VYBROTSYL
Active material: Dimethindene, Phenylephrine
When ATH: R01AB01
CCF: Medication with antiallergic and vasoconstrictive effect for local application in ENT practice
ICD-10 codes (testimony): H66, J00, J01, J06.9, J10, J30.0, J30.1, J30.3, J31, J32, Z51.4
When CSF: 13.01.03.01
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)
Pharmaceutical form, composition and packaging
◊ Nasal drops in the form of transparent solution from colorless to slightly yellow, with weak smell of lavender.
| 1 ml | |
| Phenylephrine | 2.5 mg |
| dimethindene maleate | 250 g |
Excipients: benzalkonium chloride (in shape 50% solution), citric acid monohydrate, sodium hydrogen phosphate, sorbitol, Lavender, water.
15 ml – vials of dark glass (1) complete with a cover-pipette – packs cardboard.
◊ Spray nazalynыy in the form of transparent solution from colorless to slightly yellow, with weak smell of lavender.
| 1 ml | |
| Phenylephrine | 2.5 mg |
| dimethindene maleate | 250 g |
Excipients: benzalkonium chloride (in shape 50% solution), citric acid monohydrate, sodium hydrogen phosphate, sorbitol, Lavender, Purified water.
10 ml – plastic bottles (1) with a sprayer – packs cardboard.
◊ Nasal gel homogeneous, colorless to slightly yellow, with low specific aroma of lavender, free of mechanical impurities.
| 1 g | |
| Phenylephrine | 2.5 mg |
| dimethindene maleate | 250 g |
Excipients: sodium hydrogen phosphate, anhydrous, citric acid monohydrate, sorbitol, benzalkonium chloride (in shape 50% solution), Lavender, gipromelloza, Purified water.
12 g – aluminium tubes with ferrules (1) – packs cardboard.
Pharmacological action
Medication with antiallergic and vasoconstrictive effect for local application in diseases of Lor-bodies.
Phenylephrine – sympathomimetic, the local application has moderate sossoudossouerveshchee effect (due to the stimulation of α1-adrenoretseptorov venous vessels of the nasal mucosa), eliminates swelling of nasal mucous membrane and sinusal.
Dimethindene – gistaminovыh blocker H1-receptors. It has anti-allergic effect. Does not reduce the activity of the ciliated epithelium of the nasal mucosa.
Pharmacokinetics
Vibrozil® It is intended for local use, and its activity is not dependent on the concentration of the active substances in the blood plasma.
Testimony
- Coryza (incl. for colds);
- Allergic rhinitis (incl. with hay fever);
- Vasomotor rhinitis;
- Chronic rhinitis;
- Acute and chronic sinusitis;
-acute otitis media (as an adjuvant);
— preparation for surgical procedures in the area of the nose and the Elimination of edema of the mucosa of the nose and sinuses after surgery in this area.
Dosage regimen
Before applying the product should be thoroughly clean the nasal cavity.
Nasal drops buried in each of the bow 3-4 times / day. To children aged 1 year single dose- 1 drop. For children from 1 Year to 6 years single dose of 1-2 drops. For children senior 6 years and adults single dose – 3-4 drops. Before applying the product should be thoroughly clean the nasal cavity. Nasal drops are instilled in the nose, thrown back head. It is the position of the head remain within minutes. Infants buried in the nose before feeding.
Spray nazalynыy children over the age of 6 years and adults appoint 1-2 injection into each nasal passage 3-4 times / day. Keep sprayer upright, Tip up. Keeping your head straight, Insert the tip into the nostril, 1 times short sharp movement compress the nebuliser and, removing the tip of nose, the payload. During injection it is recommended to slightly to breathe through the nose.
Nasal gel children over the age of 6 years and adults give each of the bow as deeply as possible 3-4 times / day. Application of nasal gel just before bedtime ensures that no nasal congestion throughout the night.
Side effect
Local reactions: rarely – weakly expressed and transient stinging sensation and dryness of nasal mucosa.
Contraindications
- Atrophic rhinitis (incl. with smelly discharge – Ozen);
- Simultaneous reception of MAO inhibitors and the period up to 14 days after their cancellation;
- Children up to age 6 years (dlya spray nazalynogo);
- Hypersensitivity to the drug.
FROM caution the drug should be used in cardiovascular diseases (hypertension, aritmijax, generalized atherosclerosis), Thyroid diseases, angle-closure glaucoma, benign prostatic hyperplasia, insulinzawisimam diabetes.
FROM caution assign Vibrozil® patients with acute reactions to sympathomimetic, such as insomnia and dizziness.
Pregnancy and lactation
In view of the possible system sossoudossouerveshchee effect, Vibrozil® not recommended for use in pregnancy and lactation.
Cautions
Vibrozil® in gel form is superior nasal dryness of nasal mucosa, When there are scabs in the nasal cavity, When the effects of the trauma of nose, as well as to prevent nasal congestion at night.
Vibrozil® should not be applied more 1 weeks without consultation with a physician. Long (more 2 weeks) or the excessive use of the drug can cause and effect tahifilaksiû “Ricochet” (drug-induced rhinitis), lead to the development of systematic sossoudossouerveshchego action.
Do not exceed the recommended dose of Vibrocila®. Otherwise, you may experience symptoms of systemic effects of the drug.
Use in Pediatrics
Children younger 6 years use only nasal drops.
Effects on ability to drive vehicles and management mechanisms
Vibrozil® no sedative action (does not affect the speed psychomotor reactions).
Overdose
Symptoms. In the event of accidental admission Vibrocila® inside young children not noted any major side effects.
In most cases there were no overdose symptoms, Sometimes, however, reported such symptoms, as fatigue, pain in the stomach, tachycardia, arterial hypertension, excitation, insomnia, pale skin (more commonly in children in the event of accidental ingestion).
Treatment: application of activated carbon and, perhaps, slabitelnogo means (gastric lavage is not required); adults and children over the age of 6 years shows the introduction of large quantities of liquid. No specific antidote.
Drug Interactions
Phenylephrine (like other sossoudossoujiwate means) is contraindicated in patients, receiving MAO inhibitors at this time or who received them in the past two weeks.
Nor should designate product concurrently with tricyclic antidepressants or antigipertenzivei drugs, eg, beta-blockers.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
Preparation in the form of drops bx3000t and nasal spray should be stored in the dark, inaccessible to children at temperature not exceeding 30 ° C, preparation in the form of a nasal gel should be stored out of the reach of children at a temperature of no higher than 30° c. Shelf life – 3 year.
