Sanorin® (Spray, Drops) Instructions for Use
ATC Code
R01AA08 (Naphazoline)
Active Substance
Naphazoline (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Vasoconstrictor drug for topical use in ENT practice
Pharmacotherapeutic Group
Decongestant – vasoconstrictor (alpha-adrenomimetic)
Pharmacological Action
Alpha-adrenomimetic. When applied to the mucous membranes, it has a rapid, pronounced and prolonged vasoconstrictive effect.
Pharmacokinetics
With topical application, systemic absorption is low.
Indications
For intranasal use: acute rhinitis, allergic rhinitis, sinusitis, eustachitis, laryngitis, laryngeal edema of allergic genesis, laryngeal edema against the background of irradiation, hyperemia of the mucous membrane after operations on the upper respiratory tract, to facilitate rhinoscopy, to stop nosebleeds, to prolong the action of local anesthetics used for superficial anesthesia.
For use in ophthalmology: symptomatic temporary relief of secondary eye hyperemia due to moderate irritating effects and allergic conjunctivitis.
ICD codes
| ICD-10 code | Indication |
| H10.1 | Acute atopic (allergic) conjunctivitis |
| H11.4 | Other conjunctival vascular disorders and cysts (conjunctival hyperemia, edema) |
| H68 | Inflammation and obstruction of Eustachian tube |
| J00 | Acute nasopharyngitis (common cold) |
| J01 | Acute sinusitis |
| J04.0 | Acute laryngitis |
| J30.1 | Allergic rhinitis due to pollen |
| J30.3 | Other allergic rhinitis (perennial allergic rhinitis) |
| J37.0 | Chronic laryngitis |
| J38.4 | Edema of larynx |
| R04.0 | Epistaxis |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| 9A60.01 | Acute atopic conjunctivitis |
| 9A60.02 | Allergic conjunctivitis |
| 9A60.0Y | Other specified papillary conjunctivitis |
| 9A60.0Z | Papillary conjunctivitis, unspecified |
| 9A61.4Z | Vascular disorders of conjunctiva, unspecified |
| AB10.Z | Diseases of the auditory [eustachian] tube, unspecified |
| CA00 | Acute nasopharyngitis |
| CA01 | Acute rhinosinusitis |
| CA05.0 | Acute laryngitis |
| CA08.00 | Allergic rhinitis due to pollen |
| CA08.03 | Other allergic rhinitis |
| CA0G | Chronic laryngitis or laryngotracheitis |
| CA0H.3 | Edema of larynx |
| MD20 | Epistaxis |
| 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 or as ophthalmic drops according to the specific indication and presentation.
For intranasal use in adults and adolescents: instill 1-2 drops or administer 1-2 sprays into each nostril.
Repeat the intranasal application every 4-6 hours as needed for symptom relief.
For ophthalmic use in adults and adolescents: instill 1-2 drops into the conjunctival sac of the affected eye(s).
Repeat the ophthalmic application every 3-4 hours as necessary.
Limit the duration of continuous treatment to 3-5 days for nasal formulations and 72 hours for ophthalmic formulations.
Avoid prolonged use to prevent rebound congestion (rhinitis medicamentosa) and tachyphylaxis.
For pediatric patients, use only age-appropriate formulations and strictly adhere to the specific product’s labeled instructions regarding age restrictions and dosing.
Do not exceed the recommended frequency or duration of application.
If symptoms persist beyond 3 days of nasal use or 72 hours of ophthalmic use, discontinue the product and consult a physician.
Remove contact lenses prior to instilling ophthalmic drops; wait at least 15 minutes before reinsertion.
Adverse Reactions
Local reactions: when used in ophthalmology – burning, itching, pain in the eye area; reactive conjunctival hyperemia, visual disturbance, dryness of the nasal mucosa, mydriasis, increased intraocular pressure; with intranasal use – reactive hyperemia, swelling of the nasal mucosa, irritation of the nasal mucosa, with use for more than 1 week – edema of the nasal mucosa, atrophic rhinitis.
Systemic reactions are possible, mainly in children and elderly patients – pallor of the skin, tachycardia, pain in the heart area, increased blood pressure, increased sweating, tremor, headache, agitation, nausea, drowsiness, dizziness.
