Chlorhexidine

INSTRUCTION
for medical use of medicinal product

CHLORHEXIDINE
(CHLORHEXIDINE)

Composition:

Active ingredient: chlorhexidine gluconate;

100 ml of solution contain chlorhexidine gluconate solution (20%) – 0.25 ml;

Excipient: purified water.

Pharmaceutical form. Topical solution.

Main physicochemical properties: transparent, colorless, odorless liquid.

Pharmacotherapeutic group.

Antiseptics and disinfectants.

ATC code D08A C02.

Pharmacological properties.

Pharmacodynamics. Chlorhexidine gluconate is a cationic biguanide. Chlorhexidine binds to amino groups of cellular proteins. It penetrates into intracellular membranes of bacterial cells, precipitates in the cytoplasm, and alters membrane function, interfering with oxygen uptake, which leads to a decrease in adenosine triphosphate (ATP) levels and cell death. It disrupts DNA and interferes with DNA synthesis in microorganisms. Provides prolonged persistent antimicrobial activity, preventing microbial proliferation for at least 6 hours after application.

Chlorhexidine gluconate exerts rapid and pronounced activity against gram-positive and gram-negative bacteria (Treponema pallidum, Chlamydia spp., Ureaplasma spp., Neisseria gonorrhoeae, Gardnerella vaginalis, Bacteroides fragilis), protozoa (Trichomonas vaginalis), and viruses (Herpes virus). The antimicrobial activity of chlorhexidine gluconate is not reduced in the presence of blood or other organic substances.

Pharmacokinetics. Does not penetrate through intact skin. Practically not absorbed from the gastrointestinal tract. After accidental ingestion of 300 mg, maximum concentration is reached within 30 minutes and amounts to 0.206 µg/L. It is predominantly excreted in feces (90%), with less than 1% eliminated by the kidneys.

Clinical characteristics.

Indications.

Prevention of sexually transmitted infections (syphilis, gonorrhea, trichomoniasis, chlamydia, ureaplasmosis, genital herpes).

Disinfection of purulent wounds, infected burn surfaces; treatment of skin and mucous membrane infections in surgery, obstetrics, gynecology, urology (urethritis, urethroprostatitis), and dentistry (rinsing and irrigation – gingivitis, stomatitis, aphthae, periodontitis, alveolitis).

Contraindications.

Hypersensitivity to chlorhexidine. Tendency to allergic reactions and allergic diseases, dermatitis, viral skin diseases.

It is contraindicated to use for conjunctiva treatment and irrigation of cavities or wounds with large surface area.

It is contraindicated to use during surgeries in areas of the central nervous system and auditory canal, in ophthalmology, or for administration into the ear canal.

Interaction with other medicinal products and other forms of interaction.

To avoid development of dermatitis, simultaneous use of chlorhexidine and iodine-containing products is not recommended. Chlorhexidine gluconate is a cationic substance and is incompatible with soap and other anionic substances (colloids, gum arabic, carboxymethylcellulose). It is compatible with preparations containing cationic groups (benzalkonium chloride, cetylpyridinium bromide). Ethanol enhances the effect of this medicinal product.

At a concentration of 0.05%, chlorhexidine gluconate is incompatible with borates, carbonates, chlorides, citrates, phosphates, sulfates, as poorly soluble precipitates are formed.

Inform your doctor about simultaneous use of any other medicinal products.

Special precautions.

In cases of open cranial trauma, spinal cord injury, or perforation of the eardrum, avoid contact of the medicinal product with the surface of the brain, meninges, or middle ear cavity.

Contact of hypochlorite bleaching agents with fabrics previously exposed to chlorhexidine-containing products may lead to the appearance of brown stains.

The bactericidal effect of the medicinal product increases with rising temperature. At temperatures above 100 °C, the product partially decomposes.

Chlorhexidine gluconate is practically not absorbed in the gastrointestinal tract. In case of accidental ingestion, gastric lavage should be performed using raw milk, raw egg, or gelatin. Symptomatic therapy should be administered if necessary.

