Chlorhexidine

INSTRUCTION
for medical use of medicinal product

CHLORHEXIDINE
(CHLORHEXIDINE)

Composition:

active substance: chlorhexidine gluconate;

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

excipient: purified water.

Pharmaceutical form. Topical solution.

Basic physical and chemical properties: clear, colorless, odorless liquid.

Pharmacotherapeutic group.

Antiseptics and disinfectants.

ATC code D08A C02.

Pharmacological properties.

Pharmacodynamics.

Chlorhexidine (1,6-di-(p-chlorophenyl-guanido)-hexane) belongs to the group of antiseptic agents. It exerts a rapid bactericidal effect against Gram-positive and Gram-negative bacteria (does not affect acid-resistant forms of the latter), microbial spores, viruses, protozoa, and fungi; has weak activity against certain Proteus and Pseudomonas species. Also active against treponemes, gonococci, and trichomonads. Due to its stability, after application to the skin or surgical site, it remains in small 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.

Apply in purulent-septic conditions, for disinfection in minor injuries (wounds, scratches, burns), and for prevention of sexually transmitted diseases (syphilis, gonorrhea, trichomoniasis).

Contraindications.

Hypersensitivity to chlorhexidine. Allergic predisposition, allergic diseases, dermatitis, and viral skin diseases. Not recommended for use on conjunctiva or for cavity irrigation, on large wound surfaces, during surgery in areas of the central nervous system and auditory canal, in ophthalmology, or for instillation into the ear canal.

Special precautions.

In patients with open head injuries, spinal cord injuries, or perforated eardrum, avoid contact of the medicinal product with the surface of the brain, meninges, or middle ear cavity.

Contact of hypochlorite bleaching agents with fabrics previously exposed to chlorhexidine-containing products may cause brown staining.

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

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 may be required if necessary.

Do not dilute with hard water. Can be sterilized 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.

Interaction with other medicinal products and other forms of interaction.

Simultaneous use of chlorhexidine and iodine-containing products is not recommended due to the risk of dermatitis. Chlorhexidine gluconate is a cationic substance and is incompatible with soap and other anionic substances (colloids, gum arabic, carboxymethylcellulose). Compatible with products containing cationic groups (benzalkonium chloride, cetylpyridinium bromide). Ethanol enhances the effect of the medicinal product.

At a concentration of 0.05%, chlorhexidine gluconate is incompatible with borates, carbonates, chlorides, citrates, phosphates, and sulfates, as they form poorly soluble precipitates.

The medicinal product increases bacterial sensitivity to chloramphenicol, kanamycin sulfate, neomycin sulfate, and cephalosporins.

Special instructions.

Chlorhexidine must not enter the eyes. Serious cases of persistent corneal damage, potentially requiring corneal transplantation, have been reported after accidental exposure to chlorhexidine-containing products, even when eye protection measures were used, due to solution spreading beyond the intended surgical area. Extreme caution should be exercised during application to ensure that chlorhexidine does not spread beyond the intended site, particularly into the eyes. This is especially important when treating anesthetized patients who cannot immediately report eye exposure. If chlorhexidine enters the eyes, immediately rinse thoroughly with water and consult an ophthalmologist.

Use during pregnancy or breastfeeding.

The medicinal product may be used during pregnancy or breastfeeding only if the benefit to the mother outweighs the potential risk to the fetus/child.

Do not disinfect the breast area before breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The medicinal product does not affect reaction speed when driving or operating machinery.

Method of administration and dosage.

The medicinal product is intended only for topical and local use. For minor injuries, treat the skin around the wound with the solution, then apply a gauze pad soaked in solution to the wound and secure with a bandage or plaster.

Before using the product for prevention of sexually transmitted diseases, urinate, then wash hands and genital organs. Remove the cap, squeeze the bottle walls, and apply the solution stream to the pubic skin, inner thighs, and genital organs. Insert the nozzle tip into the external urethral orifice, press it firmly against the urethral wall, and squeeze out 1.5–3 ml of solution (for men) or 1–1.5 ml (for women). Then, without separating fingers, withdraw the nozzle from the urethra and retain the solution for 2–3 minutes. Women should additionally spray the remaining solution into the vagina. After the procedure, it is recommended not to urinate for 2 hours. Antiseptic treatment of skin and mucous membranes with chlorhexidine is effective only if performed within 2 hours after sexual intercourse.

Children.

Do not use in children under 12 years of age.

Overdose.

No cases of overdose with topical use are known. Accidental ingestion of a large amount (300 mg of chlorhexidine, equivalent to 0.5 L of 0.05% solution) may result in 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. Symptomatic therapy may be required if necessary.

Adverse reactions.

The medicinal product is generally well tolerated, but hypersensitivity reactions may occur in individual cases. With increased individual sensitivity, dryness and itching of the skin, dermatitis, stickiness of the hands lasting 3–5 minutes, and photosensitization may occur.

Eye disorders (frequency unknown): corneal erosion, epithelial defect / corneal injury, severe irreversible visual impairment*.

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

If any adverse effects occur, consult a physician.

Reporting of adverse reactions and lack of efficacy

Reporting of adverse reactions after medicinal product registration is of great importance. It allows monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life.

3 years.

The medicinal product must not be used after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging. Keep out of reach of children.

Packaging.

100 ml in polymer bottles with urethral nozzle; 1 L in polymer bottles; 5 L in polymer canisters.

Prescription status.

Over-the-counter.

Manufacturer.

LLC "MEDLEV".

Manufacturer's address and place of business.

171 Bohdana Khmelnytskoho St., Dnipro, 49000, Ukraine.