Hexosept-Rn (Suppositories) Instructions for Use

Marketing Authorization Holder

Rubicon, LLC (Republic of Belarus)

ATC Code

G01AX (Other antimicrobial drugs and antiseptics)

Active Substance

Chlorhexidine (Rec.INN registered by WHO)

Dosage Form

Hexosept-Rn

Vaginal suppositories 16 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories white or yellowish-white in color, torpedo-shaped; a funnel-shaped depression is allowed; an air core may be present on the longitudinal section.

Excipients : macrogol 1000 (polyethylene oxide 1000) – up to 3100 mg.

5 pcs. – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Topical antiseptic for use in gynecology

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antiseptic agent. Chlorhexidine exhibits bactericidal action (against gram-positive and gram-negative bacteria) – at a temperature of 22°C (71.6°F) and exposure for 1 min; fungicidal action at a temperature of 22°C (71.6°F) and exposure for 10 min; virucidal action (against lipophilic viruses).

It acts on bacterial spores only at elevated temperatures. It is stable, and after skin treatment, it remains on it in a certain amount sufficient to manifest a bactericidal effect. It retains activity (although somewhat reduced) in the presence of blood, pus, various secretions, and organic substances.

It does not have a damaging effect on items made of glass, plastic, and metals.

Pharmacokinetics

When applied externally and locally, it is not absorbed into the systemic circulation and does not have a systemic effect.

Indications

Trichomonal colpitis, cervical erosion, vulvar itching, prevention of venereal diseases (including gonorrhea, syphilis, trichomoniasis, chlamydia, ureaplasmosis); prevention of infectious and inflammatory complications in obstetrics and gynecology (before surgical treatment of gynecological diseases, before childbirth, abortion, before and after insertion of an IUD, before and after diathermocoagulation of the cervix, before intrauterine examinations); treatment of bacterial vaginosis, colpitis (including nonspecific, mixed, trichomonal).

ICD codes

Dosage Regimen

For treatment of infectious and inflammatory diseases (trichomonal colpitis, bacterial vaginosis, nonspecific colpitis), administer one 16 mg vaginal suppository twice daily, for 7 to 10 days.

For prevention of infectious complications before gynecological surgery, childbirth, abortion, IUD insertion, or diathermocoagulation, administer one suppository twice daily for 5 to 7 days prior to the procedure.

For post-interventional care, administer one suppository twice daily for 5 to 7 days following the procedure.

For prevention of venereal diseases, administer one suppository as soon as possible, but no later than two hours after sexual intercourse.

Thoroughly wash hands before and after administration. Insert the suppository deeply into the vagina while lying on your back with knees bent.

For optimal efficacy, complete the full prescribed course of treatment, even if symptoms improve earlier.

Discontinue use immediately and consult a physician if bloody vaginal discharge, severe itching, rash, or burning occurs.

Adverse Reactions

Allergic reactions: skin rash, itching, severe allergic reactions, including anaphylaxis.

Skin and subcutaneous tissue disorders: dry skin, itching, dermatitis, photosensitivity.

Local reactions: enamel staining, tartar deposition, taste disturbance.

With vaginal use allergic reactions (rash, itching), burning are possible; very rarely – anaphylactic reactions; in some cases – bloody discharge from the vagina.

Contraindications

Hypersensitivity to chlorhexidine.

Use in Pregnancy and Lactation

If it is necessary to use during pregnancy and breastfeeding, the expected benefit of therapy for the mother and the possible risk to the fetus should be weighed.

Pediatric Use

Use with caution in children.

Geriatric Use

There are currently no restrictions for use in elderly patients.

Special Precautions

With intravaginal use, in case of bloody discharge from the vagina, the use of chlorhexidine should be discontinued.

Avoid getting chlorhexidine into the eyes (except for a special dosage form intended for use in ophthalmology), as well as contact with the meninges and the auditory nerve.

Drug Interactions

It is used in a neutral environment; at pH 5-8 the difference in activity is small; at pH above 8, a precipitate forms.

It is not used in combination with anionic compounds, including soap.

It is incompatible with carbonates, chlorides, phosphates, borates, sulfates, and citrates.

The use of hard water reduces bactericidal properties.

It is compatible with medicinal products containing a cationic group (benzalkonium chloride, cetrimonium bromide).

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.