Flagyl (metronidazole) coated tablets 250 mg. №20

Description

FLAGYL TABLETS COMPOSITION
active substance: metronidazole

1 tablet contains 250 mg of metronidazole

excipients: wheat starch, povidone, magnesium stearate shell: hypromellose, polyethylene glycol.

FLAGYL TABLETS DOSAGE FORM
Film-coated tablets.

FLAGYL TABLETS MAIN PHYSICAL AND CHEMICAL PROPERTIES:
round, white to creamy white film-coated tablets, embossed with F 250 on one side.

PHARMACOLOGICAL GROUP
Antibacterial agents for systemic use. Antiprotozoal drugs. Imidazole derivatives. ATX code J01X D01.

Means for the treatment of amoebiasis and other protozoal diseases. Antiprotozoal drugs. ATX code P01A B01.

PHARMACOLOGICAL PROPERTIES

Pharmacological.

The prevalence of acquired resistance in certain types of microorganisms can differ depending on geographic location and time. Therefore, it is useful to have information on the local prevalence of resistance, especially when treating severe infections. These data are only general guidelines indicating the likelihood of a particular bacterial strain being susceptible to this antibiotic.

Sensitive to the drug: Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp., Porphyromonas, Bilophila, Helicobacter pylori, Prevotella spp., Veilonella. Metronidazole inhibits the development of protozoa – Trichomonas vaginalis, Giardia intestinalis (Lamblia intestinalis), Entamoeba histolytica. Inconsistently sensitive to the drug: Bifidobacterium spp., Eubacterium spp. Insensitive strains of microorganisms: Propionibacterium, Actinomyces, Mobiluncus

Pharmacokinetics.

Absorption. When taken orally, metronidazole is rapidly and almost completely absorbed (at least 80% per hour). The maximum concentration in serum after oral administration of the drug is similar to that achieved after administration of equivalent doses.

Oral bioavailability is 100% and does not decrease significantly with simultaneous food intake.

Distribution. Approximately one hour after taking a single dose of 500 mg, the average maximum plasma concentration is 10 μg / ml. After 3:00, the average plasma concentration is 13.5 μg / ml.

The half-life is 8-10 hours, the binding to blood proteins is insignificant – no more than 20%. The volume of distribution is high (approximately 40 l, i.e. 0.65 l / kg).

Distribution is rapid and significant, with concentrations close to those in blood plasma, lungs, kidneys, liver, skin, bile, cerebrospinal fluid, saliva, seminal fluid and vaginal secretions.

Metronidazole crosses the placental barrier and is excreted in breast milk.

Metabolism. Metronidazole metabolism occurs by oxidation in the liver. Two metabolites are formed:

the main alcohol metabolite, which provides approximately 30% of the antibacterial activity of metronidazole against anaerobic bacteria, the half-life is approximately 11:00
acid metabolite, which is present in a smaller amount and provides about 5% of the antibacterial activity of metronidazole.
Output. Significant concentration in the liver and bile, low concentration in the colon, insignificant elimination with feces. The excretion of the drug is carried out by 35-65% by the kidneys (in the form of metronidazole and oxidized metabolites).

INDICATIONS
Infections caused by microorganisms sensitive to the drug: amebiasis urogenital trichomoniasis nonspecific vaginitis giardiasis surgical infections caused by anaerobic microorganisms sensitive to metronidazole replacement of intravenous treatment of infections caused by anaerobic microorganisms sensitive to metronidazole.

CONTRAINDICATIONS

INTERACTION WITH OTHER DRUGS AND OTHER INTERACTIONS
antabuse reaction

There are many drugs that trigger an antabuse reaction to alcohol, and their concomitant use with alcohol is not recommended.

Combinations are not recommended.