Polygynax

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT POLYGYNAX

Composition:

Active ingredients: neomycin sulfate, polymyxin B sulfate, nystatin;

1 vaginal capsule contains 35,000 IU of neomycin sulfate, 35,000 IU of polymyxin B sulfate, and 100,000 IU of nystatin;

Excipients: dimethicone 1000, Tefoz® 63, hydrogenated soybean oil, gelatin, glycerin, purified water.

Pharmaceutical form. Vaginal capsules.

Main physicochemical characteristics: smooth, oval capsules of light yellow to yellow color.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents used in gynecology. Antibiotics. Nystatin combinations. ATC code G01AA51.

Pharmacological Properties

Pharmacodynamics

Combination of neomycin, polymyxin B, and nystatin.

MECHANISM OF ACTION

Neomycin is an aminoglycoside antibiotic. The target of neomycin is the 30S ribosomal subunit, which induces inhibition of bacterial protein synthesis, leading to the production of non-functional proteins.

Abnormal proteins penetrate the cell membrane, alter its permeability, and disrupt other vital processes of bacteria, resulting in bactericidal activity.

Polymyxin B is a polypeptide antibiotic. Polymyxin B interacts with microbial membrane phospholipids (lipopolysaccharides of Gram-negative bacteria), leading to membrane disorganization and subsequent destruction of the bacterial cell.

Nystatin is a polyene antifungal agent active against Candida spp. Nystatin binds to sterols in the fungal cell membrane, altering membrane permeability and causing leakage of intracellular contents, which leads to cell death.

ANTIBACTERIAL SPECTRUM OF POLYJINAX

In vitro studies performed using the dilution/neutralization method under conditions simulating the vaginal environment demonstrated the bactericidal effect of the three-component combination in Polyjynax on the main bacteria responsible for bacterial vaginosis (anaerobic bacteria) and bacterial vaginitis (aerobic bacteria). Assessments were conducted at 1 hour and 4 hours after exposure.

Strain susceptibility was determined based on the logarithmic reduction in bacterial load observed for each strain. Susceptibility criteria distinguishing susceptible strains from those with intermediate susceptibility and resistant strains were defined as follows: S: log reduction ≥ 3; R: log reduction < 2.

The susceptibility of various strains to Polyjynax is presented in Table 1.

Table 1

Note. This table lists bacteria commonly associated with bacterial vaginosis/vaginitis but is not exhaustive. This list does not challenge the individual antimicrobial spectra of each active ingredient in Polyzinax against other bacterial strains.

SYNERGISTIC ACTIVITY OF POLYMYXIN B AND NEOMYCIN

In vitro studies have shown that the two antibiotics contained in Polyzinax exhibit complementary spectra of activity, resulting in a more uniform effect against the four main bacterial strains responsible for bacterial vaginosis/vaginitis (Staphylococcus aureus, Escherichia coli, Streptococcus agalactiae, Gardnerella vaginalis), and that their combined action is at least additive.

ANTIFUNGAL SPECTRUM OF POLYZINAX

In vitro studies were conducted to assess the susceptibility of Candida strains by determining the minimal inhibitory concentrations (MIC) of nystatin. The results presented in Table 2 confirm that susceptibility to nystatin remains identical for both Candida albicans and Candida non-albicans strains.

Table 2

MIC50: MIC inhibits 50% of isolates; MIC90: MIC inhibits 90% of isolates.

EFFECT ON LACTOBACILLI

An in vitro study was conducted to evaluate the effect of the combination of three active substances of the medicinal product Polygynax on the main lactobacilli found in vaginal flora under physiological conditions (Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii).

The results show that Polygynax, when used at recommended doses, does not affect the quantity of these three lactobacilli species at concentrations that may be present in the vaginal environment.

Pharmacokinetics.

Not sufficiently studied.

Clinical characteristics.

Indications.

Local 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 regarding the appropriate use of antibacterial agents should be taken into account.

Contraindications.

This medicinal product is contraindicated in cases of:

• hypersensitivity to the active or excipient ingredients (or hypersensitivity to the corresponding group of substances);
• allergy to peanuts or soy due to the presence of soybean oil in the formulation;
• use of polyurethane male condoms, female condoms, and diaphragms.

The use in combination with spermicides is not recommended.

Interaction with other medicinal products and other forms of interaction.

Contraindicated combinations

Polyurethane male condoms, female condoms, and diaphragms, due to the risk of their rupture.

Not recommended combinations

Spermicides

The use of any product for intravaginal administration may render local contraception with spermicides ineffective.

Special precautions for use.

Warning

If local intolerance or allergic reaction occurs, treatment must be discontinued. Sensitization of the body following local application of antibiotics may subsequently lead to allergic reactions upon systemic administration of the same or a related antibiotic.

Precautions for use

Treatment duration should be limited due to the risk of developing microbial resistance to the components of the drug or the occurrence of superinfection.

Due to the lack of data on the absorption of neomycin and polymyxin B through the mucous membranes, there is a risk of systemic effects, especially in the presence of renal insufficiency.

This medicinal product contains soybean oil, which may cause hypersensitivity reactions (urticaria, anaphylactic shock).

Use during pregnancy or breastfeeding.

The medicinal product Polygynax contains the aminoglycoside antibiotic neomycin. Since systemic absorption of neomycin cannot be completely ruled out, there is a potential risk of ototoxic effects. Therefore, the use of medicinal products containing neomycin should be avoided during pregnancy. In clinical studies and during long-term post-marketing surveillance of Polygynax, no cases of developmental abnormalities or fetotoxicity have been reported.

Due to insufficient data on the passage of the drug into breast milk, use during breastfeeding is not recommended.

Ability to influence the reaction rate while driving or operating machinery.

Does not affect.

Administration and Dosage

For adults, administer 1 capsule intravaginally once daily in the evening before bedtime.

Insert one capsule deeply into the vagina, preferably while lying down.

Treatment duration: 12 days.

Practical Advice

• The patient should be informed about maintaining personal hygiene (wearing cotton underwear, avoiding douching and/or using tampons during treatment) and, as far as possible, eliminating adverse factors that may have contributed to the condition.
• The issue of treating the partner should be decided individually in each case.
• Treatment should not be interrupted during menstruation.
• The treatment is compatible with latex and polyisoprene male condoms.

Children

In pediatric practice, a special dosage form – Polygynax Virgo – should be used.

Overdose

Excessive and prolonged use may lead to systemic effects (on hearing organs and kidneys), especially in patients with renal insufficiency. Prolonged use is also associated with an increased risk of developing allergic eczema.

Adverse reactions.

Adverse reactions are classified by system and organ. The frequency of adverse reactions reported in spontaneous reports is unknown (cannot be estimated from available data).

Immune system disorders

Hypersensitivity: rash, itching, urticaria, and anaphylactic reaction.

Reproductive system and breast disorders

Local reactions such as burning sensation, itching, irritation, redness, and swelling.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years. Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging. 6 capsules in a blister pack, 1 or 2 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer.

Manufacturer responsible for packaging, control, and batch release: Innothera Chouzy, France.

Manufacturer's name and address.

Rue Rene Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France.

Marketing authorization holder.

Laboratoire Innotech International, France.

Address of the marketing authorization holder.

22 avenue Aristide Briand, 94110 Arcueil, France.