Hexetidine (Solution, Spray, Aerosol) Instructions for Use

Instructions
Dosage forms

ATC Code

A01AB12 (Hexetidine)

Active Substance

Hexetidine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs used in dentistry; antimicrobial drugs and antiseptics for the local treatment of oral diseases

Pharmacological Action

Antiseptic agent. It shows activity against gram-positive and gram-negative microorganisms and fungi.

Indications

Inflammatory diseases of the oral cavity and larynx, including various forms of pharyngitis, tonsillitis, laryngitis, gingivitis, and stomatitis.
Fungal diseases of the oral cavity and larynx caused by susceptible pathogens.
Antiseptic treatment of the oral cavity and larynx before and after surgical operations and in the case of injuries.
Use as an auxiliary agent for acute respiratory viral infections (ARVI).
For oral hygiene, particularly in bedridden patients and individuals requiring care.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
J02	Acute pharyngitis
J03	Acute tonsillitis
J04.0	Acute laryngitis
J06.9	Acute upper respiratory infection, unspecified
J31.2	Chronic pharyngitis
J35.0	Chronic tonsillitis
J37.0	Chronic laryngitis
K05	Gingivitis and periodontal diseases
K12	Stomatitis and related lesions
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

ICD-11 code	Indication
CA02.Z	Acute pharyngitis, unspecified
CA03.Z	Acute tonsillitis, unspecified
CA05.0	Acute laryngitis
CA07.0	Acute upper respiratory tract infection of unspecified site
CA09.2	Chronic pharyngitis
CA0F.Y	Other specified chronic diseases of the palatine tonsils and adenoids
CA0G	Chronic laryngitis or laryngotracheitis
DA01.Z	Diseases of the oral mucosa, unspecified
DA0B.Z	Gingival diseases, unspecified
DA0C.Z	Periodontal diseases, unspecified
DA0Z	Diseases or disorders of the orofacial complex, unspecified
QB9A	Preparatory procedures for subsequent treatment

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.

Apply the solution, spray, or aerosol topically to the affected areas of the oral cavity and pharynx.

For gargling or rinsing, use approximately 10-15 ml of the undiluted solution for 30 seconds, typically twice daily (morning and evening) after meals.

When using the spray or aerosol form, administer the recommended number of actuations directly onto the affected mucosa, also two times per day.

The exact frequency and duration of use are individual and depend on the clinical presentation and the specific dosage form used; follow the specific product labeling or a physician’s directive.

Adverse Reactions

Adverse reactions are rare and typically mild. The most frequently reported local reactions include transient taste and smell disorders following application.

In very rare cases, local hypersensitivity reactions may occur, manifesting as allergic contact dermatitis or irritation at the application site.

Discontinue use immediately and consult a physician if any signs of a severe allergic reaction, such as rash, itching, or swelling, develop.

Contraindications

Hypersensitivity to hexetidine or to any of the excipients in the formulation is an absolute contraindication.
Do not use in patients with a known history of allergic reactions to this antiseptic agent or related compounds.
Avoid use in individuals who have experienced prior severe local or systemic reactions following administration of the drug.

Drug Interactions

No clinically significant drug interactions with systemically administered medications have been reported for topical hexetidine.

Due to its local mechanism of action and minimal systemic absorption, the potential for pharmacokinetic interactions is considered very low.

Concurrent use with other topical antiseptics or antimicrobials on the same area is generally not recommended unless directed by a physician, as it may lead to local irritation or inactivation of the agents.

Overdose

Acute overdose from topical application is unlikely due to minimal systemic absorption; the risk is primarily associated with accidental ingestion of large volumes.

Symptoms of ingestion may include gastrointestinal irritation, nausea, vomiting, or signs of alcohol intoxication if the vehicle contains ethanol.

In case of accidental ingestion, do not induce vomiting; seek immediate medical attention or contact a poison control center for symptomatic and supportive care.

