Chlorhexidine

INSTRUCTIONS for medical use of the medicinal product CHLORHEXIDIN (CHLORHEXIDINE)

Composition:

Active substance: chlorhexidine bigluconate;

100 ml of solution contain 0.25 ml of 20 % chlorhexidine bigluconate solution;

Excipient: purified water.

Pharmaceutical form. Topical solution.

Main physicochemical properties: clear, colorless, odorless liquid.

Pharmacotherapeutic group. Antiseptics and disinfectants.

ATC code D08AC02.

Pharmacological Properties.

Pharmacodynamics.

Chlorhexidine bigluconate is a cationic biguanide. Chlorhexidine binds to the amino groups of cellular proteins. It penetrates into the intracellular membranes of bacterial cells, precipitates in the cytoplasm, and alters membrane function, thereby inhibiting oxygen uptake, which leads to a decrease in adenosine triphosphate (ATP) levels and subsequent 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 bigluconate 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 bigluconate is not reduced in the presence of blood or other organic substances.

Pharmacokinetics.

It does not penetrate through intact skin. It is 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.

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

For disinfection of purulent wounds and infected burn surfaces; for 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).

For disinfection of minor injuries (wounds, abrasions, burns).

Contraindications.

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

It is not recommended for use on conjunctiva or for cavity irrigation, on wounds with large surface area, during surgeries in areas of the central nervous system and auditory canal, in ophthalmology, or for insertion 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 preparations 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, cetrimide bromide).

Ethanol enhances the effect of the medicinal product.

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.

Avoid contact of the medicinal product with the interior of wounds in patients with open cranial-cerebral trauma, spinal cord injury, or perforation of the tympanic membrane.

Chlorhexidine must not enter the eyes. Serious cases of persistent corneal lesions, potentially requiring corneal transplantation, have been reported following accidental exposure of eyes to medicinal products containing chlorhexidine, due to solution spread beyond the intended surgical site, despite protective measures. Extreme caution must be taken during application to ensure that chlorhexidine does not migrate beyond the intended site of application and does not enter the eyes. Particular caution is required in anesthetized patients, who are unable to immediately report exposure of the eyes to the solution. If chlorhexidine enters the eyes, they must be immediately and thoroughly rinsed with water. An ophthalmologist should be consulted.

Contact of hypochlorite bleaching agents with tissues previously exposed to chlorhexidine-containing products may lead to the formation of brown stains. The bactericidal effect of the drug increases with rising temperature. At temperatures above 100 °C, chlorhexidine digluconate is partially decomposed.

The drug 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.

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

Do not violate the instructions for use of the medicinal product, as this may harm health.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the medicinal 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 rate when driving or operating machinery. No effect.

Method of Administration and Dosage

The medicinal product is intended for external use only.

Before using the preparation for the prevention of sexually transmitted infections, empty the urinary bladder, wash hands and genital organs. Then remove the cap and, by pressing the sides of the bottle, apply the solution as a stream to treat the skin of the pubic area, inner surfaces of the thighs, and genital organs. Insert the nozzle tip into the external urethral orifice, press it tightly against the urethra with the hand, and squeeze out 2–3 mL of solution (for men) or 1–2 mL of solution (for women; into the vagina — 5–10 mL). Then, without spreading the fingers, withdraw the nozzle from the urethra and retain the solution for 2–3 minutes. Women should also spray the remaining solution into the vagina. After the procedure, it is recommended not to empty the urinary bladder for 2 hours. This preventive measure is effective if performed no later than 2 hours after sexual intercourse.

For complex treatment of urethritis and urethroprostatitis, administer 2–3 mL of the solution by urethral instillation 1–2 times daily for 10 days. Perform procedures every other day.

For minor skin injuries, treat the skin around the wound with the solution, then apply a compress soaked in the solution to the wound and secure it with a bandage or adhesive plaster. Change the dressing 2–3 times daily. The duration of treatment depends on the course of the disease, the nature of combined therapy, and the drug's tolerability.

Apply the solution as irrigations, rinses, and applications: apply 5–10 mL of solution to the affected skin or mucous membranes for 1–3 minutes, 2–3 times daily (using a swab or by spraying).

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

Children. Do not use in children under 12 years of age.

Overdose.

Cases of overdose with external use 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 — gastric lavage should be performed using milk, gelatin, or raw egg. If necessary, symptomatic therapy should be administered.

Adverse reactions.

General disorders: In individual cases, hypersensitivity reactions are possible in the presence of increased individual sensitivity, such as dryness and itching of the skin, dermatitis, stickiness of the hands' skin observed for 3–5 minutes, photosensitization. When treating gingivitis – tooth enamel discoloration, tartar 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 due to accidental eye exposure, resulting in some patients requiring corneal transplantation (see section "Special precautions").

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

Reporting of adverse reactions after medicinal product registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of this medicinal product. Healthcare professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: 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 in a place inaccessible to children, at a temperature not exceeding 25 ºC.

Packaging.

100 ml in bottles with dropper cap and lid;
200 ml in bottles with cap.

Prescription status. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of operations.

4 Korolyova Street, village Stanishivka, Zhytomyr District, Zhytomyr Oblast, 12430, Ukraine.