Flagil tablets p / o 250mg, No. 20

? Protozoal infections: extraintestinal amebiasis, including amoebic liver abscess, intestinal amebiasis (amoebic dysentery), trichomoniasis (including).

? Infections caused by Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. Vulgatus ), infections of bones and joints, infections of the central nervous system (CNS), including meningitis, brain abscess, bacterial endocarditis , pneumonia, empyema and lung abscess, sepsis.

? Infections caused by Clostridium spp., Peptococcus niger and Peptostreptococcus spp. : infections of the abdominal cavity (peritonitis, liver abscess), infections of the pelvic organs (endometritis, abscess of the fallopian tubes and ovaries, infections of the vaginal vault).

? Pseudomembranous colitis (associated with the use of antibiotics).

? Gastritis or duodenal ulcer associated with Helicobacter pylori (combination therapy).

? Prevention of postoperative complications (especially interventions on the colon, pararectal region, apendectomy, gynecological operations).

Metronidazole is intended for oral administration, before or after meals. Drink with plenty of water.
In intestinal amoebiasis, FlagilЃ is used for 7 days, 1500 mg per day in three doses. In acute amoebic dysentery - the daily dose is 2250 mg, divided into three doses. Children from 10 to 15 years old - 500 mg per day, divided into 2 doses.
With liver abscess and other extraintestinal forms of amebiasis, the maximum daily dose is 2500 mg, divided into 3 doses for 3-5 days, in combination with tetracycline antibiotics and other methods of therapy. Children from 10 to 15 years old - 500 mg per day, divided into 2 doses.
In women with trichomoniasis (urethritis and vaginitis) FlagilЃ is prescribed once in a dose of 2 g or as a course of treatment for 10 days: 1 tab. (With 250 mg) 2 times a day.
In case of trichomoniasis in men (urethritis) FlagilЃ is prescribed once in a dose of 2 g or as a course of treatment for 10 days, 1 tab. (With 250 mg) 2 times a day.
Treatment of anaerobic infections usually begins with intravenous infusions, followed by a switch to pills. For adults, the dose of FlagilЃ is 500 mg 3 times a day. The duration of treatment is up to 7 days.
For the treatment of pseudomembranous colitis, 500 mg of FlagilЃ (Table 2) is prescribed 3-4 times a day. The duration of treatment is determined by the doctor.
For the eradication of Helicobacter pylori, 500 mg of FlagilЃ is prescribed 3 times a day as part of a combination therapy (for example, with amoxicillin).
For the prevention of postoperative complications, appoint 750-1500 mg per day in 3 doses 3-4 days before the operation. 1-2 days after the operation (when ingestion is already allowed) - 750 mg of FlagilЃ per day for 7 days.

One tablet contains:

Tablet core:
Active ingredient: metronidazole - 250 mg.
Excipients: wheat starch - 82.15 mg, povidone - 17.5 mg, magnesium stearate - 0.35 mg.
Tablet shell: hypromellose - 2.1 mg, macrogol 20,000 - 0.7 mg.

? Hypersensitivity to imidazoles, as well as to nitroimidazole derivatives.

? Organic lesions of the central nervous system (including epilepsy).

? Leukopenia (including a history).

? Hepatic impairment (in the case of large doses).

? Pregnancy.

? Lactation period.

? Children under 10 years of age.

Carefully:

? Hepatic encephalopathy.

? Acute and chronic diseases of the peripheral and central nervous system (risk of worsening neurological symptoms).

? Renal failure

Trade name: FlagilЃ.

International non-proprietary name:

metronidazole.

Dosage form:

film-coated tablets.

Composition:
One tablet contains:

Tablet core:
Active ingredient: metronidazole - 250 mg.
Excipients: wheat starch - 82.15 mg, povidone - 17.5 mg, magnesium stearate - 0.35 mg.
Tablet shell: hypromellose - 2.1 mg, macrogol 20,000 - 0.7 mg.

Description:

Film-coated tablets, round, white to pale yellow in color, engraved with 'F 250' on one side. Cross-sectional view: white to light yellow

Pharmacotherapeutic group:

Antimicrobial and antiprotozoal agent

Pharmacological properties
Pharmacodynamics:
Metronidazole is a derivative of 5-nitroimidazole. The mechanism of action of metronidazole is the biochemical reduction 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 the cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.
Active against Trichomonas vaginalis, Entamoeba histolytica , as well as gram-negative anaerobes Bacteroides spp. (including B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp., and some gram-positive anaerobes (sensitive strainsEubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp .). The MIC for these strains is 0.125-6.25 ?g / ml. In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin inhibits the development of resistance to metronidazole).
Aerobic microorganisms and facultative anaerobes are insensitive to metronidazole, but in the presence of mixed flora (aerobes and anaerobes), metronidazole acts synergistically with antibiotics effective against conventional aerobes.

