Chlorhexidine

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

Composition:

Active substance: chlorhexidine digluconate;

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

Excipient: purified water.

Pharmaceutical form. Solution for external use.

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 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 administration.

Chlorhexidine digluconate exhibits 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. 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% excreted 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; for the treatment of skin and mucous membrane infections in surgery, obstetrics, gynecology, urology (urethritis, urethroprostatitis), and dentistry (rinsing and irrigation in 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. Not recommended for use on conjunctiva or for cavity irrigation. Also not recommended for application on large-surface wounds, during surgeries involving the central nervous system or 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 products is not advisable.

Compatible with cationic-containing agents (benzalkonium chloride, cetylpyridinium bromide).

Ethanol enhances the effect of the medicinal product.

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

Avoid contact of the medicinal product with the wound interior in patients with open cranial trauma, spinal cord injury, or perforated eardrum. Chlorhexidine must not enter the eyes. Serious cases of persistent corneal damage have been reported, potentially requiring corneal transplantation, following accidental exposure to medicinal products containing chlorhexidine, even when eye protection measures were used, due to solution migration beyond the intended surgical site. Extreme caution must be exercised during application to ensure that chlorhexidine does not migrate beyond the intended application site into the eyes. Particular caution is required in anesthetized patients, who may be unable to immediately report exposure of the solution to the eyes. If chlorhexidine comes into contact with ocular mucous membranes, immediately and thoroughly rinse with water. Seek immediate consultation with an ophthalmologist.

Contact of hypochlorite bleaching agents with tissues previously exposed to chlorhexidine-containing products may result in brown staining.

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

The medicinal 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. The product can be sterilized in an autoclave at 116 °C for 30 minutes. Do not sterilize using ionizing radiation.

The instructions for use of the medicinal product must not be violated, as this may harm the patient's 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/child. Do not treat the surface of mammary glands prior to breastfeeding.

Ability to influence reaction speed when driving or operating machinery

No effect.

Method of administration and dosing.

For external use only. In case of minor skin injuries, treat the wound area and surrounding skin with the solution, then apply a gauze pad soaked with the solution directly onto the wound and secure it with a bandage or adhesive dressing.

For prevention of sexually transmitted infections, the medicinal product is effective if used no later than 2 hours after sexual intercourse. Prior to application for prophylaxis of venereal diseases, empty the urinary bladder, and wash hands and genital organs. Then irrigate the skin of the pubic area, 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 (5–10 ml into the vagina for women, retained for 2–3 minutes). Afterward, treat the skin of the inner thighs, pubic area, and genital organs with the solution. The urinary bladder should not be emptied for 2 hours after the procedure.

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

The medicinal solution may be used as irrigations, rinses, or applications: apply 5–10 ml of the solution onto affected skin or mucous membranes using a swab or by spraying, leave in contact for 1–3 minutes, 2–3 times daily.

During pregnancy or breastfeeding, the medicinal product may be used at the usual recommended doses.

Children.

Do not use in children under 12 years of age.

Overdose.

Cases of overdose with external use have not been reported.

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 medicinal product is practically not absorbed systemically. In case of ingestion, gastric lavage should be performed using milk, gelatin, or raw egg. If necessary, symptomatic therapy is administered.

Adverse reactions

The medicinal product is generally well tolerated; however, hypersensitivity reactions may occur in individual cases, including dryness and itching of the skin, dermatitis, photosensitization, stickiness of the hands observed for 3–5 minutes. When treating gingivitis — tooth enamel discoloration, dental calculus deposition, taste disturbances.

Ocular adverse events may include corneal erosion, epithelial defect/corneal damage, severe irreversible visual impairment* (frequency not known).

Note: In the post-marketing period, cases of severe corneal erosion and serious irreversible visual impairment have been reported due to accidental ocular 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 marketing authorization is of great importance. It allows continuous 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 and sight of children.

Packaging

100 mL or 200 mL in a polymer bottle with a nozzle for directed application of the medicinal product.

Availability

Over-the-counter (without prescription).

Manufacturer: JSC "FITOFARM".

Manufacturer's address and location of business activity:

17 Chumatska Street, Boryspil, Kyiv region, Ukraine, 08303.

In case of adverse reactions or questions regarding the safety, quality, and efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOFARM" at +38 (044) 390 52 96 or visit https://fitofarm.ua, go to the "Pharmacovigilance" section, and choose your preferred method of communication.

Marketing Authorization Holder: JSC "FITOFARM".

Address of the Marketing Authorization Holder:

7 Verkhovnoi Rady Avenue, Kyiv, 02100, Ukraine, floor 3, room 18.