Cafcol
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 250 mg Capsules Cafcol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol BP 250 mg.
3 PHARMACEUTICAL FORM
Capsule.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
To be reserved for the treatment of infections caused by Haemophilus influenzae and typhoid fever.
4.2 Posology and method of administration
Adults (including the elderly):
The usual dose is 500 mg every 6 hours and treatment should be continued for 2 or 3 days after the patient's temperature has returned to normal.
Children: Pyogenic meningitis
50-100 mg per kg bodyweight every 6 hours.
To be taken by mouth.
4.3 Contraindications
Chloramphenicol is contra-indicated in individuals with a history of hypersensitivity or toxic reaction to the drug. Blood dyscrasias including aplastic anaemia.
4.4 Special warnings and precautions for use
Determine routine blood profile before therapy and repeat blood studies at appropriate intervals, especially during prolonged intermittent therapy. The drug should be withdrawn if evidence of depression of any of the blood elements appears to be attributable to chloramphenicol, always weighing these effects against the seriousness and course of the disease under treatment.
Avoid repeated courses of Chloramphenicol and concurrent therapy with other drugs known to cause bone marrow depression. Chloramphenicol should not be used for the treatment of trivial infections.
4.5 Interaction with other medicinal products and other forms of interaction
In patients receiving Paracetamol the half-life of Chloramphenicol is considerably prolonged. Rifampicin accelerates the metabolism leading to a reduced Chloramphenicol plasma concentration. The anti-coagulant effect of warfarin and nicoumalone are enhanced. The effect of sulphonylureas is enhanced. The plasma concentration of phenytoin is increased while the metabolism of Chloramphenicol is accelerated by phenobarbitone. The plasma concentrations of ciclosporin and tacrolimus are possibly increased by chloramphenicol.
4.6 Pregnancy and lactation
Chloramphenicol should not be used during pregnancy unless considered absolutely essential by the physician.
Chloramphenicol is excreted in the milk of the lactating mother, therefore mothers taking this drug should not breast feed their infants.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8
Undesirable effects
Excessive blood levels may result from administration of the recommended doses to patients with impaired kidney or liver function.
Concurrent therapy with other drugs known to cause bone marrow depression or aplastic anaemia should be avoided.
Blood dyscrasias and bone marrow depression have been observed. This may be irreversible and lead to aplastic anaemia which may be fatal. Paroxysmal nocturnal haemoglobinuria has been reported, as have hypoplastic anaemia, plastic anaemia, thrombocytopenia and agranulocytosis.
Gastro-intestinal reactions: Nausea, vomiting, glossitis, stomatitis, diarrhoea and enterocolitis may occur, but the incidence is low.
Neurological reactions: Peripheral neuritis, optic neuritis have been reported but usually following long-term dosage.
Hypersensitivity reactions: Rarely encountered.
4.9 Overdose
If more than 12 capsules are swallowed, the stomach should be emptied by gastric lavage and symptomatic treatment instituted. There is no antidote to Chloramphenicol.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Chloramphenicol is a broad spectrum antibiotic which acts by interfering with bacterial protein synthesis. It is bacteriostatic effective against a wide range of gram-negative and gram-positive organisms. Particularly susceptible are S. Typhi, H. Influenzae, Neisseria Meningitides and Bordetella Pertussis. It also has anti-rickettsial activity and is active against Chlamydias.
5.2 Pharmacokinetic properties
Chloramphenicol is readily absorbed when taken orally. After a single dose of
1 g blood concentrations of about 10 micrograms per ml may be reached after
2 hours.
Blood concentrations above 4 micrograms per ml are usually maintained by a dose of 500 mg every 6 hours.
The drug is readily distributed in body tissues and fluids and enters the cerebro-spinal fluid. Chloramphenicol travels across the placenta into the cerebro-spinal fluid. Chloramphenicol travels across the placenta into the foetal circulation and into breast milk and into the aqueous and vitreous humours of the eye. About 60% in the circulation is bound to plasma protein. Chloramphenicol is excreted mainly in the urine when 90% is inactivated in the liver mostly by conjugation with glucuronic acid. About 3% is excreted in the bile.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pregelatinised maize starch, sodium starch glycollate, magnesium stearate, gelatin and titanium dioxide.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25 °C in a dry place in well closed containers.
6.5 Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane or polythene inserts. Pack sizes: 100 and 500.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd floor, 1060 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0017
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12.11.1986 / 28.11.2008
10 DATE OF REVISION OF THE TEXT
28/11/2008