Flagyl film-coated tablets 250 mg No. 20

Flagyl

Flagyl ®

(lat.
Flagil
®) is an antibacterial antiprotozoal drug. The active ingredient is metronidazole.

Dosage forms of flagyl

Flagyl is available in the following dosage forms:

• film-coated tablets containing 250 mg metronidazole
• vaginal suppositories containing 500 mg of metronidazole
• solution for infusion in 100 ml bottles containing 500 mg of metronidazole in a bottle (or 5 mg in 1 ml of solution)

Flagyl activity against pathogenic microorganisms

Flagyl is active against many pathogenic microbes, including:

• protozoa: Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp.
• bacteria: Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Parabacteroides distasonis, Fusobacterium spp., Veillonella spp., Prevotella bivia, Prevotella buccae, Prevotella disiens, Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococ cus spp., Gardnerella vaginalis

The following are resistant to Flagyl: Mobiluncus spp
.,
Propionibacterium acnes, Actinomyces spp
.

Indications for use of flagyl

• infections caused by protozoa:
• trichomoniasis
• giardiasis
• amoebiasis
• amoebic liver abscess

• peritonitis
• abscesses of the abdominal cavity and liver
• endometritis
• abscesses of the ovaries and fallopian tubes
• postoperative complications
• pneumonia, pleural empyema, lung abscess
• meningitis, brain abscess
• skin infections
• bone infections
• sepsis
• endocarditis

• on the colon
• during appendectomy
• during gynecological operations

Flagyl for eradication of Helicobacter pylori

Flagyl is sometimes prescribed as one of the antibiotics as part of complex therapy for the eradication of Helicobacter pylori
.
Flagyl is not used in the eradication of Helicobacter pylori
outside of special regimens, without drugs that reduce gastric acidity.
Flagyl is also not used in any form for the treatment of gastric and duodenal ulcers and gastritis in the absence of Helicobacter pylori in the patient.
According to the Maastricht Agreements, the active substance of Flagyl, metronidazole, is recommended as one of the antibiotics for the eradication of
Helicobacter pylori.
However, in Russia, due to the very wide and not always correct use of metronidazole, the level of resistance to metronidazole is almost twice as high as the European average: 55.5% in Russia and 25.5% in Europe (Maev I.V., Vyuchnova E.S., Shchekina M.I.).
In Russia, it is recommended to use nifuratel in treatment regimens instead of metronidazole (Shcherbakov P.L.). Also, according to modern Russian Standards for the diagnosis and treatment of acid-dependent and Helicobacter pylori-associated diseases, flagyl is allowed only in one of the “second-line” regimens (used if the patient had unsuccessful treatment of Helicobacter pylori
according to one of the “first-line” regimens): flagyl by 500 mg 3 times a day, bismuth tripotassium dicitrate 120 mg 4 times a day, tetracycline 500 mg 4 times a day and one of the proton pump inhibitors in a standard dosage (omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, esomeprazole 20 mg , rabeprazole 20 mg 2 times a day) for 10–14 days.

Methods of using flagyl and dosage

Flagyl tablets are taken orally without chewing during or after meals or with milk:

• Trichomonas vaginalis
  infection - 250 mg 4 times a day for 5 days or 2 g once or 250 mg 2 times a day for 10 days
• for Entamoeba histolytica
  :
• adults - 750 mg 3 times a day for 5–10 days
• children - 35–50 mg per kg of body weight per day, in three divided doses for 10 days

• children from 2 to 5 years old - 250 mg per day
• children from 6 to 10 years old - daily dose - 375 mg
• patients over 10 years old - 500 mg per day

• children under 12 years of age, including newborns - 7.5 mg flagyl per kg body weight 3 times a day
• patients over 12 years old - 250–500 mg 3 times a day

• children from 0 to 5 years - 5 mg flagyl per kg of body weight every 8 hours for 2 days
• children from 5 to 12 years old - 125 mg every 8 hours for 2 days
• patients over 12 years old - initially 1 g once, then 250 mg 3 times a day

Vaginal suppositories are prescribed for adults. Flagyl therapy lasts no more than 10 days and is repeated no more than 2-3 times a year. The dose and duration of use depends on the disease:

• for trichomonas vaginitis, one suppository per day is used for 7-10 days in combination with taking flagyl tablets orally
• for nonspecific vaginitis and bacterial vaginosis, one vaginal suppository per day for 7 days, if necessary in combination with taking flagyl tablets orally

Use of flagyl during pregnancy and breastfeeding

Flagyl is contraindicated in the first trimester of pregnancy; in the second and third trimesters it should be taken with caution only if the benefit to the pregnant woman outweighs the risk to the unborn child, given that metronidazole crosses the placenta. FDA Fetal Category B. Flagyl (metronidazole) is excreted into human milk, creating concentrations similar to those in plasma. May impart a bitter taste to breast milk. To exclude the effect of Flagyl on the child, breastfeeding while taking Flagyl and for 2 more days after finishing it is not recommended.

