Metrogil® Plus (Metrogyl® Plus)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspgel, vaginal
Composition:

For 1 g of gel

Active substances:

Metronidazole 10.0 mg.

Clotrimazole 20.0 mg.

Excipients: benzyl alcohol 40 mg, disodium edetate 0.50 mg, carbomer 940 10.0 mg, methyl parahydroxybenzoate 1.50 mg, sodium hydroxide 2.0 mg, propyl parahydroxybenzoate 0.50 mg, propylene glycol 50.0 mg, water sk. demand, up to 1.0 g.

Description:

Homogeneous opalescent gel of white or almost white color.

Pharmacotherapeutic group:Antimicrobial and antiprotozoal means + antifungal agent
ATX: & nbsp
  • Combinations of imidazole derivatives
    • Pharmacodynamics:

    Combination drug for intravaginal application, the effectiveness of which is due to the presence in its composition of two active components: metronidazole and clotrimazole.

    The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. Active with respect to Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia intestinalis, Lamblia spp., as well as obligate anaerobes Bacteroides spp., (including Bacteroides fragilis, Bacteroides thetaitaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella buccae, Prevotella disiens) and some gram-positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.) The minimum inhibitory concentration (MIC) for these strains is 0.125-6.25 μg / ml. Metronidazole is insensitive to aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against conventional aerobes. Clotrimazole is an imidazole derivative. It has a fungicidal effect. Reduces the synthesis of ergosterol, which is an integral part of the cell membrane of the microbial wall, and leads to a change in its structure and properties. In small concentrations, it acts fungistatically, and in large concentrations (more than 20 μg / ml) it is fungicidal, not only on proliferating cells. In fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells. Has a high activity against pathogenic dermatophytes (Trichophyton mentagrophytes, Microsporum cams, Epidermophyton Jloccosum), yeast and mold fungi (genus Candida, Torulopsis glabrata, genus Rhodotorula, Pityrosporum orbiculare).

    Pharmacokinetics:

    After intravaginal administration metronidazole is subject to systemic absorption (about 56%). The relative bioavailability of the vaginal gel is 2 times higher than the bioavailability of a single dose (500 mg) of vaginal metronidazole tablets. It penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta. After a single intravaginal injection of 5 g of gel (50 mg of metronidazole), the average maximum serum concentration in healthy women is 237 ng / ml, which is 2% of the average maximum concentration of metronidazole when administered at a dose of 500 mg. The time to reach the maximum concentration is 6 -12 hours. The connection with plasma proteins is less than 20%. Metabolized in the liver by hydroxylation, oxidation and glucuronation. The activity of the main metabolite (2-hydroxymethonidazole) is 30% of the activity of the parent compound. It is excreted by the kidneys - 60 - 80% of the dose of the systemic action drug (20% of this quantity in the unchanged form), the intestine - 6 - 15% of the dose of the systemic drug.

    When clotrimazole is administered intravaginally, no more than 3-10% of the administered dose is absorbed. High concentrations in the vaginal secretion and low concentrations in the blood persist for 48 to 72 hours. In the liver clotrimazole Rapidly metabolized to inactive metabolites.

    Indications:

    Bacterial vaginosis of different etiology, confirmed by clinical and microbiological data; candidiasis vulvitis and vulvovaginitis, urogenital trichomoniasis.

    Contraindications:

    Hypersensitivity to the components of the drug. Leukopenia (including in history), organic lesions of the central nervous system (including epilepsy), liver failure, menstrual period. Pregnancy I trimester, lactation.

    Pregnancy and lactation:

    The use of the drug in the II and III trimester of pregnancy is possible only for life indications, if the potential benefit to the mother exceeds the risk to the fetus. When prescribing the drug during lactation, it is necessary to stop breastfeeding.

    Dosing and Administration:

    Intravaginal. The recommended dose is 5 g (one complete applicator) 2 times a day (morning and evening). The course of treatment is 5 days. If necessary, the course of treatment can be repeated after 2 weeks.

    Side effects:

    Local reactions: itching, burning and hyperemia of the mucous membrane of the external genitalia; a sexual partner - a burning sensation or irritation of the penis, frequent urination.

    Possible development system effects: dizziness, headache, dry mouth, taste changes, including "metallic" aftertaste, nausea, vomiting, decreased appetite, abdominal cramps, constipation or diarrhea, dark-colored staining, leukopenia or leukocytosis.

    Allergic reactions: skin rash, hives.

    In case of any undesirable side effects, stop treatment and consult a doctor!

    Overdose:

    Cases of overdose in prescribing the drug in the recommended doses are not noted.

    Interaction:

    For intravaginal use only!

    Similarly, disulfiram causes intolerance to ethanol.

    Strengthens the effect of indirect anticoagulants, it is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide).

    With simultaneous administration with lithium preparations, the concentration of lithium in the blood plasma can increase.

    Phenobarbital accelerates the metabolism of metronidazole due to the induction of microsomal liver enzymes, cimetidine - reduces, which may lead to an increase in its concentration in the serum and an increased risk of side effects. Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously.

    Special instructions:

    Simultaneous treatment of sexual partners is recommended.

    During the course of treatment it is necessary to abstain from sexual activity.

    With vaginitis caused by Trichomonas vaginalis, it is advisable to simultaneously treat the sexual partner metronidazole for oral administration. In the case of using the drug in conjunction with metronidazole for oral administration, especially in the second course, control of the picture of peripheral blood (danger of leukopenia) is necessary.

    During the period of treatment, alcohol intake is contraindicated (development of a disulfiram-like reaction is possible: spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).

    Metronidazole can immobilize treponema and lead to Nelson's false positive test.

    Avoid contact with eyes!

    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the ability of managersvehicles andIn other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:Gel is vaginal.
    Packaging:

    - 30 g per aluminum tube or plastic A laminated tube, the neck of which is sealed with an aluminum membrane and with a screw cap made of polyethylene with a protrusion for perforating the membrane. One lip together with the applicator and instruction for use in a cardboard box.

    - 50 g per aluminum lip or plastic laminated tube, neck which sealed with aluminum foil, laminated polyethylene and with a screw cap made of polypropylene with a projection (or without a lip) for perforating the foil. One tube in a cardboard box together with an applicator and instructions for use.

    - 50 g per aluminum tube or plastic laminated tube, neck which sealed with aluminum foil, laminated polyethylene and with a screw cap made of polypropylene with a projection (or without a lip) for perforating the foil. One tube in a cardboard pack together with applicators, in quantity of 10 pieces the instruction on application.

    Storage conditions:

    At a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date stated on the package

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001520
    Date of registration:23.03.2011 / 18.02.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India
    Manufacturer: & nbsp
    Information update date: & nbsp11.05.2018
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