Vagiferon, vaginal suppositories, 10pcs

Composition

1 vaginal suppository contains:

active ingredients:

human recombinant Interferon alfa-2b not less than 50,000 IU,

metronidazole 250 mg,

fluconazole 150 mg,

excipients:

boric acid-400 mg;

disodium edetate-2 mg;

base (macrogol 1500-92%, macrogol 400-8%) – up to 2 g

Pharmacological action

Pharmacodynamics

Combined drug for intravaginal use.

Vagiferon has antiviral, immunomodulatory, anti-inflammatory, antifungal, antimicrobial and antiprotozoal (trichomonacid) effects.

Interferon alfa-2b has pronounced antiviral, immunomodulatory properties.

Metronidazole is an antiprotozoal and antibacterial drug derived from 5-nitroimidazole. The mechanism of action consists in 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 microorganisms, inhibiting the synthesis of nucleic acids, which leads to the death of bacteria. Active against Trichomonas vaginalis, Gardnerella vaginalis, and gram-negative anaerobes Bacteroides spp. B. fragilis, B. 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. ). Aerobic microorganisms and facultative anaerobes are insensitive to metronidazole.

Fluconazole has a highly specific fungicidal (antifungal) effect. Active in mycoses, including those caused by Candida spp. (including generalized forms of candidiasis on the background of immunosuppression), Cryptococcus neoformans and Coccidioides immitis, Microsporum spp., Blastomyces dermatitidis. When used intravaginally, it is particularly active against Candida albicans, to a lesser extent-against Candida glabrata.

After intravaginal use, the bioavailability of metronidazole is 20% compared to oral use. After intravaginal use, it undergoes systemic absorption (about 56%). It is metabolized in the liver by hydroxylation, oxidation, and glucuronidation. The activity of the main metabolite (2-oxymetronidazole) is 30% of the activity of the parent compound. T_1/2 is 6-12 hours. It is excreted by 40-70% (about 20% in unchanged form) through the kidneys. The pharmacokinetics of interferon and fluconazole with intravaginal use have not been studied

Indications

• bacterial vaginosis;
• bacterial (non-specific) vaginitis;
• vaginitis caused by mixed infection (Trichomonas, Gardenerella, yeast-like fungi, herpes simplex virus type 1 and 2, mycoplasma, ureaplasma) as part of complex therapy.

Use during pregnancy and lactation

The drug is not used during pregnancy.

Metronidazole passes into breast milk.

Breastfeeding during the period of taking the drug should be discontinued.

Breast-feeding should be resumed no earlier than 48 hours after the end of the drug.

Contraindications

• pregnancy;
• children under 18 years of age (the effectiveness and safety of the drug has not been established);
• hypersensitivity to the components of the drug Vagiferon (including nitroimidazole derivatives).

Side effects

When applied topically, no side effects were detected.

In some cases, allergic reactions and local reactions are possible.

Side effects characteristic of metronidazole, since its systemic absorption is 56%: allergic reactions (rarely), leukopenia, ataxia, mental changes (anxiety, mood lability), convulsions, rarely: diarrhea, constipation, dizziness, headache, loss of appetite, nausea, vomiting, abdominal pain and cramps, taste changes (rarely), dry mouth, “metallic” or unpleasant taste, increased fatigue.

Interaction

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

It can be combined with a systemic antibiotic macrolide (josamycin).

How to take, course of use and dosage

Intravaginally. 1 suppository in the evening (before going to bed), for 10 days.

Overdose

Cases of overdose of the drug were not detected.

An overdose of metronidazole may cause nausea, vomiting, abdominal pain, diarrhea, itching, “metallic” taste in the mouth, ataxia, dizziness, paresthesia, convulsions, leukopenia, dark staining of urine.

Special instructions

During treatment with Vagiferon, it is recommended to refrain from sexual contact.

If the drug is used together with metronidazole for oral use, especially with a second course, it is necessary to monitor the picture of peripheral blood (risk of leukopenia).

During treatment, the use of ethanol is contraindicated (disulfiram-like reactions may develop: abdominal pain of a spastic nature, nausea, vomiting, headache, sudden “rush” of blood to the face).

Do not prescribe metronidazole to patients who have taken disulfiram in the last 2 weeks.

Influence on the ability to drive motor vehicles and manage mechanisms

The drug Vagiferon does not affect the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Vaginal suppositories

Storage conditions

At a temperature of 2-8 °C

Shelf life

2 years

Active ingredient

Interferon alfa-2b, Metronidazole, Fluconazole

Conditions of release from pharmacies

By prescription

Dosage form

vaginal suppositories

Description

For women, For adults as prescribed by a doctor

Indications

Vaginosis, Vaginitis