Loroseptin (Spray) Instructions for Use

Marketing Authorization Holder

Veropharm, JSC (Russia)

Manufactured By

Pharmactiv Ilac Sanayi Ve Ticaret, A.S. (Turkey)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Chlorhexidine (Rec.INN registered by WHO)

Benzydamine (Rec.INN registered by WHO)

Dosage Form

Loroseptin

Dosed spray for topical use 0.3 mg+0.24 mg/1 dose: 130 dose bottle.

Dosage Form, Packaging, and Composition

Spray for topical use as a clear green solution with a characteristic peppermint odor.

Excipients: sorbitol (sorbitol liquid 70%) – 4.8 g, glycerol – 1.5 g, polysorbate 20 – 0.015 g, ethanol 96%* – 2.415-2.436 g (3 ml), food coloring tartrazine – 0.00018 g, peppermint flavor – 0.009 g, patent blue coloring – 0.00009 g, purified water – up to 30 ml.

130 doses – bottles (1) with an applicator and a dosing pump – cardboard packs.

* the density of 96% ethanol is taken in the range from 0.805 – 0.812 g/ml, the weight is calculated depending on the value

Clinical-Pharmacological Group

NSAIDs for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Nonsteroidal anti-inflammatory drug (NSAID) + antiseptic agent

Pharmacological Action

Combined medicinal product for topical use.

Benzydamine is an NSAID from the indazole group. It has anti-inflammatory and local analgesic effects, 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 antibacterial and specific antimicrobial action 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.

Chlorhexidine is an antiseptic agent with a predominantly bactericidal action. Chlorhexidine, depending on the concentration used, exhibits bacteriostatic or bactericidal action against gram-positive and gram-negative bacteria. It retains activity (although somewhat reduced) in the presence of blood, pus, various secretions and organic substances.

Pharmacokinetics

Benzydamine is absorbed through the mucous membranes. 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.

Chlorhexidine is not absorbed into the systemic circulation when applied topically.

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; periodontal disease.

ICD codes

Dosage Regimen

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

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

Direct the spray nozzle toward the affected area. For oropharyngeal use, depress the actuator firmly and completely to release one measured dose.

Administer 2 to 3 sprays per application, with the frequency of application being from 2 to 6 times daily based on symptom severity.

The maximum daily number of doses is 18 sprays.

Do not eat or drink for 15-30 minutes after application to enhance local therapeutic effect.

The total duration of treatment must not exceed 7 days.

If symptoms persist beyond one week, discontinue use and consult a physician for re-evaluation.

For adolescents aged 12 to 18 years, use the same dosage as adults but with caution and under medical supervision.

This product is contraindicated for children under 12 years of age.

Adverse Reactions

From the immune system rarely – hypersensitivity reactions.

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

From the respiratory system rarely – bronchospasm.

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

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

Allergic reactions rarely – urticaria; frequency unknown – angioedema.

Contraindications

Children under 12 years of age; pregnancy, breastfeeding period; hypersensitivity to benzydamine, chlorhexidine.

With caution

Hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including history), liver diseases, alcoholism, traumatic brain injury, brain diseases, children aged 12 to 18 years.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in patients with liver diseases.

Pediatric Use

Contraindicated for use in children under 12 years of age. Use with caution in adolescents aged 12 to 18 years.

Geriatric Use

The drug is approved for use in elderly patients

Special Precautions

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.

Chlorhexidine is not used in combination with anionic compounds, including soap. Incompatible with carbonates, chlorides, phosphates, borates, sulfates and citrates. The use of hard water reduces bactericidal properties. Compatible with medicinal products containing a cationic group (benzalkonium chloride, cetrimonium bromide).

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.