Chlorhexidine-cr

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLORHEXIDIN-KR (CHLORHEXIDIN-KR)

Composition:

Active substance: chlorhexidine digluconate;

100 ml of solution contains: chlorhexidine digluconate, 20% solution, calculated as 100% substance – 0.05 g;

Excipient: purified water.

Pharmaceutical form. Topical solution.

Main physicochemical properties: colorless clear liquid.

Pharmacotherapeutic group.

Antiseptics and disinfectants.

ATC code D08A C02.

Pharmacological properties.

Pharmacodynamics.

Chlorhexidine digluconate 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, thereby inhibiting oxygen uptake, which leads to decreased levels of adenosine triphosphate (ATP) 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 administration.

Chlorhexidine digluconate 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). Its antimicrobial activity is not reduced in the presence of blood or other organic substances.

Pharmacokinetics.

It 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 excreted predominantly in feces (90%), with less than 1% eliminated by the kidneys.

Clinical characteristics.

Indications.

For the prevention of sexually transmitted infections (syphilis, gonorrhea, trichomoniasis, chlamydia, ureaplasmosis, genital herpes).

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

Contraindications.

Hypersensitivity to the components of the medicinal product. Predisposition to allergic reactions and allergic diseases, dermatitis, viral skin diseases.

It is not recommended for use on conjunctiva, for cavity irrigation, on wounds with large surface area, during surgeries involving areas of the central nervous system and auditory canal, in ophthalmology, or for administration into the auditory canal.

Interaction with other medicinal products and other types of interactions.

To avoid development of dermatitis, simultaneous use of chlorhexidine and iodine-containing products is not advisable.

Chlorhexidine digluconate is a cationic substance and is incompatible with soap and other anionic substances (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose, colloids, gum arabic).

It is compatible with preparations containing cationic groups (benzalkonium chloride, cetyltrimethylammonium bromide).

Ethanol enhances the effect of the preparation.

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

Special precautions for use

The medicinal product must not come into contact with the eyes. Serious cases of persistent corneal damage, potentially requiring corneal transplantation, have been reported following accidental exposure to eye tissues from medicinal products containing chlorhexidine, despite protective measures, due to solution spreading beyond the intended surgical area. Extreme caution must be exercised during application to ensure the medicinal product does not spread beyond the intended site of application into the eyes. This is particularly important when treating patients under anesthesia, who may not be able to immediately report exposure to the eyes. If chlorhexidine solution comes into contact with the eyes, they must be immediately and thoroughly rinsed with water. An ophthalmologist should be consulted promptly.

Avoid contact of the product with open wounds in patients with open cranial injuries, spinal cord injuries, or perforated eardrum. If the solution contacts mucous membranes of the eye, they should be quickly and thoroughly rinsed with water. Contact of hypochlorite bleaching agents with tissues previously exposed to chlorhexidine-containing products may lead to the development of brown stains. The bactericidal effect of the product increases with rising temperature. At temperatures above 100 °C, the product partially decomposes.

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

Do not dilute with hard water. Sterilization is possible 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 health.

Use during pregnancy or breastfeeding

During pregnancy or breastfeeding, the product should be used only when the expected benefit to the mother outweighs the potential risk to the fetus/infant. Do not treat the surface of mammary glands prior to breastfeeding.

Ability to affect reaction speed when driving or operating machinery

Does not affect.

Method of Administration and Dosage.

Apply externally. For minor skin injuries around the wound, treat the area with the solution, then apply a gauze pad soaked in the solution to the wound and secure it with a bandage or adhesive plaster.

For prevention of sexually transmitted infections, the drug is effective if used no later than 2 hours after sexual intercourse. Before using the drug for prophylaxis of venereal diseases, empty the bladder, and wash the hands and genital organs.

Men:

• Apply the solution from the container as a stream to treat the skin of the pubic area, inner surfaces of the thighs, and external genital organs.
• Using the directed application nozzle, introduce 2–3 mL of the solution into the urethral canal.
• Treat the skin of the pubic area, inner surfaces of the thighs, and external genital organs with the remaining solution.

Women should use the package containing the vaginal applicator:

• Before use, transfer approximately ¼ of the solution from the container into the spray bottle, then screw the vaginal applicator onto the bottle.
• Apply the solution from the container as a stream to treat the skin of the pubic area, inner surfaces of the thighs, and external genital organs.
• Using the spray bottle, insert the vaginal applicator into the vagina and squeeze in 5–10 mL of the solution; retain for 2–3 minutes.
• From the container, use the directed application nozzle to introduce 1–2 mL of the solution into the urethral canal.
• Treat the skin of the pubic area, inner surfaces of the thighs, and external genital organs with the remaining solution.

In exceptional cases, if the package with the vaginal applicator is unavailable, the container with the directed application nozzle may be used:

• Apply the solution from the container as a stream to treat the skin of the pubic area, inner surfaces of the thighs, and external genital organs.
• Using the directed application nozzle, introduce 1–2 mL of the solution into the urethral canal and 5–10 mL into the vagina; retain for 2–3 minutes.
• Treat the skin of the pubic area, inner surfaces of the thighs, and external genital organs with the remaining solution.

After the procedure, do not empty the bladder for 2 hours.

For complex treatment of urethritis and urethroprostatitis, administer 2–3 mL of chlorhexidine digluconate solution into the urethra 1–2 times daily for 10 days. Perform procedures every other day.

Use the drug solution as irrigations, rinses, or applications—apply 5–10 mL of solution to the affected skin or mucous membrane surface for 1–3 minutes, 2–3 times daily (using a swab or by irrigation).

During pregnancy or breastfeeding, use the medicinal product at the usual recommended doses.

Children.

Do not use in children under 12 years of age.

Overdose.

Cases of overdose with external application are unknown.

Accidental ingestion of a large amount of the substance (300 mL of chlorhexidine) may result in a fatal outcome with signs of hepatic and renal failure.

If ingested, the drug is practically not absorbed—perform gastric lavage using milk, gelatin, or raw egg. If necessary, symptomatic therapy should be administered.

Side effects.

In individual cases with increased individual sensitivity, hypersensitivity reactions, dryness and itching of the skin, dermatitis, stickiness of the hands' skin observed for 3–5 minutes, and photosensitization are possible. When treating gingivitis – tooth enamel discoloration, dental calculus deposition, taste disturbances.

Eye disorders

Frequency unknown: corneal erosion, epithelial defect / corneal damage, severe irreversible vision impairment*.

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

If any adverse reactions occur, discontinue use of the medicinal product immediately and consult a physician without delay.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, patients, and their legal representatives should report any suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Do not use 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.

100 ml in a container with an applicator nozzle for directed administration of the medicinal product, in a cardboard box.

100 ml in a container with an applicator nozzle for directed administration of the medicinal product, without a box.

100 ml in a container with an applicator nozzle for directed administration of the medicinal product, supplied with a vaginal applicator, a 100 ml spray bottle, and a dust-protective cap, in a cardboard box.

200 ml in a bottle with a nozzle, in a cardboard box.

200 ml in a bottle with a nozzle, without a box.

Availability. Over-the-counter.

Manufacturer. JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and location of business operations.

1, Gordienkivska Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.