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Logo LENNACOL INJECTION 1 g/VIAL (lyophilized powder)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

LENNACOL INJECTION 1 g/VIAL (lyophilized powder)

COMPOSITION:
Each vial contains
Chloramphenicol Sodium Succinate equivalent to 1 g Chloramphenicol.

PHARMACOLOGICAL CLASSIFICATION:
A20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Chloramphenicol is a broad spectrum antibiotic which was first isolated from cultures of Streptomyces venezuelae but is now produced synthetically. It acts by interfering with bacterial protein synthesis by binding reversably to the 50S ribosomal subunit. It's action is mainly bacteriostatic. Chloramphenicol sodium succinate is partially hydrolysed to free chloramphenicol in the liver, lungs and kidneys. It is inactivated in the liver and approximately 30% is excreted unchanged in the urine. Chloramphenicol has a half life range of 4 hours and about 50% in the circulation is bound to plasma protein. Chloramphenicol enters the cerebrospinal fluid, even in the absence of meningitis, giving concentrations of about 60% of those existing in the blood. It crosses the placenta into the foetal circulation, into breast milk and into the aqueous and vitreous humours of the eye.

INDICATIONS:
Typhoid fever and other types of systemic salmonella infections. (not the carrier state).
Bacterial meningitis caused byHaemophilis influenzae; Anaerobic infections caused by bacteroides species especially B. fragilis, such as foci in the pelvis or bowel, or brain abscesses.
Rickettsial diseases –drug of choice in severely ill patients e.g. in diseases like Rocky Mountain spotted fever, epidemic murine scrub and recrudescent typhus, Q-fever.
Brucellosis chronic and acute form.
Other –Infections caused by K. pneumoniae, Mycoplasma pneumoniae and Y. pestis and diseases such as lymphogranuloma venereum and psittacosis.

CONTRA-INDICATIONS:
Hypersensitivity to Chloramphenicol.

WARNINGS:
Lennacol (chloramphenicol) should never be used for minor infections or for prophylaxis.
Repeated courses and prolonged treatment should be avoided. Routine periodic blood examinations are advisable in all patients, but will not warn of aplastic anaemia.
Reduced doses should be given to patients with impaired liver function or with severe renal failure and in premature and full-term nenonates who have immature metabolic processes. Newborn infants should never be given Lennacol (chloramphenicol) unless it may be life-saving and there is no alternative treatment.

Avoid during pregnancy and while nursing as Lennacol (chloramphenicol) is excreted in mothers milk. It should also be avoided during active immunisation.

Drug interactions: Lennacol (chloramphenicol) enhances the effects of coumarin anticoagulants, some hypoglycaemic agents such as chlorpropamide and tolbutamide, and anti-epileptics such as phenytoin. The half-life may be affected by paracetamol, phenobarbitone, phenytoin or rifampicin.
Resistance occurs in salmonellae and cross-resistance with thiamphenicol. Lennacol (chloramphenicol) may interfere with the haematological response of Vitamin B12, folic acid or iron in patients with anaemia. It may also reduce the reliability of the oral contraceptive pill and increase the incidence of breakthrough bleeding. It is also dangerous in porphyria sufferers.

DOSAGE AND DIRECTIONS FOR USE:
Lennacol Injection (chloramphenicol) should be administered when oral treatment is not feasible and should be substituted as soon as possible.

The 10% dilution of Lennacol Injection (chloramphenicol) should be administered by intravenous injection over at least one minute or in larger volumes of fluid, by slow intravenous infusion. Intramuscular injection is not recommended as the absorption may be slow and unpredictable.

Lennacol (chloramphenicol) should be reconstituted with Water for Injections, Sodium Chloride injection, or Dextrose injection 5%. The following dilution table may be useful for the administration of the proportion of the contents of a vial:

Concentration Solution strength Volume of Diluent to be added Total volume after dilution
40% 400 mg/mL 1,7 mL 2,5 mL
25% 250 mg/mL 3,2 mL 4,0 mL
20% 200 mg/mL 4,2 mL 5,0 mL
10% 100 mg/mL 9,2 mL 10,0 mL
Adults and children:
50 mg/kg body mass daily in divided doses every 6 hours.
Maximum dosage: 100 mg/kg body mass daily in severe cases. This should be reduced as soon as possible.
Treatment should be continued for 4 days after the patient's temperature has returned to normal to avoid the risk of relapse in the case of rickettsial diseases, and for 8 to 10 days in typhoid fever.

Neonates –premature and full-term: It is not recommended in these cases.
In cases of severe infection, 25 mg/kg body mass daily in 4 divided doses.

Infants over 2 weeks in age:
Full term infants over 2 weeks of age may be given up to 50 mg/kg body mass daily in 4 divided doses.

Patients with impaired renal or hepatic function may require reduced doses. Discard any unused portion after dilution.
Lennacol (chloramphenicol) should only be used when there is no other suitable treatment for the severe infection and when blood concentrations can be monitored.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Adverse reactions to Lennacol (chloramphenicol) may be serious and sometimes fatal.
The most serious is bone marrow depression. This may take one of two forms: the first is more common and is dose-related and reversible. It occurs when the plasma concentrations of chloramphenicol exceed 25 µg/mL. It is characterised by morphological changes in the bone marrow, decreased iron utilisation, reticulocytopenia, anaemia, leucopenia and thrombocytopenia. The second, irreversible aplastic anaemia is apparently not dose related. Aplastic anaemia is relatively rare and usually develops after a latent period of weeks or months. There is no way of identifying susceptible patients. It may cause death.
Haemolytic anaemia has occurred when a genetic deficiency of glucose-6-phosphate dehydrogenase is present.
The "grey-syndrome" characterised by abdominal distension, vomiting, ashen colour, hypothermia, progressive pallid cyanosis, irregular respiration and circulatory collapse followed by death has occurred in premature and newborn infants receiving doses mainly in excess of 25 mg/kg body mass daily. A similar syndrome has been reported in adults and older children given very high doses.
Peripheral and optic neuritis has been reported in patients receiving the drug over prolonged periods.
Ocular symptoms are often reversible on withdrawal of treatment. Optic atrophy with blindness has occurred. Hypersensitivity and Jarisch-Herxheimer-like reactions may also occur. Patients may experience an intensely bitter taste following rapid intravenous administration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "side effects and special precautions".
Treatment is symptomatic and supportive.

IDENTIFICATION:
A white or yellowish-white hygroscopic solid or powder in 10 mL clear vials.

PRESENTATION:
10 mL clear vials packed in boxes of 10.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
Keep out of reach of children.

APPLICATION NUMBER:
A663 (Act 101 of 1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT
INTRAMED (PTY) LTD.
6 Gibaud Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1991
  12-199/4-93
  Stop Press

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