DEPANTOL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEPANTOL®

Composition:

Active substances: dexpanthenol (D-panthenol), chlorhexidine digluconate;

1 suppository contains dexpanthenol (D-panthenol) equivalent to 100% substance 0.1 g; chlorhexidine digluconate 0.016 g;

Excipients: macrogol 1500, macrogol 400.

Pharmaceutical form. Vaginal suppositories.

Main physicochemical properties: bullet-shaped suppositories of white or white with greyish or yellowish tint. Marbled surface is permissible.

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

Pharmacological properties.

Pharmacodynamics. Depantol® is a combined topical preparation that exerts regenerative, antiseptic, and metabolic effects. Chlorhexidine, one of the components of the preparation, is active against gram-positive and gram-negative bacteria: Chlamidia spp., Ureaplasma spp., Neisseria gonorrhoeae, Gardnerella vaginalis, Bacteroides fragilis, Escherichia coli, Staphylococcus spp., Streptococcus spp., Chlamidia spp., as well as yeasts, dermatophytes, and protozoa (Trichomonas vaginalis). Weakly susceptible to the preparation are some strains of Pseudomonas spp., Proteus spp., as well as acid-resistant bacterial forms, bacterial spores, fungi, and viruses.

Dexpanthenol stimulates regeneration of mucous membranes, normalizes cellular metabolism, accelerates mitosis, and increases the strength of collagen fibers. It exerts regenerative, vitaminizing, and anti-inflammatory effects.

Depantol® does not impair the functional activity of lactobacilli. It retains activity (although somewhat reduced) in the presence of blood and pus.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Treatment of acute and chronic vaginitis, endo/exocervicitis, including those complicated by cervical ectopia.

Treatment of true cervical erosions of specific etiology (as part of complex therapy).

The drug is used to improve regeneration of the vaginal and cervical mucosa following destructive treatment methods (diathermocoagulation, cryodestruction, laser destruction), in the postoperative and postpartum periods.

Contraindications.

Individual hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction. The drug is incompatible with detergents containing anionic groups (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose) and soaps, if administered intravaginally. Concomitant use with iodine is not recommended.

Special precautions.

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

Use during pregnancy or breastfeeding. Use is not contraindicated in any trimester of pregnancy or during breastfeeding.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage

Administer intravaginally. Before use, remove the suppository from the blister. For adults, apply 1 suppository twice daily for 7–10 days. If necessary, the treatment course may be extended up to 20 days. The drug may be used during menstruation; however, it is advisable to start the treatment course after menstruation ends or near its completion (after a decrease in discharge volume).

Children. There is no experience with use in children.

Overdose.

There are no data regarding cases of overdose. Overdose is unlikely when the drug is used according to the instructions.

Side effects.

In individual cases, allergic reactions are possible in case of increased individual sensitivity, including itching, burning, swelling, bloody discharge, malaise; these symptoms disappear after discontinuation of the drug.

If any adverse reactions occur, consult a physician.

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

Storage conditions.

Store in a place inaccessible to children, at a temperature not exceeding 20 ºC.

Packaging.

5 suppositories in a blister pack, 2 blisters in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address.

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