Chlorhexidine must not enter the eyes. Serious cases of persistent corneal damage, potentially requiring corneal transplantation, have been reported following accidental eye exposure to chlorhexidine-containing medicinal products, despite protective measures, due to solution spread beyond the intended surgical area. Extreme caution must be exercised during application to ensure that chlorhexidine does not reach unintended areas, particularly the eyes. This is especially important when treating patients under anesthesia who cannot immediately report eye exposure. If chlorhexidine enters the eyes, they should be immediately and thoroughly rinsed with water. An ophthalmologist should be consulted promptly.

Do not dilute with hard water. Sterilization can be performed in an autoclave at 116 °C for 30 minutes. Do not sterilize using ionizing radiation.

Do not violate the instructions for use of the medicinal product — this may harm your health.

Use during pregnancy or breastfeeding.

The product may be used during pregnancy and breastfeeding only if the benefit to the mother outweighs the potential risk to the fetus/infant. Do not treat the surface of mammary glands before breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Does not affect the ability to drive or operate machinery and does not impair tasks requiring increased attention, rapid mental or physical reactions.

Method of Administration and Dosage.

The product is intended for external use only. In case of minor skin injuries, treat the skin around the wound with the solution, then apply a gauze pad soaked in the solution directly onto the wound and secure it with a bandage or adhesive tape.

Before using the product for prevention of sexually transmitted diseases, empty the bladder, wash hands and genital organs. Then remove the cap, squeeze the bottle walls and apply the solution stream to the skin of the pubic area, inner thighs, and genital organs. Insert the nozzle tip into the external opening of the urethra, press it tightly against the urethral wall and squeeze 2–3 mL of solution (for men) or 1–2 mL of solution (for women). Without spreading the fingers, withdraw the nozzle from the urethra and retain the solution for 2–3 minutes. Women should additionally spray the remaining solution into the vagina. After the procedure, it is recommended not to urinate for 2 hours. Antiseptic treatment of skin and mucous membranes with chlorhexidine is effective only if performed no later than 2 hours after sexual intercourse.

Children.

The medicinal product is not used in children under 12 years of age.

Overdose.

Cases of overdose with external application are unknown.

Ingestion of a large amount of the substance (300 mg chlorhexidine, equivalent to 0.5 L of 0.05% solution) may result in a fatal outcome with signs of hepatic and renal failure.

If accidentally ingested, the drug is practically not absorbed – gastric lavage with milk, gelatin, or raw egg should be performed. Symptomatic therapy should be administered if necessary.

Adverse Reactions.

The product may cause transient dryness and itching of the skin, dermatitis, photosensitization, stickiness of the hands lasting for 3–5 minutes. When treating gingivitis – tooth enamel discoloration, tartar formation, taste disturbances.

Eye disorders (frequency unknown): corneal erosion, epithelial defect / corneal damage, severe irreversible visual impairment*.

* In the post-marketing period, cases of severe corneal erosion and serious irreversible visual impairment have been reported due to accidental exposure of chlorhexidine to the eyes, requiring corneal transplantation in some patients (see section "Special Instructions").

If any adverse reactions occur, consult a physician immediately.

Shelf Life.

3 years.

The product must not be used after the expiry date stated on the package.

Storage Conditions.

Store at a temperature not exceeding 25 °C in the original packaging, in a place inaccessible to children.

Packaging.

100 mL, 200 mL in bottles, 1 L in bottles or canisters.

Category of release.

Over-the-counter.

Manufacturer.

JSC "Biolyk".

Manufacturer's location and address of business activity.

131, Nezalezhnosti St., Sh., Ladizhin, Vinnytsia region, 24321, Ukraine.

Marketing Authorization Holder.

LLC "Ukrainian Pharmaceutical Company".

Address of the Marketing Authorization Holder.

1U, Starosilska St., Kyiv, 02660, Ukraine.