BICILLIN C-R 900/300 (penicillin g benzathine) · KING PHARMS
Bicillin C-R 900/300 is an injectable antibiotic combination (penicillin G benzathine and penicillin G procaine) indicated for pediatric patients. It is used to treat moderately severe to severe upper-respiratory tract infections, scarlet fever, erysipelas, and skin and soft-tissue infections caused by susceptible streptococci. It is also indicated for moderately severe pneumonia and otitis media caused by susceptible *Streptococcus pneumoniae*. This formulation is specifically not indicated for the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, or pinta.
How BICILLIN C-R 900/300 Works
Penicillin G exerts bactericidal action against susceptible microorganisms during the stage of active multiplication. It acts by inhibiting the biosynthesis of cell-wall peptidoglycan, rendering the bacterial cell wall osmotically unstable, which results in bacterial cell death.
Details
- Status
- Prescription
- First Approved
- 1953-05-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BICILLIN C-R 900/300 Approval History
What BICILLIN C-R 900/300 Treats
6 indicationsBICILLIN C-R 900/300 is approved for 6 conditions since its original approval in 1953. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Upper Respiratory Tract Infection
- Scarlet Fever
- Erysipelas
- Skin and Soft Tissue Infection
- Pneumonia
- Otitis Media
BICILLIN C-R 900/300 Boxed Warning
NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS , and DOSAGE AND ADMINISTRATION sections of the labeling....
WARNING: NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS , and DOSAGE AND ADMINISTRATION sections of the labeling.
BICILLIN C-R 900/300 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03612557 | B8441001 | Ph 1 | completed | A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects |
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.
BICILLIN C-R 900/300 FDA Label Details
Indications & Usage
FDA Label (PDF)To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin C-R 900/300 and other antibacterial drugs, Bicillin C-R 900/300 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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. Bicillin C-R 900/300 is indicated in the treatment of infection...
WARNING: NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this dru...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.