Septofort Total (Spray) Instructions for Use

Marketing Authorization Holder

Diamed-Pharma, LLC (Russia)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Cetylpyridinium chloride (Rec.INN registered by WHO)

Benzydamine (Rec.INN registered by WHO)

Dosage Form

Septofort Total

Dosed spray for topical application 0.15 mg/mL+0.5 mg/mL: 30 mL bottle

Dosage Form, Packaging, and Composition

Spray for topical application in the form of a colorless or yellowish, clear liquid with a mint odor.

Excipients: ethanol (ethyl alcohol) 96%, glycerol, macrogolglycerol hydroxystearate, peppermint leaf oil, sodium saccharin, purified water.

30 g (250 doses) – bottles – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Nonsteroidal anti-inflammatory drug (NSAID) + antiseptic agent

Pharmacological Action

A combined medicinal product for topical use.

Benzydamine is an NSAID from the indazole group. It has an anti-inflammatory and local analgesic effect, and possesses an antiseptic effect against a wide range of microorganisms. The mechanism of action of the drug is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis.

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

It has an antifungal effect against Candida albicans. It causes structural modifications of the fungal cell wall and their metabolic chains, thus preventing their reproduction, which is the basis for the use of benzydamine in inflammatory processes in the oral cavity, including those of infectious etiology.

Cetylpyridinium chloride is an antiseptic, a quaternary ammonium compound, belonging to cationic surfactants. It has antimicrobial activity against gram-positive and, to a lesser extent, gram-negative bacteria. It does not affect bacterial spores. It has variable antifungal activity and is effective against some viruses.

Pharmacokinetics

Of the two active substances – Cetylpyridinium chloride and benzydamine – only benzydamine is absorbed through the mucous membranes. Therefore, Cetylpyridinium chloride does not enter into pharmacokinetic interaction with benzydamine at the systemic level. The absorption of benzydamine through the mucous membranes of the oral cavity and pharynx was demonstrated by the detection of the active substance in the blood serum, the amount of which, however, was insufficient to exert a systemic effect. It is excreted mainly by the kidneys, mostly in the form of inactive metabolites.

Indications

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

ICD codes

Dosage Regimen

Use the spray after meals for topical application in the oral cavity and pharynx.

Before first use, perform 2-3 test sprays into the air to prime the pump mechanism.

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

For children aged 6 to 12 years, administer 2-4 sprays.

The dosing frequency is every 1.5 to 3 hours, or as directed by a physician, depending on the severity of symptoms.

Direct the spray nozzle towards the inflamed areas of the oral mucosa, tonsils, or posterior pharyngeal wall.

Refrain from eating or drinking for at least 15 minutes after application to ensure prolonged local contact.

Do not exceed the maximum daily frequency of 8 applications.

The standard treatment course is up to 7 days.

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

Avoid using the spray immediately before or after brushing teeth with toothpaste containing anionic compounds.

Adverse Reactions

Definition of adverse reaction frequency: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10,000 to <1/1000); very rare (<1/10,000); frequency unknown (cannot be estimated from the available data).

From the immune system rare – hypersensitivity reactions.

From the nervous system frequency unknown – numbness of the oral mucosa.

From the respiratory system rare – bronchospasm.

From the digestive system very rare – irritation of the oral mucosa, burning sensation in the mouth.

From the skin and subcutaneous tissues rare – photosensitivity; frequency unknown – skin itching.

Allergic reactions rare – urticaria; frequency unknown – angioedema.

Contraindications

Children under 6 years of age; children under 12 years of age (for spray); hypersensitivity to benzydamine or cetylpyridinium chloride.

With caution

Hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including history), liver disease, alcoholism, traumatic brain injury, brain diseases, pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Should not be used during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

In the presence of ulcerative lesions of the oropharyngeal mucosa, the patient should consult a doctor if symptoms persist for more than 3 days.

Should not be used simultaneously with anionic compounds (for example, they are present in toothpaste). Therefore, it is not recommended to use immediately before or after brushing teeth.

Drug Interactions

Concomitant use with other drugs from the antiseptic group should be avoided.

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.