Clotrimazole

Generic: CLOTRIMAZOLE

Prescription DrugORAL

Drug Information

Brand Name
Clotrimazole
Generic Name
CLOTRIMAZOLE
Manufacturer
Hikma Pharmacuticals USA USA Inc.
Product Type
Prescription Drug
Route
ORAL
Application Number
0bc4b876-ddee-4f03-b44f-544348739a26

Pharmacological Class

Azole Antifungal [EPC]

Indications & Usage

INDICATIONS AND USAGE Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is 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 adequat...

Read full indications

INDICATIONS AND USAGE Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is 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 .)

Warnings

WARNING Clotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis.

Adverse Reactions

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

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

Clotrimazole - Side Effects, Warnings, Uses | FDA Drug Database