Chlorhexidine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLORHEXIDINE (CHLORHEXIDIN)

Composition:

Active substance: chlorhexidine digluconate;

100 ml of the preparation contains 0.25 ml of 20% chlorhexidine digluconate solution;

Excipient: purified water.

Pharmaceutical form. Solution for external use.

Main physicochemical properties: clear, colorless, odorless 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, inhibiting oxygen uptake, which leads to a decrease in adenosine triphosphate levels and cell death. It disrupts DNA and interferes with DNA synthesis in microorganisms. It 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, Chlamidia 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. 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 excreted predominantly 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 and 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 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 or for cavity irrigation. Also not recommended for application on wounds with large surface area, during surgeries in 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.

Compatible with preparations containing cationic groups (benzalkonium chloride, cetylpyridinium bromide).

Ethanol enhances the effect of the preparation.

Chlorhexidine digluconate is a cationic substance and is incompatible with soap and other anionic substances (colloids, gum arabic, carboxymethylcellulose). 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 drug should not be allowed to enter the wound 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 damage, potentially requiring corneal transplantation, have been reported following accidental exposure to medicinal products containing chlorhexidine, despite protective measures, due to solution spread beyond the intended surgical site. Extreme caution should be exercised during application to ensure that chlorhexidine does not spread beyond the intended application site into the eyes. This is particularly important when treating patients under anesthesia, who are unable to immediately report accidental exposure to the solution. If chlorhexidine enters the eyes, they should be immediately and thoroughly rinsed with water. An ophthalmologist should be consulted promptly.

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

The bactericidal effect of the drug increases with rising temperature. The drug partially decomposes at temperatures above 100 °C.

The drug 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 drug 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 influence reaction rate when driving or operating machinery.

Does not influence.

Method of Administration and Dosage

For external use only. In case of minor skin injuries around the wound, treat the area with the solution, then apply a gauze pad moistened with the solution onto 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 urinary bladder, wash hands and genital organs. Then irrigate the skin of the pubis, inner surfaces of the thighs, and genital organs with the solution. Using the applicator, instill the solution into the urethra: 2—3 ml for men, 1—2 ml for women (for women, 5—10 ml into the vagina, retained for 2—3 minutes). Afterward, treat the skin of the inner surfaces of the thighs, pubis, and genital organs with the solution. Do not empty the urinary bladder for 2 hours after the procedure.

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

Apply the solution as sprays, 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 spraying).

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 topical 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; gastric lavage should be performed using milk, gelatin, or raw egg. If necessary, symptomatic therapy should be administered.

Adverse reactions.

In individual cases with increased individual sensitivity, hypersensitivity reactions, dryness and itching of the skin, dermatitis, sticky sensation on the hands lasting for 3–5 minutes, and photosensitization may occur. When treating gingivitis – tooth enamel discoloration, dental calculus deposition, 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 following accidental eye exposure; as a result, some patients required corneal transplantation (see section "Special precautions").

If any adverse events occur, discontinue use of the medicinal product and consult a physician immediately.

Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy 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 of children.

Packaging.

100 ml in a bottle in a carton or without carton, or 200 ml in bottles.

Supply classification.

Over-the-counter (without prescription).

Manufacturer.

JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Street, Zaporizhzhia, Ukraine, 69063.