endlessly Eryped 200 eryped 400 To reduce the development of drug-resistant bacteria and maintain the effectiveness of EryPed and other antibacterial drugs, EryPed 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: EryPed 200 and EryPed Drops (erythromycin ethylsuccinate for oral suspension) when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing fruit flavor. EryPed 400 when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. Fruit-flavored EryPed Chewable tablets are easily ingested and are particularly acceptable for the administration of antibiotic medication to young children who are unable to swallow regular tablets or in whom persuasion of a pleasant taste insures cooperation. Each chewable tablet contains erythromycin ethylsuccinate equivalent to 200 mg of erythromycin and is scored for division into half-dose (100 mg) portions. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients: EryPed 200, EryPed 400 and EryPed Drops: Caramel, polysorbate, sodium citrate, sucrose, xanthan gum and artificial flavors. EryPed Chewable Tablets: Citric acid, confectioner's sugar (contains corn starch), magnesium aluminum silicate, magnesium stearate, sodium carboxymethylcellulose, sodium citrate and artificial flavor. Clinical Pharmacology Orally administered erythromycin ethylsuccinate suspension is readily and reliably absorbed under both fasting and nonfasting conditions. 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. Staphylococci 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 locate
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