Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/129
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| rdfs:label |
ERTACZO (Cream)
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| dailymed-instance:dosage |
In the treatment of interdigital tinea pedis, ERTACZO Cream, 2%, should be applied twice daily for 4 weeks. Sufficient ERTACZO Cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis. If a patient shows no clinical improvement 2 weeks after the treatment period, the diagnosis should be reviewed.
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| dailymed-instance:descripti... |
ERTACZO (sertaconazole nitrate) Cream, 2%, contains the imidazole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers. Sertaconazole nitrate is designated chemically as (��)-1-[2,4-dichloro-��-[(7-chlorobenzo-[b]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is CHClNOS���HNO, and the structural formula is as follows: Sertaconazole nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, sparingly soluble in alcohol and in methylene chloride. Each gram of ERTACZO Cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base of ethylene glycol and polyethylene glycol palmitostearate, glyceryl isostearate, light mineral oil, methylparaben, polyoxyethylenedsaturated glycerides and glycolized saturated glycerides, sorbic acid and purified water.
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| dailymed-instance:clinicalP... |
Pharmacokinetics: In a multiple dose pharmacokinetic study that included 5 male patients with interdigital tinea pedis (range of diseased area, 42 - 140 cm; mean, 93 cm), ERTACZO Cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams sertaconazole nitrate per 100 cm). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used. Microbiology: Sertaconazole is an antifungal that belongs to the imidazole class of antifungals. While the exact mechanism of action of this class of antifungals is not known, it is believed that they act primarily by inhibiting the cytochrome P450-dependent synthesis of ergosterol. Ergosterol is a key component of the cell membrane of fungi, and lack of this component leads to fungal cell injury primarily byleakage of key constituents in the cytoplasm from the cell. ActivityIn Vivo: Sertaconazole nitrate has been shown to be active against isolates of the following microorganisms in clinical infections as described in the INDICATIONS AND USAGE section: Trichophyton rubrum Trichophyton mentagrophytes Epidermophyton floccosum
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
ERTACZO Cream, 2%, is contraindicated in patients who have a known or suspected sensitivity to sertaconazole nitrate or any of its components or to other imidazoles.
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| dailymed-instance:supply |
ERTACZO Cream, 2%, is supplied in tubes in the following size: Store at 25��C (77��F); excursions permitted to 15��-30��C (59��-86��F) [see USP Controlled Room Temperature]. Rx only. Patent No. 5,135,943 Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045 Rev November 2005128354
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:Ethylene_glycol_and_Polyethylene_glycol_palmitostearate,
dailymed-ingredient:Glyceryl_isostearate,
dailymed-ingredient:Light_mineral_oil,
dailymed-ingredient:Methylparaben,
dailymed-ingredient:Polyoxyethylened_saturated_glycerides_and_Glycolized_saturated_glyc...,
dailymed-ingredient:Sorbic_acid,
dailymed-ingredient:Water
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| dailymed-instance:precautio... |
General: ERTACZO Cream, 2%, is for use on the skin only. If irritation or sensitivity develops with the use of ERTACZO Cream, 2%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of infected superficial epidermal tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Physicians should exercise caution when prescribing ERTACZO Cream, 2%, to patients known to be sensitive to imidazole antifungals, since cross-reactivity may occur. Information for Patients: The patient should be instructed to: Drug/Laboratory Test Interactions: Potential interactions between ERTACZO Cream, 2%, and other drugs or laboratory tests have not been systematically evaluated. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies to evaluate the carcinogenic potential of sertaconazole nitrate have not been conducted. No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered negative for sister chromatid exchange (SCE) in the in vivo mouse bone marrow SCE assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in rat primary hepatocyte cultures. Sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility of male or female rats given up to 60 mg/kg/day orally by gastric intubation (16 times the maximum recommended human dose based on a body surface area comparison). Pregnancy: Teratogenic Effects. Pregnancy Category C: Oral reproduction studies in rats and rabbits did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity of sertaconazole nitrate at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose on a body surface area comparison). In an oral peri-postnatal study in rats, a reduction in live birth indices and an increase in the number of still-born pups was seen at 80 and 160 mg/kg/day. There are no adequate and well-controlled studies that have been conducted on topically applied ERTACZO Cream, 2%, in pregnant women. Because animal reproduction studies are not always predictive of human response, ERTACZO Cream, 2%, should be used during pregnancy only if clearly needed. Nursing Mothers: It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing ERTACZO Cream, 2%, to a nursing woman. Pediatric Use: The efficacy and safety of ERTACZO Cream, 2%, have not been established in pediatric patients below the age of 12 years. Geriatric Use: Clinical studies of ERTACZO Cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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| dailymed-instance:overdosag... |
Overdosage with ERTACZO Cream, 2%, has not been reported to date. ERTACZO Cream, 2%, is intended for topical dermatologic use only. It is not for oral, ophthalmic, or intravaginal use.
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| dailymed-instance:genericMe... |
Sertaconazole nitrate
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| dailymed-instance:fullName |
ERTACZO (Cream)
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| dailymed-instance:warning |
ERTACZO Cream, 2%, is not indicated for ophthalmic, oral or intravaginal use.
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| dailymed-instance:indicatio... |
ERTACZO (sertaconazole nitrate) Cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum .
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
ERTACZO
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