clotrimazole
FemCare, Gyne-Lotrimin, Lotrimin, Lotrimin AF, Mycelex, Mycelex-G, Mycelex OTC, Mycelex-7

Available forms
Available by prescription only
Oral lozenges: 10 mg
Topical cream: 1%
Topical lotion: 1%
Topical solution: 1%
Vaginal tablets: 100 mg, 200 mg, 500 mg
Combination pack: Vaginal tablets 500 mg/topical cream 1% 7 g
Vaginal cream: 1%
Vaginal tablets: 100 mg, 200 mg

Indications and dosages
 Tinea pedis, tinea cruris, tinea versicolor, tinea corporis, cutaneous candidiasis. Adults and children: Apply thin layer and massage into cleansed affected and surrounding area, morning and evening, for prescribed period (usually 1 to 4 weeks; however, therapy may take up to 8 weeks).
 Vulvovaginal candidiasis. Adults: Insert one tablet intravaginally h.s. for 7 consecutive days. If vaginal cream is used, insert one applicatorful intravaginally, h.s. for 7 to 14 consecutive days.
 Treatment of oropharyngeal candidiasis. Adults and children: Usual dosage is one lozenge P.O. five times daily for 14 consecutive days.
 Prophylaxis of oropharyngeal candidiasis in immunocompromised patients. Adults: One lozenge t.i.d. for duration of chemotherapy.

Pharmacodynamics
Antifungal action: Clotrimazole alters cell membrane permeability by binding with phospholipids in the fungal cell membrane. Clotrimazole inhibits or kills many fungi, including yeast and dermatophytes, and also is active against various species of gram-positive bacteria.

Pharmacokinetics
Absorption: Absorption is limited with topical administration. Absorption following dissolution of a lozenge in the mouth not determined.
Distribution: Distributed minimally with local application.
Metabolism: Unknown.
Excretion: Unknown.

Contraindications and precautions
Contraindicated in patients hypersensitive to drug. Also contraindicated for ophthalmic use.

Interactions
None reported.

Adverse reactions
GI: nausea, vomiting, unpleasant mouth sensation (with lozenges); lower abdominal cramps.
GU: mild vaginal burning or irritation (with vaginal use), cramping, urinary frequency.
Skin: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, skin fissures, general irritation.

Effects on lab test results
• May increase liver enzyme levels.

Overdose and treatment
No information available.

Special considerations
• Improvement usually occurs within 1 week; if no improvement occurs in 4 weeks, review diagnosis.
• Patients given clotrimazole oral lozenges, especially those who have liver dysfunction, should have periodic liver function tests.
Pregnant patients
• Use lozenges only when potential benefits outweigh the risks.
Breast-feeding patients
• It’s unknown if drug appears in breast milk. Use cautiously in breast-feeding women.
Pediatric patients
• Lozenge form isn’t recommended for use in children younger than age 3. Don’t use topical forms in children younger than age 2. Clotrimazole vaginal tablets and cream shouldn’t be used for self-medication in children younger than age 12.

Patient education
• Advise patient that lozenges must dissolve slowly (15 to 30 minutes) in the mouth to achieve maximum effect. Tell patient not to chew lozenges.
• Instruct patients using intravaginal application to insert drug high into the vagina and to refrain from sexual contact during treatment period to avoid reinfection. Also tell patient to use a sanitary napkin to prevent staining of clothing and to absorb discharge.
• Tell patient to complete the full course of therapy. Improvement usually will be noted within 1 week. Patient should call if no improvement occurs in 4 weeks or if condition worsens.
• Advise patient to watch for and report irritation or sensitivity and, if this occurs, to discontinue use.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use