Instruction for use: Afrin extro

Trade name of the drug – Afrin extro

ATX code R01AA05 Oxymetazoline

Pharmacotherapeutic group:

Alpha-adrenoceptor agonists

decongestant

The nosological classification (ICD-10)

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

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 of plants:

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

J32 Chronic sinusitis

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

Composition

Nasal Spray 1 ml

active substance:

oxymetazoline hydrochloride 0.5 mg

Excipients: MCC and carmellose sodium (Avicel RC 591) - 30 mg; sodium phosphate - 0.975 mg; sodium dihydrogen phosphate monohydrate - 5,525 mg; disodium edetate dihydrate - 0.3 mg; macrogol 1450 - 50 mg; Povidone K29-32 - 30 mg; benzyl alcohol - 3 mg; cineole - 0.2 mg; Camphor - 0.2 mg; levomenthol - 0.6 mg; benzalkonium chloride solution 17% - 1,471 mg; polypropylene - 5 mg; Purified water - q.s. to 1 ml

Description

Spray: white or almost white gel suspension with a characteristic odor.

Pharmacological Properties of Afrin extroPharmachologic effect
antikongestat, alpha-agonists.

pharmacodynamics

Alfa adrenostimuliruyuschee agent for topical administration. It has a vasoconstrictor effect. It causes vasoconstriction oxymetazoline nasal mucous membranes of the paranasal sinuses and eustachian tube, resulting in lower swelling and their release in allergic nasal breathing and / or infectious inflammatory rhinitis (common cold).

Due to the presence of the drug in the composition of excipients (MCC, carmellose sodium and povidone K29-32) EXTRA Afrin® nasal spray does not flow from the nose and throat flows because after introduction into the nasal passages spray becomes more viscous and is retained on the nasal mucous membrane is more efficient than standard aqueous solution.

On the basis of published clinical studies intranasal administration aromatic composition similar to the composition of the drug containing levomenthol (also known as menthol), cineole (also known as eucalyptus) and camphor, causes a temporary cooling sensation of the nasal mucosa as a result of interaction with the cold receptors of the trigeminal nerve on the mucosal surface.

According to clinical studies, the drug begins to act for 1 minute, and the effect lasts up to 12 hours.

Pharmacokinetics

When used as a nasal spray oxymetazoline hardly detected in the blood plasma.

Indications for Afrin extro
symptomatic treatment of rhinitis (runny nose) and allergic / inflammatory or infectious etiology;

sinusitis;

evstahiit;

hay fever.

Contraindications for Afrin extro

hypersensitivity to sympathomimetic agents, to any component of the drug;

atrophic rhinitis;

the simultaneous use of MAO inhibitors (including the period of 14 days after their cancellation);

Children up to age 6 years.

Precautions: coronary artery disease; arrhythmia; chronic heart failure; expressed atherosclerosis; arterial hypertension; hyperthyroidism; diabetes; chronic renal failure; angle-closure glaucoma; prostatic hyperplasia with clinical symptoms; pregnancy; lactation.

Side effect of Afrin extro

Overall, the drug was well tolerated, and possible adverse effects are usually mild and transient.

Transient dryness and burning of mucous membranes of the nose, dry mouth and throat, sneezing; increased blood pressure, increased anxiety, nausea, dizziness, headache, insomnia, palpitations, sleep disorders. With prolonged use - tachyphylaxis, reactive hyperemia and atrophy of the nasal mucosa. Benzalkonium chloride, part of the drug may cause local skin reactions.

Pregnancy and breast-feeding

Safety of the drug in pregnant women and during lactation has not been established, so the drug should be administered to pregnant or breast-feeding only on doctor's advice if the expected benefits of the drug to the mother outweighs the potential risk to the fetus or infant.

Interaction

Slows down the absorption of drugs mestnoanesteziruyuschih, it lengthens their actions.

The combined use with other vasoconstrictor drugs increases the risk of side effects.

With simultaneous use of MAO inhibitors (including the period of 14 days after their cancellation), maprotiline and tricyclic antidepressants - increased blood pressure.

Dosage and Administration

Intranasal. Before each use, need to vigorously shake the spray bottle. Before the first use of a nasal spray is necessary to calibrate it by pressing the spray head a few times.

Adults and children over 6 years -. 2-3 injections in each nostril with an interval of 10-12 hours multiplicity of applications can be increased to 3 times a day for adults. Do not exceed recommended dose indicated.

Overdose

Symptoms: When large overdose or accidental ingestion possible nausea, vomiting, cyanosis, fever, tachycardia, arrhythmias, increased blood pressure, shortness of breath, mental disorders, CNS depression (drowsiness, decrease in body temperature, bradycardia, decreased blood pressure, respiration and coma stop).

Treatment: symptomatic; Accidental ingestion - gastric lavage, activated charcoal. Vasopressor drugs are contraindicated.

special instructions

Prolonged use (more than 1 weeks) possible resumption of the symptoms of nasal congestion. If necessary, continue treatment over 5 days is necessary to consult a doctor.

You should avoid contact with the drug in the eye.

Effects on ability to drive and use machines. The product when properly used in the recommended doses has no effect on driving vehicles and work with the mechanisms, but in case of side effects such as dizziness, you should refrain from these activities.

release Form

Nasal Spray 0.05%. In a sealed opaque plastic bottle with a capacity of 23 ml with a dosing device fine spray and protective cap, shrink wrapped to control the first opening with the company logo, 15 ml. 1 fl. in a cardboard bundle.

Storage conditions of Afrin extro

The temperature is not higher than 25 ° C.

Keep out of the reach of children.
Shelf life of Afrin extro

2 years.

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

Available without prescription.