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ERYTHROMYCIN ETHYLSUCCINATE (Suspension)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2314

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ERYTHROMYCIN ETHYLSUCCINATE (Suspension)
dailymed-instance:dosage
Erythromycin ethylsuccinate suspensions may be administered without regard to meals.<br/>Children: Age, weight and severity of the infection are important factors in determining the proper dosage. In mild to moderate infections the usual dosage of erythromycin ethylsuccinate for children is 30 to 50 mg/kg/day in equally divided doses every 6 hours. For more severe infections this dosage may be doubled. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours. The following dosage schedule is suggested for mild to moderate infections:<br/>Adults: 400 mg erythromycin ethylsuccinate every 6 hours is the usual dose. Dosage may be increased up to 4 g per day according to the severity of the infection. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours. For adult dosage calculation, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250 mg of erythromycin activity as the stearate, base or estolate. In the treatment of streptococcal infections, a therapeutic dosage of erythromycin ethylsuccinate should be administered for at least 10 days. In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg twice a day.<br/>For Treatment of Urethritis Due to C. trachomatis or U. urealyticum: 800 mg three times a day for 7 days.<br/>For Treatment of Primary Syphilis:<br/>Adults: 48 to 64 g given in divided doses over a period of 10 to 15 days.<br/>For Intestinal Amebiasis:<br/>Adults: 400 mg four times daily for 10 to 14 days. Children30 to 50 mg/kg/day in divided doses for 10 to 14 days.<br/>For Use in Pertussis: Although optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.<br/>For Treatment of Legionnaires' Disease: Although optimal doses have not been established, doses utilized in reported clinical data were those recommended above (1.6 to 4 g daily in divided doses.)
dailymed-instance:descripti...
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 oral suspension contains 200 or 400 mg erythromycin activity per teaspoonful (5 mL) in a premixed suspension with a cherry flavor, supplied in pint (16 fl oz) bottles. The premixed suspension for oral administration is intended primarily for pediatric use but can also be used in adults. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). The molecular formula is CHNOand the molecular weight is 862.06. The structural formula is:<br/>Inactive Ingredients: Alcohol less than 0.1%, citric acid, D&C Red No. 33, FD&C Red No. 40, methylparaben, polysorbate 60, propylparaben, sodium chloride, sodium citrate, sucrose, water, xanthan gum, and natural and artificial flavoring.
dailymed-instance:clinicalP...
Orally administered erythromycin ethylsuccinate suspension is 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.<br/>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.<br/>Gram-positive Organisms: Corynebacterium diphtheriae Corynebacterium minutissimum Listeria monocytogenes Staphylococcus aureus (resistant organisms may emerge during treatment) Streptococcus pneumoniae Streptococcus pyogenes<br/>Gram-negative Organisms: Bordetella pertussis Legionella pneumophila Neisseria gonorrhoeae<br/>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��g/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.<br/>Gram-positive Organisms: Viridans group streptococci<br/>Gram-negative Organisms: Moraxella catarrhalis<br/>Susceptibility Tests:
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Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic. Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide, or cisapride. (See PRECAUTIONS - Drug Interactions .)
dailymed-instance:supply
Erythromycin ethylsuccinate oral suspension, USP, 400 mg erythromycin activity per teaspoonful (5 mL) is supplied in 1 pint (473 mL) bottles (NDC 0074-3748-16). Erythromycin ethylsuccinate oral suspension, USP, 200 mg erythromycin activity per teaspoonful (5 mL) is supplied in 1 pint (473 mL) bottles (NDC 0074-3747-16). Erythromycin ethylsuccinate oral suspensions require refrigeration to preserve taste until dispensed. Refrigeration by patient is not required if used within 14 days.
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dailymed-instance:overdosag...
In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or hemodialysis.
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erythromycin ethylsuccinate
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ERYTHROMYCIN ETHYLSUCCINATE (Suspension)
dailymed-instance:adverseRe...
The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. (See WARNINGS.) Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.) Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely. There have been rare reports of pancreatitis and convulsions. There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.
dailymed-instance:warning
There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products. There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis". After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)
dailymed-instance:indicatio...
To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate oral suspension and other antibacterial drugs, erythromycin ethylsuccinate oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be causedby susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.) Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and afollow-up serologic test for syphilis after 3 months. Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.<br/>Prophylaxis:<br/>Prevention of Initial Attacks of Rheumatic Fever: Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.The therapeutic dose should be administered for 10 days.<br/>Prevention of Recurrent Attacks of Rheumatic Fever: Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).
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ERYTHROMYCIN ETHYLSUCCINATE