Clotrimazole
Generic: CLOTRIMAZOLE
Basic Information
Manufacturer
Hikma Pharmacuticals USA USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
0bc4b876-ddee-4f03-b44f-544348739a26
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 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 .)
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.
Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.