Instructions for Polygynax vaginal capsules No. 12
Composition
active ingredients: neomycin sulfate, polymyxin B sulfate, nystatin;
1 vaginal capsule contains neomycin sulfate 35,000 IU, polymyxin B sulfate 35,000 IU, nystatin 100,000 IU;
excipients: dimethicone 1000, Tefoz® 63, hydrogenated soybean oil, gelatin, glycerin, purified water.
Dosage form
Vaginal capsules.
Main physicochemical properties: smooth oval capsules from light yellow to yellow.
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. Neomycin sulfate has a bactericidal effect by blocking the function of bacterial ribosomes in a wide range of gram-positive and gram-negative microorganisms: Corynebacterium spp., Staphylococcus spp., Mycobacterium tuberculosis, Enterococcus faecium, Escherichia coli, Enterobacter aerogenes, Haemophilus influenzae, Klebsiella pneumoniae, Proteus vulgaris.
Polymyxin B sulfate is an antibiotic from the group of polypeptides that has a bactericidal effect on mainly gram-negative flora, especially on Pseudomonas aeruginosa, strains of Escherichia coli, Schigellae, Klebsiellae, Pasteurellae, Serratiae, Enterobacter, Salmonella, Haemophilus, Bordetella. 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 exhibits fungicidal activity against fungi of the genus Candida.
Nystatin has a fungicidal or fungistatic effect by binding to ergosterol of the cytoplasmic membrane of fungi. It is active against Candida spp., Histoplasma spp., Coccidioides spp., Cryptococcus spp., Aspergillus, Blastomyces dermatidis. Resistance to the active ingredients of Polygynax develops rarely and slowly.
The active substances do not disrupt the activity of lactobacteria, which are part of the normal vaginal microflora.
Pharmacokinetics
Didn't study enough.
Indication
Treatment of vaginitis caused by microorganisms sensitive to the drug, including:
- bacterial vaginitis caused by banal pyogenic microflora;
- recurrent nonspecific vaginitis;
- vaginitis caused by fungi of the genus Candida (Candida albicans and Candida non-albicans);
- vaginitis caused by mixed infection.
In order to prevent infectious complications, Polygynax is recommended to be used before any surgical intervention on the genitals, before abortion, insertion of an intrauterine device, before and after diathermocoagulation of the cervix, before intrauterine and intraurethral examinations, and before childbirth.
Contraindication
Hypersensitivity to any component (combination of components) of the drug. Due to the presence of soybean oil, Polygynax is contraindicated in patients with allergies to soybeans and peanuts.
Interaction with other medicinal products and other types of interactions
The drug may block the action of local spermicidal contraceptives. It should be borne in mind that Polygynax, when used simultaneously with a latex condom, increases the risk of the latter breaking.
Application features
In case of local intolerance or allergic reaction, treatment should be discontinued. Hypersensitivity to topical application may indicate that the use of these antibiotics or related antibiotics is undesirable. To avoid transmission of the disease, the patient should be warned about the use of separate personal hygiene products (washcloth, towel), wearing natural cotton underwear. During treatment, do not use tampons, do not use contraceptive caps and/or latex condoms, spermicides.
To prevent reinfection, simultaneous treatment of the sexual partner is required.
Use during pregnancy or breastfeeding
In clinical studies of Polygynax, no cases of malformations or fetotoxicity have been observed or reported to date. Observations of pregnancies exposed to this drug are insufficient to exclude any risk. Therefore, the use of the drug during pregnancy is possible only on the advice of a doctor in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
Due to the lack of data on the penetration of the drug into breast milk, the use of this drug should be avoided during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Adults should use 1 capsule intravaginally in the evening before bedtime. The course of treatment is 12 days, the preventive course is 6 days.
The course of treatment should not be interrupted during menstruation.
Practical tips
- The patient should be informed about hygiene (wearing cotton underwear, avoiding douching and/or using tampons during treatment) and, as far as possible, eliminate adverse factors.
- The issue of partner treatment is decided on a case-by-case basis.
In pediatric practice, a special dosage form is used – Polygynax Virgo.
Overdose
No cases of overdose have been reported.
Adverse reactions
In rare cases, local irritation reactions occur, including redness, swelling, itching of the vaginal mucosa, contact dermatitis. Patients may be hypersensitive to the auxiliary component of the drug, soybean oil. When using the drug, allergic reactions are possible, including anaphylactic shock, urticaria.
Vaginal administration of aminoglycosides sometimes causes adverse reactions. However, due to the short recommended duration of treatment with the drug, the risk of systemic toxic effects (e.g., on the kidneys, hearing organs) is minimal.
Expiration date
2 years. Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
6 capsules in a blister, 1 or 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 L'Isle Vert, 41150 Chouzy-sur-Cisse, France/L'Isle Vert, Rue Rene Chantereau, 41150 Chouzy-sur-Cisse, France.
Applicant
Laboratoire Innotech International, France.
Location of the applicant and/or applicant's representative
22 avenue Aristide Briand, 94 110 Arcueil, France/22 avenue Aristide Briand, 94 110 Arcueil, France.
