ALLERGOMAX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALEGRGOMAX (ALERGOMAX)

Composition:

Active substances: dimethindene maleate, phenylephrine;

1 ml of the preparation contains 0.25 mg of dimethindene maleate, 2.5 mg of phenylephrine;

Excipients: citric acid monohydrate; sodium hydrogen phosphate anhydrous; sorbitol (E 420); benzalkonium chloride; peppermint oil; purified water.

Pharmaceutical form. Nasal drops, solution.

Main physicochemical properties: clear solution, colorless to slightly yellowish, with a characteristic odor. Opalescence may occur.

Pharmacotherapeutic group. Decongestants and other rhinological preparations for topical use. Sympathomimetics, combinations, excluding corticosteroids. ATC code R01A B.

Pharmacological properties.

Pharmacodynamics.

A combination drug containing phenylephrine and dimetindene.

The drug reduces nasal discharge and promotes nasal passage clearance without impairing physiological functions of the ciliated epithelium and nasal mucosa.

Phenylephrine belongs to sympathomimetic amines. It is used as a nasal decongestant with moderate vasoconstrictive action, selectively stimulating α1-adrenergic receptors of the cavernous venous tissue of the nasal mucosa. Thus, it rapidly and for a prolonged period relieves swelling of the nasal mucosa and mucosa of the paranasal sinuses.

Dimetindene is a histamine H1-receptor antagonist with antiallergic activity. It is effective at low doses and is well tolerated.

Pharmacokinetics.

The drug is administered locally; therefore, its activity does not correlate with plasma concentrations of the active substances.

Following accidental oral absorption, phenylephrine bioavailability is reduced and amounts to approximately 38% due to first-pass metabolism in the intestine and liver; elimination half-life is approximately 2.5 hours.

Systemic bioavailability of dimetindene after oral administration in solution is approximately 70%; elimination half-life is approximately 6 hours.

Clinical characteristics.

Indications.

In adults and children aged 2 years and older:

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 nasal surgery and reduction of mucosal edema of the nose and paranasal sinuses following surgical intervention.

Contraindications.

Hypersensitivity to phenylephrine, dimetindene maleate, or to any of the excipients. Due to the presence of phenylephrine, the drug, as well as other vasoconstrictors, is contraindicated in atrophic rhinitis, angle-closure glaucoma, and in patients receiving monoamine oxidase inhibitors (MAOIs) or who have received them within the previous 14 days.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of the drug with monoamine oxidase inhibitors (MAOIs) and within 14 days after discontinuation of MAOIs is contraindicated.

Vasoconstrictors should be prescribed with caution when used concomitantly with tricyclic and tetracyclic antidepressants and antihypertensive agents such as β-adrenoblockers, as their simultaneous use may potentiate the pressor effect of phenylephrine.

Special precautions for use

The drug, like other sympathomimetics, should be used with caution in patients who exhibit a pronounced response to adrenergic agents, manifested by symptoms such as insomnia, dizziness, tremor, cardiac arrhythmias, or increased blood pressure.

The drug should not be used continuously for more than 3 days. If symptoms persist for more than 3 days or worsen, medical advice should be sought. Prolonged or excessive use of the drug may lead to tachyphylaxis and rebound effect (drug-induced rhinitis).

As with other vasoconstrictive agents, the recommended dose of the drug should not be exceeded. Excessive use of the drug, especially in children and elderly patients, may result in systemic effects of the drug.

The drug should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, hyperthyroidism, diabetes mellitus, or bladder neck obstruction (e.g., due to prostate hyperplasia).

Due to the presence of the H1-antihistamine dimetindene maleate, the drug should be used with caution in patients with epilepsy.

Use during pregnancy or breastfeeding.

Studies on the use of phenylephrine and dimetindene maleate during pregnancy or breastfeeding have not been conducted. Due to the potential systemic vasoconstrictive effect of phenylephrine, the use of the drug during pregnancy is not recommended.

The use of the drug during breastfeeding is not recommended.

Fertility.

There are no adequate data on the effects of phenylephrine and dimetindene maleate on human fertility.

Ability to influence reaction speed when driving or operating machinery.

Data are lacking.

Method of Administration and Dosage

Before administering the medication, the nose should be thoroughly cleared.

The patient should tilt the head backward while sitting or standing, or to the side if lying in bed. After instillation of the drops, it is advisable to keep the head tilted for several minutes to allow the medication to spread within the nasal cavity.

The dropper cap should be washed and dried before screwing it back onto the bottle.

Children aged 2 to 6 years.

1–2 drops into each nostril 3–4 times daily.

Children aged 6 years and older, and adults.

3–4 drops into each nostril 3–4 times daily.

The duration of continuous treatment should not exceed 3 days and depends on the course of the illness.

Use of the medication in children aged 2 to 12 years should be supervised by an adult.

Children. The medication is not recommended for use in children under 2 years of age.

Overdose.

In case of overdose, the drug may cause sympathomimetic and anticholinergic effects such as increased heart rate, premature ventricular contractions, occipital pain, tremor or shaking, mild tachycardia, elevated arterial pressure, mydriasis, numbness, excitement, hallucinations, seizures, insomnia, and pallor. Overdose may also lead to moderate sedation, increased fatigue, coma, stomach pain, nausea, and vomiting.

No serious adverse effects have been reported after accidental ingestion of the medication. Accidental ingestion of doses of dimetindene up to 20 mg did not result in severe symptoms.

Treatment: administration of activated charcoal; laxatives may be considered in younger children (gastric lavage is not required); adults and older children should drink large amounts of fluids.

Phenylephrine-induced arterial hypertension, which does not respond adequately to benzodiazepines, can be managed using an α-adrenergic blocker.

Central anticholinergic symptoms can be treated with physostigmine. Consultation with a physician regarding the use of antidotes is recommended. Since data on gastrointestinal absorption of dimetindene doses exceeding 20 mg are lacking, patients with significant overdose should be placed under medical supervision and, if deemed necessary by a physician, given a single dose of activated charcoal. Severe cases of agitation and seizures should be treated with benzodiazepines.

Adverse reactions.

The drug is usually well tolerated.

Respiratory, thoracic and mediastinal disorders: nasal discomfort, dryness of the nasal cavity, epistaxis (nosebleed).

General disorders and administration site conditions: burning sensation at the application site, general weakness, development of allergic reactions (including local skin reactions, body pruritus, eyelid swelling, facial swelling).

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 15 ml in a bottle with a dropper cap and a glass pipette, in a box.

Supply category. Over-the-counter (without prescription).

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovya".

Manufacturer's address.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.