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Erythrocin Lactobionate-I.V. (Sterile Erythromycin Lactobionate, USP) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time.
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 pyogene, Streptococcus pneumoniae.
Respiratory tract infections due to Mycoplasma pneumoniae.
Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes and Staphylococcus aureus (methicillin-susceptible strains only).
Diphtheria: As an adjunct to antitoxin infections due to Corynebacterium diphtheriae to prevent establishment of carriers and to eradicate the organism in carriers.
Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.
Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae:
Erythrocin Lactobionate-I.V. (Sterile Erythromycin Lactobionate, USP) followed by erythromycin stearate of base orally, 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.
Before treatment of gonorrhea, patients who are suspected of also having syphilis should have a microscopic examination for T. pallidum (by immunofluorescence or darkfield) before receiving erythromycin and monthly serologic tests for a minimum of 4 months thereafter.
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.
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 Group A beta-hemolytic streptococcal infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).4 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days.
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).4
Prevention of Bacterial Endocarditis: Although no controlled clinical efficacy trials have been conducted, oral erythromycin has been recommended by the American Heart Association for prevention of bacterial endocarditis in penicillin-allergic patients with prosthetic cardiac valves, most congenital cardiac malformations, surgically constructed systemic pulmonary shunts, rheumatic or other acquired valvular dysfunction, idiopathic hypertrophic subaortic stenosis (IHSS), previous history of bacterial endocarditis and mitral valve prolapse with insufficiency when they undergo dental procedures and surgical procedures of the upper respiratory tract.5
To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin and other antibacterial drugs, erythromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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.
DOSAGE AND ADMINISTRATION
For the treatment of severe infections in adults and pediatric patients, the recommended intravenous dose of erythromycin lactobionate is 15 to 20 mg/kg/day. Higher doses, up to 4 g/day, may be given for severe infections.
Administration of doses of ≥ 4 g/day may increase the risk for the development of erythromycin-induced hearing loss in elderly patients, particularly those with reduced renal or hepatic function. Erythrocin Lactobionate-I.V. (Sterile Erythromycin Lactobionate, USP) must be administered by continuous or intermittent intravenous infusion only. Due to the irritative properties of erythromycin, I.V. push is an unacceptable route of administration.
Continuous infusion of erythromycin lactobionate is preferable due to the slower infusion rate and lower concentration of erythromycin; however, intermittent infusion at six hour intervals is also effective. Intravenous erythromycin should be replaced by oral erythromycin as soon as possible.
For slow continuous infusion: The final diluted solution of erythromycin lactobionate is prepared to give a concentration of 1 g per liter (1 mg/mL).
For intermittent infusion: Administer one-fourth the total daily dose of erythromycin lactobionate by intravenous infusion in 20 to 60 minutes at intervals not greater than every six hours. The final diluted solution of erythromycin lactobionate is prepared to give a concentration of 1 to 5 mg/mL. No less than 100 mL of I.V. diluent should be used. Infusion should be sufficiently slow to minimize pain along the vein.
For treatment of acute pelvic inflammatory disease caused by N. Gonorrhoeae, in female patients hypersensitive to penicillins, administer 500 mg erythromycin lactobionate every six hours for three days, followed by oral administration of 250 mg erythromycin stearate or base every six hours for seven days.
For treatment of Legionnaires' Disease: Although optimal doses have not been established, doses utilized in reported clinical data were 1 to 4 grams daily in divided doses.
Administration of doses of ≥ 4 g/day may increase the risk for the development of erythromycin-induced hearing loss in elderly patients, particularly those with reduced renal or hepatic function.
In the treatment of Group A beta-hemolytic streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for ten days. The American Heart Association suggests a dosage of 250 mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.4
In prophylaxis against bacterial endocarditis (see INDICATIONS AND USAGE) the oral regimen for penicillin allergic patients is erythromycin 1 gram, 1 hour before the procedure followed by 500 mg six hours later.5
Preparation of Solution
- PREPARE THE INITIAL SOLUTION OF ERYTHROCIN® LACTOBIONATE-I.V. BY ADDING
10 ML OF STERILE WATER FOR INJECTION, USP, TO THE 500 MG VIAL OR 20 ML OF
STERILE WATER FOR INJECTION, USP, TO THE 1 G VIAL. Use only Sterile Water
for Injection, USP, as other diluents may cause precipitation during reconstitution.
Do not use diluents containing preservatives or inorganic salts.
After reconstitution, each mL contains 50 mg of erythromycin activity. The initial solution is stable at refrigerator temperature for two weeks, or for 24 hours at room temperature.
- ADD THE INITIAL DILUTION TO ONE OF THE FOLLOWING DILUENTS BEFORE ADMINISTRATION
to give a concentration of 1 g of erythromycin activity per liter (1 mg/mL)
for continuous infusion or 1 to 5 mg/mL for intermittent infusion:
0.9% SODIUM CHLORIDE INJECTION, USP; LACTATED RINGER'S INJECTION, USP; NORMOSOL®-R.
- THE FOLLOWING SOLUTIONS MAY ALSO BE USED PROVIDING THEY ARE FIRST BUFFERED
WITH NEUT® (4% SODIUM BICARBONATE, HOSPIRA) by adding 1 mL of Neut®
per 100 mL of solution:
5% DEXTROSE INJECTION, USP
5% DEXTROSE AND LACTATED RINGER'S INJECTION
5% DEXTROSE AND 0.9% SODIUM CHLORIDE INJECTION, USP
Neut® (4% sodium bicarbonate, Hospira) must be added to these solutions so that their pH is in the optimum range for erythromycin lactobionate stability. Acidic solutions of erythromycin lactobionate are unstable and lose their potency rapidly. A pH of at least 5.5 is desirable for the final diluted solution of erythromycin lactobionate.
No drug or chemical agent should be added to an erythromycin lactobionate-I.V. fluid admixture unless its effect on the chemical and physical stability of the solution has first been determined.
The final diluted solution of erythromycin lactobionate should be completely administered within 8 hours, since it is not suitable for storage.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Erythrocin Lactobionate-I.V. (Sterile Erythromycin Lactobionate, USP) is supplied as a sterile, lyophilized powder in packages of ten vials (NDC 0409-6482-01), each vial containing the equivalent of 500 mg of erythromycin.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
4. Committee on Rheumatic Fever and Infective Endocarditis of the Council on Cardiovascular Disease of the Young: Prevention of Rheumatic Fever, Circulation 70(6):1118A-1122A, December 1984.
5. Committee on Rheumatic Fever and Infective Endocarditis of the Council on Cardiovascular Disease of the Young: Prevention of Bacterial Endocarditis, Circulation 70(6):1123A1127A, December 1984.
Hospira Inc., Lake Forest, IL 60045 USA
Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Erythrocin Lactobionate Information
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