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Rhinostop® Extra (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

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics

Pharmacological Action

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

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

Pharmacokinetics

When applied intranasally, T1/2 is 35 hours.

Indications

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

To relieve swelling before diagnostic procedures 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 appropriate for the patient’s age and condition.

For adults and children over 6 years: instill 1-2 drops or apply 1 injection into each nostril. Repeat this dosage 2-3 times daily as needed for nasal congestion.

For children aged 2 to 6 years: use only under medical supervision. Instill 1 drop or apply 1 injection into each nostril. Limit application to a maximum of 2 times daily.

Do not use in children under 2 years of age due to the high risk of severe adverse effects.

Limit the total duration of treatment to 3-5 consecutive days. Do not exceed the recommended frequency or duration of use.

To administer, gently tilt the head back. Insert the tip of the dropper or spray into the nostril. For sprays, press down firmly and quickly while breathing in gently through the nose.

Avoid prolonged use to prevent the development of 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 increased 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.

Effect 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, the ability to drive vehicles and engage in other potentially hazardous activities may be reduced.

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

Otisipharm, JSC (Russia)

Manufactured By

Lekko, CJS (Russia)

Dosage Forms

Bottle OTC Icon Rhinostop® Extra Nasal drops 0.01%: 5 ml, 10 ml, or 15 ml bottle
Nasal drops 0.05%: 5 mL, 10 mL, or 15 mL bottle
Nasal drops 0.025%: 5 mL, 10 mL, or 15 mL bottle

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless or yellowish solution.

1 ml
Oxymetazoline hydrochloride 0.1 mg

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

5 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.
10 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.
15 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.

Nasal drops as a clear, colorless or yellowish solution.

1 ml
Oxymetazoline hydrochloride 0.5 mg

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

5 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.
10 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.
15 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.

Nasal drops as a clear colorless or yellowish solution.

1 ml
Oxymetazoline hydrochloride 0.25 mg

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

5 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.
10 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.
15 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Rhinostop® Extra Nasal spray 0.025%: 15 ml bottle

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly yellowish liquid.

1 ml
Oxymetazoline hydrochloride 0.25 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 – polymer bottles (1) with a pump and actuator included with a protective cap – cardboard packs.

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Rhinostop® Extra Nasal spray 0.05%: bottle 15 ml

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly yellowish liquid.

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 – polymer bottles (1) with a pump and actuator included with a protective cap – cardboard packs.

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Rhinostop® Extra with menthol and eucalyptus Dosed nasal spray [with menthol and eucalyptus aroma] 22.5 mcg/1 dose: fl. 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Dosed nasal spray in the form of a colorless or with a yellowish tint, clear or opalescent solution with the smell of menthol and eucalyptus.

1 dose
Oxymetazoline hydrochloride 22.5 mcg

Excipients : levomenthol (L-menthol) – 18 mcg, eucalyptus rod-shaped leaves oil (eucalyptus oil) – 18 mcg, disodium edetate dihydrate – 22.5 mcg, sodium hydrogen phosphate dodecahydrate – 111.6 mcg, sodium dihydrogen phosphate dihydrate – 2339.6 mcg, propylene glycol – 4500 mcg, benzyl alcohol – 450 mcg, benzalkonium chloride – 6.8 mcg, purified water – up to 0.045 ml.

10 ml – bottles (1) with a dosing pump and sprayer – cardboard packs.
15 ml – bottles (1) with a dosing pump and sprayer – cardboard packs.

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