CONTRAPIL®

INSTRUCTION
for medical use of medicinal product

KONTRAPIL®
(KONTRAPIL®)

Composition:

active ingredient: benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride monohydrate;

1 vaginal suppository contains 0.015 g of benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride monohydrate;

excipients: propylene glycol, hard fat.

Pharmaceutical form. Vaginal suppositories.

Main physicochemical properties: white or whitish-yellowish suppositories of globular shape. A surface film on the suppository is permissible.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology, excluding combinations with corticosteroids. Other antimicrobial and antiseptic agents.

ATC code G01A X.

Pharmacological properties.

Pharmacodynamics.

CONTRAPIL® is an antimicrobial agent (antiseptic).

The active ingredient, benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride monohydrate, is a cationic surfactant with antimicrobial (antiseptic) activity.

The mechanism of action of benzyl dimethyl [3-(myristoylamino)propyl]ammonium chloride monohydrate is based on direct hydrophobic interaction of the molecule with microbial membrane lipids, leading to their fragmentation and destruction.

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 due to the 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 exerts a pronounced antimicrobial effect 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 and those multi-resistant to antibiotics.

It acts destructively on pathogens of sexually transmitted infections – gonococci, Treponema pallidum, Trichomonas, Chlamydia, as well as on herpes virus, human immunodeficiency virus, etc. It has antifungal activity against Ascomycetes of the genus Aspergillus and 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 exerts an anti-inflammatory effect, enhances local defense reactions, regenerative processes, and activates immune defense mechanisms.

Does not affect hormonal status.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Acute nonspecific colpitis.

Contraindications.

Individual hypersensitivity to the components of the drug, pregnancy (safety of use has not been studied).

Interaction with other medicinal products and other forms of interaction.

When CONTRAPIL® is used concomitantly with systemic or topical antibiotics, microbial resistance to the latter decreases.

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

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

Special precautions.

Consult your doctor before starting treatment!

The efficacy of the drug depends on strict adherence to the application instructions:

• insert the suppository as deeply as possible into the vagina;
• do not use soap or other soap-based products for genital hygiene within 2 hours before and 2 hours after intravaginal administration of the drug (only clean water should be used).

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy (safety of use has not been studied).

There are no data on the negative effect of the drug during breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

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

Method of administration and dosage.

Before use, remove 1 suppository from its protective packaging and insert it deeply into the vagina. Use 1 suppository twice daily for 7 days. If necessary, the treatment course may be extended.

Children.

The drug is not intended for use in pediatrics.

Overdose.

Not observed.

Adverse reactions.

Hypersensitivity reactions, including local irritation: itching, hyperemia, dryness. In individual cases, transient burning sensation may occur, which resolves spontaneously and does not require discontinuation of treatment.

Shelf life. 3 years.

The drug must not be used 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 of children.

Packaging.

5 suppositories per blister; 1 blister per carton.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "Lekhym-Kharkiv".

Manufacturer's address and location of its business activity.

36 Severina Pototskogo Street, Kharkiv, 61115, Ukraine.

Marketing Authorization Holder.

KNVMP "ISNA".

Address of the Marketing Authorization Holder.

8 Dubrovytska Street, bld. 8, office 160, Kyiv, 04114, Ukraine.