| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | for Injection |
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| PRODUCT NAME: | Chloramphenicol Succinate for Injection |
| STRENGTH: | 0.25g, 0.5g, 1.0g, 2.0g |
| PACKING DETAILS: | 10 vials/tray/box;1 vial +1 solvent/tray/box |
| STORAGE: | Store in a cool and dry place below 25ºC, protected from light. |
| SHELF LIFE: | 36 months |
| REGISTRATION DOSSIERS ARE AVAILABLE. | |
| CONSIGNMENT MANUFACTURING, BRAND OEM/ODM SERVICE IS AVAILABLE. | |
Chloramphenicol 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.
2. Posology and method of administration
Posology
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 intravenous 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.
Method of administration
To be given by intravenous or intramuscular injection.
In order to ensure rapid attainment of high blood levels, Kemicetine succinate is best administered by intravenous 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.
3. Contraindications
It is contraindicated in patients with a previous history of sensitivity and/or toxic reaction to chloramphenicol.
4.Undesirable effects
Tabulated summary of adverse reactions
The adverse reactions are grouped according to their system organ classes and the frequencies ranked according to the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Bone marrow depression and blood disorders
Chloramphenicol may cause severe bone marrow depression which may lead to serious and potentially fatal blood dyscrasias, such as agranulocytosis, thrombocytopenic purpura or aplastic anaemia (see section 4.4).
Paediatric population
Grey syndrome is a serious adverse effect that has been reported in neonates and infants following the intravenous administration of chloramphenicol (see section 4.4).
5.Overdose
Levels exceeding 25 mcg/ml are frequently considered toxic.
Chloramphenicol toxicity can be evidenced by serious haemopoietic effects such as aplastic anaemia, thrombocytopenia, leucopenia, as well as increasing serum iron levels, nausea, vomiting and diarrhoea.
In the case of serious overdosage, charcoal haemoperfusion may be effective in removing chloramphenicol from plasma.
Exchange transfusion is of questionable value following massive overdosage, especially in neonates and infants.
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Brief Introduction to Our Company:
Shandong Sino Pharmaceutical Technology Co., Ltd. (S.S.P.T.) is a different kind of pharmaceuticals (both finished medicine products and raw materials), health products, cosmetics and medical supplies company for human needs, focusing on global markets, especially the developing world. Working with the highest levels of government and local distributors alike, we aim to not only expand our business scale and scope but also have a special interest in serving the needs of the end consumer that requires our products the most. To this end, we have a presence in 5 continents with an expanding product range to meet the demand of our main markets.
Moreover, our manufacturing facilities follow strict GMP rules and regulations. We have intergraded all GMP guidelines into internal procedures improving the degree to which results are consistently exceeding expectations. As one of the best pharmaceutical companies in China, we take our ethical obligation to improving access to high quality and affordable WHO essential drugs seriously. This is the ethical basis our company was founded on.
Consignment Manufacturing, Brand OEM/ODM Service are available.
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