Eropol®

INSTRUCTIONS
for medical use of the medicinal product

EROPOL®
(EROPOL®)

Composition:

Active substance: benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride monohydrate;

1 ml of solution contains 0.1 mg of benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride monohydrate (calculated as anhydrous substance);

Excipients: sodium chloride, purified water.

Pharmaceutical form. Solution for external use.

Main physicochemical properties: colorless clear liquid.

Pharmacotherapeutic group.

Antiseptics and disinfectants. ATC Code D08A J.

Pharmacological properties.

Pharmacodynamics.

The mechanism of action of benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride is based on direct hydrophobic interaction of the molecule with microbial membrane lipids, leading to their fragmentation and destruction. A part of the molecule penetrates into the hydrophobic region of the membrane, disrupts the supramembrane layer, loosens the membrane, increases its permeability for high-molecular-weight substances, alters enzymatic activity of the microbial cell, and inhibits enzyme systems, resulting in suppression of microbial viability and cytolysis.

Unlike other antiseptics, benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride exhibits high selectivity towards microorganisms, as it practically does not affect human cell membranes. This effect is associated with a different structure of human cell membranes (significantly longer lipid radicals that severely limit the possibility of hydrophobic interaction between benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride and human cells).

Benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride has pronounced antimicrobial activity against Gram-positive and Gram-negative, aerobic and anaerobic, spore-forming and non-spore-forming bacteria, both as monocultures and microbial associations, including hospital strains with polyresistance to antibiotics.

Exerts a destructive effect on pathogens of sexually transmitted diseases: gonococci, Treponema pallidum, Trichomonas, Chlamydia, as well as on herpes viruses, human immunodeficiency virus, etc. Demonstrates antifungal activity against Ascomycetes of the genus Aspergillus and the genus Penicillium, yeasts (Rhodotorula rubra, Torulopsis gabrata, etc.), yeast-like fungi (Candida albicans, Candida krusei, etc.), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, T. schoenleini, T. violaceum, Epidermophyton Kaufman-Wolf, E. floccosum, Microsporum gypseum, Microsporum canis, etc.), and other pathogenic fungi [e.g., Pityrosporum orbiculare (Malassezia furfur)] as monocultures and microbial associations, including fungal microflora resistant to chemotherapeutic agents. Under the influence of benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride, microbial resistance to antibiotics decreases. Benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride has anti-inflammatory and immunoadjuvant effects, enhances local defense reactions, regenerative processes, and activates non-specific defense mechanisms by modulating cellular and local humoral immune responses.

Pharmacokinetics.

Benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride exerts a local effect. Data on the possibility of the drug penetrating into systemic circulation are lacking.

Clinical characteristics.

Indications.

Obstetrics and gynecology: for prophylaxis and treatment of postpartum wound infections, perineal and vaginal wounds, postpartum infections; inflammatory diseases of external genital organs and vagina (vulvovaginitis).

Urology, venereology: use as part of complex treatment of acute and chronic urethritis and urethroprostatitis of specific (chlamydia, trichomoniasis, gonorrhea) and non-specific origin; for individual prevention of sexually transmitted diseases (syphilis, gonorrhea, genital herpes).

Contraindications.

Increased individual sensitivity to the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly, EROPOL® enhances the efficacy of topical antibiotics.

Simultaneous use with anionic surfactants (soap solutions) may result in inactivation of the antimicrobial effect of benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride. Concurrent use should be avoided.

The product should not be used together with other antiseptics that inactivate the antimicrobial action of benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride.

Special precautions.

To minimize the risk of infection spread, the medicinal product container should be used by only one person.

Avoid contact of the medicinal product with the mucous membranes of the eyes. In case of accidental contact with eyes, rinse thoroughly with large amounts of running water.

Urology. Venereology. After application of the medicinal product to the urethra, vagina, pubic area, and external genital organs, urination should be avoided for 2 hours.

Use during pregnancy or breastfeeding.

Since the medicinal product is almost not absorbed, it may be used in women during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

The medicinal product does not affect reaction speed when driving or operating machinery.

Method of administration and dosage.

Apply locally to adults.

Obstetrics and gynecology. For prevention of postpartum infection, use before delivery (5–7 days) as vaginal douching or tampons, and after delivery — as intravaginal tampons soaked with sufficient amount of the medicinal product, with exposure of 2 hours for 5 days.

Treatment of inflammatory diseases of female genital organs is performed by inserting medicated tampons into the vagina for 2 weeks and treating the skin of external genital organs.

Urology, venereology. Use in complex treatment of urethritis and urethroprostatitis: insert the nozzle tip into the external urethral orifice and, by squeezing the bottle, administer 1.5–3 ml (in men) or 1–1.5 ml (in women) of the product, or 5–10 ml into the vagina. Without releasing pressure, withdraw the nozzle from the urethral orifice, retaining the solution for 2–3 minutes. After the procedure, bladder emptying is not recommended for 2 hours.

The procedure is performed every other day. Treatment course — 10 days.

For prevention of venereal diseases, EROPOL® is effective if used no later than 2 hours after sexual intercourse. If possible, wash the skin of the inner thighs, pubic area, and external genital organs with warm water without soap. The contents of the bottle are administered via a urethral nozzle into the urethra: 2–3 ml for men, 1–2 ml for women; into the vagina — 5–10 ml for 2–3 minutes. The remaining solution is used to treat the skin of the inner thighs, pubic area, and external genital organs. After the procedure, avoid using soap for 2 hours.

Children.

The product is not used in children.

Overdose.

Not observed.

Adverse reactions.

In individual cases, transient burning sensation may occur, which resolves spontaneously within 15–20 seconds and does not require discontinuation of treatment.

Hypersensitivity reactions, including local skin irritation: itching, hyperemia, burning sensation, dryness of the skin.

Reporting of adverse reactions

Reporting of adverse reactions after medicinal product registration is important. It allows monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in original packaging, in a place inaccessible to children. Does not require special storage conditions.

Packaging.

20 ml or 50 ml in a polymer bottle with a urethral nozzle; 1 bottle per carton.

Prescription status.

Over-the-counter.

Manufacturer.

LLC "Slaviya 2000".

Location of manufacturer and address of its business activity.

91 Varsavska Street, Kropyvnytskyi, Kirovohrad Oblast, 25005, Ukraine.

Applicant.

KNVMP "ISNA".

Location of applicant.

8 Dubrovytska Street, Office 160, Kyiv, 04114, Ukraine.