Chloramphenicol Sodium Succinate for Injection BP 1g
Each vial contains:
Chloramphenicol Sodium Succinate B.P.
Equivalent to Chloramphenicol 1g
CICHLOR (Chloramphenicol Sodium Succinate Injection) is indicated for bacterial meningitis, typhoid fever, rickettisial infections, intraocular infections and other serious infections.
CICHLOR (Chloramphenicol Sodium Succinate Injection) is contraindicated in individuals with a history of previous hypersensitivity and/or toxic reactions to the product or its components.
Chloramphenicol sodium succinate is a prodrug. After parenteral administration it is hydrolysed in the liver to produce free active chloramphenicol. The rate of hydrolysis is variable in different individuals. Chloramphenicol is effective in a wide variety of bacterial and rickettsial infections. It possesses high antimicrobial activity, crosses tissue barriers readily, and diffuses widely and rapidly through nearly all body tissues and fluids.
Serious and fatal blood dyscrasias (aplastic anemia, hypopiostic anemia. thrombocytopenia, and granulocytopenia) are known to occur after the adminiation of chloramphenicol. In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged-therapy with this drug. Chloramphenlcol must not be used when less potentially dangerous agents will be effective. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.
It is essential that adequate blood studies be made during treatment with the drug. White blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytepenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia. To facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized.
Use in Pregnancy
There are no studies to establish the safety of this drug in pregnancy.
Chloramphenicol enters the foetal circulation and, if given to the mother shortly before parturition, may cause “grey baby syndrome”, with cyanosis and hypothermia, owing to the limited glucuronidating capacity of the newborn infant’s liver. It may also cause bone marrow suppression in the neonate. Chloramphenicol treatment should therefore be avoided during the week before parturition.
Use in Lactation
Due to the possibility of toxic effects on the nursing infant, the use of chloramphenicol is not recommended during breastfeeding.
Blood and Lymphatic System Disorders: Blood dyscrasias including aplastic anaemia, hypoplastic anaemia, thrombocytopenia and granulocytopenia have been attributed to the administration of chloramphenicol. A reversible type of bone marrow depression which is dose related, may occur.
Gastrointestinal Disorders: Nausea vomiting, glossitis and stomatitis, diarrhoea and enterocolitis may occur.
Nervous System Disorders: Headache; peripheral neuritis has been reported usually following long-term dosage. If this occurs, the drug should be promptly withdrawn.
Psychiatric Disorders: Mild depression, mental confusion and delirium.
Immune System Disorders: Anaphylaxis; Herxheimer reactions have occurred during therapy for typhoid fever.
Skin and Subcutaneous Tissue Disorders: Angioedema, macular and vesicular rashes, urticaria.
Cardiac Disorders: Toxic reactions including fatalities have occurred in premature and newborn infants; the signs and symptoms associated with these reactions are known as the grey baby syndrome.
Chloramphenicol toxicity can be evidenced by serious haemopoietic effects such as aplastic anaemia, thrombocytopenia, leukopenia, as well as increasing serum iron levels, nausea, vomiting and diarrhoea. In the case of serious overdosage, charcoal haemoperfusion may be effective in removing chloremphenicol from plasma.
DOSAGE & ADMINISTRATION
Chloramphenicol in the form of chloramphenicol sodium succinate may be administered intravenously or intramuscularly in seriously ill patients.
Dosage of 50 mg/kg/day administered in divided doses at six hourly intervals is recommended for the average patient. In exceptional cases, such as with patients having infections due to moderately resistant organisms or suffering from infections such as septicaemia or meningitis, dosage schedules up to 100 mg/kg/day may be prescribed. However, these high doses should be decreased as soon as clinically indicated.
In impaired hepatic or renal function, the ability to metabolise or excrete chloramphenicol may be reduced and the medical practitioner should adjust the dose accordingly.
Premature and Newborn infants
A total of 25 mg/kg/day divided into four doses at six hour intervals usually produces and maintains a concentration of chloramphenicol in blood and tissues adequate to control most infections in premature newborn infants and children with immature metabolic processes.
After the first two weeks of life, full-term infants ordinarily may receive up to a total of 50mg/kg/day divided equally into four doses at six hour intervals. Precise control of serum blood levels may be achieved through analytical methods.
Preparation For Use
This product contains no additional antimicrobial agent. It is for single use in one patient only.
The powder in the vial is prepared for injection by the addition of an aqueous diluent such as water for injections, 0.9% sodium chloride injection or 5% glucose injection.
Constituted solution should be used immediately only when it is clear.
Store below 25oC in a dry place. Protect from light.
Ken all medicines out of reach of children.
Pack of 10 vials.
NAFDAC Reg. No.: B4-5033
Shreealoe Pharms (Nig.) Ltd.
F-46, Nwangene Street,
Shreechem Pharmaceuticals Pvt. Ltd.
R-914/915, T.T.C Indl. Area,
Navi Mumbai -40070, INDIA.