Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1798
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Mycelex (Troche)
|
| dailymed-instance:dosage |
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.
|
| dailymed-instance:descripti... |
Each Mycelex Troche contains 10 mg clotrimazole [1-(o-chloro-��,��-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.
|
| dailymed-instance:clinicalP... |
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 in vitro against Candida albicans and other species of the genus Candida at higher concentrations. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans in the laboratory; however, individual organism tolerance has been observed during successive passages in the laboratory. Such in vitro 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 Candida 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 Candida; however, the relationship between in vitro susceptibilityof 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.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Mycelex Troches are contraindicated in patients who are hypersensitive to any of its components.
|
| dailymed-instance:supply |
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. Manufactured by Bayer Pharmaceuticals CorporationWest Haven, CT 06516Made in GermanyDistributed by Ortho-McNeil Pharmaceutical, Inc.Raritan, NJ 0886908753817, R.2BAY 509712465��2004 Bayer Pharmaceuticals Corporation9/04Printed in USA
|
| dailymed-instance:genericDr... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:overdosag... |
No data available.
|
| dailymed-instance:genericMe... |
clotrimazole
|
| dailymed-instance:fullName |
Mycelex (Troche)
|
| dailymed-instance:adverseRe... |
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 . Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.
|
| dailymed-instance:indicatio... |
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.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Mycelex
|