Erythrocin Lactobionate
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Questions & Answers
Side Effects & Adverse Reactions
There have been reports of hepatic dysfunction, with or without jaundice occurring in patients receiving oral erythromycin products.
Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including erythromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Life-threatening episodes of ventricular tachycardia associated with prolonged QT intervals (torsades de pointes) have been reported in some patients after intravenous administration of erythromycin lactobionate.
Susceptibility to the development of torsades de pointes arrhythmias, a rare but serious cardiac condition, is related to electrolyte imbalance, hepatic dysfunction, myocardial ischemia, left ventricular dysfunction, idiopathic Q-T prolongation, and concurrent antiarrhythmic therapy.6 Elderly patients exhibit a greater frequency of decreased hepatic function, cardiac function, and of concomitant disease and other drug therapy, and therefore should be monitored carefully during ErythrocinTM therapy.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Erythrocin Lactobionate-IV (erythromycin lactobionate for injection, 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 (Group A beta-hemolytic streptococci); Streptococcus pneumoniae (Diplococcus 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 pyogenes (Group A beta-hemolytic streptococci); Streptococcus pneumoniae (Diplococcus 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 (resistant staphylococci may emerge during treatment).
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-IV (erythromycin lactobionate for injection, USP) followed by erythromycin stearate or erythromycin 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.
History
There is currently no drug history available for this drug.
Other Information
Erythromycin is produced by a strain of Streptomyces erythraeus and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids.
Erythrocin Lactobionate (erythromycin lactobionate for injection, USP), is a soluble salt of erythromycin suitable for intravenous administration. It is available as a sterile, lyophilized powder in vials containing the equivalent of 500 mg of erythromycin activity. It is prepared as a solution and lyophilized in its final container.
Erythromycin lactobionate is chemically known as erythromycin mono (4-0-β-D-galactopyranosyl-D-gluconate) (salt). The structural formula is:
Sources
Erythrocin Lactobionate Manufacturers
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Hospira, Inc.
![Erythrocin Lactobionate (Erythromycin Lactobionate) Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Erythrocin Lactobionate | Hospira, Inc.
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-IV (erythromycin lactobionate for injection, USP) must be administered by continuous or intermittent intravenous infusion only. Due to the irritative properties of erythromycin, IV 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 IV 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 ERYTHROCINTM LACTOBIONATE-IV BY ADDING 10 ML OF STERILE WATER FOR INJECTION, USP, TO THE 500 MG 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; NORMOSOLTM-R. THE FOLLOWING SOLUTIONS MAY ALSO BE USED PROVIDING THEY ARE FIRST BUFFERED WITH NEUTTM (4% SODIUM BICARBONATE, HOSPIRA) by adding 1 mL of NeutTM per 100 mL of solution:
5% DEXTROSE INJECTION, USP
5% DEXTROSE AND LACTATED RINGER’S INJECTION
5% DEXTROSE AND 0.9% SODIUM CHLORIDE INJECTION, USPNeutTM (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-IV fluid admixture unless its effect on the chemical and physical stability of the solution has first been determined.
Stability
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.
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Hospira, Inc.
Erythrocin Lactobionate | Hospira, Inc.
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-IV (erythromycin lactobionate for injection, USP) in the ADD-Vantage system must be administered by intermittent intravenous infusion only. Due to the irritative properties of erythromycin, IV push is an unacceptable route of administration.
Intravenous erythromycin should be replaced by oral erythromycin as soon as possible.
The drug should be administered as a single dose from the ADD-Vantage flexible diluent container. Discard any unused portion.
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 IV 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:
The Erythrocin Lactobionate-IV ADD-Vantage vial may be used with either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP in the ADD-Vantage flexible diluent container. The 500 mg ADD-Vantage vials must be used as single doses with the 100 mL ADD-Vantage flexible diluent containers. The resulting solution will contain erythromycin activity equal to approximately 5 mg/mL.
Do not administer unless solution is clear and container is undamaged. Discard any unused portion.
INSTRUCTIONS FOR USE
To Use Vial in ADD-Vantage Flexible Diluent Container
To Open:
Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container:
(Use Aseptic Technique)
• Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: 1. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (See FIGURE 1.), then pull straight up to remove the cap. (See FIGURE 2.) NOTE: Do not access vial with syringe.Figure 1 Figure 2
• Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (See FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.
NOTE: Once vial is seated, do not attempt to remove. (See FIGURE 4.)Figure 3 Figure 4
• Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. • Label appropriately.To Reconstitute the Drug:
• Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. • With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (See FIGURE 5.) • Pull the inner cap from the drug vial. (See FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. • Mix container contents thoroughly and use within the specified time.Figure 5 Figure 6
Preparation for Administration:
(Use Aseptic Technique)
• Confirm the activation and admixture of vial contents. • Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. • Close flow control clamp of administration set. • Remove cover from outlet port at bottom of container. • Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.NOTE: See full directions on administration set carton.
• Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. • Squeeze and release drip chamber to establish proper fluid level in chamber. • Open flow control clamp and clear air from set. Close clamp. • Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. • Regulate rate of administration with flow control clamp.WARNING: Do not use flexible containers in series connections.
Stability:
In 0.9% Sodium Chloride Injection, USP
The final diluted solution of erythromycin lactobionate should be completely administered within 8 hours in order to assure proper potency.In 5% Dextrose Injection, USP
The final diluted solution of erythromycin lactobionate should be completely administered within 2 hours in order to assure proper potency.No drug or chemical agent should be added to an Erythrocin Lactobionate-IV fluid admixture unless its effect on the chemical and physical stability of the solution has first been determined.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
WARNING: Do not use flexible container in series connections.
![Erythrocin Lactobionate (Erythromycin Lactobionate) Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9231d2fa-2e91-4eef-afa3-7515bc34df0b&name=erythrocin-lactobionate-iv3-figure-8-jCA-3243_front.jpg)
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