Instructions for Vibrocil nasal drops, bottle 15 ml
Composition
active ingredients: dimethindene maleate, phenylephrine;
1 ml of the drug contains dimethindene maleate 0.25 mg, phenylephrine 2.5 mg;
excipients: sorbitol (E 420), sodium hydrogen phosphate anhydrous, citric acid monohydrate, lavender oil, benzalkonium chloride, purified water.
Dosage form
Nasal drops.
Main physicochemical properties: clear solution from colorless to slightly yellowish with a faint lavender odor.
Pharmacotherapeutic group
Anti-edematous and other rhinological preparations for topical use. Sympathomimetics, combinations, except corticosteroids.
ATX code R01AB01.
Pharmacological properties
Pharmacodynamics
Vibrocil is a combination drug that contains phenylephrine and dimethindene.
Pharmacodynamics. The drug reduces nasal discharge and helps cleanse the nasal passages, without disrupting the physiological functions of the ciliated epithelium and nasal mucosa.
Phenylephrine belongs to the sympathomimetic amines. It is used as a nasal decongestant with a moderate vasoconstrictor effect, selectively stimulating alpha1-adrenergic receptors of the cavernous venous tissue of the nasal mucosa. Thus, it quickly and permanently eliminates swelling of the nasal mucosa and its paranasal sinuses.
Dimethindene maleate – an antagonist of histamine H1 receptors – has an antiallergic effect.
Effective when used in low doses, well tolerated.
Pharmacokinetics
Vibrocil is applied topically, so its activity does not correlate with the concentration of active substances in blood plasma.
With accidental oral administration, the bioavailability of phenylephrine was reduced to approximately 38% due to first-pass metabolism in the intestine and liver, with a half-life of approximately 2.5 hours.
The systemic bioavailability of dimethindene after oral administration in solution is about 70%, the half-life is about 6 hours.
Indication
In adults and children aged 2 years and over:
symptomatic treatment of colds, nasal congestion, acute and chronic rhinitis, seasonal (hay fever) and non-seasonal allergic rhinitis, acute and chronic sinusitis, vasomotor rhinitis. Adjunctive therapy in acute otitis media.
Preparation for surgical intervention in the nasal area and elimination of swelling of the nasal mucosa and paranasal sinuses after surgical intervention.
Contraindication
Hypersensitivity to phenylephrine, dimethindene maleate or to any of the excipients.
Due to the content of phenylephrine, the drug, like other vasoconstrictors, is contraindicated in atrophic rhinitis (including ozena), angle-closure glaucoma, as well as in patients taking monoamine oxidase inhibitors (MAOIs) or who have taken them in the previous 14 days.
Interaction with other medicinal products and other types of interactions
Concomitant use of the drug with monoamine oxidase inhibitors (MAO) and within 14 days after their use is contraindicated.
Caution should be exercised when prescribing vasoconstrictors with tricyclic and tetracyclic antidepressants and antihypertensive drugs such as β-blockers, as their concomitant administration may potentiate the pressor effect of phenylephrine. Phenylephrine may reduce the effectiveness of beta-blockers and antihypertensive drugs.
Application features
Vibrocil, like other sympathomimetics, should be used with caution in patients with a pronounced reaction to adrenergic substances, manifested by symptoms such as insomnia, dizziness, tremor, cardiac arrhythmias or increased blood pressure.
Vibrocil should not be used continuously for more than 3 days. If symptoms persist for more than 3 days or worsen, consult a doctor. Prolonged or excessive use of the drug may cause tachyphylaxis and rebound effect (rhinitis medicamentosa).
As with other vasoconstrictors, the recommended dose should not be exceeded. Excessive use of the drug, especially in children and elderly patients, may cause systemic effects of the drug.
The drug should be prescribed with caution to patients with cardiovascular diseases, hypertension, hyperthyroidism, diabetes mellitus, and patients with bladder neck obstruction (e.g., prostatic hypertrophy).
