Erythromycin lactobionate
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Dosing in kidney impairment
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Preparation and administration
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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.
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. 1 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. 2 Preparation of Solution: Erythrocin Lactobionate-IV is a lyophilized powder, which requires reconstitution and further dilution before administration according to the steps below: 1.
Reconstitute Erythrocin Lactobionate-IV by adding 10 mL of Sterile Water for Injection, USP to the 500 mg single-dose vial to give a concentration of 50 mg of erythromycin activity per milliliter (50 mg/mL). Do not use other diluents in this step because other diluents may cause precipitation during reconstitution. Do not use diluents containing preservatives or inorganic salts.
The reconstituted solution is stable at refrigerator temperature for 2 weeks, or for 24 hours at room temperature. 2. Add the reconstituted solution 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: Normosol TM -R.
Do not use other diluents in this step 2. Acidic solutions of Erythrocin Lactobionate-IV (solutions with a pH < 5.5) are unstable and lose their potency rapidly. Do not add any drug or chemical agent to an erythromycin lactobionate-IV solution 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. Discard unused portion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Drug interactions
Check erythromycin lactobionate against a medication listLabel text (7 paragraphs)
Drug Interactions Erythromycin administration in patients receiving 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) reductase inhibitors (statins) that are extensively metabolized by cytochrome P450 isoform 3A4 (e.g., lovastatin or simvastatin) has been reported to cause increased risk of myopathy, including rhabdomyolysis. Do not administer erythromycin with lovastatin or simvastatin (See CONTRAINDICATIONS ). 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.
In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy. 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.g., warfarin) are used concomitantly. Colchicine is a substrate for both CYP3A4 and the efflux transporter P-glycoprotein (P-gp). 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. Patients should be monitored for clinical symptoms of colchicine toxicity (See WARNINGS ). 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.
Post-marketing reports indicate that co-administration of erythromycin with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the central nervous system, extremities and other tissues (See CONTRAINDICATIONS ). Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines, terfenadine and astemizole, when taken concomitantly. Rare cases of serious cardiovascular adverse events, including electrocardiographic QT/QTc interval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have been observed (See CONTRAINDICATIONS ).
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 P450 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 P450 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).
Contraindications
Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic. Erythromycin is contraindicated in patients taking terfenadine or astemizole, cisapride, pimozide, ergotamine, or dihydroergotamine (See WARNINGS and PRECAUTIONS – Drug Interactions ). Do not use erythromycin concomitantly with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) reductase inhibitors (statins) that are extensively metabolized by cytochrome P450 isoform 3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis (See WARNINGS and PRECAUTIONS – Drug Interactions ).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for erythromycin lactobionate. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
Pregnancy There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation, and through weaning of two successive litters. 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.
Lactation
Nursing Mothers Erythromycin is excreted in breast milk. Caution should be exercised when erythromycin is administered to a nursing woman.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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