Special Precautions

Especially recommended for bedridden patients and patients requiring care.

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

Hexetidine [Binnopharm JSC (Russia)]
Topical aerosol 0.2%: 40 ml canister with sprayer and cap

Marketing Authorization Holder

Binnopharm JSC (Russia)

Dosage Form

Hexetidine

Topical aerosol 0.2%: 40 ml canister with sprayer and cap

Dosage Form, Packaging, and Composition

Topical aerosol in the form of a transparent, colorless liquid with a menthol odor.

	100 ml
Hexetidine	200 mg

Excipients: polysorbate 80, citric acid monohydrate, sodium saccharin, levomenthol, eucalyptus leaf oil, sodium calcium edetate, ethanol (ethyl alcohol) 96%, sodium hydroxide, purified water, nitrogen.

40 ml – aluminum aerosol canisters (1) with continuous action valve and protective cap – cardboard packs.

Hexetidine [Ivanovo Pharmaceutical Factory PJSC (Russia)]
Topical solution 0.1 %: bottle or jar 100 ml, 150 ml or 200 ml.

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Hexetidine

Topical solution 0.1 %: bottle or jar 100 ml, 150 ml or 200 ml.

Dosage Form, Packaging, and Composition

Topical solution transparent, red in color, with a characteristic odor.

	100 ml
Hexetidine	0.1 g

Excipients: ethyl alcohol 96%, polysorbate 60, peppermint leaf oil, common anise seed oil, citric acid monohydrate, sodium saccharin, levomenthol, methyl salicylate, clove flower oil, eucalyptus leaf oil, azorubine (E 122), purified water.

100 ml – jars (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
100 ml – jars (1) – cardboard packs (with a measuring cup or measuring syringe or measuring spoon or cap).
100 ml – bottles (1) – cardboard packs (with a measuring cup or measuring syringe or measuring spoon or cap).
100 ml – jars (9) – cardboard boxes (for hospitals).
100 ml – bottles (9) – cardboard boxes (for hospitals).
150 ml – jars (1) – cardboard packs.
150 ml – bottles (1) – cardboard packs.
150 ml – jars (1) – cardboard packs (with a measuring cup or measuring syringe or measuring spoon or cap).
150 ml – bottles (1) – cardboard packs (with a measuring cup or measuring syringe or measuring spoon or cap).
150 ml – jars (9) – cardboard boxes (for hospitals).
150 ml – bottles (9) – cardboard boxes (for hospitals).
200 ml – jars (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
200 ml – jars (1) – cardboard packs (with a measuring cup or measuring syringe or measuring spoon or cap).
200 ml – bottles (1) – cardboard packs (with a measuring cup or measuring syringe or measuring spoon or cap).
200 ml – jars (9) – cardboard boxes (for hospitals).
200 ml – bottles (9) – cardboard boxes (for hospitals).

Hexetidine [Tula Pharmaceutical Factory, LLC (Russia)]
Topical solution 0.1%: bottle 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 65 ml, 70 ml, 75 ml, 80 ml, 85 ml, 90 ml, 95 ml or 100 ml

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Hexetidine

Topical solution 0.1%: bottle 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 65 ml, 70 ml, 75 ml, 80 ml, 85 ml, 90 ml, 95 ml or 100 ml

Dosage Form, Packaging, and Composition

Topical solution in the form of a transparent red liquid with a characteristic odor.

	100 ml
Hexetidine	0.1 g

Excipients: ethanol 96% – 4.3333 g, polysorbate 60 – 0.7 g, peppermint leaf oil (peppermint oil) – 0.064 g, common anise fruit oil (anise oil) – 0.0392 g, citric acid monohydrate – 0.0418 g, sodium saccharin – 0.022 g, levomenthol – 0.0186 g, methyl salicylate – 0.0186 g, clove bud oil (clove oil) – 0.0084 g, eucalyptus leaf oil (eucalyptus oil) – 0.0011 g, azorubine 85% (E122) – 0.0023 g, purified water – up to 100 ml.