Due to the content of the H1-antihistamine dimethindene maleate, Vibrocil should be used with caution in patients with epilepsy.
The drug contains benzalkonium chloride, which may cause irritation of the nasal mucosa.
Ability to influence reaction speed when driving vehicles or other mechanisms
This drug has no or negligible influence on the reaction speed when driving vehicles or using other mechanisms.
Use during pregnancy or breastfeeding
The use of phenylephrine and dimethindene maleate during pregnancy or breastfeeding has not been studied. Given the potential systemic vasoconstrictor effect of phenylephrine, it is recommended to refrain from using the drug during pregnancy. If necessary, the lowest effective dose of the drug should be used for the shortest possible period of time.
It is necessary to refrain from using the drug during breastfeeding, except in cases where the benefit of use for the mother outweighs the potential risk to the infant. Phenylephrine and dimethindene maleate may be excreted in breast milk.
Fertility
There are no adequate data on the effects of phenylephrine and dimethindene maleate on human fertility.
Method of administration and doses
Before instillation, the nose should be thoroughly cleared. The patient should tilt their head back when sitting or standing, or to the side when lying in bed. After instillation, it is advisable to leave the head tilted for a few minutes to allow the medicine to spread throughout the nasal cavity.
The dropper cap should be washed and dried before screwing it onto the bottle.
To avoid the possible spread of infection, the bottle of drops should be used by only one person.
Children aged 2 to 6 years
1–2 drops in each nasal passage 3–4 times a day.
Children aged 6 and over and adults
3–4 drops in each nasal passage 3–4 times a day.
The use of the drug in children aged 2 to 12 years should be carried out under adult supervision. If there is no improvement after 3 days of taking the drug or if symptoms worsen, you should consult a doctor. The lowest effective dose should be used for the shortest period of time. Do not exceed the prescribed dose and frequency of use of the drug. Be careful not to apply to the eyes.
Children
Vibrocil nasal drops are not recommended for use in children under 2 years of age.
Overdose
In case of overdose, Vibrocil may cause sympathomimetic and anticholinergic effects such as increased heart rate, premature contraction of the ventricles of the heart, pain in the nape of the neck, trembling or tremor, mild tachycardia, increased blood pressure, mydriasis, numbness, agitation, hallucinations, convulsions, insomnia and pallor. Overdose with the drug may cause moderate sedation, increased fatigue, coma, stomach pain, nausea, vomiting.
No serious side effects were noted after accidental use of Vibrocil. Accidental ingestion of doses of dimetinden up to 20 mg into the gastrointestinal tract did not lead to severe symptoms.
Treatment: Use activated charcoal, possibly laxatives for younger children (gastric lavage is not necessary); adults and older children are given plenty of fluids to drink.
Phenylephrine-induced hypertension that is unresponsive to benzodiazepines can be treated with an alpha-adrenergic blocker. Central anticholinergic symptoms can be treated with physostigmine. It is advisable to consult a doctor about the use of antidotes. Since there are no data on the gastrointestinal tract absorption of doses of dimethindene exceeding 20 mg, patients with significant overdose should be kept under medical supervision and, if prescribed by a doctor, given a single dose of activated charcoal. Severe cases of agitation and seizures should be treated with benzodiazepines.
Adverse reactions
The drug is generally well tolerated. The adverse reactions listed below are classified according to frequency as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Respiratory, thoracic and mediastinal disorders: rarely - nasal discomfort, nasal dryness, nosebleeds.
General disorders and administration site reactions: rarely - burning sensation at the application site; very rarely - general weakness, development of allergic reactions (in particular, local skin reactions, itching of the body, swelling of the eyelids and face).
Expiration date
3 years.
Storage conditions
Store in the original packaging, protected from light and heat, at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
15 ml of drops in a bottle with a dropper cap; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
GSK Consumer Helsker S.A. / GSK Consumer Healthcare S.A.
Location of the manufacturer and its business address
Route de l'Etraz, 1260 Nyon, Switzerland.
