国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ERYTHROMYCIN ETHYLSUCCINATE (UNII: 1014KSJ86F) (ERYTHROMYCIN - UNII:63937KV33D), SULFISOXAZOLE ACETYL (UNII: WBT5QH3KED) (SULFISOXAZOLE - UNII:740T4C525W)
Physicians Total Care, Inc.
ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE 200 mg in 5 mL
ORAL
PRESCRIPTION DRUG
For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae . Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension is contraindicated in the following patient populations: Use in pregnant women at term, in children less than 2 months of age, and in mothers nursing infants less than 2 months of age is contraindicated because sulfonamides may promote kernicterus in the newborn by displacing bilirubin from plasma proteins. Erythromycin is contraindicated in patients taking terfenadine. (See PRECAUTIONS, Drug Interactions:.)
Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl for Oral Suspension is available for teaspoon dosage in 100 mL (NDC 54868-0971-1) bottles, in the form of granules to be reconstituted with water. The suspension provides erythromycin ethylsuccinate equivalent to 200 mg erythromycin activity and sulfisoxazole acetyl equivalent to 600 mg sulfisoxazole per teaspoonful (5 mL). Store at room temperature in dry form.
Abbreviated New Drug Application
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL - ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION PHYSICIANS TOTAL CARE, INC. ---------- ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION, USP Revised MARCH 2007 11001190 Rx only DESCRIPTION: Erythromycin ethylsuccinate and sulfisoxazole acetyl, when reconstituted with water as directed on the label, the granules form a white, cherry flavored suspension that provides the equivalent of 200 mg erythromycin activity and the equivalent of 600 mg of sulfisoxazole activity per teaspoonful (5 mL). Erythromycin is produced by a strain of _Saccaropolyspora erythraea_ and belongs to the macrolide group of antibiotics. It is basic and readily forms salts and esters. Erythromycin ethylsuccinate is the 2’- ethylsuccinyl ester of erythromycin. It is essentially a tasteless form of the antibiotic suitable for oral administration, particularly in suspension dosage forms. The chemical name is erythromycin 2’- (ethylsuccinate). Erythromycin ethylsuccinate has the following structural formula: C H NO MOLECULAR WEIG HT: 862.06 Sulfisoxazole acetyl or _N_ -acetyl sulfisoxazole is an ester of sulfisoxazole. Chemically, sulfisoxazole is _N_ -(3,4-dimethyl-5-isoxazotyl) sulfanilamide. Sulfisoxazole acetyl has the following structural formula: C H N O S MOLECULAR WEIG HT: 309.34 4 5 75 16 _1_ _1_ C H N O S MOLECULAR WEIG HT: 309.34 INACTIVE INGREDIENTS: Artificial flavor, lactose anhydrous, methylparaben, polysorbate 80, povidone, simethicone, sodium citrate anhydrous and sucrose. CLINICAL PHARMACOLOGY: Orally administered erythromycin ethylsuccinate suspensions are readily and reliably absorbed. Erythromycin ethylsuccinate products have demonstrated rapid and consistent absorption in both fasting and nonfasting conditions. However, higher serum concentrations are obtained when these products are given with food. Erythromycin is largely bound to plasma proteins. After absorption, erythromycin diffuses readily into most body fluid 阅读完整的文件