SeptaNazal^® (Spray) Instructions for Use

ATC Code

R01AB06 (Xylometazoline in combination with other drugs)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

Xylometazoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics, combinations without corticosteroids

Pharmacological Action

A combined medicinal product for topical use.

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity; it causes constriction of the blood vessels of the nasal mucosa, restores the patency of the nasal passages, and facilitates nasal breathing. The drug’s effect usually begins within a few minutes after application and lasts up to 10 hours.

Dexpanthenol is a B vitamin, a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A and is involved in acetylation processes, carbohydrate and fat metabolism, and in the synthesis of acetylcholine, corticosteroids, and porphyrins; it stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis, and increases the strength of collagen fibers. It has a regenerating, metabolic, and mild anti-inflammatory effect.

Pharmacokinetics

Xylometazoline, when applied topically, is practically not absorbed; plasma concentrations are so low that they cannot be determined by modern analytical methods.

Dexpanthenol, when applied topically, is rapidly absorbed by the skin and converted into pantothenic acid, which binds to plasma proteins (mainly beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg/L, and in the blood serum it is 100 µg/L. Pantothenic acid is not metabolized in the body (except for incorporation into CoA) and is excreted unchanged.

Indications

Acute respiratory diseases with symptoms of rhinitis; acute allergic rhinitis; vasomotor rhinitis; sinusitis; otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa); to facilitate rhinoscopy; to restore impaired nasal breathing after surgical interventions in the nasal cavity.

ICD codes

Dosage Regimen

Administer the spray intranasally only. Clear the nasal passages thoroughly before each application.

For adults and children over 6 years of age, administer one spray into each nostril. The recommended frequency is three to four times per day.

Do not exceed the recommended dosage. The maximum duration of continuous treatment is five days.

Limit use to three days if symptoms persist. Prolonged use beyond five days can lead to rebound congestion (rhinitis medicamentosa).

This product is contraindicated for children under 6 years of age. For children aged 2 to 6 years, use only formulations specifically designed for this age group.

If the condition worsens or does not improve after the recommended treatment period, discontinue use and consult a physician.

Adverse Reactions

With frequent and/or prolonged use: irritation and/or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion, allergic reactions, swelling of the nasal mucosa, vomiting, headache, dry rhinitis, palpitations, increased blood pressure, insomnia, visual disturbances, depression (with long-term use of high doses).

Contraindications

Arterial hypertension; tachycardia; severe atherosclerosis; atrophic rhinitis; hyperthyroidism; porphyria; prostatic hyperplasia; glaucoma; surgical interventions on the meninges (in history); children under 2 years of age; children under 6 years of age (for dosage forms intended for older children and adults); simultaneous therapy with MAO inhibitors and tricyclic antidepressants; hypersensitivity to the components of the medicinal product.

With caution

Diabetes mellitus, pheochromocytoma.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is not recommended.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

Before use, it is necessary to clear the nasal passages.

Should not be used for more than 5 days.

Influence on the ability to drive vehicles and mechanisms

During the period of use, precautions should be observed, or driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions should be avoided.

Drug Interactions

With simultaneous use of MAO inhibitors and tricyclic antidepressants, an increase in systemic action is possible.

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.