ERYTHROCIN (erythromycin lactobionate) · Pfizer
Erythrocin (erythromycin lactobionate) is an injectable antibiotic indicated for the treatment of infections caused by susceptible strains of microorganisms when oral administration is not possible or when the severity of the illness requires immediate high serum levels. It is used for upper and lower respiratory tract infections, skin and skin structure infections, erythrasma, and as an adjunct to antitoxin for diphtheria. It also serves as an alternative treatment for acute pelvic inflammatory disease caused by *N. gonorrhoeae* in female patients with a history of penicillin sensitivity. For respiratory infections involving *H. influenzae*, it must be used in conjunction with adequate doses of sulfonamides. Intravenous therapy should be transitioned to oral administration at the appropriate clinical juncture.
How ERYTHROCIN Works
Erythromycin exerts its antibacterial effect by binding to the 50S ribosomal subunits of susceptible organisms, thereby inhibiting RNA-dependent protein synthesis. This action prevents bacterial growth and replication without affecting nucleic acid synthesis.
Details
- Status
- Prescription
- First Approved
- 1964-06-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ERYTHROCIN Approval History
What ERYTHROCIN Treats
8 indicationsERYTHROCIN is approved for 8 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Upper Respiratory Tract Infection
- Lower Respiratory Tract Infection
- Skin and Skin Structure Infection
- Diphtheria
- Erythrasma
- Pelvic Inflammatory Disease
- Legionnaires' Disease
- Rheumatic Fever
ERYTHROCIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02755064 | 08-008620 UL1TR000135 | Ph 1 | completed | Relationship Between Gastric Emptying and Glycemic Variability in Type 1 Diabetes Mellitus |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ERYTHROCIN FDA Label Details
Indications & Usage
FDA Label (PDF)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 pne...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.