distinctiveness E.E.S. 200 liquid To reduce the development of drug-resistant bacteria and maintain the effectiveness of E.E.S. and other antibacterial drugs, E.E.S. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Description Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). The molecular formula is C 43 H 75 NO 16 and the molecular weight is 862.06. The structural formula is: E.E.S. Granules are intended for reconstitution with water. Each 5-mL teaspoonful of reconstituted cherry-flavored suspension contains erythromycin ethylsuccinate equivalent to 200 mg of erythromycin. The pleasant tasting, fruit-flavored liquids are supplied ready for oral administration. E.E.S. 200 Liquid: Each 5-mL teaspoonful of fruit-flavored suspension contains erythromycin ethylsuccinate equivalent to 200 mg of erythromycin. E.E.S. 400 Liquid: Each 5-mL teaspoonful of orange-flavored suspension contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin. Granules and ready-made suspensions are intended primarily for pediatric use but can also be used in adults. E.E.S. 400 Filmtab Tablets: Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin. The Filmtab tablets are intended primarily for adults or older children. Inactive Ingredients: E.E.S. 200 Liquid: FD&C Red No. 40, methylparaben, polysorbate 60, propylparaben, sodium citrate, sucrose, water, xanthan gum and natural and artificial flavors. E.E.S. 400 Liquid: D&C Yellow No. 10, FD&C Yellow No. 6, methylparaben, polysorbate 60, propylparaben, sodium citrate, sucrose, water, xanthan gum and natural and artificial flavors. E.E.S. Granules: Citric acid, FD&C Red No. 3, magnesium aluminum silicate, sodium carboxymethylcellulose, sodium citrate, sucrose and artificial flavor. E.E.S. 400 Filmtab Tablets: Cellulosic polymers, confectioner's sugar (contains corn starch), corn starch, D&C Red No. 30, D&C Yellow No. 10, FD&C Red No. 40, magnesium stearate, polacrilin potassium, polyethylene glycol, propylene glycol, sodium citrate, sorbic acid, and titanium dioxide. Clinical Pharmacology Orally administered erythromycin ethylsuccinate suspensions and Filmtab tablets are readily and reliably absorbed. Comparable serum levels of erythromycin are achieved in the fasting and nonfasting states. Erythromycin diffuses readily into most body fluids. Only low concentrations are normally achieved in the spinal fluid, but passage of the drug across the blood-brain barrier increases in meningitis. In the presence of normal hepatic function, erythromycin is concentrated in the liver and excreted in the bile; the effect of hepatic dysfunction on excretion of erythromycin by the liver into the bile is not known. Less than 5 percent of the orally administered dose of erythromycin is excreted in active form in the urine. Erythromycin crosses the placental barrier, but fetal plasma levels are low. The drug is excreted in human milk. Microbiology: Erythromycin acts by inhibition of protein synthesis by binding 50 S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol. Many strains of Haemophilus influenzae are resistant to erythromycin alone but are susceptible to erythromycin and sulfonamides used concomitantly. Staphylocci resistant to erythromycin may emerge during a course of therapy. Erythromycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-positive Organisms: Corynebacterium diphtheriae Corynebacterium minutissimum Listeria monocytogenes Staphylococcus aureus (resistant organisms may emerge during treatment) Streptococcus pneumoniae Streptococcus pyogenes Gram-negative Organisms: Bordetella pertussis Legionella pneumophila Neisseria gonorrhoeae Other Microorganisms: Chlamydia trachomatis Entamoeba histolytica Mycoplasma pneumoniae Treponema pallidum Ureaplasma urealyticum The following in vitro data are available, but their clinical significance is unknown. Erythromycin exhibits in vitro minimal inhibitory concentrations (MIC's) of 0.5 µg/mL or less against most (>/= 90%) strains of the following microorganisms; however, the safety and effectiveness of erythromycin in treating clinical infections due to these microorganisms have not been established in adequate and well controlled clinical trials. Gram-positive Organisms: Viridans group streptococci Gram-negative Organisms: Moraxella catarrhalis Susceptibility Tests: Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC's). These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized procedure. Standardized procedures are based on a dilution method 1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of erythromycin powder. The MIC values should be interpreted according to the following criteria: MIC (µg/mL) Interpretation FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates extensive
in vogue E.E.S. 200 liquid faithful
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