Benzydalor (Solution) Instructions for Use

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

ATC Code

A01AD02 (Benzydamine)

Active Substance

Benzydamine (Rec.INN registered by WHO)

Dosage Form

Benzydalor

Topical solution 0.15%: 120 ml or 240 ml bottle 1 pc.

Dosage Form, Packaging, and Composition

Topical solution transparent green in color with a characteristic odor.

Excipients: ethanol 96%, glycerol, methylparaben, menthol flavor, saccharin, sodium bicarbonate, polysorbate 20, quinoline yellow 70% (E104), patent blue 85% (E131), purified water.

120 ml – glass bottles (1) – cardboard packs.
120 ml – polymer bottles (1) with a measuring spoon – cardboard packs.
240 ml – glass bottles (1) – cardboard packs.
240 ml – polymer bottles (1) with a measuring spoon – cardboard packs.

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

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, penetrates well into the site of inflammation along the pH gradient (where the pH is lower) and accumulates in therapeutic concentrations.

It has anti-inflammatory and local analgesic effects, 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 non-specific 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 potent 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, 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 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 pain syndrome in 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

Dosage Regimen

Use the solution for local application only. Do not swallow. The dose depends on the patient’s age and the severity of the condition.

For oral rinsing in adults and adolescents over 12 years of age: use 15 ml of the solution (one tablespoon). Rinse the mouth and throat for 30 seconds to 1 minute every 1.5 to 3 hours as needed for pain relief.

For children aged 6 to 12 years: use 5-10 ml of the solution (one to two teaspoons). Ensure the child gargles correctly under adult supervision to prevent swallowing.

For children aged 3 to 6 years: apply the solution as an oral rinse only under direct adult supervision. Use 5 ml (one teaspoon). Adjust the frequency based on the child’s tolerance and symptom severity.

For local application to the gums or oral mucosa: apply undiluted solution using a cotton swab. Use 2-3 times daily.

Continue treatment for as long as painful symptoms persist. Do not use for more than 7 days without consulting a physician. If symptoms worsen or do not improve after 3 days of treatment, discontinue use and seek medical advice.

If a dose is missed, apply it as soon as remembered. Do not double the dose to make up for a missed one.

Adverse Reactions

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