Clotrimazole

DRUG IMAGES

CLOTRIMAZOLE 1% SOLUTION
CLOTRIMAZOLE 1% TOPICAL CREAM
CLOTRIMAZOLE 1% VAGINAL CREAM

The following indications for CLOTRIMAZOLE (clotrimazole) have been approved by the FDA:

Indications:
Cutaneous candidiasis
Diaper rash
Tinea corporis
Tinea cruris
Tinea pedis
Tinea versicolor
Vulvovaginal candidiasis

Professional Synonyms:
Corporeal ringworm
Cutaneous candidosis
Cutaneous moniliasis
Dermatomycosis pedis
Dhobie itch
Diaper dermatitis
Eczema marginatum
Jock itch
Pityriasis versicolor
Tinea circinata
Tinea furfuracea
Tinea glabrosa
Tinea inguinalis
Tinea of the foot
Vaginal candidiasis
Vulvovaginal candidosis
Vulvovaginal moniliasis

The following dosing information is available for CLOTRIMAZOLE (clotrimazole):

Dosing
Administration
CLOTRIMAZOLE
CLOTRIMAZOLE

No enhanced Dosing information available for this drug.

Clotrimazole is administered topically to the oropharyngeal area as an oral lozenge, to the skin as a cream or solution, or intravaginally as a vaginal cream. The topical cream and solution are not intended for ophthalmic use. Clotrimazole also is available in fixed combination with betamethasone dipropionate as a cream or lotion; see prescribing information for the combination product for additional details.

Store clotrimazole oral lozenges, topical cream, and topical solution at 20--25degreesC. Avoid freezing oral lozenges.

Dosing information for CLOTRIMAZOLE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CLOTRIMAZOLE 1% SOLUTION	Maintenance	Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening
CLOTRIMAZOLE 1% TOPICAL CREAM	Maintenance	Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening

Generic dosing information for CLOTRIMAZOLE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CLOTRIMAZOLE 1% TOPICAL CREAM	Maintenance	Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening
CLOTRIMAZOLE 1% SOLUTION	Maintenance	Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening
CVS CLOTRIMAZOLE 1% TOP CREAM	Maintenance	Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening
CVS CLOTRIMAZOLE 1% SOLUTION	Maintenance	Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening
TM-CLOTRIMAZOLE 1% TOP CREAM	Maintenance	Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening
QC CLOTRIMAZOLE 1% TOP CREAM	Maintenance	Adults apply to the affected and surrounding areas of skin by topical route 2 times per day in the morning and evening

Moderate List
No disease contraindications

The following adverse reaction information is available for CLOTRIMAZOLE (clotrimazole):

Overview
Severe
Less Severe

Adverse reaction overview.

Lozenge: nausea, vomiting, unpleasant mouth sensations, and pruritus. Topical cream or solution: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, and general irritation of skin.

There are 19 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal desquamation Abnormal vaginal bleeding Anaphylaxis Angioedema Blistering skin Bronchospastic pulmonary disease Dermatitis due to topical drug Dyspnea Edema Erythema Hypersensitivity drug reaction Hypotension Pruritus of skin Skin irritation Skin rash Stinging of skin Syncope Toxic epidermal necrolysis Urticaria

There are 20 less severe adverse reactions.

More Frequent	Less Frequent
None.	Dysmenorrhea Fever Genital organ pruritus Vaginal discharge

Rare/Very Rare
Acute abdominal pain Chills Contact dermatitis Cystitis Dizziness Facial edema Flu-like symptoms General weakness Headache disorder Nausea Pruritus of skin Skin rash Vaginal burning Vaginal irritation Vaginitis Vulvovaginal pain

The following precautions are available for CLOTRIMAZOLE (clotrimazole):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of clotrimazole lozenges have not been established in children <3 years of age. Safety and efficacy of prophylactic therapy with clotrimazole lozenges have not been established in children. Clotrimazole topical cream or solution is not recommended for self-medication in children <3 years of age.

Clotrimazole vaginal cream is not recommended for self-medication in children <12 years of age. Preparations containing clotrimazole in fixed combination with betamethasone dipropionate are not recommended for use in children <17 years of age or for diaper dermatitis.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

There are no adequate and controlled studies of clotrimazole lozenges in pregnant women; the drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. In clinical trials, use of intravaginal clotrimazole in pregnant women in the second and third trimester was not associated with adverse effects; there are no adequate and well-controlled studies in pregnant women in the first trimester. . In animal reproductive studies, clotrimazole demonstrated embryotoxic effects, but was not teratogenic when given in doses significantly higher than the recommended human dose.

It is not known whether clotrimazole is excreted in human milk, caution should be exercised when the drug is used in nursing woman.

There were an insufficient number of patients >=65 years of age in clinical studies of clotrimazole lozenges to determine whether geriatric patients respond differently from younger patients; other reported experience did not find any differences in response between these patients.

The following icd codes are available for CLOTRIMAZOLE (clotrimazole)'s list of indications:

Cutaneous candidiasis
B37.2	Candidiasis of skin and nail
Diaper rash
L22	Diaper dermatitis
Tinea corporis
B35.4	Tinea corporis
Tinea cruris
B35.6	Tinea cruris
Tinea pedis
B35.3	Tinea pedis
Tinea versicolor
B36.0	Pityriasis versicolor
Vulvovaginal candidiasis
B37.3	Candidiasis of vulva and vagina
B37.31	Acute candidiasis of vulva and vagina
B37.32	Chronic candidiasis of vulva and vagina