Allergomax

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALE R GOMAX (ALERGOMAX)

Composition:

Active substances: dimetindene maleate, phenylephrine;

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

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

Pharmaceutical form. Nasal spray, solution.

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

Pharmacotherapeutic group. Anti-edematous and other rhinological preparations for local use. Sympathomimetics, combinations, excluding corticosteroids. ATC code R01A B.

Pharmacological Properties.

Pharmacodynamics.

A combination medication containing phenylephrine and dimetindene.

The medication reduces nasal discharge and promotes the clearing of nasal passages without disrupting the physiological functions of the ciliated epithelium and nasal mucosa.

Phenylephrine belongs to the group of sympathomimetic amines. It is used as a nasal decongestant with moderate vasoconstrictive action and selectively stimulates α1-adrenergic receptors of the cavernous venous tissue of the nasal mucosa. Thus, it rapidly and persistently reduces swelling of the nasal mucosa and that 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 medication is intended for local application; therefore, its activity is not correlated with the concentration of active substances in blood plasma.

Following accidental oral intake, the bioavailability of phenylephrine is reduced, amounting to approximately 38% due to first-pass metabolism in the intestine and liver, with a half-life of about 2.5 hours.

Systemic bioavailability of dimetindene after oral administration in solution is approximately 70%, with a half-life of about 6 hours.

Clinical characteristics.

Indications.

In adults and children aged 6 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 after surgical intervention.

Contraindications.

Hypersensitivity to phenylephrine, dexmedetomidine maleate, or to any excipients.

Due to the presence of phenylephrine, the drug, like other vasoconstrictive agents, 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.

Vasoconstrictor agents should be used with caution in combination with tricyclic and tetracyclic antidepressants and antihypertensive agents, such as β-adrenergic blockers, as their concomitant 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 pronounced reactions to adrenergic agents, manifested by symptoms such as insomnia, dizziness, tremor, cardiac arrhythmias, or increased arterial pressure.

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

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

The drug should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, hyperthyroidism, diabetes mellitus, or those with bladder neck obstruction (e.g. benign prostatic 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 breast-feeding.

Studies on the use of phenylephrine and dimetindene maleate during pregnancy or breast-feeding 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 breast-feeding 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 while driving or operating machinery.

Data are lacking.

Method of Administration and Dosage

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

Children aged 6 years and older, and adults

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

The bottle/container must be held vertically with the spray nozzle pointing upwards. Keeping the head upright, insert the nozzle into the nostril and press once briefly and firmly on the spray pump, then remove the nozzle from the nose and release. During spraying, it is recommended to gently inhale through the nose to ensure even distribution of the medication. 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 6 to 12 years should be under adult supervision.

Children

This medicinal form of the drug is intended for children aged 6 years and older.

The medication should not be used in children under 6 years of age. An alternative medicinal form should be used, namely, AllergoMax nasal drops, solution.

Overdose

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

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

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

Phenylephrine-induced arterial hypertension, which shows insufficient response to benzodiazepines, can be managed by using an alpha-adrenergic blocker.

Central anticholinergic symptoms can be treated with physostigmine. It is advisable to consult a physician regarding the use of antidotes. 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 directed by a physician, given a single dose of activated charcoal.

Severe agitation and seizures should be treated with benzodiazepines.

Adverse reactions.

The product is usually well tolerated.

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

General disorders and administration site reactions: burning sensation at the application site, general weakness, development of allergic reactions (including skin reactions at the site, body itching, 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 spray nozzle and protective cap in a box; 15 ml in a canister with a spray nozzle and protective cap in a box.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

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