general information

According to the pharmacological index, flagyl belongs to the groups “Other synthetic antibacterial agents” and “Medicines for the correction of disorders in alcoholism, toxic and drug addiction”, according to the ATC - to the subgroup “J01XD01 metronidazole” of the group “Imidazole derivatives”, as well as to the subgroup “A01AB17 metronidazole "Group "A01AB Antimicrobials for local treatment of diseases of the oral cavity."
Flagyl has contraindications, side effects and application features; consultation with a specialist is necessary.

Manufacturer

flagila - Sanofi Aventis group, France.

On the website gastroscan.ru in the literature catalog there is a section “Antibiotics used in the treatment of gastrointestinal diseases”, containing articles on the use of antimicrobial agents in the treatment of diseases of the digestive tract.

Some official instructions for the medical use of flagyl

Instructions for medical use of flagyl (in pdf):

• “Instructions for the medical use of the drug Flagyl”, vaginal suppositories, 500 mg of metronidazole (for Kazakhstan, Russian), dated 02/21/2011.
• “Instructions for medical administration of the drug Flagyl”, film-coated tablets containing 250 mg of metronidazole (for Ukraine, Ukrainian), dated 05/13/2009.
• "Flagyl metronidazol tablets", 250 and 500 mg tablets (USA, English), April 2010.
• "Flagyl ER metronidazol extended release tablets", extended release tablets 750 mg (USA, English), September 2010.

Other medicines containing the active ingredient metronidazole

Bacimex, Deflamon, Klion, Metrovagin, Metrogyl, Metroxan, Metrolacare, Metron, Metronidazole, Metronidazole IV Brown, Metronidazole Nycomed, Metronidazole-AKOS, Metronidazole-UBF, Metronidazole tablets 0.25 g, Metronidal, Metroseptol, Orvagil, Rosamet, Rozeks, Siptrogil, Trichopol, Tricho-PIN, Trichobrol, Trichosept, Flagyl, Efloran. Back to section

Flagyl – powder, solution, suspension, tablets

Orally and parenterally.

Orally, during or after meals (or with milk), without chewing.

For trichomoniasis - 250 mg of the drug 2 times a day for 10 days or 400 mg 2 times a day for 5-8 days. Women must additionally be prescribed metronidazole in the form of vaginal suppositories or tablets. If necessary, you can repeat the course of treatment or increase the dose to 0.75-1 g/day. Between courses you should take a break of 3-4 weeks with repeated control laboratory tests. An alternative treatment regimen is to prescribe 2 g once to the patient and his sexual partner.

Children 2-5 years old - 250 mg/day; 5-10 years - 250-375 mg/day, over 10 years - 500 mg/day. The daily dose should be divided into 2 doses. The course of treatment is 10 days.

For giardiasis - 500 mg 2 times a day for 5-7 days.

Children under 1 year old - 125 mg/day, 2-4 years old - 250 mg/day, 5-8 years old - 375 mg/day, over 8 years old - 500 mg/day (in 2 doses). The course of treatment is 5 days.

For giardiasis - 15 mg/kg/day in 3 divided doses for 5 days.

Adults: for asymptomatic amebiasis (if a cyst is detected), the daily dose is 1-1.5 g (500 mg 2-3 times a day) for 5-7 days.

For chronic amebiasis, the daily dose is 1.5 g in 3 divided doses for 5-10 days, for acute amoebic dysentery - 2.25 g in 3 divided doses until the symptoms stop.

For liver abscess, the maximum daily dose is 2.5 g in 1 or 2-3 doses, for 3-5 days, in combination with antibiotics (tetracyclines) and other methods of therapy.

Children 1-3 years old - 1/4 adult dose, 3-7 years old - 1/3 adult dose, 7-10 years old - 1/2 adult dose.

For balantidiasis - 750 mg 3 times a day for 5-6 days.

For ulcerative stomatitis, adults are prescribed 500 mg 2 times a day for 3-5 days; In this case, the drug is not indicated for children.

For pseudomembranous colitis - 500 mg 3-4 times a day.

For eradication of Helicobacter pylori - 500 mg 3 times a day for 7 days (as part of combination therapy, for example in combination with amoxicillin 2.25 g/day).

When treating anaerobic infection, the maximum daily dose is 1.5-2 g.

In the treatment of chronic alcoholism, 500 mg/day is prescribed for a period of up to 6 (not more than) months.

To prevent infectious complications - 750-1500 mg/day in 3 doses 3-4 days before surgery or 1 g once on the first day after surgery. 1-2 days after surgery (when oral administration is already allowed) - 750 mg/day for 7 days.

