CLYORON

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

Composition:

Active substance: chlorhexidine;

1 suppository contains 16 mg of chlorhexidine digluconate (equivalent to 20% solution of chlorhexidine digluconate);

Excipients: macrogol 1500, macrogol 400.

Pharmaceutical form. Vaginal suppositories.

Main physicochemical properties: Suppositories are white to white with a yellowish tint, bullet-shaped. Marbled surface is acceptable.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents used in gynecology. ATC code G01AX.

Pharmacological properties

Pharmacodynamics

Chlorhexidine digluconate exerts a rapid and pronounced effect on Gram-positive and Gram-negative bacteria, yeasts, and dermatophytes: Treponema pallidum, Chlamydia spp., Neisseria gonorrhoeae, Trichomonas vaginalis. Some strains of Pseudomonas spp., Proteus spp. are weakly sensitive to the drug. The drug is ineffective against acid-resistant bacterial forms, bacterial spores, fungi, and viruses.

Pharmacokinetics

When administered intravaginally, the drug is practically not absorbed and does not produce systemic effects.

Clinical characteristics.

Indications.

Prevention of sexually transmitted diseases (syphilis, gonorrhea, trichomoniasis, chlamydia, ureaplasmosis) and infectious-inflammatory complications in obstetrics and gynecology (prior to surgical treatment of gynecological diseases, before childbirth and abortion, before and after insertion of intrauterine contraceptive devices, before and after cervical diathermocoagulation, before intrauterine examinations).

Treatment of bacterial vaginosis, colpitis, cervical erosion.

Contraindications.

Individual hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions.

Klioron must not be used concomitantly with detergents containing anionic groups (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose), as well as with soap.

The presence of soap may inactivate chlorhexidine; therefore, any soap residues must be thoroughly rinsed off before applying the Klioron medicinal product. External genital hygiene does not affect the efficacy and tolerability of vaginal suppositories, as the drug is administered intravaginally. Concomitant use with iodine is not recommended.

Special precautions for use.

Contact of hypochlorite bleaching agents with fabrics previously exposed to chlorhexidine-containing products may lead to the appearance of brown stains on the fabric.

Use during pregnancy or breastfeeding.

Not contraindicated.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

The medicinal product is administered intravaginally. Before administration, the suppository should be removed from its contour packaging.

Treatment: 1 suppository twice daily for 7–10 days, depending on the nature of the disease. If necessary, the treatment course may be extended up to 20 days.

Prophylaxis of sexually transmitted diseases: 1 suppository administered as a single dose no later than 2 hours after sexual intercourse.

Pregnancy: Depending on the severity of the infectious process, results of bacteriological examinations, and risk of pregnancy interruption, Klioron should be administered as 1 suppository once or twice daily, either as monotherapy or as part of combination therapy. Duration of treatment is 5 to 10 days.

Breastfeeding: The drug may be used in the usual recommended doses.

Children. There is no experience of use in children.

Overdose.

Overdose and toxic effects following administration of the drug have not been observed.

Side effects.

Allergic reactions, itching, burning, and irritation at the site of suppository insertion are possible.

Shelf life.

2 years. Do not use after the expiry date stated on the packaging.

Storage conditions.

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

Packaging.

5 suppositories in a blister, 2 blisters per carton.

Availability.

Over-the-counter.

Manufacturer.

Private Joint Stock Company "Lekhim-Kharkiv".

Manufacturer's location and address of its business activity.

36 Severina Pototskoho Street, Kharkiv, Kharkiv Oblast, 61115, Ukraine.