HLORNITROMYCIN 250 mg. 20 capsules
Chloramphenicol is a bacteriostatic antibiotic with a broad spectrum of action. Suppresses protein synthesis in micro-organisms sensitive to it, by combining with the 50 S subunit of the bacterial ribosome.
The spectrum of action of Chloramphenicol includes:
-Gram-Positive microorganisms - Staphylococcus sp.- St.epidermidis, St.aureus; Streptococcus sp.- Str. pneumoniae, Str.pyogenes, Str.viridans; Bacillus anthracis, Corynebacterium diphtheriae, Peptococcus sp., Peptostreptococcus sp.
-Gram-Negative organisms - Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Brucella sp., Campylobacter sp., Legionella pneumophila, Vibrio cholerae, Yersinia sp., Escherichia coli, Klebsiella sp., Proteus mirabilis, Salmonella sp., Shigella sp. , Bacteroides fragilis, Veillonella sp., Fusobacterium sp.
Chloramphenicol is active against Actinomyces sp., Leptospira sp., Chlamydia sp., Mycoplasmas, rickettsiae, Treponema pallidum and other spirochetes. Chloramphenicol e ineffective against fungi, viruses and protozoa.
Chloramphenicol should be used only when absolutely necessary in infections caused by microorganisms sensitive to it, unresponsive to other antimicrobial agents, mainly for the treatment of typhoid fever and other salmonellosis in pneumonia and meningitis caused by Haemophilus influenzae, as an alternative antibiotic in sepsis caused by pyogenic streptococci, pneumococci, gonococci, meningococci, anaerobic streptococci and clostridia, urinary tract infections with Gram (-) microorganisms, unresponsive to other antibiotics. For the treatment of bone manifestations of brucellosis.
2. Dosage and method of administration
Chlornitromycin is administered orally at the following doses:
For adults - 250-500 mg 3-4 times a day. In severe cases, can be applied to 4 g per day, divided into 3-4 times under strict control of the blood counts and those of renal function.
For children - 50 mg / kg weight for 24 hours, divided into 3-4 doses.
The course of treatment should last more than 10 days.
Hypersensitivity to chloramphenicol, pregnancy, bone marrow hypoplasia, psoriasis, eczema, athlete's foot. In neonates and premature to caution! Do not administer simultaneously suppressing blood-forming apparatus preparations!
4. Special precautions for use
Due to the serious side effects that can cause, Chlornitromycin not be used to treat mild infections, colds, sore throat, or for the prevention of bacterial infections.
Do not use in patients with evidence of impaired Hematopoietic bone marrow function or abnormal ratio of blood elements. During treatment with Chlornitromycin recommended monitoring of blood counts on the possible occurrence of leukopenia and granulocytopenia reticulocytopenia. To facilitate clinical research and to ensure constant monitoring of the patient is better that he be hospitalized. In case of serious deviations from the blood parameters Chlornitromycin treatment should be discontinued. In most cases, these reactions are reversible, but it is possible complicating them to aplastic anemia. Type irreversible aplastic anemia can occur several weeks or months after treatment with antibiotics.
It is not recommended to repeat the course of treatment with Chlornitromycin. Chlornitromycin not be administered concomitantly with other drugs that inhibit the function of the bone marrow.
Chlornitromycin be used with caution in patients with impaired liver function or severe kidney disease. In such cases the dose should be reduced to avoid an increase in the plasma concentration of the antibiotic.
When combining Chlornitromycin with another antibacterial agent, it is possible to reach the overgrowth of nonsusceptible organisms, and to develop a superinfection. The adoption of these products should be discontinued and appropriate therapy according to the clinical picture.
In the event of more severe neurotoxic effects - headache, depression, inflammation of the optic nerve and peripheral neuritis, required discontinuation of treatment. Otherwise possible permanent damage.
Possible occurrence of allergic reactions - skin rash, fever, urticaria, angioedema. In these patients treatment Chlornitromycin should be discontinued and appropriate therapy instituted. In patients with allergic diathesis particular caution in the application of the antibiotic. Chlornitromycin apply only in extreme cases of patients with anemia, as it reduces the effect of vitamin B12 and iron in hematopoietic processes.
Prolonged oral administration of Chlornitromycin can inhibit the synthesis of vitamin K as a result of which prolong the time to coagulation.
Co-administration of coumarin anticoagulants Chlornitromycin enhances its anticoagulant effect, which may lead to bleeding.
Chlornitromycin treatment of patients taking oral antidiabetic drugs or insulin may induce a state of hypoglycemia.
Implementation of Chlornitromycin of patients taking antiepileptic drugs phenytoin group inhibit their metabolism by increasing serum concentrations and respectively - their toxicity.
Coadministration of Chlornitromycin with vitamin B12 and iron products prevent erythropoietic effect of iron in iron deficiency anemia and antianaemic effect of vitamin B12 in megaloblastic anemia.
Chlornitromycin potentiate the hypnotic effect of barbiturates; reduces the cytostatic effects of cyclophosphamide.
Chlornitromycin can neutralize the effect of the oral contraceptive products.
During treatment with Chlornitromycin not recommended acceptance of pyrazolone analgesics and antipyretics (amidophen, analgin, phenylbutazone) due to the increased myelotoxic their action.
6. Use during pregnancy and lactation
Application of Chlornitromycin during pregnancy is contraindicated, as it passes the placental barrier and reaches the fetal circulation. For newborns at risk of syndrome of "gray baby", usually fatal.
Chlornitromycin is excreted in breast milk, so it is mandatory interruption of breastfeeding throughout the course of treatment.
7. Effects on ability to drive and use machines
Does not affect the ability to drive and use machines.
8. Undesirable effects
During treatment with Chlornitromycin may experience the following side effects:
- Affecting the blood system - aplastic anemia, hemolytic anemia, thrombocytopenia, granulocytopenia, leukopenia; in rare cases - leukemia;
- Reactions of the digestive tract - nausea, vomiting, diarrhea, glossitis, stomatitis, enterocolitis due to violation of the normal intestinal flora;
- Neurotoxic effects - headache, mild depression, rarely - delirium, inflammation of the optic nerve and other peripheral neuritis;
- Allergic reactions - rash, fever, urticaria, angioedema, a rare - anaphylaxis.
In patients with syphilis or tifna fever may occur reaction of Jarisch-Herxheimer, as a result of the release of endotoxins.
Overdose usually occurs nausea, vomiting, rash, fever, rarely - anaphylaxis. When an emergency or life-threatening reaction of the patient immediately apply epinephrine, intravenous steroids, antihistamines, ventilation with oxygen, if necessary - intubation.
10. Pharmacokinetic properties:
Chloramphenicol is rapidly and easily in the gastrointestinal tract. Therapeutic serum concentrations are reached usually 2-3 hours after oral administration of a dose of 1,0 g. Following the adoption in these concentrations increase. Chloramphenicol penetrates well into tissues and body fluids. High concentrations reached in the liver, the kidneys, the cerebrospinal fluid (even in the absence of inflamed meninges), synovial, pleural and ascitic fluid and vitreous humor. Chloramphenicol crosses the placenta and reaches the fetal circulation. Excreted in human milk.
About 60% of the antibiotic is bound to plasma proteins. When passing through the liver metabolize about 80-90% of the available concentration. The half-life of Chloramphenicol is 1.5 to 4 hours and may be prolonged in patients with severe renal impairment. Excreted primarily in the urine, and only 5-10% are unchanged. About 3% is excreted in bile and only 1% in the faeces.
11. Pharmacodynamic properties:
Pharmacotherapeutic group: Antibacterial drugs. Amphenicols