Flagil, vaginal suppositories 500 mg 10 pcs

Pharmgroup:

Antimicrobial and antiprotozoal agent.

Pharmic action:

Flagil is an antiprotozoal and antibacterial drug.

Metronidazole refers to nitro-5-imidazoles. The mechanism of action of metronidazole is the biochemical reduction of the 5-nitrogroup of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa.

The reduced 5-nitrogroup of metronidazole interacts with the DNA of the microbial cell, inhibiting the synthesis of their nucleic acids, which leads to the death of the microorganisms.

Metronidazole is an effective broad-spectrum antimicrobial and antiprotozoal agent. The drug shows high activity 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.

Pharmacokinetics:

About 20% of the metronidazole dose used (500 mg) is systemic absorbed, so that the plasma concentration of the drug is about 12% of that after an oral single dose of 500 mg.

The T1/2 (excretion determined by systemic use with normal hepatic function) is 8-10 hours.

The binding to plasma proteins is less than 20%.

Indications

local treatment of trichomonas and nonspecific vaginitis;
prevention of anaerobic infections during surgical interventions on the abdominal and pelvic organs.

Pharmacological effect

Pharmaceutical group:

antimicrobial and antiprotozoal agent.

Pharmaceutical action:

Flagyl is an antiprotozoal and antibacterial drug.

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.

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- 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.

Pharmacokinetics:

Approximately 20% of the administered dose of metronidazole (500 mg) is systemically absorbed, resulting in plasma concentrations of approximately 12% of those after oral administration of a single 500 mg dose.

T1/2 (excretion established during systemic use with normal liver function) is 8-10 hours.

Communication with plasma proteins is less than 20%.

Special instructions

Since simultaneous use of the drug with alcohol can have an effect similar to that of disulfiram (feeling of heat, vomiting, tachycardia), patients should be warned not to drink alcoholic beverages or medications containing alcohol during treatment with Flagyl.

Long-term administration of the drug is preferably carried out under the control of the blood count. With leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

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 treatment for trichomoniasis, control tests should be carried out during 3 consecutive cycles before and after menstruation.

After treatment of giardiasis, if symptoms persist, after 3-4 weeks, perform 3 stool tests at intervals of several days (in some successfully treated patients, lactose intolerance caused by infestation may persist for several weeks or months, resembling the symptoms of giardiasis).

Treatment should be discontinued if ataxia, dizziness, hallucinations develop, or if the neurological status of patients worsens.

It must be taken into account that metronidazole can immobilize treponemes, which leads to a false-positive Nelson test.

Impact on the ability to drive vehicles and operate machinery

Due to the possibility of dizziness and other side effects associated with taking the drug, it is recommended to refrain from driving a car or using other machinery.

Active ingredient

Metronidazole

Composition

1 supp. metronidazole 500 mg

Excipients:

solid fat – 1600 mg.

Pregnancy

Contraindication: pregnancy and breastfeeding.

Contraindications

organic lesions of the central nervous system (including epilepsy);
impaired coordination of movements;
blood diseases (including a history of leukopenia);
liver failure (if large doses are prescribed);
pregnancy;
breast-feeding;
hypersensitivity to imidazoles, as well as to nitroimidazole derivatives;
children up to 6 years old

Side Effects

From the gastrointestinal tract: nausea, metallic taste in the mouth, dry mouth, loss of appetite, glossitis, stomatitis, pancreatitis, anorexia, epigastric pain, vomiting, diarrhea, constipation.

From the nervous system: headache, dizziness, incoordination, ataxia, confusion, irritability, depression, increased excitability, weakness, insomnia, convulsions, confusion, hallucinations, peripheral neuropathy (especially with long-term use).

Allergic reactions: urticaria, skin rash, skin hyperemia, nasal congestion, fever, arthralgia.

From the urinary system: dysuria, polyuria, cystitis, urinary incontinence, candidiasis, urine may turn brownish-reddish.

Other: neutropenia, leukopenia, flattening of the T wave on the ECG.

Local reactions: burning sensation or irritation of the penis in a sexual partner, burning sensation or increased urination, vulvitis (itching, burning pain or hyperemia of the mucous membrane in the external genital area).

Interaction

Similar to disulfiram, it causes ethanol intolerance.

Concomitant use with disulfiram can lead to the development of various neurological symptoms (the interval between prescriptions is at least 2 weeks).

Strengthens the effect of indirect anticoagulants, which leads to an increase in the time of prothrombin formation.

When taken simultaneously with lithium preparations, the concentration of the latter in plasma may increase.

When taken simultaneously with cyclosporine, the concentration of the latter in plasma may increase.

Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its concentration in the blood serum and an increased risk of side effects.

The simultaneous administration of drugs that stimulate microsomal oxidation enzymes in the liver (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, resulting in a decrease in its plasma concentration.

Metronidazole reduces the clearance of 5-fluorouracil, leading to increased toxicity.

Metronidazole increases plasma levels of busulfan, leading to increased 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 of children.

Shelf life

5 years.
Do not use after the expiration date indicated on the package

Manufacturer

Uniter Liquid Manufacturing, France