CLOTRIMAZOLE
Generic: CLOTRIMAZOLE
Basic Information
Manufacturer
Rising Pharma Holdings, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
980736aa-751a-4642-ab85-a309435fd02f
Indications & Usage
INDICATIONS AND USAGE Clotrimazole Lozenges are indicated for the local treatment of oropharyngeal candidiasis.
The diagnosis 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 .)
The diagnosis 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 .)
Warnings
WARNING Clotrimazole Lozenges are 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 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
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