Instructions for use Polygynax Virgo vaginal emulsion capsules in blisters No. 6
Composition
active ingredients: neomycin sulfate, polymyxin B sulfate, nystatin;
1 capsule contains neomycin sulfate 35,000 IU, polymyxin B sulfate 35,000 IU, nystatin 100,000 IU;
excipients: Tefoz® 63, hydrogenated soybean oil, dimethicone 1000;
capsule shell: gelatin, glycerin, dimethicone 1000, purified water.
Dosage form
Vaginal emulsion in capsules.
Main physicochemical properties: smooth oval capsules with a pointed elongated end, pale yellow to beige in color.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents for use in gynecology. Antibiotics. Nystatin, combinations. ATX code G01A A51.
Pharmacological properties
Pharmacodynamics
The properties of the drug consist of the properties inherent in the individual components.
Neomycin sulfate is an aminoside antibiotic that exerts a bactericidal effect by blocking the function of bacterial ribosomes in a wide range of microorganisms:
aerobic gram-positive bacteria: Corynebacterium, Listeria monocytogenes, Staphylococcus meti-S;
aerobic gram-negative bacteria: Acinetobacter (mainly Acinetobacter baumanii), Branhamella catarrhalis, Campylobacter, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Salmonella, Serratia, Shigella, Yersinia, Pasteurella.
Polymyxin B sulfate is a polypeptide antibiotic that has a bactericidal effect mainly on aerobic gram-negative bacteria: Acinetobacter, Aeromonas, Alcaligenes, Citrobacter freundii, Citrobacter koseri, Enterobacter, Escherichia coli, Klebsiella, Moraxella, Pseudomonas aeruginosa, Salmonella, Shigella, Stenotrophomonas maltophilia. Polymyxin B disrupts the osmotic resistance of bacterial membranes and is also active against pathogens that are in the growth stage and in the resting stage.
Nystatin is a polyene antibiotic that has a fungicidal effect against fungi of the genus Candida.
Nystatin has a fungicidal or fungistatic effect by binding to ergosterol in the cytoplasmic membrane of fungi. It is active against Candida spp., Histoplasma spp., Coccidioides spp., Cryptococcus spp., Aspergillus, Blastomyces dermatidis.
The active substances do not disrupt the activity of lactobacteria, which are part of the normal vaginal microflora.
Pharmacokinetics
Didn't study enough.
Indication
Topical treatment of vaginitis caused by microorganisms sensitive to the components of the drug (bacterial vaginitis, vulvovaginitis caused by Candida albicans and Candida non-albicans, mixed vaginitis), and bacterial vaginosis.
Official recommendations on the appropriate use of antibacterial drugs should be considered.
Contraindication
This medicine is contraindicated in the following cases:
hypersensitivity to the active or auxiliary substances (or hypersensitivity to the corresponding group of substances); allergy to peanuts or soy, due to the presence of soybean oil in the composition; in the case of use of this medicinal product by sexually active teenage girls, barrier contraception (diaphragm, latex condoms) is contraindicated and the use of spermicides is not recommended.
Interaction with other medicinal products and other types of interactions
When using this medication in sexually active teenage girls, the following combinations are contraindicated:
Condoms and diaphragms due to the risk of rupture.
Not recommended combinations:
Spermicides
The use of any intravaginal drug is likely to render topical spermicide contraception ineffective.
Application features
Warning
Before prescribing the drug, a bacteriological examination should be performed. In case of local intolerance or allergic reaction, treatment should be discontinued.
Sensitization of the body with topical use of antibiotics can subsequently lead to an allergic reaction with systemic use of the same or a related antibiotic.
Precautions when using
The duration of treatment should be limited due to the risk of the emergence of resistant microorganisms and superinfection caused by these microorganisms.
The lack of data on the role of resorption of neomycin and polymyxin B fractions through the mucosa does not allow us to completely exclude the risk of systemic effects, which is especially increased in the case of renal failure.
This medicinal product contains soybean oil, which may cause hypersensitivity reactions (urticaria, anaphylactic shock).
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
The drug Polygynax Virgo contains the aminoglycoside antibiotic neomycin. Since systemic absorption of neomycin cannot be excluded, there is a possibility of ototoxic risks. Therefore, the use of drugs containing neomycin during pregnancy should be avoided. In clinical studies and during long-term medical observation of the drug Polygynax Virgo, no malformations or fetotoxicity were reported.
Due to insufficient data on the penetration of the drug into breast milk, use during breastfeeding is not recommended.
Method of administration and doses
Dosage
Children
THE MEDICATION IS INTENDED FOR USE IN CHILDREN AND TEENAGE GIRLS.
One vulvovaginal instillation (insertion into the vagina) in the evening before bedtime after the evening toilet for 6 consecutive days.
Adults
Polygynax Virgo can be used by adult women who have difficulty self-introducing the drug into the vagina for various reasons (physical or psychological). For example, a typical barrier to the vaginal route of administration is vaginal dryness during menopause.
One vulvovaginal instillation in the evening before bedtime after the evening toilet for 12 consecutive days.
Method of application
It is necessary to cut the pointed end of the capsule with scissors. Insert the emulsion into the vagina, slowly pressing on the capsule.
Practical tips
During the treatment period, hygiene recommendations should be followed (wear cotton underwear, do not use sanitary tampons, etc.) and, as far as possible, eliminate the factors that caused the disease. Treatment should not be stopped during menstruation.
Children
A special dosage form (vaginal emulsion in capsules) of the drug Polygynax Virgo is recommended for use in pediatric gynecological practice.
Overdose
Excessive and prolonged use may cause systemic effects (on the hearing organs and kidneys), especially in patients with renal insufficiency. Long-term use is also associated with an increased risk of developing allergic eczema.
Adverse reactions
Adverse reactions are classified according to organ system. The frequency of adverse reactions reported in spontaneous reports is unknown (cannot be estimated from the available data).
On the part of the immune system
Hypersensitivity: rash, itching, urticaria and anaphylactic reaction.
Reproductive system and breast disorders
Local reactions such as burning sensation, itching, irritation, redness and swelling.
Expiration date
2 years. Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
3 capsules in a blister, 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Innothera Chouzy, France.
Location of the manufacturer and its business address
Rue Rene Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France.
