Chloramphenicol

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Typhoid fever and other types of systemic salmonella infections (not the carrier state)
• Bacterial meningitis due to Haemophilus influenzae
• Anaerobic infections caused by bacteroides species, such as foci in the bowel or pelvis, or brain abscess
• Rickettsial diseases such as epidemic, murine, scrub and recrudescent typhus, Rocky Mountain spotted fever and Q. fever
• Brucellosis
• Infections caused by K. pneumoniae, Mycoplasma pneumoniae and Y. pestis and diseases such as lymphogranuloma venereum and psittacosis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Porphyria
• Minor or viral infections
• Severe renal impairment (see Special Populations)
• Severe hepatic impairment (see Special Populations)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Neonates
• Premature infants
• Prolonged treatment
• Glucose-6-phosphate dehydrogenase deficiency

Forms avail. in SA and covered in this monograph: inj, cap

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Infections caused by: Most Gram-negative bacilli;Some Gram-negative diplococci (including N. meningitidis);Some Gram-positive cocci (including Staphylococcus spp and Streptococcus spp);Other, including: Rickettsiae, B. fragilis and M. pneumoniae

General dosing range

• IV: 50-100mg/kg/day, in 4 divided doses; Max: 4g/24hrs
• Oral (cap): 50-100mg/kg/day, in 4 divided doses; Max: 4g/24hrs

See additional prescribing points for administration directions

Not commonly used for children in South Africa

Pregnancy

• Caution; not recommended
• Chloramphenicol crosses the placenta producing cord concentrations approaching maternal serum concentrations. An increased risk of teratogenic effects has not been associated with the use of chloramphenicol in pregnancy
• "Grey Syndrome" has occurred in premature infants and newborns receiving chloramphenicol

Breastfeeding

• Caution; not recommended
• Chloramphenicol is excreted into breast milk. There is an increased risk of adverse effects in the nursing infant, therefore, a decision must be made whether to discontinue breastfeeding or discontinue chloramphenicol taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother

Renal Impairment

• Mild to moderate: Caution; dose adjustment recommended
  50mg/kg/day in divided doses; Max: 1g/24hrs 
• Severe: Avoid use
  Contraindicated in severe renal impairment when:
  No plasma concentration monitoring (therapeutic drug monitoring) services are available
  Concomitant blood dyscrasias (aplastic anaemia, hypoplastic anaemia, thrombocytopenia, and granulocytopenia), or persistent immune-deficiency (agranulocytosis, HIV, systemic fungal infection)

Hepatic Impairment

• Mild to moderate: Caution; dose adjustment recommended
  50mg/kg/day in divided doses; Max: 1g/24hrs 
• Severe: Avoid use 
  Contraindicated in severe hepatic impairment when:
  No plasma concentration monitoring (therapeutic drug monitoring) services are available
  Concomitant blood dyscrasias (aplastic anaemia, hypoplastic anaemia, thrombocytopenia, and granulocytopenia), or persistent immune-deficiency (agranulocytosis, HIV, systemic fungal infection)

Elderly

• No dose adjustment recommended

Porphyria Information

• Porphyrinogenic (P)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Peripheral neuritis
• Headache
• Depression

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Dry mouth

Skin and Subcutaneous Tissue Disorders

• Urticaria

Immune, Blood and Lymphatic System Disorders

• Fungal superinfection
• Aplastic anaemia
• Agranulocytosis
• Bone marrow failure
• Pancytopenia
• Thrombocytopenic purpura

Sensory Disorders

• Eye disorders
• Optic neuritis
• Transient blindness
• Blurred vision

Others

• Neonatal Grey syndrome

• Barbiturates
• Warfarin
• Sulphonylureas
• Phenytoin
• Rifampicin
• Active immunisations
• Myelosuppressive agents
• Sodium picosulphate
• Tacrolimus

• Full blood count
• Hepatic function
• Renal function

Specific cases may require

• Serum drug concentrations

Administration directions

• Do not administer by IM injection
• IV bolus: Reconstitute with sterile water, normal saline or glucose-containing fluid to form a 10% solution; Inject over at least 1min. To create a 10% solution: reconstitute 1g with 9.2ml of diluent

Grey syndrome

• Toxic reactions, including fatalities, have occurred in premature infants and neonates. The signs and symptoms associated with these reactions have been referred to as the "Grey Syndrome"
• Symptoms first appear after 3 to 4 days of continued treatment with high doses of chloramphenicol. These include: abdominal distension with or without emesis, progressive pallid cyanosis, vasomotor collapse, frequently accompanied by irregular respiration, followed by death within a few hours of onset of these symptoms
• Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery following

Chloramphenicol acts on an intracellular level by reversibly binding to the 50S subunit of bacterial ribosomes. This prevents amino acids being transferred to peptide chains resulting in the inhibition of protein synthesis.

Spectrum of activity: Most Gram-negative bacilliSome Gram-negative diplococci (including N. meningitidis)Some Gram-positive cocci (including Staphylococcus spp and Streptococcus spp)Other, including: Rickettsiae, B. fragilis and M. pneumoniae

Capsule 250mg

• Chlorphen (Caps Pharmaceuticals)
• Chlorcol (Adcock)
• Rolab-Chlorampoulehenicol (Sandoz)

Injection (per vial) 1g

• Chlorphen (Caps Pharmaceuticals)

Also available in the following forms: Eye drops and eye ointment