Depanthol^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM Group of Companies (Russia)

ATC Code

G01AX (Other antimicrobial drugs and antiseptics)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

Chlorhexidine (Rec.INN registered by WHO)

Dosage Form

Depanthol®

Vaginal suppositories 100 mg+16 mg: 5, 10, or 20 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories white or white with a grayish or yellowish tint, torpedo-shaped; marbling and the presence of an air core and a funnel-shaped depression on the cut are allowed.

Excipients: macrogol mixture (macrogol 400 – 2%, macrogol 1500 – 98%).

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.

Clinical-Pharmacological Group

Drug improving tissue regeneration, with antimicrobial action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; other antimicrobial agents and antiseptics

Pharmacological Action

A combined drug for topical use in gynecology, which has a regenerating, antimicrobial, and metabolic effect.

Chlorhexidine is active against gram-positive and gram-negative bacteria: Treponema pallidum, Chlamydia spp., Ureaplasma spp., Neisseria gonorrhoeae, Gardnerella vaginalis, Bacteroides fragilis, Escherichia coli, Staphylococcus spp., Streptococcus spp.; yeasts, dermatophytes, protozoa (Trichomonas vaginalis). Some strains of Pseudomonas spp., Proteus spp. are weakly sensitive to chlorhexidine, and acid-resistant forms of bacteria, bacterial spores are resistant.

Dexpanthenol stimulates the regeneration of mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers.

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

Pharmacokinetics

No pharmacokinetic data for the drug have been provided.

Indications

For the treatment of

• Acute and chronic vaginitis;
• Bacterial vaginosis;
• Endo-/exocervicitis;
• True erosions of the cervix of specific etiology (as part of combination therapy).

Prophylaxis of infectious and inflammatory complications in obstetrics and gynecology

• Before surgical treatment of gynecological diseases;
• Before childbirth;
• Before medical termination of pregnancy;
• Before intrauterine examinations (including hysteroscopy, hysterosalpingography);
• Before insertion of an intrauterine contraceptive.

To improve the regeneration of the vaginal and cervical mucosa

• After destructive treatment methods (including diathermocoagulation, cryodestruction, laser destruction);
• In the postoperative period;
• In the postpartum period.

ICD codes

Dosage Regimen

Apply intravaginally. Before use, the suppository should be removed from the contour packaging.

Administer 1 suppository 2 times/day for 7-10 days. If necessary, the course of treatment can be extended up to 20 days.

If improvement does not occur after treatment, or symptoms worsen, or new symptoms appear, the patient should consult a doctor.

The drug should be used only according to the indications, method of application, and doses specified in the instructions for use.

Adverse Reactions

Allergic reactions rash and itching are possible. Chlorhexidine in very rare cases (<0.0001%) may cause hypersensitivity reactions, including severe allergic reactions and anaphylaxis.

Local reactions burning sensation is possible.

If any of the above side effects worsen or any other side effects not listed in the instructions are observed, you should immediately inform your doctor.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding.

Use in Hepatic Impairment

No data.

Use in Renal Impairment

No data.

Pediatric Use

No data.

Geriatric Use

No data.

Special Precautions

If side effects occur, the use of the drug should be discontinued and a doctor should be consulted.

During the treatment period, it is recommended to refrain from sexual intercourse.

Wash hands before and after using the drug.

Effect on the ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to drive vehicles or work with mechanisms.

Overdose

Cases of overdose are unknown.

When using the drug in accordance with the instructions for use, overdose is unlikely.

Drug Interactions

As a precaution regarding possible interaction (antagonism or inactivation), it should not be used simultaneously with other antiseptics administered intravaginally.

Depanthol^® is incompatible with detergents containing an anionic group (including saponins, sodium lauryl sulfate, sodium carboxymethylcellulose) and soaps if they are administered intravaginally.

Concomitant use with iodine-containing drugs used intravaginally is not recommended.

If it is necessary to use the above or other drugs (including over-the-counter ones), the patient should consult a doctor before using Depanthol^®.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.