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Chlorhexidine bigluconate (Solution, Spray, Suppositories) Instructions for Use

ATC Code

D08AC02 (Chlorhexidine)

Active Substance

Chlorhexidine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptics and disinfectants; biguanides and amidines

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 minute; fungicidal action at a temperature of 22°C (71.6°F) and exposure for 10 minutes; virucidal action (against lipophilic viruses).

It acts on bacterial spores only at elevated temperatures. It is stable; 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 topically and externally, 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); gingivitis, stomatitis, aphthae, periodontitis, alveolitis, disinfection of removable dentures; angina; postoperative care for patients in ENT and dentistry departments.

Treatment of wounds, burn wounds and surfaces; disinfection of the patient’s skin.

Treatment of the surgeon’s hands, medical personnel, and the surgical field before diagnostic manipulations and surgery.

Disinfection of working surfaces of devices (including thermometers) and equipment for which thermal treatment is undesirable.

ICD codes

ICD-10 code Indication
A51 Early syphilis
A52 Late syphilis
A54 Gonococcal infection
A56.0 Chlamydial infections of lower genitourinary tract
A56.1 Chlamydial infections of pelvic organs and other genitourinary organs
A59 Trichomoniasis
J03 Acute tonsillitis
J35.0 Chronic tonsillitis
K05 Gingivitis and periodontal diseases
K10.3 Alveolitis of jaws
K12 Stomatitis and related lesions
L29.2 Pruritus vulvae
N76 Other inflammatory diseases of vagina and vulva
N77.1 Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
N86 Erosion and ectropion of cervix
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.1 Open wound of unspecified body region
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
Z29.8 Other specified prophylactic measures
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
Z97.2 Presence of dental prosthesis
ICD-11 code Indication
1A61.Z Early syphilis, unspecified
1A62.Z Late syphilis, unspecified
1A7Z Gonococcal infection, unspecified
1A81.0 Chlamydial infection of lower genitourinary tract
1A81.1 Chlamydial infection of internal reproductive organs
1A92 Trichomoniasis
1F23.10 Candidiasis of vulva and vagina
1F65 Enterobiasis
1H0Z Unspecified infection
CA03.Z Acute tonsillitis, unspecified
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
DA01.Z Diseases of the oral mucosa, unspecified
DA06.1 Alveolitis of jaw
DA0B.Z Gingival diseases, unspecified
DA0C.Z Periodontal diseases, unspecified
DA0Z Diseases or disorders of the orofacial complex, unspecified
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
GA00 Vulvitis
GA02.Z Unspecified vaginitis
GA0Z Inflammatory diseases of female genital tract, unspecified
GA15.1 Erosion or ectropion of cervix
GA42.0 Pruritus vulvae
ND56.0 Superficial injury of unspecified body region
ND56.1 Open wound of unspecified body region
NE11 Burn of unspecified body region
NF0A.3 Posttraumatic wound infection, not elsewhere classified
QB51.A Presence of dental prosthetic device
QB9A Preparatory procedures for subsequent treatment
QC05.Z Prophylactic measures, unspecified
1A94.0 Genital or urogenital tract infection caused by Herpes simplex virus
GA41 Ulcerative or erosive diseases of vulva

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For wound treatment and burn surfaces, apply the solution or spray to the affected area. Use sufficient volume to ensure complete coverage.

For skin disinfection prior to injection, apply the solution to the intended site. Allow it to dry completely before the procedure.

For surgical hand scrubbing, wash and rinse hands. Apply 5 ml of solution and scrub for 3 minutes. Rinse thoroughly under running water.

For preoperative skin preparation, apply the solution generously to the surgical site. Repeat the application using a sterile sponge.

For genitourinary tract infections, insert one vaginal suppository daily, preferably at bedtime. The typical treatment course is 7 to 10 days.

For venereal disease prevention, use the solution for external genital treatment within 2 hours after sexual intercourse. Apply the solution and do not wash it off for at least 5 minutes.

For gingivitis and stomatitis, use a 0.05% to 0.1% solution as a mouth rinse. Rinse for 30 seconds twice daily after brushing.

For disinfection of removable dentures, soak the prosthesis in the solution for 15-20 minutes. Rinse thoroughly with water before reinsertion.

For angina, use a diluted solution for gargling. Gargle 3-4 times daily for 5-7 days.

For equipment disinfection, wipe surfaces or immerse items in the solution. Ensure contact time is at least 1 minute for bactericidal effect.

Avoid contact with eyes, meninges, and the auditory nerve. Do not use with soap or other anionic agents.

