Pronunciation:

(kloe TRIM a zole)

U.S. Brand Names:

Generic Available:

Canadian Brand Names:

Use:

Use - Dental:

Pregnancy Risk Factor:

Lactation:

Contraindications:

Warnings/Precautions:

Adverse Reactions:

Oral:

>10%: Hepatic: Abnormal liver function tests

1% to 10%:

Gastrointestinal: Nausea and vomiting may occur in patients on clotrimazole troches

Local: Mild burning, irritation, stinging to skin or vaginal area

Vaginal:

1% to 10%: Genitourinary: Vulvar/vaginal burning

<1% (Limited to important or life-threatening): Vulvar itching, soreness, edema, or discharge; polyuria; burning or itching of penis of sexual partner

Drug Interactions:

CYP3A4 substrates: Clotrimazole may increase the levels/effects of CYP3A4 substrates. Example substrates include benzodiazepines, calcium channel blockers, cyclosporine, mirtazapine, nateglinide, nefazodone, sildenafil (and other PDE-5 inhibitors), tacrolimus, and venlafaxine. Selected benzodiazepines (midazolam and triazolam), cisapride, ergot alkaloids, selected HMG-CoA reductase inhibitors (lovastatin and simvastatin), and pimozide are generally contraindicated with strong CYP3A4 inhibitors.

Mechanism of Action:

Pharmacodynamics/Kinetics:

Absorption: Topical: Negligible through intact skin

Time to peak, serum:

Oral topical (troche): Salivary levels occur within 3 hours following 30 minutes of dissolution time

Vaginal cream: High vaginal levels: 8-24 hours

Vaginal tablet: High vaginal levels: 1-2 days

Excretion: Feces (as metabolites)

Dosage:

Children >3 years and Adults:

Oral:

Prophylaxis: 10 mg troche dissolved 3 times/day for the duration of chemotherapy or until steroids are reduced to maintenance levels

Treatment: 10 mg troche dissolved slowly 5 times/day for 14 consecutive days

Topical (cream, solution): Apply twice daily; if no improvement occurs after 4 weeks of therapy, re-evaluate diagnosis

Children >12 years and Adults:

Vaginal:

Cream:

1%: Insert 1 applicatorful vaginal cream daily (preferably at bedtime) for 7 consecutive days

2%: Insert 1 applicatorful vaginal cream daily (preferably at bedtime) for 3 consecutive days

Tablet: Insert 100 mg/day for 7 days or 500 mg single dose

Topical (cream, solution): Apply to affected area twice daily (morning and evening) for 7 consecutive days

Administration:

Oral (troche): Allow to dissolve slowly over 15-30 minutes.

Topical: Avoid contact with eyes. For external use only. Apply sparingly. Protect hands with latex gloves. Do not use occlusive dressings.

Monitoring Parameters:

Patient Education:

Topical: Avoid contact with eyes. Wash hands before applying or wear gloves. Apply thin film to affected area. May apply porous dressing. Report persistent burning, swelling, itching, worsening of condition, or lack of response to therapy.

Vaginal: Wash hands before using. Insert full applicator into vagina gently and expel cream, or insert tablet into vagina, at bedtime. Wash applicator with soap and water following use. Remain lying down for 30 minutes following administration. Avoid intercourse during therapy (sexual partner may experience penile burning or itching). Report adverse reactions (eg, vulvar itching, frequent urination), worsening of condition, or lack of response to therapy. Contact prescriber if symptoms do not improve within 3 days or you do not feel well within 7 days. Do not use tampons until therapy is complete. Contact prescriber immediately if you experience abdominal pain, fever, or foul-smelling discharge.

Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Oncology: Emetic Potential:

Dosage Forms:

Combination pack (Mycelex®-7): Vaginal tablet 100 mg (7s) and vaginal cream 1% (7 g)

Cream, topical: 1% (15 g, 30 g, 45 g)

Cruex®: 1% (15 g)

Lotrimin® AF Athlete's Foot: 1% (12 g, 24 g)

Lotrimin® AF Jock Itch: 1% (12 g)

Cream, vaginal: 2% (21 g)

Mycelex®-7: 1% (45 g)

Solution, topical: 1% (10 mL, 30 mL)

Lotrimin® AF Athlete's Foot: 1% (10 mL)

Tablet, vaginal (Gyne-Lotrimin® 3): 200 mg (3s)

Troche (Mycelex®): 10 mg

International Brand Names: