Oxymetagen^® (Spray, Drops) Instructions for Use

Instructions
Dosage forms

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 the swelling of the mucous membrane of the upper respiratory tract.

Pharmacokinetics

When applied intranasally, the T_1/2 is 35 hours.

Indications

Nasal congestion in colds, sinus inflammation, eustachitis, hay fever, allergic rhinitis.

To relieve swelling before diagnostic manipulations in the nasal passages.

ICD codes

Open the list of 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. Clear nasal passages prior to application.

For the nasal spray: Insert the tip into the nostril. Press the pump firmly and quickly while breathing in gently through the nose. Repeat in the other nostril.

For the nasal drops: Tilt the head back. Instill the prescribed number of drops into each nostril. Remain in position for a minute to allow the solution to spread.

Adults and children over 6 years: Use 1-2 sprays or 2-3 drops into each nostril. Apply twice daily, typically in the morning and evening.

Children aged 1 to 6 years: Use only under medical supervision. Apply 1 drop into each nostril. Limit application to once or twice daily as directed.

The maximum duration of use is 3-5 days. Do not exceed the recommended dosage or frequency of administration.

Discontinue use and consult a physician if symptoms persist or worsen after 3 days of treatment. Avoid prolonged use to prevent medication-induced rhinitis.

Adverse Reactions

Local reactions possible – 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 operate machinery

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