Adverse Reactions

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

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

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

Contraindications

Hypersensitivity to chlorhexidine, dermatitis.

With caution

Children, pregnancy, breastfeeding period.

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

The drug is approved for use in elderly patients.

Special Precautions

Chlorhexidine must not be allowed to get into the eyes (except for a special dosage form intended for use in ophthalmology), as well as to come into 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 25°C (77°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Activa, JSC (Russia)

Manufactured By

Activa, JSC (Russia)

Or

RFK, CJS (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: fl. 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Solution for topical and external use 0.05% colorless, transparent or slightly opalescent, odorless.

1000 ml
Chlorhexidine bigluconate (20% solution) 2.5 ml

Excipients : purified water – up to 1000 ml.

50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
0.5 l – polyethylene canisters (for hospitals).
1 l – polyethylene canisters (for hospitals).
3 l – polyethylene canisters (for hospitals).
5 l – polyethylene canisters (for hospitals).

Marketing Authorization Holder

Aromasintez, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 25 ml, 50 ml or 100 ml bottle.

Dosage Form, Packaging, and Composition

Solution for topical and external use in the form of a colorless, transparent or slightly opalescent liquid without odor.

1000 ml
Chlorhexidine bigluconate 2.5 ml

Excipients : purified water – up to 1000 ml.

25 ml – dropper bottles (80) – cardboard boxes.
25 ml – dropper bottles (100) – cardboard boxes.
25 ml – dropper bottles (120) – cardboard boxes.
25 ml – dropper bottles (150) – cardboard boxes.
25 ml – dropper bottles (180) – cardboard boxes.
25 ml – dropper bottles (200) – cardboard boxes.
25 ml – dropper bottles (250) – cardboard boxes.
25 ml – dropper bottles (300) – cardboard boxes.
50 ml – dropper bottles (50) – cardboard boxes.
50 ml – dropper bottles (60) – cardboard boxes.
50 ml – dropper bottles (80) – cardboard boxes.
50 ml – dropper bottles (100) – cardboard boxes.
50 ml – dropper bottles (120) – cardboard boxes.
50 ml – dropper bottles (150) – cardboard boxes.
100 ml – dropper bottles (40) – cardboard boxes.
100 ml – dropper bottles (50) – cardboard boxes.
100 ml – dropper bottles (60) – cardboard boxes.
100 ml – dropper bottles (80) – cardboard boxes.
100 ml – dropper bottles (100) – cardboard boxes.
0.5 l – canisters (12) – cardboard boxes (for hospitals).
1 l – canisters (8) – cardboard boxes (for hospitals).
3 l – canisters (4) – cardboard boxes (for hospitals).
5 l – canisters (4) – cardboard boxes (for hospitals).
10 l – canisters (1) – cardboard boxes (for hospitals).
20 l – canisters (1) – cardboard boxes (for hospitals).

Marketing Authorization Holder

West, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 50 mL or 100 mL bottle 1 or 50 pcs., 1000 mL bottle

Dosage Form, Packaging, and Composition

Solution for topical and external use 0.05% colorless or light yellow, transparent or slightly opalescent, odorless.

1 l
Chlorhexidine bigluconate (in the form of a 20% solution) 0.5 g

Excipients : purified water – up to 1000 ml.

50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
1000 ml – bottles (1) – cardboard packs.
50 ml – bottles (50) – cardboard boxes (for hospitals).
100 ml – bottles (50) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 30 mL, 50 mL or 100 mL bottle

Dosage Form, Packaging, and Composition

Solution for topical and external use in the form of a colorless, transparent or slightly opalescent liquid without odor.

1000 ml
Chlorhexidine bigluconate (in the form of a 20% solution) 2.5 ml

Excipients : purified water – up to 1000 ml.

30 ml – dropper bottles (1) – cardboard packs.
50 ml – dropper bottles (1) – cardboard packs.
100 ml – dropper bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
100 ml – orange glass bottles (1) – cardboard packs.
5 l – canisters (1) – cardboard boxes (for hospitals).
10 l – canisters (1) – cardboard boxes (for hospitals).
20 l – canisters (1) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 70 mL or 100 mL bottle, 1 L or 5 L polymer bottle

Dosage Form, Packaging, and Composition

Solution for topical and external use 0.05% in the form of a colorless transparent or slightly opalescent liquid.

100 ml
Chlorhexidine bigluconate (in the form of a 20% solution) 50 mg

Excipients : purified water up to 1000 ml.

3 l – canisters (for hospitals).
5 l – canisters (for hospitals).
25 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
80 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Rosbio, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 70 ml or 100 ml bottle, 1 L or 5 L polymer bottle.