10 ml – bottle – cardboard pack – Over-the-Counter
100 ml – bottle – cardboard pack – Over-the-Counter
15 ml – bottle – cardboard pack – Over-the-Counter
20 ml – bottle – cardboard pack – Over-the-Counter
25 ml – bottle – cardboard pack – Over-the-Counter
30 ml – bottle – cardboard pack – Over-the-Counter
35 ml – bottle – cardboard pack – Over-the-Counter
40 ml – bottle – cardboard pack – Over-the-Counter
45 ml – bottle – cardboard pack – Over-the-Counter
5 ml – bottle – cardboard pack – Over-the-Counter
50 ml – bottle – cardboard pack – Over-the-Counter
55 ml – bottle – cardboard pack – Over-the-Counter
60 ml – bottle – cardboard pack – Over-the-Counter
65 ml – bottle – cardboard pack – Over-the-Counter
70 ml – bottle – cardboard pack – Over-the-Counter
75 ml – bottle – cardboard pack – Over-the-Counter
80 ml – bottle – cardboard pack – Over-the-Counter
85 ml – bottle – cardboard pack – Over-the-Counter
90 ml – bottle – cardboard pack – Over-the-Counter
95 ml – bottle – cardboard pack – Over-the-Counter

Hexetidine [Tula Pharmaceutical Factory, LLC (Russia)]
Topical aerosol 0.2%: 40 ml canister

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Hexetidine

Topical aerosol 0.2%: 40 ml canister

Dosage Form, Packaging, and Composition

Topical aerosol in the form of a transparent, slightly colored liquid with a characteristic odor.

	100 ml
Hexetidine	0.2 g

Excipients: polysorbate 80, citric acid monohydrate, sodium saccharin, levomenthol, eucalyptus leaf oil, sodium calcium edetate, ethanol 96%, sodium hydroxide, purified water, nitrogen.

40 ml – aluminum aerosol canisters (1) with spray nozzle and protective cap – cardboard packs.
40 ml – aluminum aerosol canisters (1) with protective cap – cardboard packs.

Hexetidine [YUGPHARM, LLC (Russia)]
Spray for topical use 0.2%: canisters or bottle 40 ml with dosing pump and sprayer

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Hexetidine

Spray for topical use 0.2%: canisters or bottle 40 ml with dosing pump and sprayer

Dosage Form, Packaging, and Composition

Spray for topical use in the form of a colorless or slightly colored liquid with a characteristic odor.

	100 ml
Hexetidine	200 mg

Excipients: sodium saccharin dihydrate – 40 mg, citric acid monohydrate – 70 mg, sodium hydroxide – 19 mg, glycerol (glycerin) – 17000 mg, ethanol – 4000 mg, lauromacrogol (macrogol lauryl ether) – 1500 mg, cineole (eucalyptol) – 20 mg, levomenthol – 20 mg, peppermint leaf oil – 10 mg, purified water – up to 100 ml.

40 ml – aluminum canisters (1) with dosing pump and sprayer – cardboard packs.
40 ml – polymer bottles (1) with dosing pump and sprayer – cardboard packs.

Hexetidine-Akrikhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Topical spray 0.2%: 30 ml bottle

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Manufactured By

Flumed-Pharm Kp, LLC (Republic Of Moldova)

Dosage Form

Hexetidine-Akrikhin

Topical spray 0.2%: 30 ml bottle

Dosage Form, Packaging, and Composition

Spray for topical use in the form of a colorless or slightly yellowish liquid with a characteristic odor of ethanol and essential oils.

	1 bottle
Hexetidine	0.0577 g

Excipients: sodium saccharin, eucalyptus leaf oil, orange flower oil, peppermint leaf oil, levomenthol, methyl salicylate, glycerol 85%, ethanol 96%.

30 ml – dark glass bottles (1) with spray device – cardboard packs.

Medixlife (Author)

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