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Drugs Chloramphenicol Indications for Treatment of severe infections caused by susceptible bacteria

Zidocin DHG treatment of acute, chronic or recurrent stomatological infections

Vercef Distab 125/250 mg indications for Lower respiratory infections,  Urinary tract infections

COMPOSITION:

Chloramphenicol 250mg

Excipients s.q. for 1 capsule

(Colloidal silicon dioxide, l.actone. Tale. Cassava starch).

CHLORAMPHENICOL 250mg Capsules

PHARMACOLOGY:

– Chloramphenicol is usually bactenosiatic in action, but may be bactericidal in high concentrations or against highly susceptible organisms by binding to 50S ribosomal subunuts, therefor inhibiting the sunceptible bacteria

Chloramphenicol is also active in vitro against susceptible bacteria at 0.1 – 2ug/ml

– Chloramphenicol is also active against susceptible Rickettsia, Chlamydia

– Chloramphenicol is inactive against fungi.

– Antibacterial spectrum including:

+ Gram-positive cocci Staph. epidermidis.

+ Other Gram positive bactena: Bacillus anthracis, diphtheriae, peptococcus and peptococcus spp.

+ Gram – negative cocci: Neisseria meningitidis and N, gonorrhoeae, gonorrhoea

Haemophilus influenzae

– Other Gum-negative bacteria: Bordetella pertussis, Brucella abortus

PHARMACOKINETICS:

Chloramphenicol 250mg is readily absorbed when given by mouth, and widely distnbuied in body tissues and fluids. This drug is mainly  in liver by glucuronyl transferase

INDICATIONS:

Treatment of severe infections caused by susceptible bacteria, Rickettsia or Chlamydia when potentially less toxic drugs are ineffective or contra-indicated.

DOSAGE & ADMINISTRATION:

Adults l 0 – 2.0g daily divided into 4 equally doses

– Children. 50mg/kg daily divided into 4 equally doses. CONTRA-INDICATIONS:

Patients with history of hypersensitivity and/or toxic reactions to Chloramphenicol

– It shoutd never be given tor minor  or as prophylaxis of such.

PRECAUTIONS:

There are reports of .severe adverse reactions, occasionally fatal cases occurred during the medication.

– Discontinue the medication if reticulocytopenia. leukopenia, thrombocytopenia, aplastic anemia or other hematologic adverse effects occur with Chloramphenicol.

– Discontinue the therapy if optic or peripheral neuritis occurs.

– Use the medication with extreme cautions in patients with renal and/or hepatic impairment and reduce the dosage as appropriate.

– No report about impaired driving ability and operating skills of machinery.

PREGNANCY AND LACTATION:

–  The use of Chloramphenicol is best avoided in pregnancy near term or during delivery because of toxic effects to the neonates.

– Chloramphenicol is distributed into breast milk. Caution must be exercised when this drug is given during lactation because of the risk of possibly toxic effect occur for fetus and infants.

INTERACTIONS:

– Chloramphenicol may destroy Cytochrome in the liver, which is an enzyme responsible for many drug biotransformation.

– Chloramphenicol may affect the biotransformation of Chlorpropamide. Dicumarol, Phenytoin and Tolbutamide by inhibiting enzymatic activity of the microsome and therefore increase these drugs plasma half-life l and their actions.

– Concomitant use with Phenobarbetal may decrease the plasma antibiotic concentration because Phenobarbital may cause enzyme induction that has the ability of metabolize Chloramphenicol.

– Concomitant use with iron preparations. Vitamin B12 or Folic acid may delay the response to these drugs.

– Concomitant use with Rifampicin may decrease plasma Chloramphenicol concentration since the former may induce microsomal enzymes necessary for Chloramphenicol biotransformation.

– Avoid concomitant use of Chloramphenicol with bone marrow suppressive agents.

SIDE-EFFECTS:

– Common: nausea, vomiting, diarrhea, skin rash.

– Occasional: granulocytopenia, thrombocytopenia, anemia, urticaria, hypersensitivity reaction.

– Rare: headache, agranulocytosis, aplastic anemia, optic neuritis, peripheral polyneuritis, grey syndrome in fetus and neonates under 2 weeks (especially high dosage).

Inform your doctor about side-effects when using this medicine.

OVERDOSAGE:

Overdosage symptoms including anemia, metabolic acidosis.

hypothermia, hypotension. Symptomatic treatment after gastric lavage

should be carried out.

SHELF-LIFE

36 months from the manufacturing date. Never use after the expiry dale clearly indicated on the outer packaging.

STORAGE:

Store in a dry place (RH <= 70%), not exceeding 30°C. Protect from light.

PRESENTATION:

– Blister of 10 capsules. Box of 10 blisters.

– Bottle of 100 capsules.

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