No

Antifungal Agent, Oral Nonabsorbed; Antifungal Agent, Topical; Antifungal Agent, Vaginal

Dental: Treatment of susceptible fungal infections, including oropharyngeal candidiasis; limited data suggests that the use of clotrimazole troches may be effective for prophylaxis against oropharyngeal candidiasis in neutropenic patients

Medical: Treatment of susceptible fungal infections, including oropharyngeal, candidiasis, dermatophytoses, superficial mycoses, and cutaneous candidiasis, as well as vulvovaginal candidiasis; limited data suggest that clotrimazole troches may be effective for prophylaxis against oropharyngeal candidiasis in neutropenic patients

B (topical)/C (troches)

Hypersensitivity to clotrimazole or any component

Clotrimazole should not be used for treatment of systemic fungal infection; safety and effectiveness of clotrimazole lozenges (troches) in children <3 years of age have not been established

>10%: Hepatic: Abnormal LFTs, causal relationship between troches and elevated LFTs not clearly established

1% to 10%:

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

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

CYP3A3/4 and 3A5-7 enzyme inhibitor

Binds to phospholipids in the fungal cell membrane altering cell wall permeability resulting in loss of essential intracellular elements

Absorption: Topical: Negligible through intact skin

Time to peak serum concentration:

Oral topical administration: Salivary levels occur within 3 hours following 30 minutes of dissolution time in the mouth

Vaginal cream: High vaginal levels occur within 8-24 hours

Vaginal tablet: High vaginal levels occur within 1-2 days

Elimination: As metabolites via bile

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: Apply twice daily; if no improvement occurs after 4 weeks of therapy, re-evaluate diagnosis

Children >12 years and Adults:

Vaginal:

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

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

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

No data reported

Periodic liver function tests during oral therapy with clotrimazole lozenges

None reported

None reported

No information available to require special precautions

No effects or complications reported

Oral: Do not swallow oral medication whole; allow to dissolve slowly in mouth. You may experience nausea or vomiting (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report signs of opportunistic infection (eg, white plaques in mouth, fever, chills, perianal itching or vaginal discharge, fatigue, unhealed wounds or sores).

Topical: Wash hands before applying or wear gloves. Apply thin film of gel, lotion, or solution 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.

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

Administer around-the-clock rather than 4 times/day, 3 times/day, etc, (ie, 12-6-12-6, not 9-1-5-9) to promote less variation in peak and trough serum levels

Monitor periodic liver function tests during oral therapy with clotrimazole lozenges

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

Cream:

Topical (Lotrimin®, Lotrimin® AF, Mycelex®, Mycelex® OTC) : 1% (15 g, 30 g, 45 g, 90 g)

Vaginal (Femizole-7®, Gyne-Lotrimin®, Mycelex®-G): 1% (45 g, 90 g)

Lotion (Lotrimin®): 1% (30 mL)

Solution, topical (Fungoid®, Lotrimin®, Lotrimin® AF, Mycelex®, Mycelex® OTC): 1% (10 mL, 30 mL)

Tablet, vaginal (Gyne-Lotrimin®, Gynix®, Mycelex®-G): 100 mg (7s); 500 mg (1s)

Troche (Mycelex®): 10 mg

Twin pack (Mycelex®): Vaginal tablet 500 mg (1's) and vaginal cream 1% (7 g)

Duhm B, Medenwald H, Puetter J, et al, "The Pharmacokinetics of Clotrimazole 14C," Postgrad Med J, 1974, 50(Suppl 1):13-6.

Hughes D and Kriedman T, "Treatment of Vulvovaginal Candidiasis With a 500 mg Vaginal Tablet of Clotrimazole," Clin Ther, 1984, 6(5):662-8.