Contraindications
Hypersensitivity to naphazoline, arterial hypertension, severe atherosclerosis, thyrotoxicosis, chronic rhinitis, atrophic rhinitis, severe eye diseases, angle-closure glaucoma, diabetes mellitus, tachycardia, simultaneous use of MAO inhibitors and the period up to 14 days after their discontinuation; children’s age – depending on the dosage form.
With cautioncoronary artery disease, prostatic hyperplasia; pheochromocytoma; pregnancy, breastfeeding period; hyperthyroidism, diabetes mellitus, porphyria, dry rhinitis, dry keratoconjunctivitis, glaucoma; use of other drugs that increase blood pressure.
Use in Pregnancy and Lactation
The use of naphazoline during pregnancy and lactation (breastfeeding) is possible only for strict indications in cases where the expected therapeutic effect for the mother outweighs the potential risk of side effects in the fetus or child.
Pediatric Use
It is possible to use in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the drug labels for naphazoline regarding contraindications for the use of specific naphazoline dosage forms in children of different ages. In children, especially young children, the likelihood of developing systemic adverse reactions to naphazoline increases.
Geriatric Use
In elderly patients, the likelihood of developing systemic adverse reactions to naphazoline increases.
Special Precautions
Naphazoline may have a resorptive effect.
With long-term intranasal use, the severity of the vasoconstrictor effect of naphazoline gradually decreases ( tachyphylaxis phenomenon), in connection with which it is recommended to take a break for several days after 5-7 days of use. Prolonged use of the product should be avoided.
If no improvement is observed within 72 hours of using the eye drops, or if irritation or hyperemia increases, or if eye pain or visual disturbances appear, the use of the product should be discontinued and a doctor should be consulted. Direct contact of the product with contact lenses should be avoided. It is recommended to remove contact lenses before using eye drops.
Drug Interactions
Should not be used simultaneously with MAO inhibitors or within 14 days after their discontinuation.
Naphazoline slows down the absorption of local anesthetics (prolongs their action during superficial anesthesia).
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 spray [with menthol and eucalyptus] 0.1%: bottle 10 ml with spraying device
Marketing Authorization Holder
Xantis Pharma, Limited (Cyprus)
Manufactured By
Grotex, LLC (Russia)
Dosage Form
 |
Sanorin® | Nasal spray [with menthol and eucalyptus] 0.1%: bottle 10 ml with spraying device |
Dosage Form, Packaging, and Composition
Nasal spray [with menthol and eucalyptus] in the form of a transparent, colorless or slightly colored liquid with a characteristic odor.
| 1 ml | |
| Naphazoline nitrate | 1 mg |
Excipients: boric acid – 16 mg, liquid sorbitol (non-crystallizing) – 14 mg, macrogol glyceryl hydroxystearate – 2.5 mg, levomenthol – 0.3 mg, cineole (eucalyptol) – 0.2 mg, water for injections – up to 1 ml.
10 ml – bottles (1) complete with a spraying device – cardboard packs.
Nasal spray [for children] 0.05%: fl. 10 ml with dosing applicator
Marketing Authorization Holder
Xantis Pharma, Limited (Cyprus)
Manufactured By
Saneca Pharmaceuticals, a.s. (Slovakia)
Dosage Form
|
Sanorin® | Nasal spray [for children] 0.05%: fl. 10 ml with dosing applicator |
Dosage Form, Packaging, and Composition
Nasal spray [for children] in the form of a transparent, colorless liquid, odorless.
| 1 fl. | |
| Naphazoline nitrate | 0.005 g |
Excipients: boric acid – 0.17 g, methylparahydroxybenzoate – 0.01 g, ethylenediamine – q.s., purified water – up to 10 ml.
10 ml – plastic bottles (1) with a mechanical dosing applicator – cardboard packs.
