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Clotrimazole (Topical)


VA CLASSIFICATION
Primary: DE102{04}

Commonly used brand name(s): Canesten Cream; Canesten Solution; Canesten Solution with Atomizer; Clotrimaderm Cream; Lotrimin AF Cream; Lotrimin AF Lotion; Lotrimin AF Solution; Lotrimin Cream; Lotrimin Lotion; Lotrimin Solution; Mycelex Cream; Mycelex Solution; Myclo Cream; Myclo Solution; Myclo Spray Solution; Neo-Zol Cream.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antifungal (topical)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Candidiasis, cutaneous (treatment)—Topical clotrimazole is indicated in the treatment of cutaneous candidiasis (moniliasis) caused by Candida albicans (Monilia albicans) {01}.

Tinea corporis (treatment)
Tinea cruris (treatment) or
Tinea pedis (treatment)—Topical clotrimazole is indicated in the treatment of tinea corporis (ringworm of the body), tinea cruris (ringworm of the groin; jock itch), and tinea pedis (ringworm of the foot; athlete's foot) caused by Trichophyton rubrum , T. mentagrophytes , Epidermophyton floccosum (Acrothesium floccosum) , and Microsporum canis . {01}

Tinea versicolor (treatment)—Topical clotrimazole is indicated in the treatment of tinea versicolor (pityriasis versicolor; ``sun fungus'') caused by Pityrosporon orbiculare (Malassezia furfur) {01}.

[Paronychia (treatment)]1
[Tinea barbae (treatment)]1or
[Tinea capitis (treatment)]1—Topical clotrimazole is used in the treatment of paronychia, tinea barbae, and tinea capitis.

—Not all species or strains of a particular organism may be susceptible to clotrimazole.
1 Not included in Canadian product labeling.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    344.84 {11}

Mechanism of action/Effect:

Fungistatic; may be fungicidal, depending on concentration; inhibits biosynthesis of ergosterol or other sterols, damaging the fungal cell wall membrane and altering its permeability; as a result, loss of essential intracellular elements may occur {01}; also inhibits biosynthesis of triglycerides and phospholipids by fungi; in addition, inhibits oxidative and peroxidative enzyme activity, resulting in intracellular buildup of toxic concentrations of hydrogen peroxide, which may contribute to deterioration of subcellular organelles and cellular necrosis. In Candida albicans , inhibits transformation of blastospores into invasive mycelial form.

Absorption:

Dermal penetration; minimal systemic absorption. {01}


Precautions to Consider

Carcinogenicity

Studies in rats given oral doses of clotrimazole for 18 months have not shown that clotrimazole is carcinogenic. {01} {02} {03}

Mutagenicity

Studies in Chinese hamsters given clotrimazole in five oral doses of 100 mg per kg of body weight (mg/kg) prior to testing have shown no mutagenic effects in the spermatophore chromosomes. {01} {02} {03}

Pregnancy/Reproduction
Fertility—
Clotrimazole caused impairment of mating in studies in mice and rats given oral doses of 50 to 120 mg per kg (mg/kg). {01} {02} {03}

Pregnancy—
Adequate and well-controlled studies in humans have not been done during the first trimester. Studies in humans given intravaginal clotrimazole during the second and third trimesters have not shown that clotrimazole causes adverse effects on the fetus.

Studies in rats given intravaginal doses of up to 100 mg/kg have not shown that clotrimazole causes adverse effects on the fetus. {01} However, clotrimazole caused embryotoxicity, decreased litter size and number of viable young, and decreased pup survival to weaning in studies in mice and rats given oral doses of 50 to 120 mg/kg. Clotrimazole was not shown to be teratogenic in studies in mice, rabbits, and rats given oral doses of up to 200, 180, and 100 mg/kg, respectively. {01} {02} {03}

FDA Pregnancy Category B. {01} {02} {03}

Breast-feeding

It is not known whether clotrimazole, applied topically, is distributed into breast milk. {01} However, problems in humans have not been documented.

Pediatrics

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of topical clotrimazole in children.


Geriatrics


Appropriate studies on the relationship of age to the effects of topical clotrimazole have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to clotrimazole


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
    
Hypersensitivity{01} (skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before therapy)




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Clotrimazole (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to clotrimazole

Proper use of this medication
Proper administration technique

» Avoiding contact with the eyes

» Not applying occlusive dressing over this medication unless directed to do so by physician

» Compliance with full course of therapy

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

Precautions while using this medication
Checking with physician if no improvement within 4 weeks


Side/adverse effects
Signs of potential side effects, especially hypersensitivity reactions


General Dosing Information
Use of topical antifungals may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical use of the medication. {01}

Improvement of condition, with relief of pruritus, usually occurs within the first week of therapy.

When this medication is used in the treatment of candidiasis, occlusive dressings should be avoided since they provide conditions that favor growth of yeast and release of its irritating endotoxin.


Topical Dosage Forms

CLOTRIMAZOLE CREAM USP

Usual adult and adolescent dose
Antifungal (topical)
Topical, to the affected area of skin and surrounding areas, two times a day, morning and evening. {01}


Usual pediatric dose
Antifungal (topical)
See Usual adult and adolescent dose .


