Benzydamine (Solution, Spray) Instructions for Use

Instructions
Dosage forms

ATC Code

A01AD02 (Benzydamine)

Active Substance

Benzydamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

NSAIDs for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs used in dentistry; other drugs for the local treatment of diseases in the oral cavity

Pharmacological Action

Benzydamine is an NSAID, an indazole derivative without a carboxyl group. The absence of a carboxyl group imparts the following features: Benzydamine is a weak base (whereas most NSAIDs are weak acids), has high lipophilicity, and penetrates well into the site of inflammation (where pH is lower) along the pH gradient and accumulates in therapeutic concentrations.

It has an anti-inflammatory and local analgesic effect, and possesses antiseptic (against a wide range of microorganisms), as well as antifungal action.

The anti-inflammatory effect is due to a decrease in capillary permeability, stabilization of cell membranes as a result of inhibition of the synthesis and inactivation of prostaglandins, histamine, bradykinin, cytokines, complement factors and other nonspecific endogenous damaging factors.

Benzydamine suppresses the production of pro-inflammatory cytokines, especially TNFα, and to a lesser extent IL-1β. The main feature of benzydamine is that, being a weak inhibitor of prostaglandin synthesis, it demonstrates powerful inhibition of pro-inflammatory cytokines. For this reason, Benzydamine can be classified as a cytokine-suppressing anti-inflammatory drug.

The local anesthetic effect of benzydamine is associated with the structural features of its molecule, which is similar to local anesthetics. The analgesic effect is due to an indirect decrease in the concentration of biogenic amines with algogenic properties and an increase in the pain sensitivity threshold of the receptor apparatus; Benzydamine also blocks the interaction of bradykinin with tissue receptors, restores microcirculation and reduces pain sensitivity at the site of inflammation.

Benzydamine has an antibacterial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and the function of cell lysosomes.

It has an antifungal effect against 20 strains of Candida albicans and Candida non-albicans, causing structural modifications of the fungal cell wall and their metabolic chains, thus preventing their reproduction.

Pharmacokinetics

When applied topically, it is well absorbed through the mucous membranes and quickly penetrates into inflamed tissues. It is detected in the blood plasma in an amount insufficient to obtain systemic effects. It is excreted mainly by the kidneys and through the intestines in the form of metabolites or conjugation products.

Indications

Symptomatic therapy of the pain syndrome of inflammatory diseases of the oral cavity and ENT organs (of various etiologies): pharyngitis, laryngitis, tonsillitis; gingivitis, glossitis, periodontosis, stomatitis (including after radiation and chemotherapy); calculous inflammation of the salivary glands; after dental treatment or extraction; after surgical interventions and injuries (tonsillectomy, jaw fractures); candidiasis of the oral mucosa (as part of combination therapy).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B37.0	Candidal stomatitis
J02	Acute pharyngitis
J03	Acute tonsillitis
J04.0	Acute laryngitis
J31.2	Chronic pharyngitis
J35.0	Chronic tonsillitis
J37.0	Chronic laryngitis
K05	Gingivitis and periodontal diseases
K08.8	Other specified disorders of teeth and supporting structures (including toothache)
K11.5	Sialolithiasis
K12	Stomatitis and related lesions
K14.0	Glossitis
R07.0	Pain in throat
T79.3	Posttraumatic wound infection, not elsewhere classified

ICD-11 code	Indication
1F23.0	Candidiasis of the lips or oral mucosa
CA02.Z	Acute pharyngitis, unspecified
CA03.Z	Acute tonsillitis, unspecified
CA05.0	Acute laryngitis
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
DA03.0	Glossitis
DA04.4	Sialolithiasis
DA0A.Z	Diseases of teeth and supporting structures, unspecified
DA0B.Z	Gingival diseases, unspecified
DA0C.Z	Periodontal diseases, unspecified
DA0Z	Diseases or disorders of the orofacial complex, unspecified
LA30.5Z	Anomalies of tooth resorption or loss, unspecified
MD36.0	Pain in throat
NF0A.3	Posttraumatic wound infection, not elsewhere classified

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.

Administer the spray topically into the oral cavity or oropharynx.

For adults and adolescents aged 12 years and older, administer 4-8 sprays directly onto the affected area.

For children aged 6 to 12 years, administer 4 sprays.

For children aged 3 to 6 years, administer 1 spray per every 4 kg of body weight, with a maximum single dose of 4 sprays.

Repeat the application every 1.5-3 hours, or as required for pain relief.

Adhere to a maximum frequency of 8 applications per 24-hour period.

Direct the spray nozzle toward the inflamed area of the mouth or throat before actuating.

For oral rinsing with the solution, use 15 mL undiluted.

Rinse the mouth thoroughly for 30 seconds to 2 minutes and then expectorate.

Repeat the rinsing procedure 2-3 times daily.

Continue treatment for the duration prescribed by a physician, typically not exceeding 7 days.

Discontinue use and consult a physician if symptoms persist beyond 3 days of treatment.

Do not swallow the medication; systemic absorption is not required for therapeutic effect.

Avoid contact with eyes. If contact occurs, rinse immediately with copious amounts of water.

Adverse Reactions

Local reactions: rarely – dry mouth, burning sensation in the oral cavity; frequency unknown – numbness sensation in the oral cavity.

