METRONIDAZOLE(tablets 0.25 g)
Tabulettae Metronidazoli 0,25
International nonproprietary name (INN)
Metronidazole.
Pharmacotherapeutic group
Syntheticantibacterialagent.
Composition
1 tablet contains 250 mg of metronidazoleа.
Pharmacological effect
Pharmacodynamics
Metronidazole is related to the family of nitro-5-imidazole and is of vast gamma of action towards anaerobic bacteria — Peptostreptococcus, Clostridium spp., Bacteroides spp., Fusobacterium, Prevotella, Veilonella. It inhibits the propagation of protozoa — Trichomonas vaginalis, Giardia intestinalis (Lamblia intestinalis), Entamoeba histolytica.
Pharmacokinetics
In oral intake metronidazole is easily and practically completely absorbed. Meals do not influence the drug absorption. Half-excretion is 8—10 h., plasma protein binding is low and NMT 10—20%. Metronidazole is easily absorbed in tissues (liver, kidneys, bile, saliva, spinal-cord fluid, brain, bone tissue, vaginal and urethral secrets), breast milk, to placenta barrier. Metronidazole is liver metabolized via oxidation. It is renal excreted to 40—70% (about 20% unmodified).
Indicationsforusage
Mycoticvaginitisandurethritisinwomen, mycoticurethritisinmen, lambliasis, amebic dysentery, anaerobicinfectionscausedbybacteriasensitivetothedrug. Combinedtherapyinseveremixedaerobic-anaerobicinfections. Preventionofanaerobicinfectionsinsurgery (inparticular, abdominalcavity, urinarytracts). Chronicalcoholism.
In combination with amoxicylline: chronic gastritis in acute conditions, ulcer stomach and duodena in acute conditions, associated with Helicobacter pylori.
Administrationanddosage
In amoebiasis metronidazole is administered for oral intake. In adults for 7 days 1.5 g three times a day. In children 30-40 mg/kg a day and three times a day for 7 days.
Lambliosis: for 5 days in adults 750—1000 mg of metronidazole 3 times a day. In children of 2-5 years old 250 mg, in children of 5-10 years old 375 mg, inchildreof 10-15 years old 500 mg a day (3 intakes).
Mycotic vaginitis and urethritis in women: single dose of metronidazole 2 g or course for 10 days 1 tablet (250 mg) 2 times a day.
Mycotic urethritis in men: single dose of metronidazole 2 g or course for 10 days 1 tablet (250 mg) 2 times a day.
Non-specific vaginitis: 500 mg of metronidazole 2 times a day for 7 days.
Anaerobic infections in adults and children after 12: metronidazole 400 mg 3 times a day for 7-10 days. Inchildrenunder 12 7.5 mg/kg 3 timesaday.
Adverse reaction
Rare nausea, metal taste, anorexia, epigastric pain, vomit, diarrhea, headache, vertigo, and local skin reaction as urticaria and itch. Very rare convulsions, mental confusion, hallucinations.
In long treatment of high doses possible leucopenia, peripheral neuropathia, usually regressed after termination of treatment.
Very rare reversible cases described of pancreatitis. Possible coloring of urine into brown-reddish color die to pigments related to metabolism of metronidazole.
Contraindications
Hypersensitivity to imidazole, organic injury of CNS, hepatic disorder, blood diseases, I term of pregnancy.
II and II terms of pregnancy: administration under vital necessity only.
Metronidazole is not recommended in feeding mothers as it penetrates to breast milk (cancel breast feeding).
Safetymeasures
During metronidazole treatment alcohol is prohibited.
Long introduction is under control of blood formula. In leucopenia possible prolongation of treatment is subject to infection danger.
Cancel the treatment in case of ataxy, vertigo, hallucinations, poor neurologic state.
Remember that metronidazole may immobilizes treponema that causes false-positive Nelson test.
Interaction with other drugs
Undesirable combination with disulphiram (esperal), anticoagulants of indirect action (varpharin) and non-depolarizing myorelaxants (vecuronium), lithium preparations. Metronidazole in concurrent administration potentiates varpharine/vecuronium actions, increases toxic effect of 5-phtoruracile, increases lithium level in blood plasma.
Dosageform
Tablets0.25 g. 10 tabletsinblisterorpacks.
