CHLORAMPHENICOL CAPSULE

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Product No：AMC11005-01 Specification：250mg, 10*10/box Category：Antibiotics Properties：Capsule Criteria：BP,USP Place Of Origin ： China (Mainland) Brand Name：Medipharm Validity：Three Years Main Composition： capsules containing 250 mg chloramphenicol Appearance：White、Almost White 、Light Yellow Or Yellow Granular Material Or Powder.Aramatic,Sweet Taste. Indications: 1.Typhoid fever and other types of systemic salmonella infections. The carrier state will not be eliminated. 2. Bacterial meningitis due to Haemophilus influenzae. 3. Anaerobic infections originating from foci in the bowel or pelvis. 4. Rickettsial diseases such as epidemic, murine, scrub and recrudescent typhus, Rocky Mountain spotted fever and Q. fever when tetracyclines are not indicated. 5. Brucellosis when tetracyclines are contra-indicated. The use of chloramphenicol should be limited to serious infections where positive bacteriological evidence and clinical judgement indicates that chloramphenicol is an appropriate antibiotic. Dasage： Adults: –500 mg every 6 hours or 50 mg/kg body mass daily in divided doses every 6 hours. The dose of chloramphenicol should be reduced in the presence of hepatic disease or in patients with renal insufficiency. Children: –25 to 50 mg/kg body mass daily, given in divided doses at intervals of 6 hours. Contra-Indications：Chloramphenicol is contra-indicated in the following conditions: 1. patients with a history of hypersensitivity or toxic reactions. 2. for minor infections or for prophylaxis. 3. aplastic anaemia. 4. during active immunisation. Adverse Reaction ： Hypersensitivity reactions: Macular or vesicular skin rashes occur as a result of hypersensitization to chloramphenicol. Fever may appear simultaneously or be the sole manifestation. Angioedema is a rare complication. Herxheimer reactions have been observed. Erythema multiforme has been reported. Hematological Toxicity: The most important adverse effect of chloramphenicol is on the bone-marrow.Changes in peripheral blood include leukopenia, thrombocytopenia, and aplasia of the marrow with fatal pancytopenia. The incidence is not dose-related. The fatality rate is high when bone-marrow aplasia is complete, and there is a high incidence of acute leukemia in those who recover.A second haematological effect of chloramphenicol is a predictable but reversible erythroid suppression of the bone marrow. The clinical picture is featured initially by reticulopenia, which occurs 5 to 7 days after the initiation of therapy, followed by a decrease in haemoglobin, an increase in plasma iron, cytoplasmic vacuolation of early erythroid forms and granulocyte precursors, and normoblastosis with a shift to early erythrocyte forms. Severe leukopenia and thrombocytopenia may also occur. The incidence and severity of this syndrome are dose-related. It occurs regularly when plasma concentrations are 25µg/mL or higher and is observed during the use of large doses of chloramphenicol, prolonged treatment, or both. Haemolytic anaemia has occurred in persons with a genetic deficiency of glucose-6-phosphate dehydrogenase activity. Other Effects: Gastrointestinal symptoms including nausea, vomiting, unpleasant taste, diarrhoea and perineal irritation may follow oral administration of chloramphenicol. Disturbances of the oral and intestinal flora may cause stomatitis, glossitis, and rectal or vaginal irritation. Prolonged oral administration of chloramphenicol may induce bleeding either by bone-marrow depression or by reducing the intestinal flora with consequent inhibition of vitamin K synthesis and greatly increased prothrombin time. Among the toxic effects produced by chloramphenicol are blurring of vision and digital paresthesias. Peripheral as well as optic neuritis has been reported in patients receiving chloramphenicol, usually over prolonged periods. A toxic manifestation –“the grey syndrome”– has occurred in premature and other newborn infants receiving large doses of chloramphenicol. A similar syndrome has been reported in adults and children given high doses. Chloramphenicol should never be given for minor infections or for prophylaxis and repeated courses and prolonged treatment should be avoided. Reduced doses should be given to patients with impaired liver function. Uraemic patients may be more susceptible to the depressant effect of chloramphenicol on bone-marrow but reducing the dose may result in inadequate plasma concentrations. Routine periodic blood examinations are advisable in all patients including infants; these examinations will not warn of aplastic anaemia. Because of the risk of the “grey” syndrome newborn infants should not be given chloramphenicol, unless it may be lifesaving and there is no alternative treatment. The use of chloramphenicol is best avoided during pregnancy; nursing infants should be observed with care since chloramphenicol given to the mother is excreted in the milk. Known symptoms of overdosage and particulars of its treatment: The “grey”syndrome-characterised by vomiting, abdominal distension, ashen colour, hypothermia, irregular respiration, progressive pallid cyanosis, and shock, followed by death in a few hours or days.Other toxic manifestations include aplastic anaemia, blurring of vision, digital paresthesias, optic neuritis, allergic skin rashes, and gastro-intestinal haemorrhage. Chloramphenicol should be discontinued immediately on the appearance of toxic symptoms. Treatment is symptomatic and supportive. Attention： Packing： Inner Packing ：Opaque white/white capsules，Blister Packaging Outer Packing ：10x10/Box, 200Boxes/Carton Carton Size：67*47*33.5cm3(Only For Reference) Other Options： Style；250mg,1000's/jar

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Anhui Medipharm Co.,Ltd.

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