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METRONIDASOL (METRONIDASOLUM)
INSTRUCTION TO PREPARATION

PHARMACOLOGICAL PROPERTY Antimicrobial and antiprotozoal preparation, secondary from 5-nitromedasolum. Easily gets into the cellulls of sensitive micro-organisms and binding with DNA, destroys the process of replication. Highly active towards Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, G.lamblia, Entamoeba histolytica, obligate anaerobic bacteria: Bacteroides spp Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, G.lamblia, Entamoeba histolytica, obligate anaerobic bacteria: Bacteroides spp. (Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, acteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonela spp.; Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp. Not active towards anaerobic bacteria and fungi.

INDICATION TO ADMINISTRATION Treatment of heavy and life threatening infections phlogistic diseases, caused by micro-organisms sensitive towards the medicament: intrauterine infections (peritonitis, apostasies of abdominal space and liver, appendicitis, cholecystitis); infections of organs of small pelvis (endometritis, apostasies of ootheca and of fallopian tube, after-surgery complications); infections respiratory channels (destructive pneumonia, apostasies of lungs); skin infections; sepsis; endocarditis; infections of central nervous system (meningitis and aposis of brain); hematosepsis, gaseous gangrene.
 Treatment of heavy intestinal amebiasis and amoebic apostasis of liver.
 Prevention of infectiouse complication caused by anaerobic bacteria at surgery interference, while appendectomy, gynecological surgeries.

ROUT Metronidasol is assigned for usage in hospitals. While treatment of infections caused by anaerobic micro-organisms medicament should be prescribed to adults and children after 12 intravenous dropwise 500 mg (100 ml 0,5% of solution) every 8 hours during 20 minutes with the speed of infusion 5 ml/min. Maximum fractional doze for adults constitutes 4 gr. Course of treatment - 7 - 10 days, for heavy infections -approximately 2 - 3 weeks.
 For children under 12: Metronidasol is prescribed intervenously dropwise in the doze of 7,5 mg/kg of weight  (1,5 ml/kg 0,5% of solution) every 8 hours.
 For prevention of infectious after-surgery complications adults and children after 12  5 - 10 min. before surgery should receive intervenuous dropwise injection 100 ml 0,5% of solution (500 mg), then after 8 hours - infusion should be repeated.
 For children under 12 solution is used according to the same scheme, and in this case single doze is 7,5 mg/kg of weight (1,5 ml/kh 0,5% of solution).

SIDE EFFECTS Digestive tract: nausea, emesis, and absence of appetite, diarrhea, and metallic taste in mouth. Central nervous system: headache, faintness. Destruction of consciousness increased excitement, distraction of sleep, ataxia, depression, circumferential neuropathy, paroxisms, entonic sound. Allergic reactions: cutaneous eruption, prutinus, urticaria fever. Blood formation: transient leukopenia and thrombocytopenia. Local reactions: excitation in the place of injection, sometimes thrombophlebitis. Other: leukopenia.
 
CONTRAINDICATION High sensibility to metronidazolum, organic diseases of central nervous system and diseases of blood, I trimester of pregnancy and period of lactation.

CORRELATION WITH OTHER PHARMARMACEUTICALS At simultaneous application of the preparation and of indirect anticoagulant increase of concentration of indirect anticoagulants in the plasma of blood as well as risk of blood escape are possible. That is why regular controlling over coagulogram and over indicants of circumferential blood picture is necessary. It is preferable to stop application of indirect anticoagulants 24 hours before infusion of preparation. At simultaneous application of the preparation and of lithium salts increase of concentration of lithium in the plasma of blood is possible. Simultaneous prescription of Metronidazol with barbiturates and with  phenytoin causes decrease of preparation effectiveness, as a consequence of  speed up of Metronidazol metabolism. At simultaneous application of the preparation and of disulfiram confused mental state and other neurologic symptomatology may be observed. This is connected with increasing toxic action of the preparation. 
 Cimetidine destroys metabolism of Metronidazol, which may cause increasing concentration of Metronidazol. Metronidazol for intravenous infusions cannot be mixed in one volume with other pharmaceuticals. The preparation is chemically not correlated with 10% solution of dextrose, benzylpenicillinum potassium salt, Ringer's solution.
 
OVERDOSAGE Specific symptomatology is not found. At increasing or efficient expression of side effects preparation should be cancelled and symptomatic therapy should be prescribed. Additionally haemodialysis can be applied.

SPECIFICS OF ADMINISTRATION Metronidazol should be administrated with carefulness at liver diseases. In this case correction of dosage directed to decreasing of amount of preparation is necessary.
 During treatment it is necessary to control systematically the picture of circumferential blood.
 At the time of application of preparation urine becomes more dark.
 In the period of treatment with Metronidazol it is necessary to avoid consumption of alcohol as destruction of alcohol oxiadation can cause concentration of acetic aldehydes. As a consequence stomach ache, nausea, headache may be observed. Pregnancy and lactation period. Metronidazol quickly gets though placenta. In II and III trimesters of pregnancy the preparation is used only at vitally important indications. If it is necessary to use preparation in the period of lactation, the question of cancellation of breast-feeding should be decided. Persons taking Metronidazol must be careful while driving or at the time of working with potentially dangerous devices.

STORAGE CONDITIONS Keep in dark place far from the reach of children at temperature not higher than +25‘.