Septolete^® Total (Tablets, Spray) Instructions for Use

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Cetylpyridinium chloride (Rec.INN registered by WHO)

Benzydamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antimicrobial and anti-inflammatory action for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; other drugs for the treatment of throat diseases

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 has 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 lysosomes.

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 was 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, and belongs 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 the pain syndrome of 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; periodontitis.

ICD codes

Dosage Regimen

Use the drug topically after meals. Do not eat or drink for 15 minutes after application.

For tablets, dissolve slowly in the mouth until completely dissolved. Do not chew or swallow whole.

For spray, direct the spray nozzle toward the affected area of the throat or oral cavity before actuation.

For adults and children 12 years and older, use 1 tablet or 2 sprays up to 5 times daily.

For children 6 to 11 years old, use 1 tablet up to 5 times daily. The spray is contraindicated for this age group.

The maximum daily dosage is 5 tablets or 10 sprays.

Do not use the drug for more than 7 consecutive days without medical consultation.

If symptoms persist or worsen after 3 days of treatment, discontinue use and consult a physician.

Avoid simultaneous use with toothpaste or other products containing anionic compounds.

Adverse Reactions

Definition of the frequency of adverse reactions: 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 group of antiseptics 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.