CLOTRIMAZOLE cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis . Clotrimazole cream USP is contraindicated in individuals sensitive to its components.
Product summary:
Clotrimazole Cream USP, 1% is supplied in 15 g ( NDC 68071-2315-5) Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
68071-2315-5

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CLOTRIMAZOLE- clotrimazole cream

NuCare Pharmaceuticals,Inc.

----------

Clotrimazole

Cream USP, 1%

For external use only.

Not for ophthalmic use.

Rx only

DESCRIPTION

Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical

name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C

; a molecular

weight of 344.84; and the structural formula:

Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly

soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform.

Each gram of clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base

of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan

monostearate, and benzyl alcohol (1%) as preservative.

CLINICAL PHARMACOLOGY

Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections

caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur. The primary

action of clotrimazole is against dividing and growing organisms.

In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum,

Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis and Candida species

including Candida albicans. In general, the in vitro activity of clotrimazole corresponds to that of

tolnaftate and griseofulvin against the mycelia of dermatophytes ( Trichophyton, Microsporum, and

Epidermophyton), and to that of the polyenes (amphotericin B and nystatin) against budding fungi (

Candida). Using an in vivo (mouse) and an in vitro (mouse kidney homogenate) testing system,

clotrimazole and miconazole were equally effective in preventing the growth of the pseudomycelia and

mycelia of Candida albicans.

Strains of fungi having a natural resistance to clotrimazole are rare. Only a single isolate of Candida

guilliermondi has been reported to have primary resistance to clotrimazole.

No single-step or multiple-step resistance to clotrimazole has developed during successive passages

of Candida albicans and Trichophyton mentagrophytes. No appreciable change in sensitivity was detected

after successive passage of isolates of C. albicans, C. krusei, or C. pseudotropicalis in liquid or solid

media containing clotrimazole. Also, resistance could not be developed in chemically induced mutant

strains of polyene-resistant strains of polyene-resistant isolates of C. albicans. Slight, reversible

resistance was noted in three isolates of C. albicans tested by one investigator. There is a single report

that records the clinical emergence of C. albicans strain with considerable resistance to flucytosine and

miconazole, and with cross-resistance to clotrimazole, the strain remained sensitive to nystatin and

amphotericin B.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused

leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of

cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively

after addition of the drug.

Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated

mainly as inactive metabolites. Following topical and vaginal administration, however, clotrimazole

appears to be minimally absorbed.

Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and

acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm

in the stratum

corneum to 0.5 to 1 mcg/cm

in the stratum reticulare, and 0.1 mcg/cm

in the subcutis. No measurable

amount of radioactivity (≤0.001 mcg/mL) was found in the serum within 48 hours after application under

occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream. Only 0.5% or less of the applied

radioactivity was excreted in the urine.

Following intravaginal administration of 100 mg

C-clotrimazole vaginal tablets to nine adult females,

an average peak serum level, corresponding to only 0.03 μg equivalents/mL of clotrimazole, was

reached one to two days after application. After intravaginal administration of 5 g of 1%

clotrimazole vaginal cream containing 50 mg active drug, to five subjects (one with candidal colpitis),

serum levels corresponding to approximately 0.01 μg equivalents/mL were reached between 8 and 24

hours after application.

INDICATIONS AND USAGE

Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and

tinea versicolor due to Malassezia furfur.

Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of

the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum,

Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.

CONTRAINDICATIONS

Clotrimazole cream USP is contraindicated in individuals sensitive to its components.

WARNINGS

Clotrimazole cream USP is not for ophthalmic use.

PRECAUTIONS

General

If irritation or sensitivity develops with the use of clotrimazole cream, treatment should be discontinued

and appropriate therapy instituted.

Information for Patients

The patient should be advised to:

1. Use the medication for the full treatment time even though the symptoms may have improved.

Notify the physician if there is no improvement after four weeks of treatment.

2. Inform the physician if the area of application shows signs of increased irritation (redness, itching,

burning, blistering, swelling, oozing) indicative of possible sensitization.

3. Avoid the use of occlusive wrappings or dressings.

4. Avoid sources of infection or reinfection.

Laboratory Tests

If there is a lack of response to clotrimazole cream, appropriate microbiological studies should be

repeated to confirm the diagnosis and rule out other pathogens before instituting another course of

antimycotic therapy.

Drug Interactions

Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against

strains of C. albicans has not been reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been

exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing,

the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight. The results of this

study showed that clotrimazole had not mutagenic effect.

Usage in Pregnancy

Pregnancy Category B

The disposition of

C-clotrimazole has been studied in humans and animals. Clotrimazole is very

poorly absorbed following dermal application or intravaginal administration to humans. (See

CLINICAL PHARMACOLOGY.)

In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third

trimesters has not been associated with ill effects. There are, however, no adequate and well-controlled

studies in pregnant women during their first trimester of pregnancy.

Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to

the fetus due to clotrimazole.

High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in

embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and

number of viable young and decreased pup survival to weaning. However, clotrimazole was not

teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg respectively. Oral

absorption in the rats amounts to approximately 90% of the administered dose.

Because animal reproductive studies are not always predictive of human response, this drug should be

used only if clearly indicated during the first trimester of pregnancy.

Nursing Mothers

It is not known whether this drug is excreted in human milk, caution should be exercised when

clotrimazole is used by a nursing woman.

Pediatric Use

Safety and effectiveness in children have been established for clotrimazole when used as indicated and

in the recommended dosage.

ADVERSE REACTIONS

The following adverse reactions have been reported in connection with the use of this product:

erythema, stinging, blistering, peeling, edema, pruritus, urticaria, burning, and general irritation of the

skin.

OVERDOSAGE

Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to

lead to a life-threatening situation.

DOSAGE AND ADMINISTRATION

Gently massage sufficient Clotrimazole Cream USP, 1% into the affected and surrounding skin areas

twice a day, in the morning and evening.

Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with

clotrimazole cream. If the patient shows no clinical improvement after four weeks of treatment with

clotrimazole cream, the diagnosis should be reviewed.

HOW SUPPLIED

Clotrimazole Cream USP, 1% is supplied in 15 g ( NDC 68071-2315-5)

Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Revised: November, 2014

PK-0739-6

1114-6

PRINCIPAL DISPLAY PANEL

CLOTRIMAZOLE

clotrimazole cream

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 0 71-2315(NDC:516 72-1275)

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CLO TRIMAZO LE (UNII: G0 7GZ9 7H6 5) (CLOTRIMAZOLE - UNII:G0 7GZ9 7H6 5)

CLOTRIMAZOLE

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

CETYL ESTERS WAX (UNII: D0 72FFP9 GU)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

WATER (UNII: 0 59 QF0 KO0 R)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

NuCare Pharmaceuticals,Inc.

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-2315-5

1 in 1 CARTON

12/15/20 20

1

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 726 40

0 8 /31/19 9 3

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re la be l(6 8 0 71-2315)

Revised: 12/2020

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