Instructions Chlorhexidine-KR solution for external use 0.05% bottle with nozzle 200 ml
Composition
active ingredient: chlorhexidine digluconate;
100 ml of solution contain: chlorhexidine digluconate, 20% solution, calculated per 100% substance – 0.05 g;
excipient: purified water.
Dosage form
Solution for external use.
Main physicochemical properties: colorless transparent liquid.
Pharmacotherapeutic group
Antiseptics and disinfectants.
ATX code D08A C02.
Pharmacological properties
Pharmacodynamics.
Chlorhexidine digluconate is a cationic biguanide. Chlorhexidine has amino groups of cellular proteins. Penetrates into the intracellular membranes of bacterial cells, settles in the cytoplasm and changes the function of the membrane, preventing oxygen consumption, which causes a decrease in the level of adenosine triphosphate (ATP) and cell death. Destroys DNA and disrupts DNA synthesis in microorganisms. Provides long-lasting persistent antimicrobial activity, preventing the reproduction of microorganisms for at least 6 hours after application of the drug.
Chlorhexidine digluconate has a rapid and pronounced effect on gram-positive and gram-negative bacteria (Treponema pallidum, Chlamidia spp., Ureaplasma spp., Neisseria gonorrhoeae, Gardnerella vaginalis, Bacteroides fragilis), protozoa (Trichomonas vaginalis), viruses (Herpes virus). In the presence of blood and other organic substances, the antimicrobial activity of chlorhexidine digluconate does not decrease.
Pharmacokinetics.
Does not penetrate intact skin. Practically not absorbed from the gastrointestinal tract. After accidental ingestion of 300 mg, the maximum concentration is reached after 30 minutes and is 0.206 μg/l. It is excreted mainly with feces (90%), less than 1% is excreted by the kidneys.
Indication
For the prevention of sexually transmitted infections (syphilis, gonorrhea, trichomoniasis, chlamydia, ureaplasmosis, genital herpes).
For disinfection of purulent wounds, infected burn surfaces; treatment of skin and mucous membrane infections in surgery, obstetrics, gynecology, urology (urethritis, urethroprostatitis), dentistry (rinsing and irrigation - gingivitis, stomatitis, aphthae, periodontitis, alveolitis).
Contraindication
Hypersensitivity to the components of the drug. Tendency to allergic reactions and allergic diseases, dermatitis, viral skin diseases.
It is not recommended for use for treating the conjunctiva and rinsing the cavity, on wounds with a large surface area, during operations in areas of the central nervous system and auditory canal, in ophthalmology, for introduction into the auditory canal.
Interaction with other medicinal products and other types of interactions
To avoid the development of dermatitis, it is not advisable to use chlorhexidine and iodine preparations simultaneously.
Chlorhexidine digluconate is a cationic substance and is incompatible with soap and other anionic substances (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose, colloids, gum arabic).
Compatible with drugs containing a cationic group (benzalkonium chloride, cetrimonium 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 insoluble precipitates are formed.
Application features
The product should not come into contact with the eyes. Serious cases of permanent corneal damage, potentially requiring corneal transplantation, have been reported following accidental eye contact with chlorhexidine-containing products despite eye protection, resulting in the solution spreading beyond the intended surgical site. Care should be taken during use to ensure that the product does not enter the eye beyond the intended site of application. This is particularly important in patients under anaesthesia who may not be able to immediately report eye contact. If chlorhexidine solution does come into contact with the eyes, rinse them thoroughly with water immediately. An ophthalmologist should be consulted.
It is necessary to avoid getting the drug inside the wound in patients with open craniocerebral trauma, spinal cord injury, perforation of the eardrum. If the solution gets on the mucous membranes of the eye, they should be washed quickly and thoroughly with water. The contact of hypochlorite bleaching agents with tissues that have previously been in contact with preparations containing chlorhexidine may contribute to the appearance of brown spots on them. The bactericidal effect of the drug increases with increasing temperature. At temperatures above 100 °C, the drug partially decomposes.
The drug is practically not absorbed in the stomach. In case of accidental ingestion, the stomach should be washed using raw milk, raw egg, gelatin. If necessary, symptomatic therapy should be carried out.
