Universal reference book for medicines
Product name: VAGIFERON (VAGIFERON)

Active substance: fluconazole, interferon alfa-2b, metronidazole

Type: The drug with antibacterial, antiprotozoal and antifungal action for topical application in gynecology

Manufacturer: FIRN M (Russia)
Composition, form of production and packaging
Suppositories vaginal
white or white with a yellowish tint of color, torpedo-shaped.

1 supp.

interferon alpha-2b human recombinant not less than 50000 IU

metronidazole 150 mg

fluconazole 200 mg

Excipients: boric acid 400 mg, disodium edetate 2 mg, base (macrogol 1500 92%, macrogol 400 8%) to 2 g.

5 pieces.
- packings of cellular contour (1) - packs cardboard.
5 pieces.
- packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Combination drug for intravaginal application.

Vagiferon has antiviral, immunomodulatory, anti-inflammatory, antifungal, antimicrobial and antiprotozoal (trihomonatsidnym) action.

Interferon alfa-2b has pronounced antiviral, immunomodulating 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. distasonis, B. status, B. thеtaiotaomicron, B. vulgaris), Fusobacterium spp. and some Gram-positive anaerobes (sensitive strains of Eubacterium spp., Clostridium spp., Peptococcus 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 spr. (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. T 1/2 is 6 to 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.

DOSING MODE

Intravaginal.

For 1 suppository in the evening (before bedtime), for 10 days.

SIDE EFFECT

When topical application of side effects are not identified.
In some cases, allergic reactions and local reactions are possible.
Side effects typical for metronidazole , since its systemic absorption is 56%: allergic reactions (rarely), leukopenia, ataxia, changes in the psyche (anxiety, lability of mood), convulsions, rarely: diarrhea, constipation, dizziness, headache, loss of appetite, nausea , vomiting, pain and cramps in the abdomen, change in taste (rarely), dry mouth, "metallic" or unpleasant aftertaste, increased fatigue.

CONTRAINDICATIONS

- Pregnancy;

- Children under 18 years of age (efficacy and safety of the drug has not been established);

- Hypersensitivity to the components of the drug (including the derivatives of nitroimidazole).

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 be no earlier than 48 hours after the end of the drug.
APPLICATION FOR CHILDREN

Contraindicated:

- Children under 18 years of age (efficacy and safety of the drug has not been established).

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.

In the period of treatment, 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 administer metronidazole to patients who have taken disulfiram for the past 2 weeks.
Impact on the ability to drive vehicles and manage mechanisms

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.

OVERDOSE

Cases of drug overdose have not been identified.
In case of an overdose of metronidazole, nausea, vomiting, abdominal pain, diarrhea, itching, "metallic" taste in the mouth, ataxia, dizziness, paresthesia, convulsions, leukopenia, dark staining of urine are possible.
DRUG INTERACTION

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

Possible a joint application with antibiotic-macrolide (dzhozamycin) systemic action.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

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.
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