Zvezdochka noz plus (Spray) Instructions for Use

Marketing Authorization Holder

Dominanta-Service, JSC (Russia)

Manufactured By

Danapha Pharmaceutical, Joint Stock Company (Vietnam)

ATC Code

R01AB06 (Xylometazoline in combination with other drugs)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	Zvezdochka noz plus	Nasal spray 0.1 mg+5 mg/dose
		Nasal spray 0.05 mg+5 mg/dose

Dosage Form, Packaging, and Composition

Nasal spray

10 ml – bottles – carton packs – Over-the-Counter
15 ml – bottles – carton packs – Over-the-Counter
20 ml – bottles – carton packs – Over-the-Counter

Nasal spray

10 ml – bottles – carton packs – Over-the-Counter
15 ml – bottles – carton packs – Over-the-Counter
20 ml – bottles – carton packs – Over-the-Counter

Pharmacotherapeutic Group

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

Pharmacological Action

Combined medicinal product for topical use.

Xylometazoline belongs to the group of topical 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-group 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 to beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg/L, and in the blood serum 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

For intranasal use only. Clean the nasal passages thoroughly before each administration.

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

For the 0.05 mg+5 mg/dose strength, use in children aged 2 to 6 years only under strict medical supervision. Administer one spray into each nostril, up to two times per day.

The maximum duration of continuous treatment is 5 days. Do not exceed the recommended dosage or duration of use.

To administer, hold the bottle upright. Insert the tip into the nostril. Press the pump firmly and briefly while breathing in gently through the nose. Repeat for the other nostril.

If no improvement is observed within 3 days, discontinue use and consult a physician. Avoid prolonged use to prevent rebound congestion and medication-induced rhinitis.

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 clean the nasal passages.

Should not be used for more than 5 days.

Effect on the ability to drive vehicles and operate machinery

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 30°C (86°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.