Universal reference book for medicines
Name of the drug: VAGISEPT (VAGISEPT)

Active substance: fluconazole, 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 or kremovatym color shade, torpedo-shaped.

1 supp.

metronidazole 150 mg

fluconazole 200 mg

Excipients: boric acid 0.2 g, disodium edetate 0.002 g, basis (macrogol 1500 92%, macrogol 400 8%) to 2 g.

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

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

PHARMACHOLOGIC EFFECT

Combined drug for intravaginal application.
It is active against diseases caused by Trichomonas spp. and / or fungi.
Metronidazole is an antimicrobial drug with high activity against Trichomonas vaginalis, Gardnerella vaginalis, Giardiaintes tinalis, 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.
Not active against 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 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. Systemic absorption of fluconazole with intravaginal application is very low, fluconazole in plasma is not detected; pharmacokinetics were not studied.
INDICATIONS

- bacterial vaginosis;

- nonspecific vaginitis;

- Vaginitis of various etiologies (Trichomonas, Candidiasis, Gardnerella, and also caused by mixed infections).

DOSING MODE

Intravaginal, 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 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 cramps in the abdomen, change in taste (rarely), dry mouth, metallic or unpleasant aftertaste, increased fatigue.

CONTRAINDICATIONS

- violation of hemopoiesis;

- severe violations of the liver (including porphyria);

- diseases of the peripheral nervous system and central nervous system;

- Pregnancy;

- Children's age under 18 years (not enough data on the application in this age category);

- Hypersensitivity to the components of the drug.

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.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated:

- severe violations of the liver (including porphyria).

APPLICATION FOR CHILDREN

Contraindicated:

- Children under the age of 18 years (not enough data on the application in this age category).

SPECIAL INSTRUCTIONS

During treatment with the drug it is recommended to abstain from sexual intercourse.
It is advisable to simultaneously treat a sexual partner.
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.
DRUG INTERACTION

With the simultaneous use of metronidazole with ethanol, disulfiramide-like reactions occur.
With the simultaneous use of metronidazole with disulfiram, there may be abnormalities from the CNS (mental reactions).
With the simultaneous use of metronidazole increases the effect of indirect anticoagulants.

With simultaneous use with lithium preparations, an increase in lithium toxicity can be observed.

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.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store the drug at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiration date printed on the package.
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