Vicks Sinex (Spray) Instructions for Use

Marketing Authorization Holder

Procter & Gamble Distributor Company LLC (Russia)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Form

Vicks Sinex

Dosed nasal spray 25 mcg/1 dose: 15 ml bottle

Dosage Form, Packaging, and Composition

Dosed nasal spray colorless or colorless with a yellowish tint, transparent, with a characteristic odor, without visible inclusions.

Excipients : sorbitol (70% aqueous solution) – 3570 mcg, sodium citrate dihydrate – 437.5 mcg, polysorbate 80 – 350 mcg, anhydrous citric acid – 100 mcg, benzyl alcohol – 100 mcg, aloe vera – 50 mcg, benzalkonium chloride (50% solution) – 10 mcg, levomenthol – 7.5 mcg, potassium acesulfame – 7.5 mcg, cineole – 6.4 mcg, L-carvone – 5 mcg, disodium edetate – 5 mcg, purified water – up to 50 µl.

15 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – alpha-adrenomimetic

Pharmacological Action

Adrenomimetic agent for topical use. It has a vasoconstrictive effect. With intranasal application, the swelling of the mucous membrane of the upper respiratory tract decreases.

Pharmacokinetics

With intranasal application, T_1/2 is 35 h.

Indications

Difficulty in nasal breathing during colds, inflammation of the nasal sinuses, eustachitis, hay fever, allergic rhinitis.

To eliminate edema before diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only. Prime the pump before first use by pressing the actuator several times until a fine spray appears.

For adults and children over 6 years of age, apply one spray into each nostril. Use no more than two times within a 24-hour period, typically every 10 to 12 hours.

Do not use for more than 3 to 5 consecutive days. Prolonged use can lead to rebound congestion (medication-induced rhinitis).

For children under 6 years of age, consult a physician before use. Do not exceed the recommended dosage or frequency of administration.

To administer, keep the head upright. Insert the tip into the nostril. Squeeze the bottle quickly and firmly while breathing in gently through the nose. Repeat for the other nostril.

Wipe the spray tip clean after each use. Replace the protective cap securely. Discard the product after the recommended duration of therapy to avoid complications from overuse.

Adverse Reactions

Local reactions possibly – burning, dryness of the nasal mucosa, sneezing; rarely – after the effect of the application wears off, the development of a strong feeling of nasal congestion (reactive hyperemia).

Systemic reactions multiple overdoses with topical application can lead to tachycardia and increased blood pressure; very rarely – anxiety, insomnia, fatigue, headaches, nausea.

Contraindications

Atrophic rhinitis, closed-angle glaucoma, hypersensitivity to oxymetazoline.

With caution

Use of MAO inhibitors and the period up to 10 days after their intake; use of drugs that promote an increase in blood pressure and the period up to 10 days after their intake; increased intraocular pressure; severe forms of cardiovascular diseases (arterial hypertension, coronary artery disease), thyrotoxicosis, diabetes mellitus, pregnancy, period of breastfeeding.

Use in Pregnancy and Lactation

Use with caution during pregnancy and during lactation (breastfeeding).

Pediatric Use

Used in children according to indications in appropriate dosage forms.

Geriatric Use

Use with caution in elderly patients to avoid exacerbation of chronic diseases.

Special Precautions

Avoid prolonged use and overdose, especially in children.

Influence on the ability to drive vehicles and mechanisms

When used in doses exceeding the recommended ones, a general effect on the cardiovascular system and central nervous system cannot be excluded. In such cases, a decrease in the ability to drive vehicles and engage in other potentially hazardous activities is possible.

Drug Interactions

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

Oxymetazoline slows down the absorption of local anesthetics, prolongs their action.

Concomitant use of other vasoconstrictor drugs increases the risk of side effects.

Storage Conditions

Store at 15°C (59°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.