Mycelex 10mg Information
Mycelex 10mg (Clotrimazole) Description
Each Mycelex Troche contains 10 mg clotrimazole [1-(o-chloro-α,α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth.
Structural Formula:
Chemical Formula: CHCIN
The troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole dispersed in dextrose, microcrystalline cellulose, povidone, and magnesium stearate.
Mycelex 10mg (Clotrimazole) Clinical Pharmacology
Clotrimazole is a broad-spectrum antifungal agent that inhibits the growth of pathogenic yeasts by altering the permeability of cell membranes. The action of clotrimazole is fungistatic at concentrations of drug up to 20 mcg/mL and may be fungicidal against and other species of the genus at higher concentrations. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of in the laboratory; however, individual organism tolerance has been observed during successive passages in the laboratory. Such tolerance has resolved once the organism has been removed from the antifungal environment.
After oral administration of a 10 mg clotrimazole troche to healthy volunteers, concentrations sufficient to inhibit most species of persist in saliva for up to three hours following the approximately 30 minutes needed for a troche to dissolve. The long term persistence of drug in saliva appears to be related to the slow release of clotrimazole from the oral mucosa to which the drug is apparently bound. Repetitive dosing at three hour intervals maintains salivary levels above the minimum inhibitory concentrations of most strains of ; however, the relationship between susceptibility of pathogenic fungi to clotrimazole and prophylaxis or cure of infections in humans has not been established.
In another study, the mean serum concentrations were 4.98 ± 3.7 and 3.23 ± 1.4 nanograms/mL of clotrimazole at 30 and 60 minutes, respectively, after administration as a troche.
Mycelex 10mg (Clotrimazole) Indications And Usage
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 .)
Mycelex 10mg (Clotrimazole) Contraindications
Mycelex Troches are contraindicated in patients who are hypersensitive to any of its components.
Mycelex 10mg (Clotrimazole) Warning
Mycelex Troches are not indicated for the treatment of systemic mycoses including systemic candidiasis.
Mycelex 10mg (Clotrimazole) Precautions
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. In most cases the elevations were minimal and it was often impossible to distinguish effects of clotrimazole from those of other therapy and the underlying disease (malignancy in most cases). Periodic assessment of hepatic function is advisable particularly in patients with pre-existing hepatic impairment.
Since patients must be instructed to allow each troche to dissolve slowly in the mouth in order to achieve maximum effect of the medication, they must be of such an age and physical and/or mental condition to comprehend such instructions.
Mycelex 10mg (Clotrimazole) 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 section).
Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.
Mycelex 10mg (Clotrimazole) Overdosage
Mycelex 10mg (Clotrimazole) Drug Abuse And Dependence
Mycelex 10mg (Clotrimazole) Dosage And Administration
Mycelex Troches are administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche 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 troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Mycelex 10mg (Clotrimazole) How Supplied
Mycelex Troches, white discoid, uncoated tablets are supplied in bottles of 70 and 140. Mycelex Troches are also available for institutional use in foil packages of 70 tablets. Each tablet will be identified with the following: Mycelex 10.
Store below 86°F (30°C). Avoid freezing.
