reynolds , 2000)

References

General Bibliography

    1) Burgess JL, Kirk M, Borron SW, et al: Emergency department hazardous materials protocol for contaminated patients. Ann Emerg Med 1999; 34(2):205-212.
    2) Emmett EA & Marrs JM: Allergic contact dermatitis from tolnaftate. Arch Dermatol 1973; 108:98-99.
    3) Gellin GA, Maibach HI, & Wachs GN: Contact allergy to tolnaftate. Arch Dermatol 1972; 106:715-716.
    4) JEF Reynolds : Martindale: The Extra Pharmacopeia (Intranet version). The Pharmaceutical Press. London, UK (Internet Version). Edition expires 2000; provided by Truven Health Analytics Inc., Greenwood Village, CO.
    5) Naradzay J & Barish RA: Approach to ophthalmologic emergencies. Med Clin North Am 2006; 90(2):305-328.
    6) OTC Product Information: Athlete's Foot Liquid Spray topical spray, tolnaftate 1% topical spray. Dolgencorp, LLC., Goodlettsville, TN, as posted to the DailyMed site 11/2014.
    7) OTC Product Information: CVS ATHLETE'S FOOT CREAM topical cream, tolnaftate 1% topical cream. CVS Pharmacy, Inc., Woonsocket, RI, as posted to the DailyMed site 10/2014.
    8) OTC Product Information: Formula 3(R) Antifungal topical solution, tolnaftate 1% topical solution. The Tetra Corporation, Eaton Rapids, MI, as posted to the DailyMed site 01/2014.
    9) OTC Product Information: Tinactin(R) topical powder, tolnaftate 1% topical powder. MSD Consumer Care, Inc., Memphis, TN, as posted to the DailyMed site 09/2014.
    10) Peate WF: Work-related eye injuries and illnesses. Am Fam Physician 2007; 75(7):1017-1022.
    11) Product Information: tolnaftate topical cream, tolnaftate topical cream. G&W Laboratories, South Plainfield, NJ, 2005.
    12) RTECS : Registry of Toxic Effects of Chemical Substances. National Institute for Occupational Safety and Health. Cincinnati, OH (Internet Version). Edition expires 2000; provided by Truven Health Analytics Inc., Greenwood Village, CO.
    13) Tharp CK: Contact urticaria. Arch Dermatol 1973; 108:135.
    14) Thompson RD & Carlson M: Liquid chromatographic determination of tolnaftate in commercial products. J Assoc Off Anal Chem 1991; 74:603-607.
    15) USPDI: Advice for the Health Care Professional, 8th ed, US Pharmacopeial Convention, Inc, Rockvill, MD, 1988, pp 1134-1135.