Vagiféron® (Vagiferon®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInterferon alfa-2b + Metronidazole + FluconazoleInterferon alfa-2b + Metronidazole + Fluconazole
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  • Vagiféron®
    suppositories the vagina. 
    FIRN M, ZAO     Russia
    • Dosage form: & nbspVaginal suppositories
    Composition:1 suppository contains:
    Active substances: Interferon alfa-2b human recombinant not less than 50 000 ME, metronidazole 250 mg, fluconazole 150 mg.
    Excipients: boric acid 400 mg, disodium edetate 2 mg, basis up to 2 g: macrogol 1500 - 92%, macrogol 400 ~ 8%.
    Description:Suppositories white or white with a yellowish hue of color, torpedo-shaped.
    Pharmacotherapeutic group:Antimicrobial agent combined (antiviral + antimicrobial and antiprotozoal + antifungal)
    ATX: & nbsp

    G.01.A.F.20   Combinations of imidazole derivatives

    Pharmacodynamics:
    Combined drug for intravaginal application.
    VAGIFERON® has antiviral, immunomodulatory, anti-inflammatory, antifungal, antimicrobial and antiprotozoal (trichomonacid) action.
    Interferon alfa-2b has pronounced antiviral, immunomodulatory properties.
    Metronidazole is an antiprotozoal and antibacterial drug, a derivative of 5-nitroimidazole. The mechanism of action 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 reacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. It is active against Trichomonas vaginalis, Gardnerella vaginalis, as well as gram-negative anaerobes Bacteroides spp. (including B. fragilis, V. dista-sonis, B. status, B. thetaiotaomicron, B. vulgaris), Fusobacterium spp. and some Gram-positive anaerobes (sensitive strains of Eubacterium spp., Clostridium spp., Pepto-coccus niger., Peptostreptococcus spp., Mobiluncus spp.). Metronidazole is insensitive to aerobic microorganisms and facultative anaerobes.
    Fluconazole has a highly specific fungicidal (antifungal) action. Active with fungal infections, incl. caused by Candida spp. (including generalized forms of candidiasis on the background of immunodepression), Cryptococcus neoformans and Coccidioides immitis, Microsporum spp., Blastoyces dermatitidis ,. When intravaginal application is particularly active against Candida albicans, to a lesser extent - against Candida glabrata.
    Pharmacokinetics:After intravaginal administration, the bioavailability of metronidazole is 20% compared to oral administration. After intravaginal administration, it undergoes systemic absorption (about 56%). 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.The half-life is 6-12 hours. It is excreted by 40-70% (about 20% unchanged) through the kidneys. The pharmacokinetics of interferon and fluconazole for intravaginal application has not been studied.
    Indications:
    - bacterial vaginosis,
    - bacterial (nonspecific) vaginitis,
    - Vaginitis caused by a mixed infection (Trichomonas, Gardenerella, yeast-like fungi, Herpes simplex virus type 1 and type 2, mycoplasma, ureaplasma,) as part of complex therapy.
    Contraindications:Hypersensitivity to the components of the drug (including the derivatives of nitroimidazole), pregnancy, children under 18 years of age (efficacy and safety of the drug is not established).
    Pregnancy and lactation:
    The drug is not used in pregnancy.
    Metronidazole penetrates into breast milk. Breastfeeding during the period of taking the drug should be canceled. Renew breastfeeding should not be earlier than 48 hours after the end of the drug.
    Dosing and Administration:
    Intravaginal.
    1 suppository in the evening (before bedtime), for 10 days.
    Side effects:
    When topical application of side effects are not identified.In some cases, allergic reactions and local reactions are possible
    Side effects specific to metronidazole, as its systemic absorption is 56%: an allergic reaction (rare), leukopenia, ataxia, mental changes (anxiety, mood lability), convulsion, seldom diarrhea, constipation, dizziness, headache, loss of appetite, nausea , vomiting, abdominal pain and cramps, changes in taste (rare), dry mouth, "metal", or bad taste, fatigue.
    Overdose:Cases of drug overdose have not been identified. When metronidazole overdose may be nausea, vomiting, abdominal pain, diarrhea, itching, "metallic" taste in the mouth, ataxia, dizziness, paraesthesia, seizures, leukopenia, dark urine staining.
    Interaction:It is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide). Possible a joint application with antibiotic-macrolide (dzhozamycin) systemic action.
    Special instructions:During treatment with the drug it is recommended to abstain from sexual intercourse. 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 treatment period, the use of ethanol is contraindicated (development of disulfiram-like reactions is possible: abdominal pain of a spastic nature, nausea, vomiting, headache, sudden "tide" of blood to the face). Do not assign metronidazole patients who took disulfiram in the last 2 weeks.
    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:Suppositories are vaginal.
    Packaging:There are 5 suppositories in a contiguous cell package. One or two contoured cell packs, along with instructions for medical use, are placed in a cardboard box.
    Storage conditions:At a temperature of 2 ° C to 8 ° C. Keep out of the reach of children.
    Shelf life:2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001339
    Date of registration:08.12.2011 / 14.08.2013
    Expiration Date:08.12.2016
    The owner of the registration certificate:FIRN M, ZAO FIRN M, ZAO Russia
    Manufacturer: & nbsp
    FIRN M, ZAO Republic of Belarus
    Information update date: & nbsp09.01.2017
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