In case of severe renal dysfunction (creatinine clearance less than 10 ml/min), the daily dose should be reduced by 2 times.

Suspension for oral administration. Anaerobic bacterial infections: children - 7 mg/kg every 8 hours, course of treatment - 7-10 days; Giardiasis: children 2-5 years old - 200 mg/day, 5-10 years old - 300 mg/day, 10-15 years old - 400 mg/day. The duration of treatment for giardiasis is 5 days. The course of treatment can be repeated after 10-15 days

Parenterally. For adults and children over 12 years of age, an initial dose of 0.5-1 g IV drip (infusion duration is 30-40 minutes), and then every 8 hours, 500 mg at a rate of 5 ml/min. If well tolerated, after the first 2-3 infusions they switch to jet administration. The course of treatment is 7 days. If necessary, intravenous administration is continued for a longer time. The maximum daily dose is 4 g. According to indications, switch to maintenance oral administration at a dose of 400 mg 3 times a day. Children under 12 years of age are prescribed according to the same regimen in a single dose of 7.5 mg/kg.

For purulent-septic diseases, 1 course of treatment is usually carried out.

For preventive purposes, adults and children over 12 years of age are prescribed 0.5-1 g intravenously on the eve of surgery, on the day of surgery and the next day - 1.5 g / day (500 mg every 8 hours). After 1-2 days, they switch to maintenance therapy orally. For patients with chronic renal failure and creatinine clearance less than 30 ml/min and/or liver failure, the maximum daily dose is no more than 1 g, the frequency of administration is 2 times a day.

As a radiosensitizing drug, it is administered intravenously at a rate of 160 mg/kg or 4-6 g/sq.m of body surface 0.5-1 hour before the start of irradiation. Apply before each irradiation session for 1-2 weeks. During the remaining period of radiation treatment, metronidazole is not used. The maximum single dose should not exceed 10 g, course dose - 60 g. To relieve intoxication caused by radiation, drip administration of a 5% dextrose solution, Hemodez or 0.9% NaCl solution is used.

For cervical and uterine cancer, skin cancer, they are used in the form of local applications (3 g dissolved in a 10% DMSO solution), moisten tampons, which are used topically, 1.5-2 hours before irradiation). In case of poor tumor regression, applications are carried out throughout the entire course of radiation therapy. If there is a positive dynamics of tumor clearance from necrosis - during the first 2 weeks of treatment.

Flagyl oral tablets

Instructions for medical use of the drug

Description of pharmacological action

Metronidazole belongs to the nitro-5-imidazoles. 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. The main metabolite (2-oxymetronidazole) also has antiprotozoal and antimicrobial effects. Metronidazole is an effective antimicrobial and antiprotozoal agent with a broad spectrum of action. The drug exhibits high activity against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as against obligate anaerobes (spore-forming 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 use

Amebiasis, urogenital trichomoniasis, nonspecific vaginitis, giardiasis (intestinal and hepatic), surgical infections caused by anaerobes.

Release form

tablets, coated with spit coating 250 mg; blister 10, cardboard pack 2; tablets, coated with spit coating 250 mg; blister 10, cardboard pack 2; Warehouse 1 tablet, sealed, containing metronidazole 250 mg; 10 pcs in a blister, 2 blisters in a cardboard box. 1 vaginal suppository - 500 mg; There are 5 pcs in a blister, 2 blisters in a cardboard box. 100 ml of 0.5% rose for intravenous administration - 500 mg; bottles of 100 ml, cardboard boxes of 25 pcs.

Pharmacodynamics

Metronidazole is added to nitro-5-imidazole. The mechanism of action of metronidazole lies in the biochemical updated 5-nitro group of metronidazole with intracellular transport proteins of anaerobic microorganisms and protozoa. The 5-nitro group of metronidazole has been updated to interact with the cell DNA of microorganisms, inhibiting the synthesis of their nucleic acids, leading to the death of microorganisms. The main metabolite (2-oxymetronidazole) also exhibits protoprotozoal and antimicrobial activity. Metronidazole is an effective antimicrobial and protoprotozoal agent for a wide range of diseases. The drug exhibits high activity against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as obligate anaerobes (spore- and non-spore-soluble) - Bacteroides spp. (B.fragilis, B.ovatus, B.distasonis, B.thetaiotaomicron, B.vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp., sensitive Eubacterium species. Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole.

