Product Information
Registration Status: ActiveCHLORAMPHENICOL EAR DROPS 5% W/V is approved to be sold in Singapore with effective from 1988-05-04. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN00230P.
This product contains Chloramphenicol 5% w/v in the form of SOLUTION. It is approved for AURICULAR (OTIC) use.
This product is manufactured by XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD in MALAYSIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
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)
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.
Mechanism of Action
Chloramphenicol is lipid-soluble, allowing it to diffuse through the bacterial cell membrane. It then reversibly binds to the L16 protein of the 50S subunit of bacterial ribosomes, where transfer of amino acids to growing peptide chains is prevented (perhaps by suppression of peptidyl transferase activity), thus inhibiting peptide bond formation and subsequent protein synthesis.
Pharmacokinetics
- Absorption
- Rapidly and completely absorbed from gastrointestinal tract following oral administration (bioavailability 80%). Well absorbed following intramuscular administration (bioavailability 70%). Intraocular and some systemic absorption also occurs after topical application to the eye.
- Distribution
- Metabolism
- Hepatic, with 90% conjugated to inactive glucuronide.
- Elimination
Toxicity
Oral, mouse: LD50 = 1500 mg/kg; Oral, rat: LD50 = 2500 mg/kg. Toxic reactions including fatalities have occurred in the premature and newborn; the signs and symptoms associated with these reactions have been referred to as the gray syndrome. Symptoms include (in order of appearance) abdominal distension with or without emesis, progressive pallid cyanosis, vasomotor collapse frequently accompanied by irregular respiration, and death within a few hours of onset of these symptoms.
Active Ingredient/Synonyms
Chloramex | Chloramphenicol | Chloramphenicolum | Chlornitromycin | Chlorocid | Chlorocol | Cloramfenicol | D-(-)-2,2-Dichloro-N-(beta-hydroxy-alpha-(hydroxymethyl)-P-nitrophenylethyl)acetamide | D-(-)-threo-1-P-Nitrophenyl-2-dichloroacetylamino-1,3-propanediol | Fenicol | Globenicol | Halomycetin | Laevomycetinum | Levomicetina | Levomycetin | Oleomycetin | Sificetina | Chloramphenicol |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.