Lactobionate

• 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.

• 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 ).contraindicated

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.

Hepatotoxicity There have been reports of hepatic dysfunction, with or without jaundice occurring in patients receiving oral erythromycin products. Since erythromycin is principally excreted by the liver, monitor for liver toxicity when erythromycin is administered to patients with impaired hepatic function (See CLINICAL PHARMACOLOGY ). 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. 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 2 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.

Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes (See WARNINGS ). 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. Elderly patients, particularly those with reduced renal or hepatic function, may also be at increased risk for developing this effect when Erythrocin TM doses of 4 grams/day or higher are given (See DOSAGE AND ADMINISTRATION ).

In the case of overdosage, erythromycin infusion should be discontinued and all other appropriate measures should be instituted. 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.

• Sep 24, 1986NDANDA050609Hospira
• Nov 19, 2024ANDAANDA216761Gland

1. 1Agranulocytosis1812%
2. 2Leukopenia1812%
3. 3Neutropenia1510%
4. 4Off Label Use128.2%
5. 5Condition Aggravated64.1%
6. 6Diarrhoea64.1%
7. 7Mixed Liver Injury64.1%
8. 8Pneumonia64.1%
9. 9Alanine Aminotransferase Increased53.4%
10. 10Pyrexia53.4%
11. 11Drug Ineffective42.7%
12. 12Hepatic Function Abnormal42.7%
13. 13Nausea42.7%
14. 14Pain42.7%
15. 15Respiratory Failure42.7%

The 10 most recently updated of 15 ClinicalTrials.gov registrations naming Lactobionate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Alcohol Induced de Novo Lipogenesis in Women
  Active not recruiting · Interventional · 27 enrolled · University of Texas Southwestern Medical Center
  NCT04829110updated 2026-05-07
• The Effectiveness of Sweet Solution Versus Cryotherapy in Reducing Pain During Administration of Local Anesthesia Among Children
  Active not recruiting · Interventional · 180 enrolled · Mansoura University
  NCT07002528updated 2025-08-26
• Effects of Seaweed Extract on Blood Glucose Response to Sucrose
  Unknown · Interventional · 20 enrolled · University College Dublin
  NCT05461560updated 2022-07-19
• ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model
  Terminated · Interventional · 5 enrolled · Prof Dr Jan Tack
  NCT04066231updated 2020-08-12
• Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
  Terminated · Phase 2 · Phase 3 · Interventional · 97 enrolled · Melinta Therapeutics, Inc.
  NCT02605122updated 2019-01-03
• University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation
  Unknown · Interventional · 7 enrolled · SB Istanbul Education and Research Hospital
  NCT03051308updated 2017-02-13
• Relationship Between Gastric Emptying and Glycemic Variability in Type 1 Diabetes Mellitus
  Completed · Phase 1 · Interventional · 30 enrolled · Adil Bharucha
  NCT02755064updated 2016-04-28
• Effect of the Motilin Receptor Agonist, Erythromycin, on Hunger and Food Intake; Study of Role of Cholinergic Pathways
  Completed · Interventional · 28 enrolled · Universitaire Ziekenhuizen KU Leuven
  NCT02633579updated 2015-12-17
• Patch Test of Benzalkonium Chloride Disinfectant Spray
  Completed · Interventional · 36 enrolled · GlaxoSmithKline
  NCT01762982updated 2014-01-22
• Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation
  Completed · Interventional · 141 enrolled · Shanghai Jiao Tong University School of Medicine
  NCT01271179updated 2011-01-06

Frequently asked questions

What is Lactobionate used for?

According to FDA labeling, Lactobionate carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Lactobionate?

Lactobionate labeling lists contraindications including: 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 ).. Always consult the full prescribing information and a clinician.