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Clotrimazole

Pronunciation: (kloe-TRIM-uh-zole)
Class: Antifungal, Mouth and throat product, Vaginal antifungal

Trade Names:
Cruex
- Cream 1%

Trade Names:
Desenex
- Cream 1%

Trade Names:
Gyne-Lotrimin 3
- Vaginal suppositories 200 mg
- Vaginal cream 2%

Trade Names:
Gyne-Lotrimin 3 Combination Pack
- Vaginal suppositories 200 mg
- Topical cream 1%

Trade Names:
Gyne-Lotrimin 7
- Vaginal cream 1%

Trade Names:
Lotrimin AF
- Cream 1%
- Solution, topical 1%
- Lotion 1%

Trade Names:
Mycelex
- Troches 10 mg

Trade Names:
Mycelex-7
- Vaginal cream 1%

Trade Names:
Mycelex-7 Combination Pack
- Vaginal suppositories 100 mg
- Topical cream 1%

Canesten Topical (Canada)
Canesten Vaginal (Canada)
Clotrimaderm (Canada)

Pharmacology

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Inhibits yeast growth by increasing cell membrane permeability in susceptible fungi.

Pharmacokinetics

Absorption

After oral administration, the mean serum concentrations were about 4.98 and 3.23 ng/mL at 30 and 60 min, respectively. Minimally absorbed following topical and vaginal administration.

Indications and Usage

Topical use

Treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), candidiasis, and tinea versicolor.

Oral use (troche)

Treatment of oropharyngeal candidiasis; prophylaxis of oropharyngeal candidiasis in specific groups of immunocompromised patients.

Vaginal use

Treatment of vulvovaginal candidiasis.

Contraindications

Standard considerations.

Dosage and Administration

Oropharyngeal Candidiasis
Adults and Children Older Than 3 yr of Age

PO One 10 mg troche (lozenge) dissolved slowly in the mouth 5 times/day for 14 days.

Prophylaxis

PO One 10 mg troche dissolved slowly in the mouth 3 times daily.

Dermal Infections

Topical cream Apply thin layer to affected and surrounding areas twice daily in the morning and evening. Topical lotion Apply thin layer to affected areas twice daily.

Vaginal Infections
Women and Girls Older Than 12 Yr of Age

Intravaginal Insert 1 applicatorful (5 g) of cream or one suppository at bedtime for 7 to 14 days (treatment for 14 days may yield higher cure rate).

Gyne-Lotrimin Combination Pack

Insert suppository intravaginally at bedtime for 7 consecutive days. Apply topical cream to affected areas twice daily (morning and evening) for 7 consecutive days.

Mycelex 7 Combination Pack

Insert suppository intravaginally at bedtime for 7 consecutive days. Apply topical cream to affected area twice daily (morning and evening) for 7 consecutive days.

General Advice

Topical cream, lotion, solution
For topical use only. Not for ophthalmic use.
Avoid contact with eyes. If eye contact occurs, flush immediately and thoroughly with water.
Shake lotion well before application.
Use gloves if applying cream, lotion, or solution on patient; thoroughly massage cream or lotion into the affected and surrounding skin areas twice daily.

Vaginal cream and tablets
For vaginal use only. Not for oral or ophthalmic use.

Oral troche
For treatment of oropharyngeal infections only. Not for intravaginal use or to treat systemic fungal infections.
Have patient slowly dissolve troche in mouth. Instruct patient not to chew or swallow troche and to retain saliva as long as possible before swallowing.

Storage/Stability

Topical cream, lotion, solution

Store cream and lotion in refrigerator (36° to 46°F) or at controlled room temperature (59° to 86°F). Keep tightly capped.

Vaginal cream and tablets

Store vaginal cream and tablets at controlled room temperature (less than 86°F). Protect from freezing.

Oral troche

Store troches at controlled room temperature (below 86°F). Protect from freezing.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Pruritus; erythema, stinging, blistering, peeling, edema, urticaria, burning, general skin irritation, rash (topical and vaginal products).

EENT

Unpleasant mouth sensations (troche).

GI

Nausea, vomiting (troche).

Hepatic

Abnormal LFT results (troche).

Precautions

Monitor

Microbiological studies

Ensure that appropriate microbiological studies are completed before starting therapy and repeated to confirm diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.

Oral troche adverse reactions

Notify health care provider if patient using oral troche develops nausea, vomiting, abdominal cramps or discomfort, or unpleasant mouth sensations.

Response to therapy

Monitor patient's response to therapy. Notify health care provider if symptoms do not improve or worsen.

Skin sensitivity

Notify health care provider if skin inflammation, irritation, or sensitization are noted at cream, lotion, or solution application site(s).

Transaminases

Ensure that transaminases are determined periodically during prolonged therapy with oral troches, especially in patient with pre-existing hepatic function impairment.

Pregnancy

Category C (troches); Category B (topical and vaginal use).

Lactation

Undetermined.

Children

Oral (troches)

Safety not established in children younger than 3 yr of age.

Topical

Safety and efficacy not established in children younger than 2 yr of age.

Recurrent infections

May indicate underlying medical cause, including diabetes or HIV infection.

Systemic or ophthalmic infections

Do not use for these conditions.

Patient Information

Instruct patient using OTC products to carefully read and follow the instructions that come with each package.
Caution patient or caregiver to avoid contact with eyes and that if accidental eye contact occurs to immediately flush the eyes with water to remove medication. Advise patient or caregiver to notify health care provider if eye irritation or sensitivity follows exposure to the eyes.

Topical Cream, Solution, or Lotion
Teach patient or caregiver proper technique for applying cream, lotion, or solution: wash hands; use gloves if applying to another person; thoroughly massage medication into affected and surrounding skin areas.
Advise patient that improvement in symptoms may take up to a wk to occur and to notify health care provider if there is no improvement after 4 wk.
Advise patient to use medication for the full treatment time even if symptoms have improved.
Advise patient to notify health care provider if application site shows signs of increased irritation (redness, itching, burning, itching, blistering, swelling, oozing).

Vaginal Cream and Vaginal Tablets
Teach patient proper technique for inserting vaginal cream or suppository. Advise patient that cream may also be applied to irritated area(s) of vulva to relieve external vaginal itching.
Caution patient that cream may reduce the effectiveness of vaginal spermicides and may damage condoms and diaphragms, causing them to fail. Advise patient to use another method of birth control while using vaginal cream.
Advise patient to avoid using tampons while infection is being treated with this medication.
Advise patient to notify health care provider if any of the following occur: symptoms do not improve after 3 days of treatment or persist for more than 7 days; stomach or pelvic pain; fever; foul-smelling discharge; infection returns within 2 mo.

Oral Troche
Teach patient proper technique for using oral troche as follows: slowly dissolve troche in mouth and retain saliva as long as possible before swallowing. Caution patient not to chew or swallow the troche.
Advise patient to notify health care provider if any of the following occur: nausea, vomiting, abdominal cramps or discomfort, unpleasant mouth sensations, symptoms do not improve or worsen.