Vibrocil, drops 15 ml

Pharmacological action – vasoconstrictor, anti-allergic, anticongestive.

Pharmacodynamics

Phenylephrine and dimethindene combined drug.

Phenylephrine is a sympathomimetic agent and when applied topically it has moderate vasoconstrictor action (due to stimulation of alpha 1-adrenoreceptors located in the venous vessels of the nasal mucosa), it eliminates edema of the nasal mucosa and its accessory sinuses.

Dimetinden is an anti-allergic agent – an antagonist of histamine H1-receptors; it does not reduce activity of the nasal mucosal epithelium.

Pharmacokinetics

Vibrocil® is for topical use; its activity is independent of the concentration of active substances in the blood plasma.

Indications

Pollinosis, Colds, Otitis, Allergic rhinitis, Sore throat, Runny nose (rhinitis)

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Active ingredient

Dimethinden, Phenylephrine

Composition

Active ingredients:

Phenylephrine 2.5 mg;

Dimethindene maleate 250 µg.

Associates:

Benzalkonium chloride 50% solution (in terms of benzalkonium chloride) – 0.2 mg (0.1 mg);

Citric acid monohydrate – 2.6 mg;

Sodium hydrophosphate – 4.4 mg;

Sorbitol – 35 mg;

Lavender oil – 0.2 mg;

Water – up to 1 ml.

How to take, the dosage

Intranasally, the nasal passages should be cleaned before insertion.

nasal drops. Adults and children over 6 years – 3-4 drops in each nasal passage 3-4 times a day. Children from 1 to 6 years – only as nasal drops 1-2 drops in each nostril 3-4 times a day: from 1 to 6 years – 1-2 drops, up to 1 year – 1 drop in each nostril 3-4 times a day. The drops are placed intranasally with the head tilted back. The head position is maintained for several minutes.

Nasal spray. Adults and children over 6 years of age are prescribed 1-2 sprays into each nasal passage 3-4 times a day. When using the spray, the sprayer should be held vertically, with the tip up. Holding the head straight, insert the tip into the nasal passage, once a short sharp movement squeeze the spray, and taking the tip out of the nose, unclench. During the spraying it is recommended to inhale slightly through the nose.

nasal gel. Adults and children over 6 years old apply the gel into each nasal passage as deeply as possible 3-4 times a day (the last application is made shortly before bedtime). Application of the drug just before going to bed ensures the effect throughout the night.

Interaction

Phenylephrine (as well as other vasoconstrictors) is contraindicated in patients currently receiving MAOIs or who received them during the previous 2 weeks.

The drug should not be prescribed concomitantly with tricyclic antidepressants, beta-adrenoblockers.

Special Instructions

Vibrocil should not be used for more than 1 week without consulting a doctor. Prolonged (more than 2 weeks) or excessive use of the drug may cause tachyphylaxis and “ricochet” effect (drug-induced rhinitis), lead to the development of systemic vasoconstrictor action. Do not exceed the recommended doses of Vibrocil. Otherwise there may be symptoms of systemic action of the drug.

Pediatric use. In children under 6 years of age is used.

The effect on the ability to drive and operate machinery. Vibrocil has no sedative effect (does not affect the speed of psychomotor reactions).

Synopsis

Nasal drops in the form of a clear solution of colorless to slightly yellow color, with a faint odor of lavender.

Contraindications

Hypersensitivity to the components of the drug, atrophic rhinitis (including with foul-smelling discharge – ozenema), simultaneous use of MAO inhibitors and the period up to 14 days after their withdrawal, hypersensitivity to the components of the drug.

The drug should be used with caution in patients with cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), thyroid diseases, closed-angle glaucoma, benign prostatic hyperplasia, insulin-dependent diabetes.

Patients with significant reactions to sympathomimetics, such as insomnia and dizziness should be cautiously prescribed Vibrocil.

Side effects

Local reactions: rarely – a mild and transient sensation of burning and dryness of the nasal mucosa.

Overdose

Symptoms: In accidental ingestion of Vibrocil in young children, no serious side effects have been reported. In most cases there were no symptoms of overdose, but sometimes symptoms such as fatigue, stomach pain, tachycardia, arterial hypertension, agitation, insomnia, pale skin (more often in children when accidental oral administration) were reported.

Treatment:The use of activated charcoal and possibly a laxative (gastric lavage is not required); adults and children over 6 years of age are indicated to take plenty of fluids. There is no specific antidote.

Pregnancy use

With regard to the possible systemic vasoconstrictor effect, Vibrocil® is not recommended for use during pregnancy and lactation (breast-feeding).