Document
DailyMed Label: CLOTRIMAZOLE
Title
DailyMed Label: Clotrimazole
Date
2009
Document type
DailyMed Prescription
Name
Clotrimazole
Generic name
clotrimazole
Manufacturer
Physicians Total Care, Inc.
Product information
NDC: 54868-5463
Product information
NDC: 54868-5463
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.
image of chemical structure
Indications
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.)
Dosage
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.
Contraindications
Clotrimazole lozenges are contraindicated in patients who are hypersensitive to
any of its components.
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.
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).
How supplied
Clotrimazole lozenges, white discoid, uncoated tablets are
supplied in bottles of 70 and 140. Each lozenge is debossed with "PAD" over
"0107" on one side and plain on the other side.
Strength
NDC Code
Lozenge Identification
Bottles of 35:
10 mg
54868-5463-0
PAD 0107
Bottles of 70:
10 mg
54868-5463-1
PAD 0107
Store below 86°F (30°C).
Avoid freezing.
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.
Package label
Clotrimazole Troche Lozenges, 10 mg
image of package labels for 10 mg lozenges
12 organizations
1 product
Product
CLOTRIMAZOLEOrganization
STAT RX USA LLCOrganization
RPK Pharmaceuticals, Inc.Organization
NuCare Pharmaceuticals,Inc.Organization
A-S Medication SolutionsOrganization
Proficient Rx LPOrganization
Bayer Pharmaceuticals CorpOrganization
REMEDYREPACK INC. Organization
Rising Pharma Holdings, Inc.Organization
Padagis US LLCOrganization
Hikma Pharmacuticals USA USA Inc.Organization
RoxaneOrganization
Physicians Total Care, Inc.