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Manufacturer: Piramal Enterprise Ltd. / Vikram Pharmaceuticals Pvt Ltd

Active Ingredient: Metronidazole

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What is Flagyl?

Flagyl is an antiprotozoal and antimicrobial drug derived from 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group interacts with the DNA of the cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

The drug is active against: Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia intestinalis, Lamblia spp .;
anaerobic bacteria: Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens), Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp. The MIC for these strains is 0.125-6.25 μg / 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 resistant to the drug, but in the presence of a mixed flora (aerobes and anaerobes), metronidazole acts synergistically with antibiotics effective against aerobes.

The drug increases the sensitivity of tumors to radiation, has a disulfiram-like effect, and stimulates reparative processes.

Indications for use

– protozoal infections (extraintestinal amebiasis / including liver abscess /, intestinal amebiasis, trichomoniasis, balantidiasis, giardiasis (giardiasis), cutaneous leishmaniasis, trichomonas vaginitis, trichomonas urethritis);

– infections caused by Bacteroides spp., Including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus (bone and joint infections, CNS infections / including meningitis, brain abscess /, bacterial endocarditis, pneumonia, empyema and lung abscess);

– infections caused by Bacteroides spp. (including Bacteroides fragilis), Clostridium spp., Peptococcus spp., Peptostreptococcus spp. (abdominal infections / peritonitis, liver abscess /, pelvic infections / endometritis, endomyometritis, abscess of the fallopian tubes and ovaries, vaginal vaginal infections after surgery /, skin and soft tissue infections);

– sepsis caused by Bacteroides spp. (including Bacteroides fragilis) and Clostridium spp .;

– pseudomembranous colitis (associated with the use of antibiotics);

Gastritis or duodenal ulcer associated with Helicobacter pylori;

– alcoholism;

– as a radiosensitizing agent in radiation therapy (in cases where the resistance of the tumor is due to hypoxia in the tumor cells);

– prevention of postoperative infections (especially after operations on the colon, periorectal region, appendectomy, gynecological interventions).

Contraindications

– leukopenia (including history);

– organic lesions of the central nervous system;

– epilepsy;

– liver failure (when using the drug in high doses);

– pregnancy (I trimester);

– lactation (breastfeeding);

– Hypersensitivity to the drug.

Instruction for use

With amoebiasis, Flagil is prescribed by mouth inside adults for 7 days, 1.5 g per day in 3 divided doses;

children 30-40 mg / kg per day, also in 3 doses.

With giardiasis, the drug is prescribed for 5 days – for adults 750-1000 mg per day, children 2-5 years old 250 mg per day, children 5-10 years old – 375 mg per day, children 10-15 years old – 500 mg in a day. Take after meals 2-3 times a day.

With trichomoniasis in women (urethritis and vaginitis), Flagil is prescribed once at a dose of 2 g or as a course of treatment for 10 days: 1 tablet (250 mg) 2 times a day. In parallel with oral administration, 1 vaginal suppository or vaginal tablet containing 250 mg of flagyl is prescribed in the evening.

To exclude possible reinfection, it is necessary to conduct treatment at the same time as sexual partners.

The course of treatment is repeated if necessary after 4-6 weeks.

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 tablet (250 mg) 2 times a day.

For non-specific vaginitis, 500 mg of Flagil is used 2 times a day for 7 days.

In the treatment of anaerobic infections, adults are prescribed Flagil 1-1.5 g per day,

children – at the rate of 20-30 mg / kg per day.

Side effects

From the digestive system: nausea, vomiting, diarrhea, intestinal colic, constipation, metallic taste in the mouth, dry mouth, glossitis, stomatitis, pancreatitis.

From the nervous system: dizziness, impaired coordination of movements, ataxia, confusion, irritability, depression, increased irritability, weakness, insomnia, headache, convulsions, hallucinations, peripheral neuropathy.

From the urinary system: dysuria, cystitis, polyuria, urinary incontinence, urine staining in red-brown color.

Allergic reactions: skin rash, urticaria, flushing of the skin, nasal congestion, fever, arthralgia.

Special instructions

It should be borne in mind that during the use of the drug, ethanol is contraindicated, because a disulfiram-like reaction is possible (spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).

With prolonged therapy, the blood picture should be monitored.

With leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

With the development of neurological symptoms, discontinue use of the drug.

In the treatment of trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to refrain from sexual activity. Simultaneous treatment of sexual partners is required. During menstruation, treatment should be continued. After completing the treatment of trichomoniasis, control studies should be carried out for 3 successive cycles before and after menstruation.

After treatment for giardiasis (if symptoms persist), after 3–4 weeks, 3 feces should be performed at intervals of several days (in some successfully treated patients, lactose intolerance caused by invasion may persist for several weeks or months, resembling symptoms of giardiasis).

The drug can immobilize treponema and lead to a false-positive Nelson test.

It is not recommended to combine with non-depolarizing muscle relaxants (for example, vecuronium bromide).

Pediatric Use

It is not recommended to use the drug in combination with amoxicillin for patients under 18 years of age.