Dosage Form, Packaging, and Composition

Solution for topical and external use 0.05% 100 ml
Chlorhexidine bigluconate (in the form of a 20% solution) 50 mg

70 ml – polyethylene bottles (1) with a polymer nozzle – cardboard packs.
100 ml – polyethylene bottles (1) with a polymer nozzle – cardboard packs.
100 ml – dark glass bottles.
1 l – polymer bottles (for hospitals).
5 l – polymer bottles (for hospitals).

Marketing Authorization Holder

Rosbio, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.2%: 100 ml bottle, 1 L polymer bottle.

Dosage Form, Packaging, and Composition

Solution for topical and external use 0.2% 100 ml
Chlorhexidine bigluconate (in the form of a 20% solution) 200 mg

100 ml – dark glass bottles.
100 ml – dark glass bottles (1) – cardboard packs.
1 l – polymer bottles (for hospitals).

Marketing Authorization Holder

Rosbio, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.5%: 100 ml bottle, 1 L polymer bottle.

Dosage Form, Packaging, and Composition

Solution for topical and external use 0.5% 100 ml
Chlorhexidine bigluconate (as a 20% solution) 500 mg

100 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles.
1 L – polymer bottles (for hospitals).

Marketing Authorization Holder

Rosbio, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 1%: 100 ml bottle, 1 L polymer bottle.

Dosage Form, Packaging, and Composition

Solution for topical and external use 1% 100 ml
Chlorhexidine bigluconate (as a 20% solution) 1 g

100 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles.
1 L – polymer bottles (for hospitals).

Marketing Authorization Holder

Rosbio, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 5%: 100 ml bottle.

Dosage Form, Packaging, and Composition

Solution for topical and external use 5% 100 ml
Chlorhexidine bigluconate (as a 20% solution) 5 g

100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 80 mL or 100 mL bottle.

Dosage Form, Packaging, and Composition

Solution for topical and external use 1000 ml
Chlorhexidine bigluconate (as a 20% solution) 0.5 g

Excipients: purified water up to 1000 ml.

100 ml – orange glass bottles (1) – cardboard packs.
80 ml – polymer bottles (1) with dropper nozzles – cardboard packs.
100 ml – polymer bottles (1) with dropper nozzles – cardboard packs.

Marketing Authorization Holder

Pharmregister LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 80 mL or 100 mL bottle

Dosage Form, Packaging, and Composition

Solution for topical and external use as a colorless, transparent liquid without odor.

1000 ml
Chlorhexidine bigluconate 20% solution* 2.5 ml

Excipients: purified water – up to 1000 ml.

*equivalent to chlorhexidine bigluconate content – 0.5 g

100 ml – orange glass bottles (1) – cardboard packs.
80 ml – polymer bottles (1) – cardboard packs.
100 ml – polymer bottles (1) – cardboard packs.

Marketing Authorization Holder

Flora Kavkaza, JSC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 25 mL, 40 mL, 50 mL, 60 mL, 70 mL, 80 mL, 90 mL or 100 mL

Dosage Form, Packaging, and Composition

Solution for topical and external use as a colorless, transparent or slightly opalescent liquid without odor.

1 L
Chlorhexidine bigluconate 2.5 ml

Excipients: purified water – up to 1 L.

25 ml – bottles – cardboard packs.
25 ml – bottles 20-200 pcs. – cardboard boxes (for hospitals).
40 ml – bottles – cardboard packs.
40 ml – bottles 20-200 pcs. – cardboard boxes (for hospitals).
50 ml – bottles – cardboard packs.
50 ml – bottles 20-200 pcs. – cardboard boxes (for hospitals).
60 ml – bottles – cardboard packs.
60 ml – bottles 20-200 pcs. – cardboard boxes (for hospitals).
70 ml – bottles – cardboard packs.
70 ml – bottles 20-200 pcs. – cardboard boxes (for hospitals).
80 ml – bottles – cardboard packs.
80 ml – bottles 20-200 pcs. – cardboard boxes (for hospitals).
90 ml – bottles – cardboard packs.
90 ml – bottles 20-200 pcs. – cardboard boxes (for hospitals).
100 ml – bottles – cardboard packs.
100 ml – bottles 20-200 pcs. – cardboard boxes (for hospitals).

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine bigluconate Solution for topical and external use 0.05%: 80 mL or 100 mL bottle

Dosage Form, Packaging, and Composition

Solution for topical and external use transparent, without odor.

1000 ml
Chlorhexidine bigluconate (as a 20% solution) 0.5 g

Excipients: purified water – up to 1000 ml.

