Flagyl, vaginal suppositories 500mg, 10pcs

Composition

of 1 sup. metronidazole 500 mg

Auxiliary substances:

solid fat – 1600 mg

Pharmacological action

Pharmaceutical group:

antimicrobial and antiprotozoal agent.

Pharmaceutical action:

Flagil is an antiprotozoal and antibacterial drug.

Metronidazole belongs to 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 microbial cell, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.

Metronidazole is an effective broad-spectrum antimicrobial and antiprotozoal agent. The drug is highly active 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 subject to systemic absorption, resulting in the concentration of the drug in the blood plasma is approximately 12% of that after ingestion of a single dose of 500 mg

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

Binding to plasma proteins is less than 20%.

Indications

• local treatment of trichomonas and non-specific vaginitis;
• prevention of anaerobic infections during surgical interventions on the abdominal and pelvic organs.

Use during pregnancy and lactation

Contraindication: pregnancy and breast-feeding.

Contraindications

• : central nervous system disorders (including epilepsy);
• impaired coordination of movements;
• blood diseases (including a history of leukopenia);
• liver failure (in the case of high doses);
• pregnancy;
• breastfeeding;
• hypersensitivity to imidazoles, as well as to nitroimidazole derivatives;
• children under 6 years of age

Side effects

From the gastrointestinal tract:  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, convulsions, confusion, hallucinations, peripheral neuropathy (especially with prolonged use).

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

From the urinary system:  dysuria, polyuria, cystitis, urinary incontinence, candidiasis, possible staining of urine in a brown-reddish color.

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

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

Interaction

Similarly to disulfiram, it causes an intolerance to ethanol.

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

Increases 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 concomitantly with cyclosporine, the concentration of the latter in plasma may increase.

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

Concomitant use of drugs that stimulate microsomal oxidation enzymes in the liver (phenobarbital, phenytoin) may accelerate the elimination of metronidazole, resulting in a decrease in its concentration in plasma.

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

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

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

How to take, course of use and dosage

The drug is used only in adults.

Adults

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

Non-specific vaginitis:  1 suppository 2 times / day for 7 days, if necessary in combination with taking the drug metronidazole, tablets inside. Simultaneous treatment of the sexual partner with metronidazole is mandatory, regardless of whether he has symptoms of the disease.

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

After releasing the suppository from the contour package with scissors, cut the film along the contour of the suppository and insert it deep into the vagina.

Special instructions

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

Long-term use of the drug is preferably carried out under the control of the blood formula. 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 refrain from sexual activity. Simultaneous treatment of sexual partners is mandatory. Treatment does not stop during menstruation. After trichomoniasis therapy, follow-up tests should be performed for 3 consecutive cycles before and after menstruation.

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

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

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

Influence on the ability to drive motor vehicles and manage mechanisms

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

Form of production

Vaginal suppositories are white to light yellow in color, torpedo-shaped.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

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

Active ingredient

Metronidazole

Conditions of release from pharmacies

By prescription

Dosage form

vaginal suppositories

Description

For adults as directed by your doctor

Indications

Vaginitis, Trichomoniasis, Inflammation of the female genital organs