ORO-fort (Spray) Instructions for Use

Marketing Authorization Holder

Fortiva Med, LLC (Republic of Belarus)

ATC Code

A01AD02 (Benzydamine)

Active Substance

Benzydamine (Rec.INN registered by WHO)

Dosage Form

ORO-fort

Spray for topical use 1.5 mg/1 ml: bottle 30 ml with nozzle

Dosage Form, Packaging, and Composition

Spray for topical use in the form of a colorless, transparent liquid with a faint mint odor.

Excipients: ethanol (ethyl alcohol) 96% – 80 mg, glycerol – 50 mg, methylparahydroxybenzoate – 1 mg, natural flavor “Peppermint” (mint oil, peppermint oil, levomenthol acetate, propylene glycol USP (E1520)) – 0.3 mg, sodium saccharin – 0.24 mg, sodium bicarbonate – 0.11 mg, polysorbate 20 – 0.05 mg, purified water – up to 1 ml.

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

Clinical-Pharmacological Group

NSAIDs for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

NSAID

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 (while 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 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 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 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, 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 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 produce 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, periodontal disease, 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 topically only. Administer the spray directly to the affected areas of the oral cavity or oropharynx.

For adults and adolescents aged 12 years and older, administer 4 to 8 sprays, equivalent to 2 to 4 mg of benzydamine, every 1.5 to 3 hours as needed for pain relief.

For children aged 6 to 12 years, administer 4 sprays, equivalent to 2 mg of benzydamine, every 1.5 to 3 hours.

For children aged 3 to 6 years, administer 1 spray per 4 kg of body weight, with a maximum single dose of 4 sprays; administer every 1.5 to 3 hours.

Do not use in children under 3 years of age due to risk of laryngospasm.

Before first use, prime the pump by pressing the nozzle several times until a fine spray is produced.

Direct the spray nozzle towards the inflamed area. Hold your breath during administration to avoid inhalation.

Continue treatment for as long as painful symptoms persist. Do not exceed 7 days of continuous use without medical consultation.

If symptoms worsen or do not improve after 3 days of treatment, discontinue use and consult a physician.

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 drug 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 drug 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.