Nasivin® Sensitive (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 elimination half-life (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 formulation as appropriate for the patient’s age and condition.
For adults and children over 6 years, apply one spray or 1-2 drops into each nostril. For the spray, press the applicator once firmly. Repeat this application 2-3 times per day as needed for nasal congestion.
For children aged 1 to 6 years, use only the formulation and concentration specifically approved for this age group. Apply one drop into each nostril. Repeat this application 2-3 times per day as required.
Do not use in infants under 1 year of age unless explicitly directed by a physician.
Limit the total duration of treatment to 3-5 days. Do not exceed the recommended dosage frequency. Prolonged use increases the risk of rebound congestion (medication-induced rhinitis).
Before using the spray, clear the nasal passages. Tilt your head back slightly for drops. Avoid the tip of the applicator touching the nasal septum or other surfaces to prevent contamination.
If symptoms persist beyond 5 days, discontinue use and consult a physician. Do not use with other intranasal vasoconstrictors concurrently.
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 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 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.
Effect on 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 30°C (86°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
Dosed nasal spray 11.25 µg/1 dose: 10 ml bottle (220 doses) with dosing device
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Famar Health Care Services Madrid, S.A.U. (Spain)
Dosage Form
 |
Nasivin® Sensitive | Dosed nasal spray 11.25 µg/1 dose: 10 ml bottle (220 doses) with dosing device |
Dosage Form, Packaging, and Composition
Dosed nasal spray in the form of a transparent or almost transparent solution from almost colorless to slightly yellow.
| 1 dose | 1 ml | |
| Oxymetazoline hydrochloride | 11.25 µg | 250 µg |
Excipients : citric acid monohydrate – 27.40 µg, sodium citrate dihydrate – 172.03 µg, glycerol 85% – 1121.44 µg, purified water – 44027.86 µg.
10 ml (220 doses) – polyethylene bottles with a dosing device (1) – cardboard packs.
Dosed nasal spray 22.5 µg/1 dose: 10 ml bottle (220 doses) with dosing device
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Famar Health Care Services Madrid, S.A.U. (Spain)
Dosage Form
|
Nasivin® Sensitive | Dosed nasal spray 22.5 µg/1 dose: 10 ml bottle (220 doses) with dosing device |
Dosage Form, Packaging, and Composition
Dosed nasal spray in the form of a transparent or almost transparent solution from almost colorless to slightly yellow.
| 1 dose | 1 ml | |
| Oxymetazoline hydrochloride | 22.5 µg | 500 µg |
Excipients : citric acid monohydrate – 27.40 µg, sodium citrate dihydrate – 172.03 µg, glycerol 85% – 1121.44 µg, purified water – 44016.6 µg.
10 ml (220 doses) – polyethylene bottles with a dosing device (1) – cardboard packs.
Dosed nasal spray 11.25 µg/1 dose: 10 ml bottle (220 doses) with dosing device
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Pharmaster (France)
Dosage Form
|
Nasivin® Sensitive | Dosed nasal spray 11.25 µg/1 dose: 10 ml bottle (220 doses) with dosing device |
Dosage Form, Packaging, and Composition
Dosed nasal spray in the form of a transparent or almost transparent solution from almost colorless to slightly yellow.
| 1 dose | 1 ml | |
| Oxymetazoline hydrochloride | 11.25 µg | 250 µg |
Excipients : citric acid monohydrate – 609 µg, sodium citrate dihydrate – 3.823 mg, glycerol 85% – 24.921 mg, purified water – 978.397 mg.
10 ml (220 doses) – polyethylene bottles with a dosing device (1) – cardboard packs.
Dosed nasal spray 22.5 µg/1 dose: 10 ml bottle (220 doses) with dosing device
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Pharmaster (France)
Dosage Form
|
Nasivin® Sensitive | Dosed nasal spray 22.5 µg/1 dose: 10 ml bottle (220 doses) with dosing device |
Dosage Form, Packaging, and Composition
Dosed nasal spray in the form of a transparent or almost transparent solution from almost colorless to slightly yellow.
| 1 dose | 1 ml | |
| Oxymetazoline hydrochloride | 22.5 µg | 500 µg |
Excipients : citric acid monohydrate – 609 µg, sodium citrate dihydrate – 3.823 mg, glycerol 85% – 24.921 mg, purified water – 978.147 mg.
