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Chlorocidin (CHLORAMPHENICOL)
Chloramphenicol (Chlorocidin), marketed by Parkedale, is an antibiotic primarily indicated for bacterial skin infections, with a key composition patent expiring in 2028. Its mechanism of action, inhibiting bacterial protein synthesis by binding to the 50S ribosomal subunit, provides a broad-spectrum antibacterial effect. However, the primary risk lies in the highly competitive landscape, with multiple off-patent generics such as neomycin, bacitracin, gentamicin, and mupirocin, which may limit market share and revenue potential.
At a glance
| Generic name | CHLORAMPHENICOL |
|---|---|
| Sponsor | Parkedale |
| Drug class | Amphenicol-class Antibacterial |
| Target | Cytochrome P450 3A4 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1950 |
Approved indications
- Bacterial infection of skin
- Bacteroides Brain Abscess
- Boutonneuse fever
- Disease caused by rickettsiae
- H. Influenzae Meningitis
- Meningococcal meningitis
- Otitis externa
- Paratyphoid fever
- Streptococcal meningitis
- Superficial Ocular Infection
- Typhoid fever
Boxed warnings
- WARNING Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia) are known to occur after the administration of chloramphenicol. In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the INDICATIONS AND USAGE section. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections. Precautions: It is essential that adequate blood studies be made during treatment with the drug. While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia. To facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized.
Common side effects
- Keratopathy
- Appendicolith
- Lip swelling
- Appendicitis
- Cardiospasm
- Ventricular fibrillation
- Palmoplantar keratoderma
- Pruritus genital
- Sleep terror
- Cardiogenic shock
- Blood phosphorus increased
- Atrial tachycardia
Drug interactions
- other drugs that may cause bone marrow depression
Key clinical trials
- Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp Necrosis (PHASE1,PHASE2)
- Non-instrumentation Root Canal Treatment of Primary Molars (NA)
- Village Integrated Eye Workers Trial (NA)
- Studying the Distribution of Accessory Gene Regulator (Agr) Quorum Sensing System and the Prevalence of Linezolid and Mupirocin Resistance in Biofilm Producer/Non Producer Staphylococcus Aureus in Sohag University Hospitals (NA)
- Lubricating Eye Drops After Routine Cataract Surgery (NA)
- Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth (PHASE1,PHASE2)
- Effects of LiveSpo X-secret in Supporting Treatment of Sexually Transmitted Diseases (NA)
- Root Canal Treatment in Primary Molars With Necrotic Pulp Using Two Different Pulp Therapies (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |