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

Itching and dryness in the genital area, vaginitis, inflammation of the female genitalia

• treatment of trichomonas and nonspecific vaginitis
• prevention of anaerobic infections in surgical interventions on the abdominal and pelvic organs.
  

Active ingredient

Metronidazole

Composition

1 sup.metronidazole 500 mg

Excipients:

solid fat – 1600 mg.

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How to take, the dosage

The drug is used only in adults.

Adults

Trichomonas vaginitis: 1 suppository per day in the vagina, for 10 days in combination with the drug metronidazole, tablets orally.

Nonspecific vaginitis: 1 suppository 2 times / day for 7 days, if necessary in combination with oral administration of metronidazole, tablets. Simultaneous treatment of the sexual partner with metronidazole is mandatory, regardless of whether he has manifestations of the disease.

Treatment with metronidazole should not be prescribed for more than 10 days and should be repeated more often than 2 or 3 times a year.

Preliminarily loosen the suppository from the contour pack with scissors, cut the film around the contour of the suppository and insert it deep into the vagina.

Interaction

Similar to disulfiram causes ethanol intolerance.

Simultaneous use with disulfiram may lead to the development of various neurological symptoms (interval between prescriptions – at least 2 weeks).

It enhances the effect of indirect, anticoagulants, which leads to increased prothrombin formation time.

Concomitant administration with lithium preparations may increase the concentration of the latter in plasma.

Concomitant use with cyclosporine may increase the plasma concentration of the latter.

Cimetidine inhibits the metabolism of metronidazole, which may increase its serum concentrations and increase the risk of side effects.

The concomitant administration of drugs stimulating enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin) may accelerate elimination of metronidazole, resulting in lower plasma concentrations.

Metronidazole decreases clearance of 5-fluorouracil, leading to an increase in its toxicity.

Metronidazole increases plasma levels of busulfan, leading to an increase in its toxicity (severe form).

It is not recommended to combine with nondepolarizing myorelaxants (vecuronium bromide).

Special Instructions

Because concomitant administration of the drug with alcohol may have effects similar to those of disulfiram (fever, vomiting, tachycardia), patients should be warned not to consume alcoholic beverages or drugs containing alcohol during treatment with Flagyl.

Long-term administration of the drug should preferably be performed under monitoring of blood counts. In case of leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

When treating trichomonad vaginitis in women and trichomonad urethritis in men it is necessary to abstain from sexual activity. The simultaneous treatment of sexual partners is mandatory. The treatment does not stop during menstruation. After the therapy of trichomoniasis, control tests should be carried out for 3 consecutive cycles before and after menstruation.

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

The treatment should be stopped if ataxia, dizziness, hallucinations develop, the neurological status of patients deteriorates.

It should be taken into account that metronidazole may immobilize treponemes, which leads to a false-positive Nelson’s test.

Impact on driving and operating machinery

In view of the possibility of dizziness and other side effects associated with taking the drug, it is recommended to refrain from driving and operating other machinery.

Contraindications

• organic CNS lesions (including epilepsy);
• disorders of movement coordination;
• blood diseases (including leukopenia in anamnesis;
• hepatic failure (in case of high doses). blood diseases (including history of leukopenia);
• hepatic insufficiency (in case of high doses);
• pregnancy;
• breastfeeding;
• high sensitivity to imidazoles as well as to nitroimidazole derivatives;
• children under 6 years

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Side effects

Gastrointestinal system disorders: nausea, metallic taste in the mouth, dry mouth, decreased appetite, glossitis, stomatitis, pancreatitis, anorexia, epigastric pain, vomiting, diarrhea, constipation.

Nervous system disorders: headache, dizziness, impaired coordination of movements, ataxia, confusion, irritability, depression, increased excitability, weakness, insomnia, seizures, confusion, hallucinations, peripheral neuropathy (especially with long-term use).

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

Uinary system disorders: dysuria, polyuria, cystitis, urinary incontinence, candidiasis, possible brownish-reddish coloring of urine.

Others: neutropenia, leukopenia, flatness of the T wave on the ECG.

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

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Pregnancy use

Contraindication: pregnancy and breastfeeding.

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Similarities

Flagil, Metrogil, Trichopol, Metronidazole, Rosamet, Metronidazole-Acos, Metronidazole Renewal