10 ml (220 doses) – polyethylene bottles with a dosing device (1) – cardboard packs.
Nasal drops 0.01%: 5 ml bottle
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Famar Health Care Services Madrid, S.A.U. (Spain)
Quality Control Release
MERCK KGaA & Co. Werk Spittal (Austria)
Dosage Form
|
Nasivin® Sensitive | Nasal drops 0.01%: 5 ml bottle |
Dosage Form, Packaging, and Composition
Nasal drops 0.01% in the form of a transparent or almost transparent solution from almost colorless to slightly yellow.
| 1 ml | |
| Oxymetazoline hydrochloride | 100 µg |
Excipients : citric acid monohydrate – 0.609 mg, sodium citrate dihydrate – 3.823 mg, glycerol 85% – 24.921 mg, purified water – 978.547 mg.
5 ml – polyethylene bottles (1) – cardboard packs.
Nasal drops 0.01%: bottle 5 ml with dropper cap
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Sofarimex Industria Quimica e Farmaceutica S.A. (Portugal)
Dosage Form
|
Nasivin® | Nasal drops 0.01%: bottle 5 ml with dropper cap |
Dosage Form, Packaging, and Composition
Nasal drops in the form of an almost transparent solution from colorless to slightly yellowish.
| 1 ml | |
| Oxymetazoline hydrochloride | 100 µg |
Excipients : benzalkonium chloride (50% solution), disodium edetate dihydrate, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, sodium hydroxide (1M solution), purified water.
5 ml – dark glass bottles with a dropper cap (1) – cardboard packs.
Nasal drops 0.025%: 10 ml bottle with dropper cap
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Sofarimex Industria Quimica e Farmaceutica S.A. (Portugal)
Dosage Form
|
Nasivin® | Nasal drops 0.025%: 10 ml bottle with dropper cap |
Dosage Form, Packaging, and Composition
Nasal drops in the form of an almost transparent solution from colorless to slightly yellowish.
| 1 ml | |
| Oxymetazoline hydrochloride | 250 µg |
Excipients : benzalkonium chloride (50% solution), disodium edetate dihydrate, sodium dihydrogen phosphate dihydrate, sodium hydroxide (1M solution), purified water.
10 ml – dark glass bottles with a dropper cap (1) – cardboard packs.
Nasal drops 0.05%: 10 ml bottle with dropper cap
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Sofarimex Industria Quimica e Farmaceutica S.A. (Portugal)
Dosage Form
|
Nasivin® | Nasal drops 0.05%: 10 ml bottle with dropper cap |
Dosage Form, Packaging, and Composition
Nasal drops in the form of an almost transparent solution from colorless to slightly yellowish.
| 1 ml | |
| Oxymetazoline hydrochloride | 500 µg |
Excipients : benzalkonium chloride (50% solution), disodium edetate dihydrate, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, sodium hydroxide (1M solution), purified water.
10 ml – dark glass bottles with a dropper cap (1) – cardboard packs.
Dosed nasal spray 22.5 µl/dose: 10 ml bottle
Marketing Authorization Holder
P&G Health Germany, GmbH (Germany)
Manufactured By
Sofarimex Industria Quimica e Farmaceutica S.A. (Portugal)
Dosage Form
|
Nasivin® | Dosed nasal spray 22.5 µl/dose: 10 ml bottle |
Dosage Form, Packaging, and Composition
Dosed nasal spray in the form of an almost transparent solution from almost colorless to slightly yellow.
| 1 dose | |
| Oxymetazoline hydrochloride | 22.5 µg |
Excipients : citric acid monohydrate – 27.4 µg, sodium citrate dihydrate – 172.0 µg, glycerol 85% – 1095.66 µg, benzalkonium chloride (50% solution) – 4.5 µg, purified water – 44037 µg.
10 ml – brown glass bottles with a dosing device and a protective cap (1) – cardboard packs.
![Nasivin® Sensitive [Spray, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Nasivin® Sensitive [Spray, Drops] 2")