Pharmacokinetics:
When taken orally, metronidazole is rapidly and almost completely absorbed (approximately 80% in 1 hour). Food intake does not affect the absorption of metronidazole. Bioavailability is not less than 80%. After oral administration of 500 mg of metronidazole, the plasma concentration after 1 hour is 10 ?g / ml, and after 3 hours - 13.5 ?g / ml. The half-life is 8-10 hours, the connection with blood proteins is insignificant and does not exceed 10-20%). Metronidazole quickly penetrates into tissues (lungs, kidneys, liver, skin, bile, cerebrospinal fluid, saliva, seminal fluid, vaginal secretions), into breast milk and passes through the placental barrier. About 30-60% of metronidazole is metabolized by hydroxylation, oxidation and glucuronidation. The main metabolite (2-oxymetronidazole) also has antiprotozoal and antimicrobial effects.
Excretion of metronidazole is carried out by 40-70% through the kidneys (unchanged - about 35% of the dose taken). In patients with impaired renal function during the course of metronidazole administration, an increase in its concentration in the blood serum is possible.

Indications for use:

? Protozoal infections: extraintestinal amebiasis, including amoebic liver abscess, intestinal amebiasis (amoebic dysentery), trichomoniasis (including).

? Infections caused by Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. Vulgatus ), infections of bones and joints, infections of the central nervous system (CNS), including meningitis, brain abscess, bacterial endocarditis , pneumonia, empyema and lung abscess, sepsis.

? Infections caused by Clostridium spp., Peptococcus niger and Peptostreptococcus spp. : infections of the abdominal cavity (peritonitis, liver abscess), infections of the pelvic organs (endometritis, abscess of the fallopian tubes and ovaries, infections of the vaginal vault).

? Pseudomembranous colitis (associated with the use of antibiotics).

? Gastritis or duodenal ulcer associated with Helicobacter pylori (combination therapy).

? Prevention of postoperative complications (especially interventions on the colon, pararectal region, apendectomy, gynecological operations).

Contraindications:

? Hypersensitivity to imidazoles, as well as to nitroimidazole derivatives.

? Organic lesions of the central nervous system (including epilepsy).

? Leukopenia (including a history).

? Hepatic impairment (in the case of large doses).

? Pregnancy.

? Lactation period.

? Children under 10 years of age.

Carefully:

? Hepatic encephalopathy.

? Acute and chronic diseases of the peripheral and central nervous system (risk of worsening neurological symptoms).

? Renal failure

Method of administration and dosage:

Metronidazole is intended for oral administration, before or after meals. Drink with plenty of water.
In intestinal amoebiasis, FlagilЃ is used for 7 days, 1500 mg per day in three doses. In acute amoebic dysentery - the daily dose is 2250 mg, divided into three doses. Children from 10 to 15 years old - 500 mg per day, divided into 2 doses.
With liver abscess and other extraintestinal forms of amebiasis, the maximum daily dose is 2500 mg, divided into 3 doses for 3-5 days, in combination with tetracycline antibiotics and other methods of therapy. Children from 10 to 15 years old - 500 mg per day, divided into 2 doses.
In women with trichomoniasis (urethritis and vaginitis) FlagilЃ is prescribed once in a dose of 2 g or as a course of treatment for 10 days: 1 tab. (With 250 mg) 2 times a day.
In case of trichomoniasis in men (urethritis) FlagilЃ is prescribed once in a dose of 2 g or as a course of treatment for 10 days, 1 tab. (With 250 mg) 2 times a day.
Treatment of anaerobic infections usually begins with intravenous infusions, followed by a switch to pills. For adults, the dose of FlagilЃ is 500 mg 3 times a day. The duration of treatment is up to 7 days.
For the treatment of pseudomembranous colitis, 500 mg of FlagilЃ (Table 2) is prescribed 3-4 times a day. The duration of treatment is determined by the doctor.
For the eradication of Helicobacter pylori, 500 mg of FlagilЃ is prescribed 3 times a day as part of a combination therapy (for example, with amoxicillin).
For the prevention of postoperative complications, appoint 750-1500 mg per day in 3 doses 3-4 days before the operation. 1-2 days after the operation (when ingestion is already allowed) - 750 mg of FlagilЃ per day for 7 days.

Possible side effects when using the drug:
Disorders from the gastrointestinal tract

? Epigastric pain, nausea, vomiting, diarrhea.

? Inflammation of the oral mucosa (glossitis, stomatitis), taste disturbances ('metallic' taste in the mouth), loss of appetite, anorexia, dryness of the oral mucosa, constipation.

? Pancreatitis (reversible cases).
Immune system disorders

? Angioedema, anaphylactic shock.
Nervous system disorders

? Peripheral sensory neuropathy.

? Headache, convulsions, dizziness.

