Instruction for use: Vagiferon

Dosage form: Vaginal suppositories

Active substance: Interferonum alpha-2b + Metronidazolum + Fluconazolum

ATX

G01AF20 Combinations of imidazole derivatives

Pharmacological groups

Antimicrobial agent combined (antiviral + antimicrobial and antiprotozoal + antifungal) [Other synthetic antibacterial agents in combination]

Antimicrobial agent combined (antiviral + antimicrobial and antiprotozoal + antifungal) [Antifungal agents in combinations]

Antimicrobial agent combined (antiviral + antimicrobial and antiprotozoal + antifungal) [Interferon in combination]

The nosological classification (ICD-10)

A49.3 Mycoplasma infection, unspecified: Mycoplasma infection; Urogenital mycoplasmosis; Pulmonary infection caused by mycoplasma; Mycoplasma infections; Mycoplasmosis; Genitourinary infection caused by mycoplasma; Mycoplasma meningoencephalitis

A59.0 Urogenital Trichomoniasis: Trichomonas Colpitis; Trichomonas infection of the urinary tract; Vaginal trichomoniasis; Trichomonal vaginitis; Trichomonas inflammation of the vagina; Trichomonas inflammation of the urinary tract; Trichomonas vaginitis; Trichomonal Urethritis; Trichomonatal balanoposthitis; Trichomonas vulvovaginitis; Trichomonal Urethritis; Urethritis caused by Trichomonas; Trichomonas urethritis; Vaginitis due to Trichomonas; Trichomoniasis of the genitourinary system; Trichomonas colpitis; Trichomonas infection of the urogenital organs

A60 Anogenital herpetic viral infection [herpes simplex]: Herpes simplex genitalis; Banal recurrent genital herpes; Secondary genital herpes; Genital herpesvirus infection; Genital herpetic infections; Genital herpes; Herpes genitalia; Genital herpes; Herpes simplex organs; Herpetic lesions of the mucocutaneous urinary organs; Herpetic lesions of the genitals; Primary genital herpes; Primary herpes simplex; Simple herpes extragenital and genital localization; Recurrent genital herpes; Recurrent herpes of genital organs; Herpes of the lips and genitals

A63.8 Other specified diseases, mainly sexually transmitted: Ureaplasmosis infection; Ureaplasmic infection; Ureaplasmosis

B37.3 Candidiasis of the vulva and vagina (N77.1 *): Vaginal candidiasis; Vaginal candidiasis; Vulval candidiasis; Vulvovaginal candidiasis; Vulvovaginal candidiasis; Vulvovaginitis candidiasis; Mycotic vulvovaginitis; Fungal vaginitis; Candidiasis of the vagina; Candidiasis of internal organs; Candidiasis of the urogenital; Candidiasis of the urogenital organs in women; Candidiasis with lesions of the skin and mucous membranes; Candidiasis of the mucous membranes; Candidiasis of mucous membranes and skin; Candidiasis of the vaginitis; Candidiasis vulvitis; Candidiasis vulvovaginitis; Colpitis of fungal etiology; Vaginal yeast infection; Moniliasis vulvovaginitis; Acute vaginal candidiasis; Acute mycosis of the vagina; Superficial candidiasis of the genital mucosa; Recurrent vaginal candidiasis; Recurrent vaginal candidiasis; Urogenital Candidiasis; Chronic vaginal candidiasis; Chronic candidiasis of mucous membranes; Chronic recurrent vaginal candidiasis

