Vibrocil nasal drops, 15ml

Composition

Active ingredients:  

Phenylephrine 2.5 mg;

Dimethindenee maleate 250 mcg.

Auxiliary substances:  

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

Pharmacological action

Vibrocil® is a combination drug containing phenylephrine and Dimethindenee. Phenylephrine is a sympathomimetic, when applied topically, it has a moderate vasoconstrictive effect (due to stimulation of α1-adrenergic receptors located in the venous vessels of the nasal mucosa), eliminates edema of the nasal mucosa and its paranasal sinuses. Dimethindenee is an anti-allergic agent-an antagonist of histamine H1-receptors; it does not reduce the activity of the ciliated epithelium of the nasal mucosa.

Clinical pharmacology

Vibrocil® is intended for topical use, and its activity does not depend on the concentration of active substances in the blood plasma.

Indications

• Acute rhinitis (including colds);
• allergic rhinitis (including hay fever);
• vasomotor rhinitis;
• chronic rhinitis;
• acute and chronic sinusitis,
• acute otitis media (as adjuvant);
• preparation for surgical interventions in the nasal area and elimination of edema of the mucous membrane of the nose and paranasal sinuses after surgery in this area.

Use during pregnancy and lactation

Given the possible systemic vasoconstrictor effect, Vibrocil® is not recommended for use during pregnancy and lactation (breastfeeding).

Contraindications

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

With caution, the drug should be used for cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), thyroid diseases, angle-closure glaucoma, benign prostatic hyperplasia, insulin-dependent diabetes mellitus.

Vibrocil should be used with caution in patients with severe reactions to sympathomimetics, such as insomnia and dizziness.

Side effects

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

Interaction

Phenylephrine (like other vasoconstrictors) is contraindicated in patients who are currently receiving MAO inhibitors or who have received them during the previous 2 weeks.

Do not prescribe the drug simultaneously with tricyclic antidepressants, beta-blockers.

How to take, course of use and dosage

Children under 1 year of age: contraindicated. Children aged 1 to 6 years (under adult supervision): 1-2 drops in each nasal passage 3-4 times / day. Children aged 6-12 years (under adult supervision): 3-4 drops in each nasal passage 3-4 times / day. Adolescents over 12 years of age and adults: 3-4 drops in each nasal passage 3-4 times / day. Before use, it is recommended to thoroughly clean the nasal passages; instill in the nose, throwing back the head. This position of the head is maintained for several minutes. The drug should not be used continuously for more than 7 days. If symptoms persist, you should consult your doctor.

Overdose

Symptoms: no serious side effects were observed when Vibrocil was accidentally ingested by young children. In most cases, there were no symptoms of overdose, but sometimes symptoms such as fatigue, stomach pain, tachycardia, hypertension, agitation, insomnia, pallor of the skin were reported (more often in children with accidental ingestion).

Treatment: the use of activated charcoal and possibly a laxative (gastric lavage is not required); adults and children over the age of 6 years are shown to take a large amount of liquid. There is no specific antidote.

Description

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

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 can cause tachyphylaxis and the effect of “rebound” (drug-induced rhinitis), lead to the development of a systemic vasoconstrictor effect. Do not exceed the recommended dose of Vibrocil. Otherwise, symptoms of systemic action of the drug may occur.

Use in pediatrics. In children under 6 years of age, it is used.

Influence on the ability to drive motor vehicles and manage mechanisms. Vibrocil does not have a sedative effect (it does not affect the speed of psychomotor reactions).

Form of production

Nasal drops of 15 ml in a dark glass bottle with a screw-on cap-pipette. The bottle together with the instructions for use is placed in a cardboard pack. On the secondary packaging, the first opening control is allowed.

Storage conditions

The drug should be stored out of the reach of children, at a temperature not exceeding 30°C.

Shelf life

3 years

Active ingredient

Dimethindenee, Phenylephrine

Dosage form

nasal drops

Description

For adults, For children from birth

Indications

Allergic Rhinitis, Sinusitis, Otitis Media, Hay Fever, Runny Nose, Cold