Chlorhexidine

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLORHEXIDINE

Composition:

Active substance: chlorhexidine gluconate;

100 ml of solution contains 0.25 ml of 20% chlorhexidine gluconate 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 gluconate is a cationic biguanide. Chlorhexidine binds to amino groups of cellular proteins. It penetrates into bacterial cell membranes, precipitates in the cytoplasm, and alters membrane function, thereby inhibiting oxygen uptake, which leads to decreased adenosine triphosphate 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 gluconate 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 (Herpesvirus). 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% eliminated by the kidneys.

Clinical characteristics.

Indications.

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

Disinfection of purulent wounds, infected burn surfaces; treatment of skin and mucous membrane infections in surgery, obstetrics, gynecology, urology (urethritis, urethroprostatitis), and dentistry (mouthwashes and irrigations – gingivitis, stomatitis, aphthae, periodontitis, alveolitis).

Contraindications.

Hypersensitivity to the components of the drug. Predisposition to allergic reactions and allergic diseases, dermatitis, viral skin diseases. Not recommended for conjunctival treatment or cavity irrigation. Also not recommended for use on wounds with large surface area, during surgeries involving central nervous system or auditory canal, in ophthalmology, or for administration into the auditory canal.

Interaction with other medicinal products and other forms of interactions.

To avoid development of dermatitis, simultaneous use of chlorhexidine and iodine-containing products is not recommended.

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

Ethanol enhances the effect of the drug.

Chlorhexidine gluconate is a cationic substance and is incompatible with soap and other anionic substances (colloids, gum arabic, carboxymethylcellulose). At a concentration of 0.05%, chlorhexidine gluconate is incompatible with borates, carbonates, chlorides, citrates, phosphates, and sulfates, as poorly soluble precipitates are formed.

Special precautions for use.

Avoid getting the agent into the wound in patients with open cranial-cerebral trauma, spinal cord injury, or perforation of the tympanic membrane. Contact of hypochlorite bleaching agents with tissues previously exposed to chlorhexidine-containing products may lead to the appearance of brown stains. The bactericidal effect of the agent increases with rising temperature. At temperatures above 100 °C, the agent partially decomposes.

The agent is practically not absorbed in the stomach. In case of accidental ingestion, gastric lavage should be performed using raw milk, raw egg, or gelatin. If necessary, symptomatic therapy should be administered.

Do not dilute with hard water. Sterilization can be performed 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.

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, even when eye protection measures were taken, due to solution runoff beyond the intended surgical site. Extreme caution should be exercised during application to ensure that chlorhexidine does not reach the eyes. This is particularly important when treating patients under anesthesia, who may not be able to immediately report exposure to the eyes. If chlorhexidine gets into the eyes, they should be immediately and thoroughly rinsed with water. An ophthalmologist should be consulted promptly.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the agent should be used only when the expected benefit to the woman outweighs the potential risk to the fetus/child. Do not treat the surface of mammary glands prior to breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Does not affect the ability to drive vehicles or perform other tasks requiring increased attention, quick mental and physical reactions.

Method of Administration and Dosage

Apply externally or locally (instillation into the urethra, applications, irrigation, and rinsing).

For minor skin injuries around the wound, treat the area with the solution, then apply a gauze pad moistened with 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 patient's tolerance to the drug.

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 prevention 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 nozzle, instill the solution into the urethral canal: 2–3 ml for men, 1–2 ml for women (5–10 ml into the vagina for women, retaining for 2–3 minutes). After the procedure, do not empty the urinary bladder for 2 hours.

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

In dentistry, use the solution as irrigation, rinses, or applications.

Apply 5–10 ml of the solution to the affected skin or oral mucosa surfaces, leaving it in place for 1–3 minutes, 2–3 times daily (using a swab or by irrigation).

During pregnancy or breastfeeding, the drug 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 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.

Adverse Reactions

In individual cases with increased individual sensitivity, dryness and itching of the skin, dermatitis, and photosensitization are possible. When treating gingivitis – tooth enamel discoloration, tartar deposition, taste disturbances.

Eye disorders: corneal erosion, epithelial defect/corneal damage, serious irreversible vision impairment. Frequency unknown.

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

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after marketing authorization of the medicinal product 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 at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

100 ml, 200 ml in bottles.

Supply classification.

Over-the-counter (without prescription).

Manufacturer.

LLC "Pharma Cherkasy".

Manufacturer's address and place of business.

18028, Ukraine, Cherkasy region, city of Cherkasy, Lieutenant Mukana Street, building 14 A