Nasal drops 0.1%: 10 ml bottle with dropper
Nasal drops 0.05%: 10 ml bottle with dropper
Marketing Authorization Holder
Xantis Pharma, Limited (Cyprus)
Manufactured By
Saneca Pharmaceuticals, a.s. (Slovakia)
Dosage Forms
|
Sanorin® | Nasal drops 0.1%: 10 ml bottle with dropper |
| Nasal drops 0.05%: 10 ml bottle with dropper |
Dosage Form, Packaging, and Composition
Nasal drops 0.1% in the form of a transparent, colorless liquid.
| 1 fl. | |
| Naphazoline nitrate | 0.01 g |
Excipients: boric acid – 0.17 g, methylparahydroxybenzoate – 0.01 g, ethylenediamine – q.s., purified water – up to 10 ml.
10 ml – dark glass bottles (1) with a “SANO” dropper – cardboard packs.
Nasal drops 0.05% in the form of a transparent, colorless liquid.
| 1 fl. | |
| Naphazoline nitrate | 0.005 g |
Excipients: boric acid – 0.17 g, methylparahydroxybenzoate – 0.01 g, ethylenediamine – q.s., purified water – up to 10 ml.
10 ml – dark glass bottles (1) with a “SANO” dropper – cardboard packs.
Nasal spray 0.1%: 10 mL bottle with dosing applicator
Marketing Authorization Holder
Xantis Pharma, Limited (Cyprus)
Manufactured By
Saneca Pharmaceuticals, a.s. (Slovakia)
Dosage Form
|
Sanorin® | Nasal spray 0.1%: 10 mL bottle with dosing applicator |
Dosage Form, Packaging, and Composition
Nasal spray in the form of a transparent, colorless liquid without visible particles and odorless.
| 1 fl. (10 ml) | |
| Naphazoline nitrate | 0.01 g |
Excipients: boric acid – 0.17 g, methylparahydroxybenzoate – 0.01 g, ethylenediamine – q.s. (to pH 4.5-6.0), purified water – up to 10 ml.
10 ml – plastic bottles (1) with a mechanical dosing applicator – cardboard packs.
Nasal drops 0.1%: 10 ml bottle or dropper bottle
Nasal drops 0.05%: 10 ml bottle or dropper bottle
Marketing Authorization Holder
Alsi Pharma, JSC (Russia)
Manufactured By
Grotex, LLC (Russia)
Dosage Forms
|
Sanorin® | Nasal drops 0.1%: 10 ml bottle or dropper bottle |
| Nasal drops 0.05%: 10 ml bottle or dropper bottle |
Dosage Form, Packaging, and Composition
Nasal drops in the form of a transparent, colorless or slightly colored liquid.
| 1 ml | |
| Naphazoline nitrate | 1 mg |
Excipients: boric acid – 20 mg, sea water – 5 mg, 0.1 M sodium hydroxide solution – to pH 4.5-6.0, water for injections – up to 1 ml.
10 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
10 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
Nasal drops in the form of a transparent, colorless or slightly colored liquid.
| 1 ml | |
| Naphazoline nitrate | 0.5 mg |
Excipients: boric acid – 20 mg, sea water – 5 mg, 0.1 M sodium hydroxide solution – to pH 4.5-6.0, water for injections – up to 1 ml.
10 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
10 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
Nasal drops 0.1%: 10 ml bottle with dropper
Marketing Authorization Holder
Xantis Pharma, Limited (Cyprus)
Manufactured By
Saneca Pharmaceuticals, a.s. (Slovakia)
Dosage Form
|
Sanorin® with eucalyptus oil | Nasal drops 0.1%: 10 ml bottle with dropper |
Dosage Form, Packaging, and Composition
Nasal drops 0.1% in the form of a white homogeneous emulsion.
| 1 fl. (10 ml) | |
| Naphazoline nitrate | 0.01 g |
Excipients: boric acid – 0.3 g, cetyl alcohol – 0.004 g, methylparahydroxybenzoate – 0.01 g, eucalyptus globulus leaf oil – 0.00025 g, polysorbate 80 – 0.055 g, cholesterol – 0.008 g, liquid paraffin (mineral oil) – 1.15 g, ethylenediamine – q.s. (to pH 3.0-6.0), purified water – up to 10 ml.
10 ml – dark glass bottles (1) with a “SANO” dropper and cap – cardboard packs.
![Sanorin® [Spray, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Sanorin® [Spray, Drops] 2")