Chlorhexidine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLORHEXIDINE

Composition:

Active ingredient: chlorhexidine bigluconate;

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

Excipient: purified water.

Pharmaceutical form. 0.05% topical solution.

Main physicochemical properties: clear, colorless, odorless liquid.

Pharmacotherapeutic group. Antiseptics and disinfectants. ATC code D08A C02

Pharmacological properties.

Pharmacodynamics.

Chlorhexidine exhibits rapid and pronounced bactericidal activity against gram-positive and gram-negative bacteria (does not affect acid-resistant forms of the latter). It is also active against pathogens of venereal diseases—treponemes, gonococci, trichomonads. Due to its stability, after application on hands or surgical sites, it remains in certain amounts and continues to exert a bactericidal effect. It retains activity in the presence of blood and pus, although somewhat reduced.

Pharmacokinetics. Does not penetrate through intact skin.

Clinical characteristics.

Indications.

Purulent-septic processes, disinfection of minor injuries (wounds, scratches, burns). The drug can also be used for the prevention of venereal diseases (syphilis, gonorrhea, trichomoniasis).

Contraindications.

Hypersensitivity to chlorhexidine, allergic diseases, dermatitis, viral skin diseases. It is not recommended for use on conjunctiva or for cavity irrigation, on large-surface wounds, during surgery in areas of the central nervous system and auditory canal, in ophthalmology, or for administration into the auditory apparatus.

Interaction with other medicinal products and other types of interactions.

To avoid the risk 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 compounds (colloids, gum arabic, carboxymethylcellulose). It is compatible with preparations containing cationic groups (benzalkonium chloride, cetrimide bromide).

Ethanol enhances the effect of the drug. At a concentration of 0.05%, chlorhexidine digluconate is incompatible with borates, carbonates, chlorides, citrates, phosphates, and sulfates, as poorly soluble precipitates may form.

Special precautions for use

In patients with open craniocerebral trauma, spinal cord injury, or perforation of the tympanic membrane, care should be taken to avoid contact of the medicinal product with the surface of the brain, meninges, and middle ear cavity.

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 unintentional spread of the solution beyond the intended surgical site. Extreme caution must be exercised during application to ensure that chlorhexidine does not reach the eyes. This is particularly important when treating anesthetized patients who are unable to immediately report exposure to the eyes. If chlorhexidine comes into contact with the eyes, immediately rinse thoroughly with water. Seek immediate consultation with an ophthalmologist.

Use during pregnancy or breastfeeding

The medicinal product may be used during pregnancy or breastfeeding only if the anticipated benefit to the mother outweighs the potential risk to the fetus or infant. Do not apply to the surface of mammary glands prior to breastfeeding.

Ability to influence reaction rate when driving or operating machinery

Does not affect.

Method of Administration and Dosage.

The medication is intended for external and local use only. In case of minor skin injuries around the wound, the area should be treated with the solution, then a gauze pad soaked in the solution should be applied to the wound and secured with a bandage or adhesive tape.

Before using the medication for prevention of sexually transmitted diseases, empty the bladder, wash your hands and genitals. Then remove the cap, press the sides of the bottle and irrigate the skin of the pubic area, inner surfaces of the thighs, and genitals with the solution. Insert the nozzle tip into the external opening of the urethra, press it tightly against the wall of the urethra, and squeeze out 1.5–3 mL of the solution (for men) or 1–1.5 mL of the solution (for women). Then, without spreading the fingers, withdraw the nozzle from the urethra and retain the solution for 2–3 minutes. Women should additionally irrigate the vagina with the remaining solution. After the procedure, it is recommended not to empty the bladder for 2 hours. Antiseptic treatment of skin and mucous membranes with chlorhexidine is effective if performed no later than 2 hours after sexual intercourse.

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 mg chlorhexidine, equivalent to 0.5 L of a 0.05% solution) 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 is administered.

Side effects

The product is generally well tolerated; however, hypersensitivity reactions may occur. In cases of increased individual sensitivity, dryness and itching of the skin, dermatitis, stickiness of the hands' skin observed within 3–5 minutes, and photosensitization are possible.

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 eye exposure. As a consequence, some patients required corneal transplantation (see section "Instructions for Use").

If any adverse reactions occur, consult a physician immediately.

Reporting of adverse reactions and lack of efficacy of the medicinal product

Reporting suspected adverse reactions and lack of efficacy after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life: 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions: Store in a protected from light, child-proof place at a temperature not exceeding 25 °C.

Packaging: 100 mL or 200 mL in jars or bottles.

Availability: Over-the-counter (without prescription)

Manufacturer: PP "Kilaff"

Manufacturer's name and address of the place of business:

6 Kharkivska Street, Sumy, Sumy Oblast, 40035, Ukraine