MedPath

Chloramphenicol

Generic Name
Chloramphenicol
Brand Names
Chloromycetin
Drug Type
Small Molecule
Chemical Formula
C11H12Cl2N2O5
CAS Number
56-75-7
Unique Ingredient Identifier
66974FR9Q1

Overview

An antibiotic first isolated from cultures of Streptomyces venequelae in 1947 but now produced synthetically. It has a relatively simple structure and was the first broad-spectrum antibiotic to be discovered. It acts by interfering with bacterial protein synthesis and is mainly bacteriostatic. (From Martindale, The Extra Pharmacopoeia, 29th ed, p106) The FDA has withdrawn all oral drug products containing chloramphenicol, due to the high risk of fatal aplastic anemia associated with this specific route of administration.

Background

An antibiotic first isolated from cultures of Streptomyces venequelae in 1947 but now produced synthetically. It has a relatively simple structure and was the first broad-spectrum antibiotic to be discovered. It acts by interfering with bacterial protein synthesis and is mainly bacteriostatic. (From Martindale, The Extra Pharmacopoeia, 29th ed, p106) The FDA has withdrawn all oral drug products containing chloramphenicol, due to the high risk of fatal aplastic anemia associated with this specific route of administration.

Indication

Used in treatment of cholera, as it destroys the vibrios and decreases the diarrhea. It is effective against tetracycline-resistant vibrios. It is also used in eye drops or ointment to treat bacterial conjunctivitis.

Associated Conditions

  • Acne
  • Allergic Conjunctivitis (AC)
  • Bacterial Conjunctivitis
  • Bacterial Conjunctivitis caused by susceptible bacteria
  • Bacterial Infections
  • Bacterial Keratitis
  • Bacterial dacryocystitis
  • Bacterial diarrhoea
  • Keratitis
  • Ocular Inflammation
  • Trachoma
  • Anterior eye segment inflammation
  • Bacterial blepharitis
  • Bacterial corneal ulcers
  • Non-purulent ophthalmic infections caused by susceptible bacteria
  • Superficial ocular infections
  • Swelling of the eyes

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
Bestmade Natural Products BM64
Bestmade Natural Products
ORAL
200 [hp_C] in 200 [hp_C]
2025/01/30
82969-2064

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

Singapore Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
CHLORAMPHENICOL EAR DROPS 5% w/v
SOLUTION
5%
1990/06/02
SIN04574P
XEPANICOL EYE DROPS 0.5%
SOLUTION
5MG/ML
1988/04/05
SIN00231P
OPTICHLOR EYE DROPS
Ashford Laboratories Ltd
SOLUTION, STERILE
5.0 mg/ml
2005/03/09
SIN13054P
CHLORAMPHENICOL EAR DROPS 5% w/v
SOLUTION
5%
1988/04/05
SIN00230P
OFTALMOLOSA CUSI CHLORAMPHENICOL EYE OINTMENT 1%
OINTMENT
10 mg/g
1991/06/03
SIN06023P

China Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
Vaginal Chloramphenicol Soft Capsules
国药准字H10940265
软胶囊剂
复皆舒
0.1g
Chemical Drug
Approved
2020/05/22
Domestic
Vaginal Chloramphenicol Soft Capsules
国药准字H20066016
软胶囊剂
N/A
0.1g
Chemical Drug
Approved
2020/12/21
Domestic
Vaginal Chloramphenicol Soft Capsules
国药准字H20057036
胶囊剂
N/A
0.1g
Chemical Drug
Approved
2024/06/26
Domestic
Chloramphenicol Palmitate(Polymorph B)Tablets
国药准字H32020733
片剂
N/A
50mg(按C11H12Cl2N2O5计算)
Chemical Drug
Approved
2015/06/12
Domestic
Chloramphenicol Palmitate(PolymorphB) Tablets
国药准字H44023788
片剂
N/A
50mg(按C11H12Cl2N2O5计)
Chemical Drug
Approved
2015/07/22
Domestic
Chloramphenicol Palmitate(PolymorphB) Tablets
国药准字H22022312
公主岭市红光制药厂
片剂
N/A
50mg(按C11H12Cl2N2O5计)
Chemical Drug
Approved
2002/09/13
Domestic
Chloramphenicol Palmitate(Polymorph B)Tablets
国药准字H44022740
片剂
N/A
50mg(按C11H12C12N2O5计)
Chemical Drug
Approved
2020/04/21
Domestic
Chloramphenicol Palmitate(Polymorph B) Tablets
国药准字H42021954
片剂
N/A
50mg
Chemical Drug
Approved
2020/06/10
Domestic
Chloramphenicol Palmitate(Polymorph B)Tablets
国药准字H42020744
片剂
N/A
50mg(按C11H12Cl2N2O5计)
Chemical Drug
Approved
2020/05/19
Domestic
Chloramphenicol Palmitate(Polymorph B) Tablets
国药准字H31020835
片剂
N/A
50mg(按C11H12Cl2N2O5计)
Chemical Drug
Approved
2002/09/13
Domestic

Australia Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient
AMCAL Chloramphenicol 5 mg/mL (0.5 %) Eye Drops bottle
338569
Neo Health (OTC) Pty Ltd
Active
2020/06/29
chloramphenicol
Minims Chloramphenicol 0.5% 5mg/mL eye drops tube
32263
Bausch & Lomb Australia Pty Ltd
Active
1991/10/30
chloramphenicol
CHLORSIG 1% chloramphenicol 10 mg/g eye ointment tube
19662
Active
1991/10/14
chloramphenicol
CHLORAMPHENICOL GPPL chloramphenicol 5 mg/mL eyedrops bottle
222778
Active
2014/04/24
chloramphenicol
OCUZO EYE OINTMENT chloramphenicol 10 mg/g tube
450127
Neo Health (OTC) Pty Ltd
Active
2024/05/29
chloramphenicol
CHEMISTS' OWN CLORAH chloramphenicol 5 mg/mL eyedrops bottle
222549
Active
2014/04/15
chloramphenicol
PRICELINE PHARMACY CHLORAMPHENICOL EYE DROPS chloramphenicol 5 mg/mL bottle
330168
Neo Health (OTC) Pty Ltd
Active
2020/02/19
chloramphenicol
TERRYWHITE CHEMMART CHLORAMPHENICOL EYE DROPS chloramphenicol 5 mg/mL bottle
330169
Neo Health (OTC) Pty Ltd
Active
2020/02/19
chloramphenicol
NEO-CHLOR chloramphenicol 5 mg/mL eye drops bottle
474090
Neo Health (OTC) Pty Ltd
Active
2024/12/19
chloramphenicol
CHLORAMPHENICOL AH chloramphenicol 5 mg/mL eyedrops bottle
222546
Juno Pharmaceuticals Pty Ltd
Active
2014/04/15
chloramphenicol
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