Instruction for use: Otrivin

Active substance: Xylometazoline

ATX Code R01AA07 Xylometazoline

Pharmacotherapeutic group:

Alpha-adrenoceptor agonists

decongestant

The nosological classification (ICD-10)

H66.9 Otitis media, unspecified

Chronic otitis, Otitis, otitis media, middle ear infections, Otitis media in children

H68 inflammation and blockage of the ear [Eustachian] pipes

Eustachian, acute evstahiit, Qatar Eustachian tubes, Evstaheit

J00 Acute nasopharyngitis [runny nose]

Viral rhinitis, Inflammation of the nasopharynx, Inflammatory diseases of the nose, purulent rhinitis, Nasal congestion, Nasal congestion with colds and flu, The difficulty of nasal breathing, The difficulty of nasal breathing for colds, Difficulty in nasal breathing, Difficulty in nasal breathing in colds, nasal, hypersecretion, cold, ARI with rhinitis phenomena, coryza, Acute rhinitis of various origins, Acute rhinitis with thick purulent mucous exudate, Acute nasopharyngitis, Swelling of the mucosa of the nasopharynx, Rhinitis, rhinorrhea, Infectious-inflammatory diseases of ENT organs, heavy cold, rhinopharyngitis, nasopharyngitis

J01 Acute sinusitis

Inflammation of the sinuses, Inflammatory diseases of the paranasal sinuses, Purulent inflammation of the paranasal sinuses, Infectious-inflammatory diseases of ENT organs, Infection of the sinuses, Combined sinusitis, Exacerbation of sinusitis, Acute inflammation of the paranasal sinuses, Acute bacterial sinusitis, Acute sinusitis in adults, Subacute sinusitis, acute Sinusitis, sinusitis

J06 Acute upper respiratory infections of multiple and unspecified

Frequent colds viral diseases, Infections of the upper respiratory tract, Acute respiratory disease influenza character, for colds Pain, Acute colds,Cold, respiratory infection,Seasonal colds, Pain in infectious and inflammatory diseases of the upper respiratory tract, Bacterial infections of the upper respiratory tract, Bacterial respiratory infections, Viral disease of the respiratory tract, Viral respiratory tract infections, Inflammatory disease of the upper respiratory tract, Inflammation of the upper respiratory tract disease, Inflammation of the upper respiratory tract illness with difficult sputum, Inflammatory airway disease, Secondary infections with colds, Shortness of sputum in acute and chronic respiratory diseases, Upper respiratory tract infection, Infections of the upper respiratory tract, Respiratory Tract Infections, Infections of the respiratory tract and lungs, Infectious-inflammatory diseases of the upper respiratory tract, Infectious-inflammatory diseases of the upper respiratory tract and ENT-organs, Infectious-inflammatory diseases of the upper respiratory tract in children and adults, Infectious-inflammatory diseases of the upper respiratory tract, Infectious inflammation of the airways,respiratory infection, Qatar upper respiratory tract, Catarrh of the upper respiratory tract, Catarrhal disease of the upper respiratory tract, Catarrhal symptoms of the upper respiratory tract, Coughing with a cold, SARS, ARI, ARI with rhinitis phenomena, Acute respiratory infection, Acute infectious and inflammatory disease of the upper respiratory tract, Acute respiratory disease, Sore throat or nose, Respiratory viral infections, Respiratory diseases, Respiratory infections, Recurrent respiratory infections, Secondary infection with influenza, cold in the chest, Feverish condition with flu

J30 Vasomotor and allergic rhinitis

Allergic rinopatiya, Allergic rhinosinusopathy, Allergic respiratory diseases, Allergic rhinitis, nasal allergy, Seasonal Allergic Rhinitis, Vasomotor rhinitis, Long-allergic rhinitis, Perennial allergic rhinitis, Perennial allergic rhinitis, Year-round or seasonal allergic rhinitis, Year-round allergic rhinitis nature, Rhinitis allergic vasomotor, Exacerbation of pollen allergy in the form of Syndrome rinokonyunktivalnogo, Acute allergic rhinitis, Edema of the nasal mucosa, Edema of the nasal mucosa, Swelling of the mucosa of the nasal cavity, Swelling of the nasal mucosa, Swelling of the nasal mucosa, pollen disease, Permanent allergic rhinitis, rhinoconjunctivitis, rhinosinusitis,rhinosinusopathy, Seasonal allergic rhinitis, Seasonal Allergic Rhinitis, Haymarket rhinitis, Chronic allergic rhinitis, Allergic respiratory diseases

J30.1 Allergic rhinitis caused by the pollen

hay fever, Hypersensitivity to pollen, Polypoid allergic rhinosinusitisá Seasonal hay fever, Seasonal rhinitis

J32 Chronic sinusitis

Allergic rhinosinusopathy, purulent sinusitis, Catarrh nasopharyngeal area, Catarrh of the sinuses, Exacerbation of sinusitis, chronic Sinusitis

