Label: CLOTRIMAZOLE- clotrimazole lozenge 

  • NDC Code(s): 0054-4146-22, 0054-4146-23, 0054-8146-22
  • Packager: Roxane Laboratories, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 10/13

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  • SPL UNCLASSIFIED SECTION

    FOR TOPICAL ORAL ADMINISTRATION

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  • Rx only
  • DESCRIPTION

    Each Clotrimazole Troche (clotrimazole lozenges) USP contains 10 mg clotrimazole [1-(o-chloro-α,α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth.

    Structural Formula:

    chemical structure.jpg

    The troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole USP dispersed in croscarmellose sodium, dextrates, magnesium stearate, microcrystalline cellulose, and povidone.

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  • CLINICAL PHARMACOLOGY

    Clotrimazole is a broad-spectrum antifungal agent that inhibits the growth of pathogenic yeasts by altering the permeability of cell membranes. The action of clotrimazole is fungistatic at concentrations of drug up to 20 mcg/mL and may be fungicidal in vitro against Candida albicans and other species of the genus Candida at higher concentrations. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans in the laboratory; however, individual organism tolerance has been observed during successive passages in the laboratory. Such in vitro tolerance has resolved once the organism has been removed from the antifungal environment.

    After oral administration of a 10 mg clotrimazole troche to healthy volunteers, concentrations sufficient to inhibit most species of Candida persist in saliva for up to three hours following the approximately 30 minutes needed for a troche to dissolve. The long term persistence of drug in saliva appears to be related to the slow release of clotrimazole from the oral mucosa to which the drug is apparently bound. Repetitive dosing at three hour intervals maintains salivary levels above the minimum inhibitory concentrations of most strains of Candida; however, the relationship between in vitro susceptibility of pathogenic fungi to clotrimazole and prophylaxis or cure of infections in humans has not been established.

    In another study, the mean serum concentrations were 4.98 ± 3.7 and 3.23 ± 1.4 nanograms/mL of clotrimazole at 30 and 60 minutes, respectively, after administration as a troche.

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  • INDICATIONS AND USAGE

    Clotrimazole Troches (clotrimazole lozenges) USP are indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment.

    Clotrimazole Troches (clotrimazole lozenges) USP are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION.)

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  • CONTRAINDICATIONS

    Clotrimazole Troches (clotrimazole lozenges) USP are contraindicated in patients who are hypersensitive to any of its components.

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  • WARNING

    Clotrimazole Troches (clotrimazole lozenges) USP are not indicated for the treatment of systemic mycoses including systemic candidiasis.

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  • PRECAUTIONS

    Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials. In most cases the elevations were minimal and it was often impossible to distinguish effects of clotrimazole from those of other therapy and the underlying disease (malignancy in most cases). Periodic assessment of hepatic function is advisable particularly in patients with pre-existing hepatic impairment.

    Since patients must be instructed to allow each troche to dissolve slowly in the mouth in order to achieve maximum effect of the medication, they must be of such an age and physical and/or mental condition to comprehend such instructions.

    Carcinogenesis

    An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.

    Use In Pregnancy

    Pregnancy Category C: Clotrimazole has been shown to be embryotoxic in rats and mice when given in doses 100 times the adult human dose (in mg/kg), possibly secondary to maternal toxicity. The drug was not teratogenic in mice, rabbits, and rats when given in doses up to 200, 180, and 100 times the human dose.

    Clotrimazole given orally to mice from nine weeks before mating through weaning at a dose 120 times the human dose was associated with impairment of mating, decreased number of viable young, and decreased survival to weaning. No effects were observed at 60 times the human dose. When the drug was given to rats during a similar time period at 50 times the human dose, there was a slight decrease in the number of pups per litter and decreased pup viability.

    There are no adequate and well controlled studies in pregnant women. Clotrimazole troches should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Pediatric Use

    Safety and effectiveness of clotrimazole in children below the age of 3 years have not been established; therefore, its use in such patients is not recommended.

    The safety and efficacy of the prophylactic use of clotrimazole troches in children have not been established.

    Geriatric Use

    Clinical studies of clotrimazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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  • ADVERSE REACTIONS

    Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See PRECAUTIONS).

    Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.

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  • OVERDOSAGE

    No data available.

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  • DRUG ABUSE AND DEPENDENCE

    No data available.

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  • DOSAGE AND ADMINISTRATION

    Clotrimazole Troches (clotrimazole lozenges) USP are administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible.

    For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

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  • HOW SUPPLIED

    Clotrimazole Troches (clotrimazole lozenges) USP are white, flat face tablets that are plain on one side and embossed with “54 552” on the other side.

    Clotrimazole Troche (clotrimazole lozenges) USP, 10 mg

    0054-4146-22: Bottles of 70

    0054-4146-23: Bottles of 140

    0054-8146-22: 7 x 10 Unit-Dose Tablets

    Store below 86°F (30°C). Avoid freezing.

    10001777/07 Revised August 2013

    © RLI, 2013

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  • PRINCIPAL DISPLAY PANEL

    Roxane Laboratories, Inc.

    NDC 0054-4146-22

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  • Package/Label Display Panel

    Roxane Laboratories, Inc.

    NDC 0054-8146-22

    \\eu.boehringer.com\depts\col\groups\DRA-MA\LABELING\XML Files\Clotrimazole Troche\Labels\FPL 10001790_04.jpg
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  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole lozenge
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0054-4146
    Route of Administration ORAL, TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    DEXTRATES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 16mm
    Flavor Imprint Code 54;552
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0054-4146-22 70 in 1 BOTTLE, PLASTIC
    2 NDC:0054-4146-23 140 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076387 07/29/2004
    CLOTRIMAZOLE 
    clotrimazole lozenge
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0054-8146
    Route of Administration ORAL, TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    DEXTRATES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 16mm
    Flavor Imprint Code 54;552
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0054-8146-22 70 in 1 CARTON
    1 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076387 07/29/2004
    Labeler - Roxane Laboratories, Inc (833490464)
    Registrant - Roxane Laboratories, Inc (833490464)
    Establishment
    Name Address ID/FEI Business Operations
    Boehringer Ingelheim Roxane Inc 058839929 MANUFACTURE(0054-4146, 0054-8146)
    Establishment
    Name Address ID/FEI Business Operations
    Erregierre S.p.A. 437721244 API MANUFACTURE(0054-4146, 0054-8146)
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