Polygynax (Capsules, Emulsion) Instructions for Use

ATC Code

G01AA51 (Nystatin in combination with other drugs)

Active Substances

Nystatin (Rec.INN registered by WHO)

Neomycin (Rec.INN registered by WHO)

Polymyxin B (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antibacterial and antifungal action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, excluding combinations with corticosteroids; antibiotics

Pharmacological Action

Mechanism of action

A combined drug, the action of which is due to its constituent components.

Neomycin is an antibiotic from the aminoglycoside group. It is active against a number of gram-positive and gram-negative microorganisms. Neomycin irreversibly binds to specific receptor proteins on the 30S ribosomal subunit. This disrupts protein synthesis in the bacterial cell, leading to the formation of defective proteins that penetrate the cell membrane, change its permeability, and disrupt other vital processes, resulting in a bactericidal effect.

Polymyxin B is a polypeptide antibiotic. Polymyxin B interacts with lipopolysaccharides in the membranes of gram-negative bacteria, leading to impaired membrane permeability and subsequent destruction of the bacterial cell.

Nystatin is a polyene antimycotic active against Candida spp. Nystatin binds to sterols in the fungal cell membrane, altering cell permeability and causing leakage of intracellular material, leading to fungal cell death.

Spectrum of antibacterial activity

In vitro studies conducted under conditions recreating the vaginal environment demonstrated the bactericidal activity of Polygynax, as well as its effect on the main bacteria causing bacterial vaginosis (anaerobic bacteria) and aerobic vaginitis (aerobic bacteria) with exposure times of 1 and 4 hours using the dilution/neutralization method. The sensitivity of various strains was determined based on the reduction in the decimal logarithm of the bacterial load determined for each strain.

The threshold values that distinguish sensitive strains from intermediately sensitive and resistant strains are: sensitive – reduction in the logarithm of bacterial load ≥ 3, resistant < 2.

The sensitivity of various strains to Polygynax is presented in the following table.

Note. This table presents an incomplete list of bacteria that are frequently encountered in bacterial vaginosis/vaginitis. This list does not question the individual activity of the active substances in Polygynax against other bacterial strains.

Synergy of polymyxin B and neomycin

An in vitro study showed that polymyxin B and neomycin in Polygynax have complementary spectra of action, leading to an additive effect against four main bacterial strains causing bacterial vaginitis/vaginosis (Staphylococcus aureus, Escherichia coli, Streptococcus agalactiae, Gardnerella vaginalis).

Spectrum of antifungal activity of Polygynax

An in vitro study assessing the sensitivity of Candida strains by determining the minimum inhibitory concentration (MIC) of nystatin confirms that Candida albicans and Candida non-albicans strains have comparable sensitivity to nystatin.

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

Activity against lactobacilli

An in vitro study to assess the effect on the main lactobacilli present in the vaginal flora under physiological conditions (Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus jensenii) shows that the active substances of Polygynax, at concentrations found in the vaginal environment after administration of the drug at the recommended dosage, do not affect the growth of the specified lactobacillus species.

Pharmacokinetics

Pharmacokinetic properties have not been studied.

Indications

Local treatment of vaginal infections caused by susceptible microorganisms

• Aerobic vaginitis;
• Candidal vulvovaginitis;
• Mixed vaginitis;
• Non-specific vaginitis.

Prevention of infectious complications

• Preoperative prevention of infectious complications in gynecological interventions;
• Before and after diathermocoagulation of the cervix;
• Before intrauterine diagnostic procedures;
• Before childbirth.

Official clinical guidelines for the use of antibacterial agents should be considered.

ICD codes

Dosage Regimen

Capsules

For adult female patients only.

For vaginal use.

1 vaginal capsule in the evening before bedtime.

Treatment course: 12 days. Prophylactic course: 6 days.

Method of administration

The capsule should be inserted deep into the vagina, in a supine position.

Emulsion

For intravaginal use.

Treatment

Adults administer the contents of one capsule into the vagina after evening toilet, before bedtime. Treatment course: 12 days.

Children administer the contents of one capsule into the vagina after evening toilet, before bedtime. Treatment course: 6 days.

Prophylaxis

For prophylaxis, the drug is used for 6 days.

Method of administration

After cutting the pointed end and lightly pressing the capsule, the contents of the capsule are introduced into the vagina. After administration of the medicinal product into the vagina, the capsule is discarded.

If one or more capsules are missed, the use of the drug should be continued at the usual dosage.

Adverse Reactions

Adverse reactions are listed according to the system organ class and frequency of occurrence: very common (≥1/10), common (from ≥1/100 to <1/10), uncommon (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000), very rare (<1/10000), frequency not known (cannot be estimated from the available data).

The following adverse reactions may occur with the use of Polygynax

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to neomycin, nystatin, polymyxin B or to any of the excipients included in the drug;
• Simultaneous use of the drug with polyurethane condoms (male and female) or diaphragms;
• Allergic reactions to peanuts or soy (due to the presence of soybean oil in the composition);
• Not recommended for use in combination with spermicides.

Use in Pregnancy and Lactation

Pregnancy

Data on the use of Polygynax in pregnant women are limited, therefore the use of the drug during pregnancy is not recommended. Use of the drug as prescribed by a doctor is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Lactation

Data on the use of Polygynax in breastfeeding women are limited, therefore the use of the drug during breastfeeding is not recommended. Use of the drug as prescribed by a doctor is possible only in cases where the expected benefit to the mother outweighs the potential risk to the child.

Special Precautions

In case of local intolerance or allergic reaction, treatment should be discontinued.

Sensitization to an antibiotic during topical use may adversely affect subsequent systemic use of the same antibiotic or other antibiotics of this group.

The recommended duration of treatment should not be exceeded due to the risk of resistant strains and superinfection.

In the absence of data on the degree of absorption of neomycin and polymyxin B from the surface of the mucous membrane, the risk of systemic action cannot be excluded, especially in renal failure.

The drug contains soybean oil and may cause hypersensitivity reactions (urticaria, anaphylactic shock).

Practical recommendations

During treatment, hygiene recommendations should be followed (wear cotton underwear, avoid douching and the use of vaginal tampons) and, as far as possible, eliminate factors contributing to the development of the disease.

Treatment of the partner is discussed on a case-by-case basis.

Treatment should not be interrupted during menstruation.

Treatment is compatible with the use of male condoms made of latex and polyisoprene.

If one or more capsules are missed, the use of the drug should be continued at the usual dosage.

Effect on ability to drive vehicles and operate machinery

There are no data on the negative effect of the drug on the ability to drive vehicles and operate machinery.

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Overdose

Overdose is unlikely when the drug is used in accordance with the instructions for use. Excessive and prolonged use of the drug may cause systemic effects (on the organ of hearing and kidneys), especially in patients with renal failure. Prolonged use of the drug also entails an increased risk of developing allergic eczema.

Symptoms hearing impairment, impaired renal function, rash, itching, swelling, skin hyperemia.

Treatment discontinuation of the drug, symptomatic therapy.

Drug Interactions

Contraindicated combinations

Do not use concomitantly with polyurethane condoms (male and female) and diaphragms due to the risk of their rupture.

Not recommended combinations

Not recommended for use in combination with spermicides, as a decrease in the contraceptive effect is possible.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.