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 (From Martindale, The Extra Pharmacopoeia, 29th ed, p106) The FDA has withdrawn all oral drug products containing chloramphenicol, due to the high risk of fatal aplastic anemia associated with this specific route of administration.

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 Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bestmade Natural Products
82969-2064
ORAL
200 [hp_C] in 200 [hp_C]
1/30/2025

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
CHLORAMPHENICOL EAR DROPS 5% w/v
SIN04574P
SOLUTION
5%
6/2/1990
XEPANICOL EYE DROPS 0.5%
SIN00231P
SOLUTION
5MG/ML
4/5/1988
OPTICHLOR EYE DROPS
SIN13054P
SOLUTION, STERILE
5.0 mg/ml
3/9/2005
CHLORAMPHENICOL EAR DROPS 5% w/v
SIN00230P
SOLUTION
5%
4/5/1988
OFTALMOLOSA CUSI CHLORAMPHENICOL EYE OINTMENT 1%
SIN06023P
OINTMENT
10 mg/g
6/3/1991

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
VANAFEN OPHTHALMIC OINTMENT 1% W/W
N/A
N/A
N/A
12/19/2012

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CHLOROMYCETIN OPH SOLN 0.5%
parke-davis division, warner-lambert canada inc.
00221678
Liquid - Ophthalmic
.5 %
12/31/1971
SOPAMYCETIN/HC SUSP
laboratoires charton laboratories
00438669
Drops - Ophthalmic
.2 %
12/31/1988
PENTAMYCETIN/HC
01980572
Suspension - Otic ,  Ophthalmic
2 MG / ML
12/31/1992
PMS-CHLORAMPHENICOL OPHTHALMIC SOLN 0.5%
00861383
Drops - Ophthalmic
.5 %
12/31/1992
ELASE CHLOROMYCETIN ONT
parke-davis division, warner-lambert canada inc.
00156124
Ointment - Topical ,  Vaginal
10 MG / G
12/31/1962
MINIMS CHLORAMPHENICOL 0.5%
chauvin pharmaceuticals limited
02148374
Drops - Topical ,  Ophthalmic
.5 %
12/31/1995
NOVO-CHLOROCAP CAP 250MG
novopharm limited
00020907
Capsule - Oral
250 MG / CAP
12/31/1966
CHLORAMPHENICOL
pharma stulln inc.
02023857
Solution - Ophthalmic
0.5 %
12/31/1994
ACTINAC PWR
roussel canada inc.
00429090
Powder - Topical
40 MG / G
12/31/1978
SOPAMYCETIN SOLN OTIQUE 5%
laboratoires charton laboratories
00717932
Drops - Otic
5 %
12/31/1988

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
CORTISON CHEMICETINA 25mg/g + 20mg/g POMADA
Teofarma S.R.L.
26231
POMADA
Medicamento Sujeto A Prescripción Médica
Commercialized
CORTISON CHEMICETINA POMADA 5mg/g + 10mg/g POMADA
Teofarma S.R.L.
26230
POMADA
Medicamento Sujeto A Prescripción Médica
Commercialized
OFTALMOLOSA CUSI DE ICOL POMADA OFTALMICA
Fidia Farmaceutici S.P.A.
40356
POMADA OFTÁLMICA
Medicamento Sujeto A Prescripción Médica
Commercialized
OFTALMOLOSA CUSI CLORAMFENICOL 10 MG/G POMADA OFTÁLMICA
19495
POMADA OFTÁLMICA
Medicamento Sujeto A Prescripción Médica
Commercialized

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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