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| Product NDC Code | 0574-0107 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Clotrimazole |
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| Type | Generic | ||||||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | LOZENGE | ||||||||
| RxCUI drug identifier | 309371 | ||||||||
| Application Number | ANDA076763 | ||||||||
| Labeler Name | Padagis US LLC | ||||||||
| Packages |
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Drug abuse and dependence
Information about whether the drug is a controlled substance, the types of abuse that can occur with the drug, and adverse reactions pertinent to those types of abuse.DRUG ABUSE AND DEPENDENCE No data available.
Overdosage of clotrimazole
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE No data available.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Abnormal liver function tests have been reported in patients treated with clotrimazole lozenges; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See Precautions section). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the lozenge.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 lozenge 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 lozenge 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 lozenge.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Clotrimazole lozenges are contraindicated in patients who are hypersensitive to any of its components.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Each clotrimazole lozenge contains 10 mg clotrimazole [1-(o-chloro-α, α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. Structural Formula: Chemical Formula: C 22 H 17 ClN 2 The lozenge dosage form is a large, slowly dissolving tablet (troche) containing 10 mg of clotrimazole dispersed in dextrose, microcrystalline cellulose, povidone, and magnesium stearate. structural formula
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Clotrimazole lozenges must be slowly dissolved in the mouth. The recommended dose is one lozenge five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole lozenge 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 lozenge three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Clotrimazole lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnoses should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole lozenges 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 .)
Spl product data elements
Usually a list of ingredients in a drug product.Clotrimazole clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE DEXTROSE, UNSPECIFIED FORM MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED MAGNESIUM STEARATE PAD;0107
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis: An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 0574-0107-70 Rx Only Clotrimazole Lozenge (Clotrimazole Troche) 10 mg DESCRIPTION: Each lozenge contains 10 mg of clotrimazole, [1-(ο-chloro-α,α-diphenylbenzyl)imidazole]. DOSAGE: Each lozenge must be dissolved slowly in the mouth. See accompanying literature for complete information. Dispense in tight containers (USP). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. 70 Lozenges The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. label image serialization-template
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.FOR TOPICAL ORAL ADMINISTRATION
Manufactured By Padagis Minneapolis, MN 55427 2204645 Rev 05-22A 8N904 RC F3
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.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.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.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 lozenges in children have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Usage 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 lozenges should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Clotrimazole lozenges, 10 mg, white discoid, uncoated tablets, debossed with "PAD" over "0107" on one side and plain on the other, are supplied as follows: Strength NDC Code Lozenge Identification Bottles of 70: 10 mg 0574-0107-70 PAD 0107 Bottles of 140: 10 mg 0574-0107-14 PAD 0107 Boxes of 70 foil packs: 10 mg 0574-0107-77 PAD 0107 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. Rx Only
Storage and handling
Information about safe storage and handling of the drug product.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. Rx Only
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Abnormal liver function tests have been reported in patients treated with clotrimazole lozenges; 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 lozenge 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. Usage 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 lozenges 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 lozenges 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNING Clotrimazole lozenges are not indicated for the treatment of systemic mycoses including systemic candidiasis.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API