1. Name Of The Medicinal Product
Kemicetine Succinate Injection or Chloramphenicol Sodium Succinate 1.377g Injection
2. Qualitative And Quantitative Composition
Chloramphenicol sodium succinate (BP) 1.377 g
– equivalent to laevorotatory chloramphenicol 1.0 g
3. Pharmaceutical Form
Freeze dried powder for injection.
4. Clinical Particulars
4.1 Therapeutic Indications
Kemicetine (chloramphenicol) is a broad-spectrum antibiotic and is active against many gram-negative organisms, Spirillae and Rickettsia. Kemicetine should not be used for trivial infections due to the possibility of severe blood dyscrasias, which may prove fatal.
Kemicetine succinate is indicated for typhoid, meningitis caused by H. influenzae and other serious infections caused by bacteria susceptible to chloramphenicol. It is also indicated wherever chloramphenicol is deemed the antibiotic of choice and oral administration is not possible, or where higher than usual blood concentrations are required.
4.2 Posology And Method Of Administration
To be given by i.v. or i.m. injection.
In order to ensure rapid attainment of high blood levels, Kemicetine succinate is best administered by i.v. injection. Where this is not possible, however, intramuscular administration may be used, although it should be borne in mind that absorption may be slow and unpredictable.
The injection should be reconstituted with Water for Injections, Sodium ChlorideInjection, or Dextrose Injection 5 %. The following dilution table may be useful for the administration of a proportion of the contents of a vial:
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The dose administered and the concentration used is dependent on the severity of the infection. The recommended standard dosage is as follows:
Adults : The equivalent of 1 g of chloramphenicol every 6-8 hours.
Elderly : The usual adult dosage should be given subject to normal hepatic and renal function.
Children : The equivalent of 50 mg/kg chloramphenicol according to body weight, daily in divided doses every 6 hours (this dose should not be exceeded). The patient should be carefully observed for signs of toxicity.
Neonates and Premature Infants : 25 mg/kg in divided doses.
Only 10% or lower concentrations to be used. The 10% solution can be prepared by extracting 5ml of the 20% solution and adding 5ml of diluent (Water for Injections, Sodium Chloride Injection or Dextrose Injection 5%) under aseptic conditions.
The 10 % solution should be given by intravenous injection over a period of about a minute, or in a larger volume of fluid, by slow intravenous infusion. The concurrent administration of i.v. Kemicetine succinate with topical treatment has been found to be very effective in the treatment of osteomyelitic foci, abscesses, empyema and skin and urinary infections.
In exceptional cases, such as patients with septicaemia or meningitis, dosage schedule up to 100 mg/kg/day may be prescribed. However, these high doses should be decreased as soon as clinically indicated. To prevent relapses treatment should be continued after the temperature has returned to normal for 4 days in rickettsial diseases and for 8 – 10 days in typhoid fever.
4.3 Contraindications
Kemicetine succinate is contra-indicated in patients with a previous history of sensitivity and/or toxic reaction to chloramphenicol.
4.4 Special Warnings And Precautions For Use
Kemicetine is to be administered only under the direction of a medical practitioner.
Chloramphenicol may cause severe bone marrow depression which may lead to agranulocytosis, thrombocytopenic purpura or aplastic anaemia. These effects of the haemopoietic system are usually associated with a high dose, prolonged administration, or repeated courses, but they may occur at relatively low doses.
Chloramphenicol should not be used in the treatment of any infection for which a less toxic antibiotic is available. It is also advisable to perform blood tests in the case of prolonged or repeated administration. Evidence of any detrimental effect on blood elements is an indication to discontinue therapy immediately.
The dosage of chloramphenicol should be reduced in patients with impairment of hepatic or renal function.
Because of its toxic nature it is important to monitor serum levels of this antibiotic particularly in new-born and premature infants, in the elderly, in patients with renal or hepatic disease and in those receiving other drugs with which chloramphenicol may interact.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Chloramphenicol has been shown to interact with, and enhance the effects of coumarin anticoagulants, some hypoglycaemic agents (e.g. tolbutamide) and phenytoin. When given concurrently, a dose reduction of these agents may be necessary.
Plasma concentrations of chloramphenicol may be reduced with concomitant usage of phenobarbital and rifampicin.
4.6 Pregnancy And Lactation
The use of chloramphenicol is contra-indicated in pregnancy and whilst breastfeeding.
4.7 Effects On Ability To Drive And Use Machines
None stated.
4.8 Undesirable Effects
The following may become apparent after chloramphenicol treatment: dryness of the mouth, nausea and vomiting, diarrhoea, urticaria, optic neuritis with blurring or temporary loss of vision, peripheral neuritis, headache and depression.
Superinfection by fungi e.g. C. albicans in the gastro-intestinal tract or vagina, may also occur due to the disturbance of normal bacterial flora.
Chloramphenicol may also impede the development of immunity and should therefore not be given during active immunisation.
The “Grey syndrome” may occur after administration in patients with immature hepatic metabolic capacity, i.e. infants and neonates, usually in those treated with doses substantially in excess of those recommended.
4.9 Overdose
General supportive therapy.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
After administration chloramphenicol is rapidly released from chloramphenicol sodium succinate. Chloramphenicol is active against many gram-positive and gram negative organisms, Spirillae and Rickettsia. It acts b interfering with bacterial protein synthesis. Chloramphenicol is widely distributed in body tissues and fluids and enters the cerebrospinal fluid.
Chloramphenicol sodium succinate, free chloramphenicol and metabolites are excreted in the urine.
5.2 Pharmacokinetic Properties
After intravenous administration of chloramphenicol succinate every 6 hours elimination half-lives were 4.03 hours for chloramphenicol and 2.65 hours for chloramphenicol succinate. After intravenous chloramphenicol sodium succinate, steady state peak concentrations were reached on average 18.0 minutes after cessation of the infusion.
In infants and children aged 3 days to 16 years the apparent half-life was extremely variable ranging from 1.7 to 12.0 hours.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
There are no excipients.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
48 months.
6.4 Special Precautions For Storage
Keep container in the outer carton.
6.5 Nature And Contents Of Container
Type III colourless glass vials with grey chlorobutyl rubber bung and aluminium seal.
Pack size : 1, 20 or 25 vials.
6.6 Special Precautions For Disposal And Other Handling
To be reconstituted with Water for Injection, Sodium Chloride Injection or Dextrose Injection 5%.
7. Marketing Authorisation Holder
Pharmacia Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8. Marketing Authorisation Number(S)
PL 00032/0341
9. Date Of First Authorisation/Renewal Of The Authorisation
13th September 2002/ 2nd March 2009
10. Date Of Revision Of The Text
March 2009
LEGAL CATEGORY
POM
Company Ref: KM4_0
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