Oxyfrin (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 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, inflammation of the nasal sinuses, 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 according to the specific product form and concentration.
For adults and children over 6 years: instill 1-2 drops or apply 1-2 sprays into each nostril. For the spray, press the actuator quickly and firmly while keeping the bottle upright.
For children aged 2 to 6 years: use only the formulation specifically indicated for this age group. Instill 1 drop or apply 1 spray into each nostril.
Do not use in children under 2 years of age due to the high risk of serious adverse effects.
Apply the medication 2-3 times per day, or as directed by a physician. Allow an interval of at least 8-10 hours between applications.
The maximum duration of continuous use is 3 to 5 days. Do not exceed this duration to avoid the development of rhinitis medicamentosa (rebound congestion).
If symptoms persist beyond 5 days, discontinue use and consult a physician for further evaluation.
Before first use, prime the spray pump by pressing it several times until a fine mist is produced. To administer, gently blow your nose to clear nasal passages. Tilt your head slightly forward and insert the tip into the nostril. Close the other nostril with a finger and breathe in gently while administering the dose.
Avoid exceeding the recommended dosage and frequency. Prolonged use can lead to tolerance and chronic nasal congestion.
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 use may lead to tachycardia and increased blood pressure; very rarely – anxiety, insomnia, fatigue, headaches, nausea.
Contraindications
Atrophic rhinitis, closed-angle glaucoma, hypersensitivity to oxymetazoline.
Use 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, 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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Nasal drops 0.01%: 5 ml bottle
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
 |
Oxyfrin | Nasal drops 0.01%: 5 ml bottle |
Dosage Form, Packaging, and Composition
Nasal drops in the form of a transparent or almost transparent, from almost colorless to light yellow liquid.
| 1 ml | |
| Oxymetazoline hydrochloride | 0.1 mg |
Excipients: anhydrous citric acid – 0.577 mg, sodium citrate dihydrate – 3.823 mg, anhydrous glycerol – 21.165 mg, purified water – up to 1 ml.
5 ml – plastic bottles (1) with a dropper dispenser – cardboard packs.
Metered-dose nasal spray 11.25 mcg/1 dose: 10 ml bottle (190 doses) or 15 ml bottle (280 doses)
Metered-dose nasal spray 22.5 mcg/1 dose: 10 ml bottle (190 doses) or 15 ml bottle (280 doses)
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Forms
|
Oxyfrin | Metered-dose nasal spray 11.25 mcg/1 dose: 10 ml bottle (190 doses) or 15 ml bottle (280 doses) |
| Metered-dose nasal spray 22.5 mcg/1 dose: 10 ml bottle (190 doses) or 15 ml bottle (280 doses) |
Dosage Form, Packaging, and Composition
Metered-dose nasal spray in the form of a transparent or almost transparent, from almost colorless to light yellow liquid.
| 1 dose (45 µl) | |
| Oxymetazoline hydrochloride | 11.25 mcg |
Excipients: anhydrous citric acid – 25.065 mcg, sodium citrate dihydrate – 172.035 mcg, anhydrous glycerol – 952.425 mcg, purified water – 43.839 mg.
10 ml (190 doses) – high-density polyethylene bottles (1) with a dosing nozzle – cardboard packs.
15 ml (280 doses) – high-density polyethylene bottles (1) with a dosing nozzle – cardboard packs.
Metered-dose nasal spray in the form of a transparent or almost transparent, from almost colorless to light yellow liquid.
| 1 dose (45 µl) | |
| Oxymetazoline hydrochloride | 22.5 mcg |
Excipients: anhydrous citric acid – 25.065 mcg, sodium citrate dihydrate – 172.035 mcg, anhydrous glycerol – 952.425 mcg, purified water – 43.828 mg.
10 ml (190 doses) – high-density polyethylene bottles (1) with a dosing nozzle – cardboard packs.
15 ml (280 doses) – high-density polyethylene bottles (1) with a dosing nozzle – cardboard packs.
![Oxyfrin [Spray, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Oxyfrin [Spray, Drops] 2")