Strength(s) usually available
U.S.—
{01}{13}

1% (10 mg per gram) (Rx/OTC) [Lotrimin AF Cream (OTC) (benzyl alcohol 1%)] [Lotrimin Cream (Rx) (benzyl alcohol 1%)] [Mycelex Cream (OTC) (benzyl alcohol 1%)][Generic]

Canada—
{07}{08}

1% (10 mg per gram) (Rx) [Canesten Cream (benzyl alcohol 1%)] [Clotrimaderm Cream (benzyl alcohol 1%)] [Myclo Cream] [Neo-Zol Cream]

Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F). Store in a collapsible tube or in a tight container. Protect from freezing. {01}

Auxiliary labeling:
   • For external use only.
   • Continue medicine for full time of treatment.


CLOTRIMAZOLE LOTION USP

Usual adult and adolescent dose
Antifungal (topical)
See Clotrimazole Cream USP .


Usual pediatric dose
Antifungal (topical)
See Clotrimazole Cream USP .


Strength(s) usually available
U.S.—
{13}

1% (10 mg per gram) (Rx/OTC) [Lotrimin AF Lotion (OTC) (benzyl alcohol) (ceteryl alcohol)] [Lotrimin Lotion (Rx) (benzyl alcohol) (ceteryl alcohol)]

Canada—
Not commercially available.

Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F). Store in a tight container. Protect from freezing. {15}

Auxiliary labeling:
   • Shake well. {03}
   • For external use only.
   • Continue medicine for full time of treatment.


CLOTRIMAZOLE TOPICAL SOLUTION USP

Usual adult and adolescent dose
Antifungal (topical)
See Clotrimazole Cream USP .


Usual pediatric dose
Antifungal (topical)
See Clotrimazole Cream USP .


Strength(s) usually available
U.S.—
{13}{14}

1% (10 mg per mL) (Rx/OTC) [Lotrimin AF Solution (OTC) (polyethylene glycol)] [Lotrimin Solution (Rx) (polyethylene glycol)] [Mycelex Solution (OTC) (polyethylene glycol)]

Canada—
{07}{08}

1% (10 mg per mL) (Rx) [Canesten Solution (isopropyl alcohol)] [Canesten Solution with Atomizer (isopropyl alcohol)] [Myclo Solution (isopropyl alcohol)] [Myclo Spray Solution (isopropyl alcohol)]

Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F). Store in a tight container. Protect from freezing. {13}

Auxiliary labeling:
   • For external use only.
   • Keep container tightly closed.
   • Continue medicine for full time of treatment.



Revised: 03/29/1994



References

Note: References used in the development and earlier revisions of this monograph have not yet been incorporated into the computer database and, therefore, are not listed below. Citations for information not yet referenced in the monograph will be provided upon request.

  1. Mycelex Cream package insert (Miles—US), Rev /88, Rec 4/89.
  1. Mycelex Solution package insert (Miles—US), Rev 2/88, Rec 4/89.
  1. Lotrimin Lotion package insert (Schering—US), Rev 8/89.
  1. VA Medication Classification System. USP DI 1989: 2472.
  1. Lotrimin Cream package insert (Schering—US), Rev 8/89.
  1. PDR Physicians' desk reference. 42nd ed. 1988. Oradell, NJ: Medical Economics Company, 1988: 1455-6, 1922.
  1. Canesten Cream, Solution, Solution with Atomizer package insert (Miles—Canada), Rec 8/91.
  1. Myclo Cream, Solution, Spray Solution (Pump) product monograph (Boehringer-Ingelheim—Canada), Rev 3/81, Rec 6/89.
  1. PDR Physicians' desk reference. 43rd ed. 1989. Oradell, NJ: Medical Economics Company, 1989: 1455, 1553, 1937.
  1. McEvoy GK, editor. AHFS Drug information 1988. Bethesda, MD: American Society of Hospital Pharmacists, 1988: 1990.
  1. Fleeger CA, editor. USAN 1989. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1988: 144.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1991: 578a.
  1. Lotrimin Solution package insert (Schering—US), Rev 6/89.
  1. PDR Physicians' desk reference. 45th ed. 1991. Oradell, NJ: Medical Economics Data, 1991: 2002.
  1. Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 445.
  1. Lotrimin AF Cream package insert (Schering—US), Rec 4/90.
  1. Lotrimin AF Solution package insert (Schering—US), Rec 4/90.
  1. Lotrimin AF Lotion package insert (Schering—US), Rec 4/90.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23th ed. Ottawa: Canadian Pharmaceutical Association, 1988: 135, 581.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 26th ed. Ottawa: Canadian Pharmaceutical Association, 1991: 218, 269, 760, 786.
  1. PDR Physicians' desk reference for nonprescription drugs. 12th ed. 1991. Montvale, NJ: Medical Economics Data, 1991: 702.
  1. Lotrimin Cream, Lotion, Topical Solution package insert (Schering—US), Rev 7/91, Rec 12/93.
  1. FDC Rep Drugs Cosmet 1993 Oct: 15.
  1. Canesten products monograph (Miles—Canada), Rev 7/92, Rec 7/93.
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