Overview
Ampicillin is a semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.
Indication
For treatment of infection (Respiratory, GI, UTI and meningitis) due to E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, nonpenicillinase-producing N. gononhoeae, H. influenzae, staphylococci, streptococci including streptoc
Associated Conditions
- Bacterial Infections
- Endocarditis
- Gastrointestinal Tract Infections
- Genitourinary tract infection
- Infection
- Infection caused by eikenella corrodens
- Listeria infection
- Meningitis, Bacterial
- Pertussis
- Respiratory Tract Infections (RTI)
- Salmonella
- Septicemia
- Shigella
- Subcutaneous bacterial infection
- Urinary Tract Infection
- Bacterial skin infections
- Disease caused by Salmonella typhi
- Perinatal group B streptococcus
- Susceptible Bacterial Infections
Research Report
A Comprehensive Monograph on Ampicillin (DB00415): From Molecular Structure to Clinical Practice
Executive Summary
Ampicillin is a seminal semi-synthetic, broad-spectrum β-lactam antibiotic belonging to the aminopenicillin class. Developed in 1961, it represented a significant advancement over natural penicillins by extending antimicrobial coverage to include various Gram-negative pathogens. Its bactericidal action is achieved through the irreversible inhibition of bacterial cell wall synthesis via binding to penicillin-binding proteins (PBPs). Despite its historical importance, its clinical utility has been significantly curtailed by the global rise of bacterial resistance, primarily mediated by β-lactamase enzymes. Consequently, its use is now more targeted, often guided by susceptibility testing or used in combination with β-lactamase inhibitors like sulbactam. This monograph provides an exhaustive analysis of Ampicillin's chemical properties, pharmacology, microbiology, clinical applications, and safety profile, contextualizing its enduring, albeit diminished, role in modern antimicrobial therapy.
Section 1: Chemical Profile and Formulations
The foundational identity and physical characteristics of Ampicillin are critical to understanding its biological function, pharmaceutical development, and clinical handling. Its unique chemical structure is directly responsible for its expanded spectrum of activity compared to earlier penicillins, while its physicochemical properties dictate the specific protocols required for its safe and effective administration.
1.1 Identification and Nomenclature
A precise and standardized identification is essential for any pharmaceutical agent. Ampicillin is cataloged across numerous chemical and pharmacological databases under specific identifiers that define its structure and therapeutic class.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/07/10 | Phase 4 | Recruiting | |||
2024/06/07 | Phase 4 | Completed | |||
2024/05/02 | Phase 4 | Recruiting | |||
2024/04/16 | Phase 4 | Recruiting | Uji Takeda Hospital | ||
2023/08/04 | Phase 3 | Not yet recruiting | |||
2022/07/22 | Not Applicable | Recruiting | |||
2021/09/21 | Phase 2 | UNKNOWN | |||
2021/08/25 | Phase 2 | Recruiting | |||
2019/12/17 | Not Applicable | Completed | |||
2019/08/01 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Fresenius Kabi USA, LLC | 65219-018 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 1/24/2020 | |
NorthStar Rx, LLC | 72603-220 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 2/28/2024 | |
NorthStar Rx, LLC | 72603-454 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 2/22/2024 | |
Medical Purchasing Solutions, LLC | 71872-7240 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 5/8/2023 | |
Medical Purchasing Solutions, LLC | 71872-7286 | INTRAVENOUS | 1 g in 1 1 | 5/2/2023 | |
Sandoz Inc | 0781-3402 | INTRAVENOUS, INTRAMUSCULAR | 250 mg in 1 1 | 10/20/2017 | |
Methapharm, Inc. | 67850-131 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 1 1 | 1/21/2022 | |
Eugia US LLC | 55150-114 | INTRAVENOUS | 2 g in 1 1 | 8/14/2025 | |
WG Critical Care, LLC | 44567-211 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 20 mL | 2/23/2023 | |
Physicians Total Care, Inc. | 54868-3113 | ORAL | 500 mg in 1 1 | 6/5/2012 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
STANDACILLIN FOR INJECTION 0.5 g/vial | SIN00680P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 5/3/1988 | |
UNASYN 750 FOR INJECTION | SIN01950P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 6/23/1988 | |
UNASYN 3000 FOR INJECTION | SIN01949P | INJECTION, POWDER, FOR SOLUTION | 2 g/vial | 6/23/1988 | |
UNASYN 1500 FOR INJECTION | SIN01948P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 6/23/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
NEO A.C.2 CAP | N/A | N/A | N/A | 12/16/1985 | |
LOXAMP CAPSULES | N/A | N/A | N/A | 5/22/2015 | |
KINTAMVY FOR INJ 0.75G | N/A | N/A | N/A | 11/19/2007 | |
REICHLOX CAP 500MG | N/A | N/A | N/A | 3/14/2005 | |
REICHLIN CAP 250MG | N/A | N/A | N/A | 1/7/2005 | |
AMPICILLIN SODIUM FOR INJ 0.5G | N/A | N/A | N/A | 8/15/2008 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Austrapen 1g powder for injection vial | 29354 | Medicine | A | 11/4/1991 | |
IBIMICYN ampicillin 1g (as sodium) powder for injection vial | 92840 | Medicine | A | 2/20/2003 | |
IBIMICYN ampicillin 500mg (as sodium) powder for injection vial | 92839 | Medicine | A | 2/20/2003 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PRO AMPI 500 CAP 500MG | PRO DOC LIMITEE | 00628360 | Capsule - Oral | 500 MG / CAP | 12/31/1985 |
APO AMPI CAPSULES 250MG | 00603279 | Capsule - Oral | 250 MG | 12/31/1984 | |
NU-AMPI SUSPENSION 250MG/5ML | nu-pharm inc | 00717649 | Suspension - Oral | 250 MG / 5 ML | 12/31/1990 |
NOVO-AMPICILLIN SUS 125MG/5ML | novopharm limited | 00021121 | Powder For Solution - Oral | 125 MG / 5 ML | 12/31/1971 |
NOVO-AMPICILLIN SUS 250MG/5ML | novopharm limited | 00021148 | Powder For Solution - Oral | 250 MG / 5 ML | 12/31/1971 |
PRO BIOSAN KIT | icn canada ltd. | 00284009 | Tablet
,
Capsule - Oral | 500 MG / PCK | 12/31/1979 |
NOVO-AMPICILLIN PWS 500MG/5ML | novopharm limited | 00231207 | Powder For Solution - Oral | 500 MG / 5 ML | 12/31/1972 |
NU-AMPI CAPSULES 250MG | nu-pharm inc | 00717657 | Capsule - Oral | 250 MG | 12/31/1990 |
PENBRITIN CAP 250MG | ayerst laboratories | 00002003 | Capsule - Oral | 250 MG / CAP | 12/31/1962 |
NU-AMPI CAPSULES 500MG | nu-pharm inc | 00717673 | Capsule - Oral | 500 MG | 12/31/1990 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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