Polygynax virgo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT POLYGYNAX VIRGO

Composition:

Active substances: 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.

Pharmaceutical form. Vaginal emulsion in capsules.

Main physicochemical characteristics: smooth, oval capsules with a pointed elongated end, pale yellow to beige in color.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents for gynecological use. 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, resulting in the production of non-functional proteins.

Aberrant proteins penetrate the cell membrane, altering its permeability and disrupting other vital processes of bacteria, thereby providing 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 cell permeability and causing leakage of intracellular contents, which leads to cell death.

ANTIBACTERIAL SPECTRUM OF POLYGYNAX VIRGO

In vitro studies performed using the dilution/neutralization method under conditions simulating the vaginal environment demonstrated the bactericidal activity of the combination of the three active substances in Polygynax Virgo against the main bacteria responsible for bacterial vaginosis (anaerobic bacteria) and bacterial vaginitis (aerobic bacteria). Assessments were performed 1 hour and 4 hours after contact.

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

The susceptibility of various strains to Polygynax Virgo 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 undermine the individual antimicrobial spectra of each active ingredient of Polygynax Virgo against other bacterial strains.

SYNERGISTIC ACTIVITY OF POLYMYXIN B AND NEOMYCIN

In vitro studies have shown that the two antibiotics contained in Polygynax Virgo have 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 POLYGYNAX VIRGO

An in vitro study was conducted to assess the susceptibility of Candida strains by determining the minimum inhibitory concentrations (MICs) of nystatin. The results presented in Table 2 confirm that susceptibility to nystatin remains identical for both Candida albicans and non-albicans Candida 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 Virgo on the main lactobacilli found in vaginal flora under physiological conditions (Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii). The results show that Polygynax Virgo, 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 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 substances (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.

It is not recommended to use in combination with spermicides.

Interaction with other medicinal products and other forms of interaction.

When this medicinal product is used by sexually active adolescent girls:

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

Before prescribing the medicinal product, bacteriological testing should be performed. If local intolerance or allergic reaction occurs, treatment should be discontinued.

Sensitization of the body during local administration of antibiotics may subsequently lead to allergic reactions upon systemic use of the same or related antibiotic.

Precautionary measures during use

Treatment duration should be limited due to the risk of development of resistant microorganisms and superinfection caused by such organisms.

The lack of data on the absorption of neomycin and polymyxin B fractions through the mucous membrane does not allow complete exclusion of the risk of systemic effects, which is particularly increased in cases of renal impairment.

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

Use during pregnancy or breastfeeding

The composition of Polijinax Virgo includes the aminoglycoside antibiotic neomycin. Since systemic absorption of neomycin cannot be entirely 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 Polijinax Virgo, 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 reaction speed when driving or operating machinery

No effect.

Method of Administration and Dosage

THE PRODUCT IS INDICATED FOR USE IN CHILDREN AND ADOLESCENT GIRLS.

Method of Administration

The pointed end of the capsule should be cut with scissors. Insert the emulsion into the vagina by slowly squeezing the capsule.

Dosage

Children

One vulvovaginal instillation (insertion into the vagina) in the evening before bedtime, after evening hygiene procedures, for 6 consecutive days.

Adults

Polygynax Virgo may be used in adult women who experience difficulties with self-insertion of a medicinal product into the vagina for various reasons (physical or psychological). For example, a typical barrier to vaginal administration is vaginal dryness during menopause.

One vulvovaginal instillation in the evening before bedtime, after evening hygiene procedures, for 12 consecutive days.

Practical Advice

• During treatment, hygiene recommendations should be followed (wear cotton underwear, avoid using sanitary tampons, etc.), and, as far as possible, factors contributing to the disease should be eliminated.
• Treatment should not be interrupted during menstruation.
• The treatment is compatible with latex and polyisoprene male condoms.

Children

The special pharmaceutical form (vaginal emulsion in capsules) of Polygynax Virgo is recommended for use in pediatric gynecological practice.

Overdose

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

Side effects

Side effects are classified according to their effects on systems and organs. The frequency of adverse reactions reported in spontaneous reports is unknown (cannot be estimated from available data).

Immune system disorders

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

Reproductive system and breast disorders

Local reactions such as burning sensation, pruritus, irritation, erythema, and swelling.

Reporting suspected side effects

Reporting suspected adverse reactions after marketing 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, should 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 in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 3 capsules in a blister, 2 blisters in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

Innothera Chouzy, France/Innothera Chouzy, France.

Manufacturer's address.

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

Marketing authorization holder.

Laboratoire Innotech International, France/Laboratoire Innotech International, France.

Address of the marketing authorization holder.

22 avenue Aristide Briand, 94110 Arcueil, France/22 avenue Aristide Briand, 94110 Arcueil, France.