Chlorhexidine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLORHEXIDINE

Composition:

Active substance: chlorhexidine;

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

Excipient: polyethylene oxide.

Dosage form. Suppositories.

Main physicochemical properties: suppositories are white to white with a yellowish tinge; marbling is permissible. Presence of a funnel-shaped depression and an air core is allowed.

Pharmacotherapeutic group.

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

Pharmacological properties.

Pharmacodynamics.

Chlorhexidine digluconate exerts a rapid and pronounced effect against gram-positive and gram-negative bacteria, yeasts, and dermatophytes: Treponema pallidum, Chlamydia spp., Ureaplasma spp., Neisseria gonorrhoeae, Trichomonas vaginalis. Some strains of Pseudomonas spp. and 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, it 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 delivery and abortion, before and after insertion of intrauterine contraceptive device, before and after cervical diathermocoagulation, before intrauterine examinations).

Treatment of bacterial vaginosis, colpitis, cervical erosion.

Contraindications.

Individual hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

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

The presence of soap may inactivate chlorhexidine; therefore, soap residues must be thoroughly washed off before application of the medicinal product CHLORHEXIDINE. Hygiene of external genital organs does not affect the efficacy and tolerability of the pessaries, 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 in contact with chlorhexidine-containing medicinal products may lead to the appearance of brown stains on the fabric.

Use during pregnancy or breastfeeding

Not contraindicated.

Ability to influence reaction rate when driving or operating machinery

Has no effect.

Method of administration and dosage.

The medicinal product is intended for intravaginal use. Before administration, remove the suppository from its blister packaging.

Treatment: apply 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: apply a single dose of 1 suppository no later than 2 hours after sexual intercourse.

Pregnancy. Depending on the severity of the infection, bacteriological test results, and the presence of a threat of pregnancy termination, apply 1 suppository of chlorhexidine bigluconate once or twice daily as monotherapy or as part of combination therapy. Duration of use is 5 to 10 days.

During breastfeeding, the drug should be used at the usual recommended doses.

Children.

There is no experience with use in pediatric practice.

Overdose.

Overdose and toxic effects have not been observed with the use of this drug.

Side effects.

Allergic reactions, itching, burning, and irritation at the site of administration may occur.

Shelf life. 2 years.

Storage conditions.

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

Packaging. 5 suppositories per strip, 2 strips per cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

LLC "FARMEKS GROUP".

Manufacturer's address and place of business.

100, Shevchenka Street, Boryspil, Kyiv region, 08301, Ukraine.