Clotrimazole

Mycelex® Troches are indicated for the local treatment of oropharyngeal candidiasis.The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment.

Mycelex® Troches are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION.)

Use clotrimazole exactly as prescribed.

Topical cream and solution:

Clotrimazole comes in topical cream and solution forms and is applied to affected skin twice daily, in the morning and evening, to treat yeast infections of the skin.

Oral lozenges:

Clotrimazole comes in an oral lozenge and is used five times daily for the treatment of yeast infections of the mouth. For prevention of yeast infections of the mouth, the lozenges are used three times daily.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not use two doses of clotrimazole at the same time.

Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See PRECAUTIONS section).

Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.

Drug Abuse And Dependence

No data available.

Read the entire FDA prescribing information for Mycelex (Clotrimazole)

Clotrimazole is an antifungal medication. It is like an antibiotic but is used to treat yeast (fungal) infections.

Oral clotrimazole is used to treat and prevent yeast infections of the mouth and throat.

Clotrimazole may also be used for purposes other than those listed in this medication guide.

Take clotrimazole exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

The troches should be allowed to dissolve slowly in your mouth. Suck on one troche at a time until it is completely dissolved, usually 30 minutes.

Do not chew or swallow the troches whole.

The troches are usually used five times a day. Follow your doctor's instructions.

Store clotrimazole at room temperature away from moisture and heat.

Storage

Oral

≤30°C; avoid freezing.125

Topical

2–30°C.100

Intravaginal

15–30°C; avoid temperatures >30°C.101

2–30°C.158

Acute overdosage with topical application of Clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.

Commonly reported side effects of clotrimazole include: increased serum aspartate aminotransferase. See below for a comprehensive list of adverse effects.

Applies to clotrimazole: oral lozenge, topical cream, topical lotion, topical powder, topical solution, vaginal cream with applicator, vaginal kit, vaginal tablet

Hepatic

Very common (10% or more): AST elevation (up to 15%)
Frequency not reported: Abnormal liver function tests[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, unpleasant mouth sensations[Ref]

Dermatologic

Frequency not reported: Pruritus[Ref]

Some side effects of clotrimazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Administration advice:
-Troches must be allowed to slowly dissolve in the mouth for maximal effect.

Storage requirements:
-Store at room temperature; avoid freezing.

General:
-Limitation of use: This drug should not be used to treat systemic mycoses, including systemic candidiasis.
-Safety and efficacy have not been established for prophylactic use in patients who are immunocompromised by etiologies other than chemo-, radio-, or steroid therapy in the treatment of leukemia, solid tumors, or renal transplantation.

Monitoring:
-Periodic hepatic function, especially in patients with preexisting hepatic dysfunction

Patient advice:
-Patients should be instructed to allow the troche to slowly dissolve in the mouth.

The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Data not available Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.