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Sopioxym® (Spray, Drops) Instructions for Use

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – vasoconstrictor (alpha-adrenomimetic)

Pharmacological Action

Adrenomimetic agent for topical use. It has a vasoconstrictive effect.

When applied intranasally, it reduces the swelling of the mucous membrane of the upper respiratory tract.

Pharmacokinetics

When applied intranasally, the T1/2 is 35 hours.

Indications

Difficulty in nasal breathing during colds, sinus inflammation, eustachitis, hay fever, allergic rhinitis.

To eliminate edema before diagnostic manipulations in the nasal passages.

ICD codes

ICD-10 code Indication
H68 Inflammation and obstruction of Eustachian tube
J00 Acute nasopharyngitis (common cold)
J01 Acute sinusitis
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
J31.0 Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J32 Chronic sinusitis
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
AB10.Z Diseases of the auditory [eustachian] tube, unspecified
CA00 Acute nasopharyngitis
CA01 Acute rhinosinusitis
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis
CA09.0 Chronic rhinitis
CA0A.Z Chronic rhinosinusitis, unspecified
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer intranasally only. Use the spray or drops formulation as directed.

For adults and children over 6 years: apply 1-2 drops or 1 injection into each nostril.

Repeat this dosage 2-3 times per day as needed for nasal congestion relief.

The maximum duration of use is 3-5 days. Do not exceed this treatment period.

For children aged 2 to 6 years, use only under medical supervision. Apply 1 drop or a single, brief spray into each nostril.

Administer to children no more than 2 times per day. The total treatment course should not exceed 3 days.

Do not use in children under 2 years of age. This is contraindicated due to the risk of serious adverse effects.

Wait at least 8-10 hours between applications to avoid overuse. Exceeding the recommended dosage or frequency increases the risk of systemic side effects and rebound congestion (rhinitis medicamentosa).

If symptoms persist beyond 5 days, discontinue use and consult a physician.

Adverse Reactions

Local reactions possibly – burning, dryness of the nasal mucosa, sneezing; rarely – after the effect of 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 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 and prolongs their action.

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

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

Bottle OTC Icon SOPIOXYM® CAP Nasal drops 0.01%: 10 ml dropper bottle
Nasal drops 0.05%: 10 ml dropper bottle
Nasal drops 0.025%: 10 ml dropper bottle

Dosage Form, Packaging, and Composition

Nasal drops – a transparent colorless or slightly yellowish solution.

1 ml
Oxymetazoline hydrochloride 0.1 mg

Excipients : benzalkonium chloride 50% solution (consisting of: benzalkonium chloride – 0.05 mg, purified water – 0.05 mg) – 0.1 mg, citric acid monohydrate – 0.6093 mg, sodium citrate dihydrate – 3.823 mg, glycerol 85% – 24.348 mg, purified water – up to 1 ml.

10 ml – dropper bottle (1) – cardboard packs.

Nasal drops – a transparent colorless or slightly yellowish solution.

1 ml
Oxymetazoline hydrochloride 0.5 mg

Excipients : benzalkonium chloride 50% solution (consisting of: benzalkonium chloride – 0.05 mg, purified water – 0.05 mg) – 0.1 mg, citric acid monohydrate – 0.6093 mg, sodium citrate dihydrate – 3.823 mg, glycerol 85% – 24.348 mg, purified water – up to 1 ml.

10 ml – dropper bottle (1) – cardboard packs.

Nasal drops – a transparent colorless or slightly yellowish solution.

1 ml
Oxymetazoline hydrochloride 0.25 mg

Excipients : benzalkonium chloride 50% solution (consisting of: benzalkonium chloride – 0.05 mg, purified water – 0.05 mg) – 0.1 mg, citric acid monohydrate – 0.6093 mg, sodium citrate dihydrate – 3.823 mg, glycerol 85% – 24.348 mg, purified water – up to 1 ml.

10 ml – dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Manufactured By

Usolye-Sibirskiy Chemical and Pharmaceutical Combine, JSC (Russia)

Dosage Forms

Bottle OTC Icon SOPIOXYM® S Nasal spray 0.05%: 15 ml bottle, 1 pc. with spray nozzle
Nasal spray 0.025%: 15 ml bottle, 1 pc. with spray nozzle

Dosage Form, Packaging, and Composition

Nasal spray as a transparent colorless or slightly yellowish solution.

1 ml
Oxymetazoline hydrochloride 0.5 mg

Excipients : citric acid monohydrate – 0.609 mg, sodium citrate dihydrate – 3.823 mg, glycerol – 24.348 mg, benzalkonium chloride – 0.15 mg, purified water – up to 1 ml.

15 ml – polyethylene bottles with a spray nozzle (1) – cardboard packs.

Nasal spray as a transparent colorless or slightly yellowish solution.

1 ml
Oxymetazoline hydrochloride 0.25 mg

Excipients : citric acid anhydride – 0.609 mg, sodium citrate dihydrate – 3.823 mg, glycerol – 24.348 mg, benzalkonium chloride – 0.15 mg, purified water – up to 1 ml.

15 ml – polyethylene bottles with a spray nozzle (1) – cardboard packs.

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