Allergic reactions: infrequently – photosensitivity; rarely – sensitivity reactions, skin rash, skin itching; very rarely – angioedema, laryngospasm; frequency unknown – anaphylactic reactions.

Contraindications

Children under 3 years of age; children over 3 years of age (depending on the dosage form used); hypersensitivity to benzydamine.

With caution

Hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including history).

Use in Pregnancy and Lactation

Should not be used during pregnancy and breastfeeding.

Pediatric Use

Contraindicated in children under 3 years of age; in children over 3 years of age – depending on the dosage form used.

Geriatric Use

There are no specific restrictions on use in elderly patients.

Special Precautions

If there is an ulcerative lesion of the oropharyngeal mucosa, the patient should consult a doctor if symptoms persist for more than 3 days.

Not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

Use with caution in patients with bronchial asthma, as bronchospasm may develop.

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

Benzydamine [Vertex, JSC (Russia)]
Topical solution 0.15%: 50 ml or 100 ml bottle with a measuring cup

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Benzydamine

Topical solution 0.15%: 50 ml or 100 ml bottle with a measuring cup

Dosage Form, Packaging, and Composition

Topical solution colorless, transparent, with a characteristic odor.

	1 ml
Benzydamine hydrochloride	1.5 mg

Excipients : ethanol (ethyl alcohol 95%) – 80 mg, glycerol – 50 mg, methylparahydroxybenzoate (methylparaben) – 1 mg, natural food flavoring MINT – 0.3 mg, sodium saccharin – 0.24 mg, polysorbate 20 – 0.05 mg, sodium bicarbonate – in the amount necessary to adjust pH, purified water – up to 1 ml.

50 ml – bottles (1) with a measuring cup – cardboard boxes.
100 ml – bottles (1) with a measuring cup – cardboard boxes.

Benzydamine [Marbiopharm, JSC (Russia)]
Topical solution 0.15%: 120 ml bottle with a measuring cup

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Benzydamine

Topical solution 0.15%: 120 ml bottle with a measuring cup

Dosage Form, Packaging, and Composition

Topical solution colorless or slightly yellowish with a characteristic menthol odor.

	100 ml
Benzydamine hydrochloride	0.15 g

Excipients : ethanol 95% – 8.084 g, glycerol (glycerin) – 5 g, methylparahydroxybenzoate – 0.1 g, levomenthol (L-menthol) – 0.03 g, saccharin – 0.024 g, sodium bicarbonate – 0.011 g, polysorbate 20 – 0.005 g, purified water – up to 100 ml.

120 ml – brown glass bottles (1) with a measuring cup – cardboard boxes.

Benzydamine [Oxyflurin, LLC (Russia)]
Topical spray, metered 0.255 mg/dose: 30 ml bottle

Marketing Authorization Holder

Oxyflurin, LLC (Russia)

Manufactured By

YUGPHARM, LLC (Russia)

Dosage Form

Benzydamine

Topical spray, metered 0.255 mg/dose: 30 ml bottle

Dosage Form, Packaging, and Composition

Topical metered spray colorless, transparent, with a characteristic mint odor.

	1 dose	1 ml
Benzydamine hydrochloride	0.255 mg	1.5 mg

Excipients : ethanol 95%, glycerol, methylparahydroxybenzoate, mint flavor, sodium saccharin dihydrate, sodium bicarbonate, polysorbate 20, purified water.

30 ml (176 doses) – polyethylene bottles with a dispenser (1) – cardboard boxes.

Benzydamine DS [Solotrade, LLC (Russia)]
Topical spray 0.3%: 15 ml bottle 1 pc.
Topical spray 0.15%: 30 ml bottle 1 pc.

Marketing Authorization Holder

Solotrade, LLC (Russia)

Manufactured By

Danapha Pharmaceutical, Joint Stock Company (Vietnam)

Dosage Forms

	Benzydamine DS	Topical spray 0.3%: 15 ml bottle 1 pc.
		Topical spray 0.15%: 30 ml bottle 1 pc.

Dosage Form, Packaging, and Composition

Topical spray transparent, colorless, with a characteristic mint odor.

	1 ml	15 ml
Benzydamine hydrochloride	3 mg	45 mg

Excipients : glycerol – 1.5 g, ethanol 96% – 2.54 g, sodium saccharin – 7.5 mg, macrogol glyceryl hydroxystearate (PEG-40) – 37.5 mg, sodium hydroxide – 0.014 mg, mint flavor (propylene glycol 63.8%, peppermint oil 15.8%, L-menthol 20.4%) – 15 mg, purified water – up to 15 ml.

15 ml – polyethylene bottles with a spray nozzle (1) – cardboard boxes.

Topical spray transparent, colorless, with a characteristic mint odor.

	1 ml	30 ml
Benzydamine hydrochloride	1.5 mg	45 mg

Excipients : glycerol – 3 g, ethanol 96% – 5.06 g, sodium saccharin – 15 mg, macrogol glyceryl hydroxystearate (PEG-40) – 75 mg, sodium hydroxide – 0.028 mg, mint flavor (propylene glycol 63.8%, peppermint oil 15.8%, L-menthol 20.4%) – 30 mg, purified water – up to 30 ml.

30 ml – polyethylene bottles with a spray nozzle (1) – cardboard boxes.

Benzydamine-Akrikhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Topical spray, metered 0.255 mg/dose: 30 ml bottle