ERYTHROMYCIN LACTOBIONATE PACKAGE INSERT PDF

Other Microorganisms Mycoplasma pneumoniae The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration MIC less than or equal to the susceptible breakpoint for erythromycin against isolates of similar genus or organism group. However, the efficacy of erythromycin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials. Indications and Usage for Erythrocin Injection 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. See appropriate sulfonamide labeling for prescribing information.

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Other Microorganisms Mycoplasma pneumoniae The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration MIC less than or equal to the susceptible breakpoint for erythromycin against isolates of similar genus or organism group. However, the efficacy of erythromycin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials.

Intravenous therapy should be replaced by oral administration at the appropriate time. See appropriate sulfonamide labeling for prescribing information. 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.

Before treatment of gonorrhea, patients who are suspected of also having syphilis should have a microscopic examination for T. 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.

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. 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.

Clostridioides difficile-Associated Diarrhea Clostridioides 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. Hypertoxin producing strains of C. 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 2 months after the administration of antibacterial agents. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. QT Prolongation 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.

Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity such as pertussis or chlamydia , the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents or caregivers of infants receiving erythromycin should be informed to contact their physician if vomiting or irritability with feeding occurs.

Drug Interactions Serious adverse reactions have been reported in patients taking erythromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by CYP3A4 e. Development of Drug-Resistant Bacteria Prolonged or repeated use of erythromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy. Prescribing erythromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Laboratory Tests Erythromycin interferes with the fluorometric determination of urinary catecholamines. Drug Interactions Erythromycin administration in patients receiving 3-hydroxymethylglutaryl-coenzyme A HMG CoA reductase inhibitors statins that are extensively metabolized by cytochrome P isoform 3A4 e.

Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. There have been published reports suggesting that when oral erythromycin is given concurrently with theophylline there is a significant decrease in erythromycin serum concentrations. This decrease could result in subtherapeutic concentrations of erythromycin. Erythromycin administration in patients receiving carbamazepine has been reported to cause increased serum levels of carbamazepine with subsequent development of signs of carbamazepine toxicity.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated serum digoxin levels. There have been reports of increased anticoagulant effects, which may be more pronounced in elderly when erythromycin and oral anticoagulants e. Erythromycin is considered a moderate inhibitor of CYP3A4.

A significant increase in colchicine plasma concentration is anticipated when co-administered with moderate CYP3A4 inhibitors such as erythromycin. If co-administration of colchicine and erythromycin is necessary, the starting dose of colchicine may need to be reduced, and the maximum colchicine dose should be lowered. Erythromycin has been reported to increase the systemic exposure AUC of sildenafil. Reduction of sildenafil dosage should be considered See sildenafil prescribing information.

Erythromycin has been reported to decrease the clearance of triazolam, midazolam and related benzodiazepines, and thus may increase the pharmacological effect of these benzodiazepines.

Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines, terfenadine and astemizole, when taken concomitantly.

In addition, deaths have been reported rarely with concomitant administration of terfenadine and erythromycin. The use of erythromycin in patients concurrently taking drugs metabolized by the cytochrome P system may be associated with elevations in serum levels of these other drugs. There have been reports of interactions of erythromycin with carbamazepine, cyclosporine, hexobarbital, phenytoin, alfentanil, disopyramide, bromocriptine, valproate, terfenadine, and astemizole.

Serum concentrations of drugs metabolized by the cytochrome P system should be monitored closely in patients concurrently receiving erythromycin. Hypotension, bradyarrhythmias and lactic acidosis have been observed in patients receiving concurrent verapamil, a calcium-channel blocker. Cimetidine may inhibit the metabolism of erythromycin, which may lead to an increased plasma concentration. Erythromycin has been reported to decrease the clearance of racemic zopiclone and, thus, may also decrease the clearance of eszopiclone, the S-enantiomer of racemic zopiclone.

Accordingly, erythromycin may increase the pharmacodynamic effects of eszopiclone. Dose reduction of eszopiclone may be necessary See eszopiclone prescribing information.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal data with erythromycin lactobionate for use in determination of possible carcinogenic effects are not available.

However, long-term oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. There was no apparent effect on male or female fertility in rats fed erythromycin base at levels up to 0. Pregnancy There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base up to 0. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low. Labor and Delivery The effect of erythromycin on labor and delivery is unknown.

Nursing Mothers Erythromycin is excreted in breast milk. Caution should be exercised when erythromycin is administered to a nursing woman.

Erythromycin Lactobionate does not contain sodium. Information for Patients Patients should be counseled that antibacterial drugs including erythromycin should only be used to treat bacterial infections. They do not treat viral infections e.

When erythromycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may 1 decrease the effectiveness of the immediate treatment and 2 increase the likelihood that bacteria will develop resistance and will not be treatable by erythromycin or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools with or without stomach cramps and fever even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible. Side effects following the use of intravenous erythromycin are rare. Occasional venous irritation has been encountered, but if the infusion is given slowly, in dilute solution, preferably by continuous intravenous infusion or intermittent infusion in no less than 20 to 60 minutes, pain and vessel trauma are minimized.

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 isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

Adverse reactions at higher than recommended doses could be similar to those reported with oral formulations of erythromycin, particularly, severe abdominal pain, nausea, vomiting, diarrhea, hepatitis, pancreatitis, and transient hearing loss. Erythromycin is not removed by peritoneal dialysis or hemodialysis.

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 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. No less than 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 mg erythromycin lactobionate every six hours for three days, followed by oral administration of mg erythromycin stearate or base every six hours for seven days.

In the treatment of Group A beta-hemolytic streptococcal infections of the upper respiratory tract e. The American Heart Association suggests a dosage of 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. 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. Acidic solutions of erythromycin lactobionate are unstable and lose their potency rapidly.

A pH of at least 5.

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Erythrocin™ Lactobionate - IV

There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis. Development of Drug-Resistant Bacteria Prolonged or repeated use of erythromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted. When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.

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Prescription Drug Information: Erythrocin Lactobionate

Other Microorganisms Mycoplasma pneumoniae The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration MIC less than or equal to the susceptible breakpoint for erythromycin against isolates of similar genus or organism group. However, the efficacy of erythromycin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials. Intravenous therapy should be replaced by oral administration at the appropriate time.

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