Cidocetine Vials – Capsules – suspension Chloramphenicol Composition: Cidocetine succinate vials: Each vial contains Chloramphenicol sodium succinate 1.378 gm Equivalent to 1 gm Chloramphenicol Cidocetine capsules: Each capsule contains Chloramphenicol 250 mg Cidocetine suspension: Each 5ml contains Chloramphenicol palmitate 0.217 gm Equivalent to 125 mg Chloramphenicol Properties: Chloramphenicol is a potent broad-spectrum antibiotic that is clinically useful and should be reserved for serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. Chloramphenicol exerts mainly a bacteriostatic effect on a wide range of gram-negative and gram-positive bacteria. The mode of action is through the interference or inhibition of protein synthesis of bacterial cell . Indications &usage : Acute infections caused by Salmonella typhi, but it is not recommended for the routine treatment of the typhoid carrier state. Chloramphenicol is used as alternative therapy to other antimicrobial drugs on the clinical impression that one of the infections below is believed to be present: - Salmonella specie, cholera, Yersinia enteritis. - H. influenza, specifically meningeal infections. - Lymphogranuloma -psittacosis group. - Rickettsia. - various gram-negative bacteria causing bacteremia, meningitis, gas gangrene, Listeriosis, Pneumonia, tularemia, or other serious gram- negative infections. - Severe anaerobic infections particularly in brain abscesses. - infections below the diaphragm where Bacteroids fragilis is often implicated. - other susceptible organisms which have been demonstrated to be resistance to all other appropriate antimicrobial agents N.B: Its used is restricted to situation where there is no alternative treatment. Contra-indications : · History of pervious hypersensitivity and/ or toxic reaction to chloramphenicol . · 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. · Pregnancy & lactation. Side effects: · Blood dyscrasias: aplastic & hypoplastic anemia, thrombocytopenia, granulocytopenia, bone marrow depression & paroxysmal nocturnal hemoglobinuria. · Gastrointestinal disorder: nausea, vomiting, glossitis, stomatitis, diarrhea & enterocolitis may rarely occur. · Headache, mild depression, mental confusion & delirium. Optic & peripheral neuritis may occur after long term therapy. · Hypersensitivity reactions such as urticaria and erythema.. · Grey syndrome in the premature & newborn. Drug interactions: Rifampicin and Phenobarbital accelerate metabolism of chloramphenicol. Anticoagulant effect of acenocoumarol & warfarin is enhanced. Antidiabetic effect of sulphonylurea is enhanced. Warnings & precautions : Avoid repeated courses & prolonged treatment. Reduce dose in hepatic & renal impairment Blood counts required before & periodically during treatment. Monitor plasma-chloramphenicol concentrations in neonates. Chloramphenicol is not recommended for the routine treatment of the typhoid carrier state. Chloramphenicol should be avoided in cases of acute porphyria. Dosage & administration : By mouth or IV injection or infusion: For adults & children: 50 mg/kg/day in divided doses at 6 hours intervals. For newborn infants: a total of 25mg/kg/day in 4 equal doses at 6 hours intervals. N.B: - patients with infections due to moderately resistant organisms may require to increase dose up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen. But these high doses should be decreased as soon as possible . In infants and immature metabolic processes: in young infants & other children in whom immature metabolic functions are suspected a dose of 25 mg/kg/day are usually produce therapeutic concentrations of the drug in the blood. Intravenous dose should be injected over at least 1 minute. Intramuscular injection is controversial because of doubts whether absorption is adequate Packing : Cidocetine succinate vials : Box of 50 vials. Cidocetine capsules : Box of 12 capsules. Cidocetine suspension: bottle of 60 ml. Storage : Capsules : store below 30 oc and R.H below 70 % . Suspension : store below 30 oc . Injection : store below 25 oc |