VibroxDuo (Drops) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

Contact Information

GLENMARK IMPEX LLC (Russia)

ATC Code

R01AB01 (Phenylephrine in combination with other drugs)

Active Substances

Phenylephrine (Rec.INN registered by WHO)

Dimetindene (Rec.INN registered by WHO)

Dosage Form

VibroxDuo

Nasal drops 0.25 mg+2.5 mg/1 ml: 15 ml bottle

Dosage Form, Packaging, and Composition

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

Excipients: sodium hydrogen phosphate, citric acid monohydrate, sorbitol, benzalkonium chloride 50% solution (calculated as benzalkonium chloride), lavender angustifolia flower oil (lavender oil), purified water.

15 ml – dark glass bottles (1) complete with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

Drug with vasoconstrictive and antiallergic action for topical use in ENT practice

Pharmacotherapeutic Group

Nasal preparations; decongestants and other topical preparations; sympathomimetics, combinations without corticosteroids

Pharmacological Action

VibroxDuo is a combined preparation containing Phenylephrine and Dimetindene.

Phenylephrine is a sympathomimetic agent; with topical application it has a moderate vasoconstrictive effect (due to stimulation of α₁-adrenergic receptors located in the venous vessels of the nasal mucosa), it eliminates swelling of the nasal mucosa and its paranasal sinuses.

Dimetindene is an antiallergic agent, an antagonist of histamine H₁-receptors; it does not reduce the activity of the ciliated epithelium of the nasal mucosa.

Pharmacokinetics

VibroxDuo is intended for topical application, its activity does not depend on the concentration of active substances in the blood plasma.

Indications

VibroxDuo is indicated for use in adults and children aged 1 year and older for

• Acute rhinitis (including the common cold);
• Allergic rhinitis (including hay fever);
• Vasomotor rhinitis;
• Chronic rhinitis;
• Acute and chronic sinusitis;
• Acute otitis media (as an auxiliary method of treatment);
• Preparation for surgical interventions in the nasal area and to eliminate swelling of the nasal mucosa and paranasal sinuses after surgical interventions in this area.

ICD codes

Dosage Regimen

Intranasally.

Before use, thoroughly clean the nasal passages; instill into the nose, tilting the head back. When lying on a bed, the head should be turned to the side. Maintain this head position for several minutes. Close the bottle with the dropper cap immediately after use.

Adults and children aged 6 to 18 years

3-4 drops into each nostril 3-4 times/day.

Elderly patients (over 65 years). Relevant information is not available.

Patients with impaired liver function. Relevant information is not available.

Patients with impaired renal function. Relevant information is not available.

Children aged 1 to 5 years 1-2 drops into each nostril 3-4 times/day.

In children aged 1 year to 11 years, the drug should be used under adult supervision.

The safety and efficacy of the drug VibroxDuo, nasal drops in children aged 0 to 1 year have not been established. Data are not available.

The recommended doses of the drug should not be exceeded. The lowest effective dose and the shortest duration of treatment should be used.

The drug should not be used continuously for more than 7 days.

Adverse Reactions

The frequency of adverse reactions was determined in accordance with the WHO classification: very common (≥1/10); common (≥1/100 but <1/10); uncommon (≥1/1000 but <1/100); rare (≥1/10000 but <1/1000); very rare (<1/10000); frequency not known (cannot be estimated from the available data).

Contraindications

• Hypersensitivity to dimetindene, phenylephrine or to any of the excipients included in the drug;
• Atrophic rhinitis (including with foul-smelling discharge – ozena);
• Concomitant use of MAO inhibitors (simultaneously or within the previous 14 days);
• Closed-angle glaucoma;
• Pregnancy;
• Breastfeeding period;
• Children under 1 year of age.

With caution should be prescribed for cardiovascular diseases (arterial hypertension, arrhythmia, generalized atherosclerosis), hyperthyroidism, prostate adenoma, diabetes mellitus, obstruction of the bladder neck (for example, due to prostate hypertrophy), epilepsy; as well as to patients with pronounced reactions to sympathomimetics, manifested in the form of insomnia, dizziness, tremor, cardiac arrhythmia or increased blood pressure.

Use in Pregnancy and Lactation

Pregnancy

There are no studies on the use of the drug during pregnancy. Given the possible systemic vasoconstrictive effect of phenylephrine, the drug VibroxDuo is not recommended for use during pregnancy.

Phenylephrine. Data on the use of phenylephrine during pregnancy are limited.

Dimetindene maleate. Relevant data on the use of dimetindene maleate during pregnancy are not available.

Breastfeeding period

There are no studies on the use of the drug during breastfeeding. Given the possible systemic vasoconstrictive effect of phenylephrine, the drug VibroxDuo is not recommended for use during breastfeeding.

Phenylephrine. Phenylephrine may be excreted in breast milk.

Dimetindene maleate. Dimetindene maleate may be excreted in breast milk.

Fertility

Relevant data on the effect of phenylephrine and dimetindene maleate on fertility in humans are not available.

Phenylephrine. Relevant experimental animal data regarding the effect of phenylephrine on animal fertility are not available.

Dimetindene maleate. Based on animal studies, no adverse effects of dimetindene on animal fertility have been found.

Pediatric Use

Contraindicated for use in children under 1 year of age (safety and efficacy have not been established). In children aged 1 year to 11 years, the drug should be used under adult supervision.

Special Precautions

VibroxDuo should not be used continuously for more than 7 days. Prolonged or excessive use of the drug may cause tachyphylaxis and a “rebound” effect associated with the re-development of nasal congestion (medicinal rhinitis), and lead to the development of a systemic vasoconstrictive effect.

The recommended doses of VibroxDuo should not be exceeded. Otherwise, manifestations of the systemic vasoconstrictive effect of the drug may develop, especially in children and elderly patients.

To avoid possible spread of infection, the drug bottle should be used by only one person.

Care should be taken to avoid getting the drug into the eyes.

Excipients

The drug contains benzalkonium chloride, which may cause irritation and swelling of the nasal mucosa.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and work with mechanisms.

Overdose

Symptoms: sympathomimetic effects, such as palpitations, premature ventricular contraction, occipital headache, tremor, feeling of fatigue, increased blood pressure, emotional agitation, insomnia, pallor of the skin. The drug may also cause mild sedative effect, dizziness, feeling of stomach pain, nausea, vomiting.

Treatment: use of activated charcoal, laxatives in young children from 1 year to 5 years inclusive (if possible); in adults and children over 6 years – intake of large amounts of fluid.

There is no specific antidote.

Increased blood pressure caused by phenylephrine can be eliminated by the use of alpha-blockers.

Further treatment with the drug should be carried out in accordance with clinical indications or based on the recommendations of the national toxicology center.

Drug Interactions

Phenylephrine (like other vasoconstrictors) is contraindicated in patients currently receiving MAO inhibitors or who have received them within the previous 2 weeks, because an interaction is possible, leading to an increase in blood pressure.

Should not be taken simultaneously with tricyclic and tetracyclic antidepressants (for example, amitriptyline, mirtazapine): simultaneous administration with phenylephrine may increase the risk of developing vasoconstrictive effects.

Should not be taken simultaneously with beta-blockers and other antihypertensive drugs: Phenylephrine may reduce the effectiveness of beta-blockers and antihypertensive drugs. Accordingly, the risk of developing arterial hypertension and other systemic side effects may increase.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2 years.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.