J999 * Diagnosis of Respiratory Diseases

bronchography, bronchoscopy, Diagnostic procedures in the nasal passages, Diagnostic Study of the bronchi, laryngoscopy, Preparing for rhinoscopy, Preparing the patient for bronchoscopy and / or bronhografii, Preparing the patient for bronchoscopy or bronhografii, Preparing the patient for diagnostic procedures in the nasal passages, Preparing the patient for diagnostic procedures in the area of the nasal passages, rhinoscopy, Visualization of the chest cavity, Chest X-ray, Mediastinoscopy

Composition

Spray nasal, in doses of 1 ml

active substance:

Xylometazoline hydrochloride 1 mg

Excipients: sodium dihydrogen phosphate dihydrate - 2 mg; Sodium phosphate dodecahydrate - 2.8 mg; sodium chloride - 5 mg; Benzalkonium chloride 50% solution - 0.1 mg (calculated as benzalkonium chloride - 0.05 mg); Sorbitol 70% - 14 mg; Disodium edetate - 0.5 mg; levomenthol (menthol) - 0.3 mg; cineole (eucalyptol) - 0.2 mg; macrogol glitserilgidroksistearat - 2.5 mg; Purified water - up to 1 ml

Description of Otrivin

Colorless, opalescent solution with the smell of menthol and eucalyptus ..

pharmachologic effect

Mode of action - antikongestat, alpha-agonists

pharmacodynamics

Xylometazoline belongs to a group of local vasoconstrictor (decongestant) with α-adrenomimeticheskim action, causes narrowing of the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the mucous membrane of the nasopharynx. Facilitates nasal breathing in rhinitis.

Otrivin® well tolerated by patients with sensitive mucosa, its effect does not interfere with the separation of mucus. Otrivin® has a balanced pH of typical nasal cavity.

Contained in the formulation eucalyptol and menthol have a cooling effect on the nasal mucosa, giving a feeling of freshness. At therapeutic concentrations of the drug does not irritate the nasal mucosa, does not cause flushing.

Mode of action occurs within a few minutes and lasts for 12 hours.

Pharmacokinetics

When applied topically practically not absorbed, the plasma concentration below the detection limit.

Indications of Otrivin

acute respiratory disease with symptoms of rhinitis (runny nose);

Acute allergic rhinitis, hay fever, sinusitis, evstahiit, otitis media (to reduce swelling of the mucous nasopharynx);

preparation of the patient for diagnostic manipulations in the nasal passages.

Contraindications

Hypersensitivity to xylometazoline and other ingredients;

arterial hypertension;

tachycardia;

expressed atherosclerosis;

glaucoma;

atrophic rhinitis;

hyperthyroidism;

state after transsphenoidal hypophysectomy;

surgical intervention on meninges (in history);

children's age (12 years).

Precautions: diabetes mellitus; CVD; prostatic hyperplasia; increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, elevated blood pressure.

Pregnancy and breast-feeding

The drug should not be used during pregnancy. During lactation the drug should only be used after careful assessment of risks and benefits for mother and baby, under the supervision of a physician. Do not exceed the recommended dosage.

Side effects

Classification of the incidence of adverse reactions: very common (≥10); commonly (≥1 / 100, <1/10); uncommon (≥1 / 1000, <1/100); rare (≥1 / 10,000, <1/1000); very rare (<1/10000).

Immune system: very rarely - hypersensitivity reactions (angioedema, rash, pruritus).

From the nervous system: often - headache; rarely - insomnia, depression (with prolonged use at high doses).

From the sensory organs: rarely - a violation of sharpness of vision.

From the CCC: rarely - palpitations, increased blood pressure; very rarely - tachycardia, arrhythmia.

With the respiratory system: often - irritation and / or dryness of the nasal mucosa, burning, stinging, sneezing, hypersecretion of the mucous membrane of the nasopharynx.

From the digestive system: often - nausea; rarely - vomiting.

Local reactions: often - burning at the application site.

If any of the above in the description of side effects observed are exacerbated or any other side effects, you should inform your doctor.

Interaction

Incompatible with MAO inhibitors and tricyclic antidepressants.

Dosing and Administration

Intranasal. Adults and children over 12 years - 1 injection in each nostril, 3 times a day. Should not be applied more than 3 times a day.

Overdose

Symptoms: increased side effects, such as tachycardia, arrhythmia, increased blood pressure, sometimes there may be confusion.

Treatment: symptomatic, under the supervision of a physician.

special instructions

Not recommended for use in continuous operation for more than 10 days. Do not exceed the recommended dose, especially in children and the elderly. Long term (over 10 days), or excessive use of the drug can cause a rebound effect (rhinitis medicamentosa).

Effects on ability to drive a vehicle and machinery. Xylometazoline has no effect on the ability to drive a vehicle and machinery.

release Form

Spray nasal dosage, 0.1%. 10 or 15 ml of the product in a transparent or white HDPE bottle equipped with a dosing pump action device with a tip and a protective cap with PE. The bottle was placed in a pile of cardboard.

Storage conditions of Otrivin

The temperature is not higher than 25 ° C.

Keep out of the reach of children.
Shelf life of Otrivin

2,5 years.

Do not use beyond the expiration date printed on the package.

Available without prescription