Vagisept - instructions for use, dose, side effects, contraindications

Active substanceMetronidazole + FluconazoleMetronidazole + Fluconazole

Similar drugsTo uncover

Vagisept®

suppositories the vagina.

FIRN M, ZAO Russia

Dosage form: & nbspfromvaginal suppositories.

Composition:

1 suppository contains:

Active substances: metronidazole 0.25 g, fluconazole 0.15 g;

Excipients: boric acid 0.2 g, disodium edetate 0.002 g, base up to 2 g: macrogol 1500 - 92%, macrogol 400 - 8%.

Description:

Suppositories white or white with a yellowish or kremovatym shade of color, torpedo-shaped.

Pharmacotherapeutic group:Antimicrobial agent combined (antimicrobial and antiprotozoal + antifungal)

ATX: & nbsp

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

Pharmacodynamics: Combined drug for intravaginal application. It is active against diseases caused by Trichomonas spp. and / or fungi. Metronidazole - antimicrobial drug with high activity against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Giardia lamblia, and obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, 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., Mobiluncus spp.). Has a bactericidal and anti-cystic effect. Inactive with respect to aerobic infections. Fluconazole has a highly specific fungicidal (antifungal) action. Active with opportunistic fungal infections, incl.caused by Candida spp., Cryptococcus neoformans and Coccidioides immitis, Microsporum spp., Blastomyces dermatitidis, Histoplasma capsulatum. 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 with 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% in unchanged form) through the kidneys.

Systemic absorption of fluconazole with intravaginal application is very low, fluconazole in plasma was not determined; pharmacokinetics were not studied.

Indications:Bacterial vaginosis, nonspecific vaginitis, vaginitis of various etiology, (trichomoniasis, candidiasis, gardnerellezny), and also caused by mixed infections).

Contraindications:

Hypersensitivity to the components of the drug, pregnancy, children under 18 years (not enough data on the use in this age category), violation of hemopoiesis,severe violations of the liver (including porphyria), diseases of the peripheral nervous system and central nervous system.

Pregnancy and lactation:

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.

Dosing and Administration:

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

Side effects:

When topical application: side effects are not identified. In some cases, allergic reactions and local reactions are possible.

The side effects associated with systemic absorption of metronidazole include: 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 abdominal cramps, change in taste (rarely), dry mouth, metallic or unpleasant aftertaste, increased fatigue.

Overdose:

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

Symptoms of an overdose of fluconazole are not revealed.

Interaction:

With the simultaneous use of metronidazole with ethanol, disulfiram-like reactions occur.

With the simultaneous use of metronidazole with disulfiram, there may be abnormalities from the CNS (mental reactions).

With simultaneous application metronidazole enhances the effect of indirect anticoagulants.

When used simultaneously with lithium preparations there may be an increase in lithium toxicity.

Phenytoin and phenobarbital accelerate the metabolism of metronidazole due to the induction of microsomal liver enzymes, the concentration of metronidazole in the blood decreases.

Cimetidine reduces the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum.

The interaction of fluconazole with other drugs in the intravaginal route of administration has not been studied.

Special instructions:

During treatment with the drug it is recommended to abstain from sexual intercourse.

It is advisable to simultaneously treat a sexual partner.

Form release / dosage:

Vaginal suppositories, 250 mg + 150 mg.

Packaging:There are 5 suppositories in a contiguous cell package.

One or two contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

At a temperature below 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001331

Date of registration:07.12.2011 / 14.08.2013

Expiration Date:07.12.2016

The owner of the registration certificate:FIRN M, ZAO FIRN M, ZAO Russia

Manufacturer: & nbsp

FIRN M, ZAO Republic of Belarus

Information update date: & nbsp08.01.2017

Illustrated instructions

Instructions

Vagisept® (Vagisept®)