Clotrimazole is used in the treatment of vaginitis, based on its FDA-labeled indications. It is an azole antifungal [epc].
What is vaginitis? Vaginitis, also called vulvovaginitis, is an inflammation or infection of the vagina. It can also affect the vulva, which is the external part of a woman's genitals. Vaginitis can cause itching, pain, discharge, and odor. Vaginitis is common, especially in wome… More on Vaginitis →
INDICATIONS AND USAGE Clotrimazole lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnoses should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole lozenges 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 .)
Dosage
DOSAGE AND ADMINISTRATION Clotrimazole Lozenges are administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one lozenge five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole lozenge after prolonged administration; therefore, therapy should be limited to short term use, if possible. For prophylaxis 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, the recommended dose is one lozenge three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Warnings
WARNING Clotrimazole lozenges are not indicated for the treatment of systemic mycoses including systemic candidiasis.
Drug interactions
Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
Side effects
ADVERSE REACTIONS Abnormal liver function tests have been reported in patients treated with clotrimazole lozenges; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See PRECAUTIONS ). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the lozenge. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Based on its FDA-labeled indications, Clotrimazole is used in the treatment of vaginitis — azole antifungal [epc]. Use it only as prescribed — your clinician decides whether it's right for you.
What ICD-10 codes apply to Vaginitis?
Vaginitis is coded in ICD-10-CM as B37.
Informational only, drawn from FDA labeling and NIH MedlinePlus — not medical advice. Talk to your clinician about whether Clotrimazole is right for you.
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