? It was reported about the development of encephalopathy (for example, confusion) and subacute cerebellar syndrome (impaired coordination and synergism of movements, ataxia, dysarthria, gait disturbances, nystagmus and tremor), which undergo a regression after discontinuation of metronidazole.

? Aseptic meningitis.
Mental disorders

? Psychotic disorders, including confusion, hallucinations.

? Depression, insomnia, irritability, hyperexcitability.
Violations of the organ of vision

? Transient visual impairments such as diplopia, myopia.
Disorders of the blood and lymphatic system

? Agranulocytosis, leukopenia, neutropenia and thrombocytopenia.
Liver and biliary tract disorders

? Reported the development of reversible abnormalities in laboratory parameters of liver function and cholestatic hepatitis, sometimes with jaundice.
Skin and subcutaneous tissue disorders

? Rash, itching, flushing of the skin, urticaria.

? Pustular skin rash.
Kidney and urinary tract disorders

? Possible staining of urine in a brownish-reddish color, due to the presence in the urine of a water-soluble metabolite of metronidazole.

? Dysuria, polyuria, cystitis, urinary incontinence, candidiasis.
General disorders and disorders at the injection site

? Fever, nasal congestion, arthralgia, weakness.
Laboratory and instrumental data

? Flattening of the T wave on the ECG.

Interaction with other medicinal products:

With disulfiram

It was reported about the development of psychotic reactions in patients who received simultaneously metronidazole and disulfiram (the interval between the appointment of these metronidazoles should be at least 2 weeks).
With ethanol

Difulfiram-like reactions (hyperemia of the skin, vomiting, tachycardia) are possible.
With indirect anticoagulants (warfarin)

An increase in the anticoagulant effect and an increase in hemorrhagic risk associated with a slowdown in their hepatic metabolism, which can lead to an increase in prothrombin time. In the case of simultaneous use, more frequent monitoring of prothrombin time is required and, if necessary, correction of doses of anticoagulants.
With lithium preparations

With the simultaneous administration of metronidazole with lithium preparations, the concentration of the latter in the blood plasma may increase. With simultaneous use, plasma concentrations of lithium, creatinine and electrolytes should be monitored.
With cyclosporine

With the simultaneous administration of metronidazole with cyclosporine, the serum concentration of cyclosporine may increase. If necessary, the simultaneous use of these two metronidazoles requires monitoring the serum concentration of cyclosporine and creatinine.
With cimetidine

Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of side effects.
With drugs that induce microsomal oxidation enzymes in the liver (phenobarbital, phenytoin)

The simultaneous administration of metronidazole with drugs that stimulate enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, as a result of which its concentration in plasma decreases.
With fluorouracil

Metronidazole reduces the clearance of fluorouracil, leading to an increase in its toxicity.
With busulfan

Metronidazole increases the concentration of busulfan in the blood plasma, which can lead to the development of a severe toxic effect of busulfan.
With non-depolarizing muscle relaxants (vecuronium bromide)

It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide).
Sulfonamides enhance the antimicrobial effect of metronidazole.

Precautions when using the drug:

Since the simultaneous administration of metronidazole with alcohol can have an effect similar to the effect of disulfiram (fever, vomiting, tachycardia), patients should be warned that alcoholic beverages or medications containing alcohol should not be consumed during treatment with FlagilЃ.
Indications for long-term use of the drug should be carefully weighed and long-term use should be avoided without strict indications. If, in the presence of strict indications, the drug is used for a longer period than is usually recommended, then the treatment should be carried out under the control of hematological parameters and adverse reactions, such as peripheral or central neuropathy (paresthesias, ataxia, dizziness, convulsions), in the event of which the treatment should be discontinued ...
When treating Trichomonas vaginitis in women and Trichomonas urethritis in men, it is necessary to abstain from sexual activity. Simultaneous treatment of sexual partners is mandatory. Treatment does not stop during menstruation. After trichomoniasis therapy, control tests should be carried out for 3 successive cycles before and after menstruation.
It must be taken into account that metronidazole can immobilize treponemas, which leads to a false positive Nelson's test.

Impact on the ability to drive and engage in other potentially hazardous activities:

”читыва¤ профиль побочных эффектов (головокружение, нарушени¤ зрени¤ и другие) рекомендуетс¤ воздерживатьс¤ от управлени¤ автомобилем, от зан¤тий другими потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций.

‘орма выпуска:

“аблетки, покрытые пленочной оболочкой 250 мг.
ѕо 10 таблеток в блистер из ѕ¬’/алюминиевой фольги.
ѕо 2 блистера вместе с инструкцией по применению в картонную пачку.

”слови¤ хранени¤

’ранить при температуре не выше 25?—.
’ранить в недоступном дл¤ детей месте.

—рок годности 5 лет.
ѕо истечении срока годности препарат примен¤ть нельз¤.

”слови¤ отпуска: ѕо рецепту.