Pharmacokinetics

When taken whole, Flagyl will be absorbed completely (approximately 80% in 1 year). Taking hedgehogs does not affect the absorption of the drug. Bioavailability becomes approximately 100%. After taking 500 mg of the drug, the plasma concentration becomes 10 mcg/ml after 1 year, and 13.5 mcg/ml after 3 years. T1/2 lasts for 8-10 years, binding to blood proteins is insignificant and does not exceed 10-20%. The drug quickly penetrates into tissues (legenia, cervix, liver, skin, gallbladder, spinal cord, mucus, uterus, vaginal secretion), 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 exhibits protoprotozoal and antimicrobial activity. The drug is administered by 40-70% via drugs (in the unchanged form - about 35% of the dose taken). In patients with impaired function, after repeated administration, the accumulation of metronidazole in serum may be prevented.

Contraindications for use

Hypersensitivity.

Side effects

Nudity, metallic taste in the mouth, anorexia, pain in the epigastrium, vomiting, diarrhea, headache, confusion, allergic reactions (kropivyanka, itching), leukopenia, peripheral neuropathy, with trival urination and in large doses it is possible to have a brown-red-red barbed cut.

Directions for use and doses

For amebiasis, in the middle - 1.5 g / dose for 3 doses (adults) and 30-40 mg / kg / dose also for 3 doses (children) for 7 days. For giardiasis - adults - 750-1000 mg / dose, children 2-5 years old - 250 mg / dose, children 5-10 years old - 375 mg / dose, 10-15 years old - 500 mg / dose for 5 days. For trichomoniasis in women (urethritis and vaginitis) - a single dose of 2 g or for a course of treatment lasting 10 days - 250 mg 2 times a day and 1 vaginal suppository per day. For trichomonas urethritis in humans - a single dose of 2 g or as a course of treatment for 10 days, 250 mg 2 times a day. For nonspecific vaginitis - 500 mg 2 times a day, stretched out. For anaerobic infections, adults - 1-1.5 g / dose, children - 20-30 mg / kg / dose. V/v administration is indicated only when it is impossible to take it in any other way or in case of important forms of illness. 100 ml (500 mg) of the drug is administered with a stretch of 30-60 min.

Interactions with other drugs

Suicide with sulfonamides and antibiotics. It is not recommended to use disulfiram, indirect anticoagulants and non-depolarizing muscle relaxants. Crazy with alcoholic drinks. Promotes lithium concentration in plasma.

Precautions for use

Trival treatment should be carried out under the control of the blood count. Possible hibnopositive Nelson test, fragments of immobilizing treponemes. Use caution when combining with indirect anticoagulants and non-depolarizing muscle relaxants. For the hour of celebration, turn off alcoholic beverages.

Storage conditions

List B.: At a temperature not exceeding 25 ° C.

Best before date

60 months

ATX classification:

J Antimicrobials for systemic use

J01 Antimicrobials for systemic use

J01X Other antibacterial drugs

J01XD Imidazole derivatives

J01XD01 Metronidazole

Flagyl film-coated tablets 250 mg No. 20

Side effects

Gastrointestinal disorders Epigastric
pain, nausea, vomiting, diarrhea.

Inflammation of the oral mucosa (glossitis, stomatitis), taste disturbances (metallic taste in the mouth), decreased appetite, anorexia, dry oral mucosa, constipation.

Pancreatitis (reversible cases).

Change in tongue color/coated tongue (due to overgrowth of fungal microflora).

Immune system disorders

Angioedema, anaphylactic shock.

Nervous system disorders

Peripheral sensory neuropathy.

Headache, cramps, dizziness.

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 are reversed after discontinuation of metronidazole, have been reported.

Aseptic meningitis.

Mental disorders

Psychotic disorders, including confusion, hallucinations.

Depression, insomnia, irritability, increased excitability.

Visual disorders

Transient visual impairments, such as diplopia, myopia, blurred outlines of objects, decreased visual acuity, impaired color perception.

Neuropathy/optic neuritis.

Blood and lymphatic system disorders

Agranulocytosis, leukopenia, neutropenia and thrombocytopenia.

Disorders of the liver and biliary tract

Increased activity of liver enzymes (aspartate aminotransferase (AST) and alanine aminotransferase (ALT), alkaline phosphatase), development of cholestatic or mixed hepatitis and hepatocellular liver damage, sometimes accompanied by jaundice.

Cases of liver failure requiring liver transplantation have been observed in patients treated with metronidazole in combination with other antibiotics.

Skin and subcutaneous tissue disorders

Rash, itching, skin hyperemia, urticaria.

Pustular skin rash.

Stevens-Johnson syndrome, toxic epidermal necrolysis.

Renal and urinary tract disorders

Urine may turn brownish-reddish in color, due to the presence of a water-soluble metabolite of metronidazole in the urine.

Dysuria, polyuria, cystitis, urinary incontinence, candidiasis.

General and administration site disorders

Fever, nasal congestion, arthralgia, weakness.

Laboratory and instrumental data

Flattening of the T wave on the ECG.