Do not dilute with hard water. Can be sterilized in an autoclave at 116°C for 30 minutes. Do not sterilize with ionizing radiation.
You should not violate the rules for using the medicine - this can harm your health.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus/child. Do not treat the surface of the mammary glands before breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Apply externally. For microtraumas, treat the skin around the wound with the solution, then apply a napkin moistened with the solution to the wound and secure it with a bandage or plaster.
For the prevention of sexually transmitted infections, the drug is effective if used no later than 2 hours after sexual intercourse. Before using the drug for the prevention of sexually transmitted diseases, you should empty your bladder, wash your hands and genitals.
For men:
- Use a jet of solution from the container to treat the skin of the pubis, inner thighs, and external genitalia.
- Using a directional nozzle, inject 2-3 ml of solution into the urethra.
- Treat the skin of the pubis, inner thighs, and external genitalia with the remaining solution.
Women use a package with a vaginal applicator:
- Before using the container, pour approximately ¼ of the solution into a douche bottle and screw the vaginal applicator onto the bottle.
- Use a jet of solution from the container to treat the skin of the pubis, inner thighs, and external genitalia.
- Using a douche bottle, insert the vaginal applicator into the vagina and, by pressing, inject 5-10 ml of the solution, hold for 2-3 minutes.
- From the container, using a nozzle for directed administration, inject 1-2 ml of the solution into the urethra.
- Treat the skin of the pubis, inner thighs, and external genitalia with the remaining solution.
In exceptional cases, if there is no package with a vaginal applicator, you can use a container with a nozzle for directional administration:
- Use a jet of solution from the container to treat the skin of the pubis, inner thighs, and external genitalia.
- Using a nozzle for directed administration, inject 1-2 ml of solution into the urethra, and 5-10 ml of solution into the vagina, hold for 2-3 minutes.
- Treat the skin of the pubis, inner thighs, and external genitalia with the remaining solution.
After the procedure, you should not empty your bladder for 2 hours.
Comprehensive treatment of urethritis and urethroprostatitis is carried out by injecting 2-3 ml of chlorhexidine digluconate solution into the urethra 1-2 times a day, the course of treatment is 10 days. The procedures are prescribed every other day.
The drug solution should be used in the form of irrigations, rinses and applications - apply 5-10 ml of the solution to the affected surface of the skin or mucous membranes with exposure for 1-3 minutes 2-3 times a day (on a swab or by irrigation).
During pregnancy or breastfeeding, the drug should be used in the usual recommended doses.
Children.
Do not use in children under 12 years of age.
Overdose
Cases of overdose with external use are unknown.
Incorrect internal use of a large amount of the substance (300 ml of chlorhexidine) leads to death with signs of liver and kidney failure.
When ingested, the drug is practically not absorbed - the stomach should be washed with milk, gelatin or raw egg. If necessary, symptomatic therapy is carried out.
Side effects
In some cases, with increased individual sensitivity, hypersensitivity reactions, dryness and itching of the skin, dermatitis, stickiness of the skin of the hands, which is observed for 3-5 minutes, photosensitization are possible. In the treatment of gingivitis - discoloration of tooth enamel, tartar deposits, taste disturbances.
Vision disorders
Frequency unknown: corneal erosion, epithelial defect/corneal damage, serious irreversible visual impairment*.
* In the post-marketing period, cases of severe corneal erosion and serious irreversible visual impairment due to inadvertent contact with chlorhexidine in the eyes have been reported, some patients requiring corneal transplantation (see section "Special instructions").
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
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 container with a nozzle for directed administration of the drug, in a cardboard pack.
100 ml in a container with a nozzle for directional administration of the drug, without a pack.
100 ml in a container with a nozzle for directional administration of the drug, complete with a vaginal applicator with a 100 ml irrigation bottle and a dust-proof cap, in a cardboard pack.
200 ml in a bottle with a nozzle, in a cardboard pack.
200 ml in a bottle with a nozzle, without a pack.
Vacation category
Without a prescription.
Producer
Location of the manufacturer and address of its place of business.
61010, Ukraine, Kharkiv, 1 Hordienkivska St.