N76 Other inflammatory diseases of the vagina and vulva: Vulvovaginitis atrophic; Vulvovaginitis bacterial; Vulvovaginitis estrogen-deficient; Bacterial vaginosis; Vaginitis; Vaginitis bacterial; Inflammatory diseases of the vagina and vulva; Inflammatory diseases of female genitalia; Inflammatory diseases of female genital organs; Vulvit; Vulvovaginitis; Vulvovaginitis; Gardnerella; Fungal vulvovaginitis in girls and virgins; Infection of the vagina; Infection of the genitals; Colpitis; Violation of purity of the vaginal secretion; Nonspecific cervicovaginitis; Nonspecific vulvitis; Nonspecific vulvovaginitis; Nonspecific colpitis; Recurrent nonspecific bacterial vaginosis; Senylic coverings; Mixed Colpus; Chronic vaginitis; Vulvovaginal infections; Bacterial vaginitis; Bacterial vaginosis; Bacterial vaginitis; Mixed vaginal infections

N76.8 Other specified inflammatory diseases of the vagina and vulva: Genital infections; Vaginosis; Nonspecific vaginitis; Nonspecific vulvovaginitis

N77.1 Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere: Cervicovaginitis; Fungal vulvovaginitis in girls and virgins; Specific vulvovaginitis; Mixed vaginal infection; Mixed Vaginitis; Chronic recurrent mycosis of the vagina

Composition

Vaginal suppositories 1 supp.

Active substances: Interferon alpha-2b human recombinant not less than 50000 IU

Metronidazole 250 mg

Fluconazole 150 mg

Auxiliary substances: boric acid - 400 mg; Disodium edetate - 2 mg; Base (macrogol 1500 - 92%, macrogol 400 - 8%) - up to 2 g

Description of dosage form

Suppositories: white or white with a yellowish tint of color, torpedo-shaped.

Pharmachologic effect

Mode of action - antiviral, anti-inflammatory, immunomodulating, antifungal, antiprotozoal, antimicrobial.

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 restored 5-nitro group of metronidazole interacts with the DNA of microorganisms, inhibiting the synthesis of 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. thetaiotaomicron, 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 spp. (Including generalized forms of candidiasis on the background of immunodepression), Cryptococcus neoformans and Coccidioides immitis, Microsporum spp., Blastomyces dermatitidis. In case of intravaginal application it is especially 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. T1 / 2 is 6-12 hours. It is deduced by 40-70% (about 20% - in unchanged form) through the kidneys. The pharmacokinetics of interferon and fluconazole for intravaginal application has not been studied.

Indications for the drug Vagiferon®

Bacterial vaginosis;

Bacterial (nonspecific) vaginitis;

Vaginitis caused by a mixed infection (Trichomonas, Gardnerella, 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).

Application in pregnancy and breastfeeding

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.

Side effects

With topical application of the drug, side effects were not revealed. In some cases, allergic reactions and local reactions are possible.

Side effects typical for metronidazole

Allergic reactions (rarely), leukopenia, ataxia, changes in the psyche (anxiety, mood lability), convulsions, rarely: diarrhea, constipation, dizziness, headache, loss of appetite, nausea, vomiting, pain and abdominal cramps, taste change, dryness Mouth, metallic or unpleasant aftertaste, increased fatigue.

Interaction

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

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

Dosing and Administration

Intravaginal.

For 1 soup. In the evening (before bedtime), within 10 days.

Overdose

Cases of drug overdose have not been identified.

When an overdose of metronidazole is possible:

Symptoms: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, dizziness, paresthesia, seizures, leukopenia, dark staining of urine.

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 intake of ethanol is contraindicated (development of disulfiram-like reactions is possible - abdominal pain of a spastic nature, nausea, vomiting, headache, sudden rush of blood to the face). Do not administer metronidazole to patients who took disulfiram within the last 2 weeks.

Influence on the ability to drive vehicles and work with machinery. 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.

Release form

Suppositories are vaginal. By 5 soups. In a planar cell package. 1 or 2 packs in a pack of cardboard.

Manufacturer

ZAO "Firn M". Moscow

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Vagiferon

At a temperature of 2-8 ° C.

Keep out of the reach of children.

The shelf life of the drug Vagiferon

2 years.

Do not use beyond the expiration date printed on the package.