Description
Latin name
Flagyl
Release form
Tablets, film-coated, from white to light yellow in color, round, with F250 engraving on one side in cross section – from white to light yellow in color.
Packing
10 pcs – blisters (2) – packs of cardboard.
Pharmacological action
Antiprotozoal, antibacterial.
Metronidazole belongs to nitro-5-imidazoles. The mechanism of action of metronidazole is the biochemical recovery of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa.
The reduced 5-nitro group of metronidazole interacts with the DNA of microorganism cells, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.
Metronidazole is an effective antimicrobial and antiprotozoal agent with a wide spectrum of action. The drug is highly active against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as against obligate anaerobes (spore-and non-spore-forming) – Bacteroides spp. (B.fragilis, B.ovatus, B.distasonis, B.thetaiotaomicron, B.vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp., Sensitive strains of Eubacterium.
Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole
Indications for
protozoal infections: extraintestinal amoebiasis, including amoebic liver abscess, intestinal amoebiasis (amoebic dysentery), trichomoniasis, balantidiasis, giardiasis, cutaneous leishmaniasis, trichomonas vaginitis, trichomonas sulcus infection. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus): infections of the bones and joints, infections of the central nervous system, including meningitis, brain abscess, bacterial endocarditis, pneumonia, empyema and lung abscess, sepsis
infections caused by species of Clostridium spp., Peptococcus and Peptostreptococcus: infections of the abdominal cavity (peritonitis, liver abscess), infections of the pelvic organs (endometritis, abscesses of the fallopian tubes , vaginal vaginal infections)
pseudomembranous colitis (associated with the use of antibiotics)
gastritis or duodenal ulcer associated with Helicobacter pylori (complex therapy)
prevention of postoperative complications (especially interventions on the colon, pararectal area, appendectomy.
Contraindications
organic damage to the central nervous system (including epilepsy)
impaired coordination of movements
blood disease (including history of leukopenia)
liver failure (in case of high doses)
pregnancy
pregnancy
to imidazoles, as well as derivatives of nitroimidazole
children under 6 years of age
Use during pregnancy and lactation
Contraindication: pregnancy and breastfeeding.
Composition
1 tab.
metronidazole 250 mg
Excipients: wheat starch – 82.15 mg, povidone – 17.5 mg, magnesium stearate – 0.35 mg.
Shell composition: hypromellose – 2.1 mg, macrogol 20,000 – 0.7 mg.
Dosage and Administration
Inside. With amoebiasis, Flagil is used orally for 7 days at 1.5 g / day for 3 doses (adults).
Giardiasis is treated for 5 days: adults are prescribed 750-1000 mg / day, children 6-10 years old – 375 mg / day (1.5 tablets) and children 10-15 years old – 500 mg / day (2 tablets. ) For children under 6 years of age, the use of metronidazole in the form of a suspension is preferable.
With trichomoniasis in women (urethritis and vaginitis) Flagil is prescribed once in a dose of 2 g or as a course of treatment for 10 days: 1 tab. (250 mg) 2 times / day.
With trichomoniasis in men (urethritis), Flagil is prescribed once at a dose of 2 g or as a course of treatment for 10 days, 1 tab. (250 mg) 2 times / day.
For nonspecific vaginitis, 500 mg of Flagil is used 2 times / day for 7 days.
In the treatment of anaerobic infections, adults are prescribed Flagil at 1-1.5 g / day.
In case of severe renal impairment (CC less than 10 ml / min), it is recommended to reduce the daily dose by 2 times.
Side effects of
From the gastrointestinal tract: nausea, metallic taste in the mouth, dry mouth, decreased appetite, glossitis, stomatitis, pancreatitis, anorexia, epigastric pain, vomiting, diarrhea, constipation.
From the nervous system: headache, dizziness, impaired coordination of movements, ataxia, confusion, irritability, depression, irritability, weakness, insomnia, convulsions, confusion, hallucinations, peripheral neuropathy (especially with prolonged use).
Allergic reactions: urticaria, skin rash, flushing of the skin, nasal congestion, fever, arthralgia.
From the urinary system: dysuria, polyuria, cystitis, urinary incontinence, candidiasis, it is possible to stain the urine in a brownish-red color.
Other: neutropenia, leukopenia, flattening of the T wave on the ECG.
Drug Interaction
Similar to disulfiram causes ethanol intolerance.
Concomitant use with disulfiram can lead to the development of various neurological symptoms (at least 2 weeks between appointments).
Increases the effect of indirect anticoagulants, leading to an increase in the time of prothrombin formation.
When taken with lithium, the plasma concentration of the latter may increase.
When co-administered with cyclosporine, plasma concentrations of the latter may increase.
Cimetidine inhibits the metabolism of metronidazole, which may increase its serum concentration and increase the risk of side effects.
The simultaneous administration of drugs that stimulate enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin) may accelerate the elimination of metronidazole, resulting in a decrease in its plasma concentration.
Metronidazole reduces the clearance of 5-fluorouracil, leading to an increase in its toxicity.
Metronidazole increases the level of busulfan in the blood plasma, leading to an increase in its toxicity (severe form).
It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide).
Storage conditions
At a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Shelf life
5 years.
Do not use after the expiration date printed on the package
Terms and conditions
prescription
Dosage form
tablets
Prescription
Prescription
Children prescribed by a doctor, Children over 10 years old, Adults prescribed by a doctor
Sanofi-Aventis, France