100 ml – orange glass bottles (1) – cardboard packs.
80 ml – polymer bottles (1) – cardboard packs.
100 ml – polymer bottles (1) – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine Avexima Vaginal suppositories 16 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

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

1 supp.
Chlorhexidine bigluconate 20% solution 85.2 mg
   (calculated as chlorhexidine bigluconate) 16 mg

Excipients: macrogol 400 (polyethylene glycol 400), macrogol 1500 (polyethylene glycol 1500).

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

Marketing Authorization Holder

Medsintez Plant, LLC (Russia)

Dosage Form

Bottle Rx Icon Chlorhexidine C Solution for topical and external use 0.05%: 100 ml containers 50 or 75 pcs., 250 ml containers 24 or 36 pcs., 500 ml containers 12 or 18 pcs., 1000 ml containers 6 or 9 pcs., 1500 ml or 2000 ml containers 4 pcs.

Dosage Form, Packaging, and Composition

Solution for topical and external use colorless or light yellow, transparent, odorless or with a weak odor.

1 L
Chlorhexidine bigluconate (substance-solution 20%) 2.5 ml,
   Which corresponds to the content of chlorhexidine bigluconate 0.5 g

Excipients: purified water – up to 1 L.

100 ml – containers (1) – polyethylene bags (50) – cardboard boxes.
100 ml – containers (1) – polyethylene bags (75) – cardboard boxes.
250 ml – containers (1) – polyethylene bags (24) – cardboard boxes.
250 ml – containers (1) – polyethylene bags (36) – cardboard boxes.
500 ml – containers (1) – polyethylene bags (12) – cardboard boxes.
500 ml – containers (1) – polyethylene bags (18) – cardboard boxes.
1000 ml – containers (1) – polyethylene bags (6) – cardboard boxes.
1000 ml – containers (1) – polyethylene bags (9) – cardboard boxes.
1500 ml – containers (1) – polyethylene bags (4) – cardboard boxes.
2000 ml – containers (1) – polyethylene bags (4) – cardboard boxes.

Marketing Authorization Holder

Medisorb, JSC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine Medisorb Solution for topical and external use 0.05%: 10 mL or 100 mL bottle.

Dosage Form, Packaging, and Composition

Solution for topical and external use colorless, transparent or slightly opalescent.

1000 ml
Chlorhexidine bigluconate (20% solution) 2.5 ml

Excipients: purified water – up to 1000 ml.

10 ml – opaque polyethylene bottles, equipped with a spray nozzle (1) – cardboard packs.
100 ml – polyethylene terephthalate bottles equipped with a dropper nozzle (1) – cardboard packs.

Marketing Authorization Holder

Ecolab, CJS (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine-ECOlab Topical and external use spray 0.05%: 50 ml, 100 ml, or 150 ml bottle or dropper bottle

Dosage Form, Packaging, and Composition

Spray for topical and external use as a colorless, transparent, slightly opalescent liquid, without odor.

1000 ml
Chlorhexidine bigluconate (as a 20% solution) 0.5 g

Excipients: purified water – up to 1000 ml.

50 ml – bottles or dropper bottles – cardboard packs.
100 ml – bottles or dropper bottles – cardboard packs.
50 ml – bottles or dropper bottles – cardboard packs.

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

Rubicon, LLC (Republic of Belarus)

Dosage Form

Bottle OTC Icon Chlorhexidine-Salvus Vaginal suppositories 16 mg

Dosage Form, Packaging, and Composition

Vaginal suppositories

1 supp.
Chlorhexidine (as bigluconate) 16 mg

5 pcs. – contour cell packaging – cardboard packs (5 pcs.) – Over-the-Counter
5 pcs. – contour cell packaging (2 pcs.) – cardboard packs (10 pcs.) – Over-the-Counter

Marketing Authorization Holder

Sphere-Pharm, LLC (Russia)

Dosage Form

Bottle OTC Icon Chlorhexidine-SF Solution for topical and external use 0.02%: 500 mL bottles

Dosage Form, Packaging, and Composition

Solution for topical and external use as a colorless, transparent or slightly opalescent liquid.

1 L
Chlorhexidine bigluconate (as a 20% solution) 1 ml

Excipients: purified water – up to 1 L.

500 ml – bottles (1) – cardboard packs.
500 ml – bottles (16) – cardboard boxes (for hospitals).
500 ml – containers (18) – cardboard boxes (for hospitals).
1000 ml – containers (6) – cardboard boxes (for hospitals).
2000 ml – containers (4) – cardboard boxes (for hospitals).

Table of Contents

TABLE OF CONTENTS