Psilo-allergo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PSYLO-ALERGO (PSILO-ALERGO)

Composition:

Active substance: desloratadine;

1 ml of oral solution contains 0.5 mg of desloratadine;

Excipients: propylene glycol (E 1520); sorbitol solution, non-crystallizing (E 420); citric acid monohydrate (E 330); sodium citrate (E 331); hypromellose; sucralose (E 955); disodium edetate (Trilon B); "Tutti-Frutti" flavor (glyceryl triacetate (E 1518), alpha-tocopherol (E 307)); purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear, colorless solution, free from foreign particles.

Pharmacotherapeutic group. Antihistamines for systemic use.

ATC code: R06AX27.

Pharmacological properties.

Pharmacodynamics.

Desloratadine is a selective blocker of peripheral histamine H1-receptors that does not produce sedative effects. Desloratadine is the primary active metabolite of loratadine.

After oral administration, PSYLO-ALLERGO selectively blocks peripheral H1-histamine receptors and does not penetrate the blood-brain barrier.

In addition to its antihistaminic activity, PSYLO-ALLERGO exerts anti-allergic and anti-inflammatory effects. It has been established that PSYLO-ALLERGO suppresses the cascade of various reactions underlying the development of allergic inflammation, namely:

• release of proinflammatory cytokines, including IL-4, IL-6, IL-8, IL-13;
• release of proinflammatory chemokines, such as RANTES;
• production of superoxide anion by activated polymorphonuclear neutrophils;
• adhesion and chemotaxis of eosinophils;
• expression of adhesion molecules, such as P-selectin;
• IgE-dependent release of histamine, prostaglandin D2, and leukotriene C4;
• acute allergic bronchospasm in animal studies.

Pharmacokinetics.

Desloratadine becomes detectable in blood plasma within 30 minutes after administration. Maximum plasma concentration of desloratadine is reached on average within 3 hours; elimination half-life averages 27 hours. The extent of desloratadine accumulation corresponds to its half-life (approximately 27 hours) and frequency of administration (once daily). Desloratadine bioavailability was dose-proportional over the range of 5 to 20 mg.

Desloratadine is moderately bound (83–87%) to plasma proteins. No signs of clinically significant drug accumulation were observed after administration of desloratadine at doses of 5 to 20 mg once daily for 14 days.

Cross-over comparative studies at the same dosage demonstrated bioequivalence between the tablet and oral solution formulations.

Pharmacokinetic studies in pediatric practice have shown that AUC and Cmax values of desloratadine (when administered at recommended doses) are comparable to those observed in adults receiving 5 mg of desloratadine oral solution.

Study results indicate that desloratadine does not inhibit CYP3A4 or CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.

A single-dose study with 7.5 mg of desloratadine showed that food (a high-fat, high-calorie meal) or grapefruit juice does not affect desloratadine distribution.

Clinical characteristics.

Indications.

For relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge, itching, nasal swelling and congestion, as well as eye itching and redness, tearing, itching of the palate, and cough.

For relief of symptoms associated with urticaria, such as itching and skin rash.

Contraindications.

Hypersensitivity to desloratadine, loratadine, or to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

No clinically significant changes in plasma concentrations of desloratadine were observed during repeated co-administration with ketoconazole, erythromycin, azithromycin, fluoxetine, or cimetidine. Since the enzyme responsible for desloratadine metabolism has not been identified, interactions with other medicinal products cannot be completely excluded.

Food (high-fat, high-calorie breakfast) or grapefruit juice do not affect the distribution of desloratadine.

Effect on laboratory test results

The use of the medicinal product should be discontinued approximately 48 hours prior to skin testing, as antihistamines may prevent or reduce the manifestation of positive dermatological reactions to allergens.

Special precautions for use

During clinical and pharmacological studies, desloratadine did not enhance alcohol-induced effects such as psychomotor impairment and drowsiness. Psychomotor test results did not significantly differ between patients receiving desloratadine and those receiving placebo, either alone or in combination with alcohol.

For patients with severe renal impairment, treatment with PSYLO-ALLERGO should be administered under medical supervision. Patients with rare hereditary conditions of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication.

Desloratadine should be prescribed with caution to patients with a history of seizures. Children may be more susceptible to developing new seizures during desloratadine treatment. Physicians should decide whether to discontinue desloratadine treatment in patients who experience a seizure while taking the drug.

Use during pregnancy or breastfeeding

Extensive data on the use of desloratadine during pregnancy (over 1000 cases) indicate no evidence of teratogenic or fetotoxic effects, or adverse effects on the newborn. Animal studies have not revealed any direct or indirect adverse effects on reproductive function. As a precautionary measure, it is advisable to avoid using this medicinal product during pregnancy.

Desloratadine passes into breast milk; therefore, breastfeeding women should decide whether to discontinue breastfeeding or avoid using the drug, taking into account the benefits of breastfeeding for the infant and the therapeutic benefit of the drug for the mother.

Fertility
Data regarding effects on fertility are lacking.

Ability to influence reaction speed while driving or operating machinery

Clinical study data indicate that desloratadine does not affect or has only a negligible effect on the ability to drive or operate machinery. Patients should be informed that most individuals do not experience drowsiness. However, individual responses to medications may vary. Patients should avoid activities requiring mental alertness, such as driving a car or operating machinery, until they have determined their individual response to the medication.

Method of Administration and Dosage.

To relieve symptoms associated with allergic rhinitis (including both intermittent and persistent forms) and chronic idiopathic urticaria, PSYLO-ALLERGO can be administered regardless of food intake at the following doses:

Adults and children aged 12 years and older: 10 mL of oral solution (5 mg of desloratadine) once daily.

Treatment of intermittent allergic rhinitis, when symptoms are present less than 4 days per week or for less than 4 weeks, should be based on the patient's medical history and may be discontinued after symptoms resolve, and resumed upon their recurrence. Continuous treatment may be recommended for patients with persistent allergic rhinitis during the period of allergen exposure, if symptoms occur for 4 or more days per week and for more than 4 weeks.

Children.

The efficacy and safety of PSYLO-ALLERGO syrup in children under 6 months of age have not been established.

The drug is not recommended for children under 6 months of age for the treatment of chronic idiopathic urticaria and for children under 12 months of age for the treatment of allergic rhinitis.

For treatment, the following dosing regimen should be used:

Children aged 6 to 12 months: 2 mL of oral solution (1 mg of desloratadine) once daily;
Children aged 1 to 5 years: 2.5 mL of oral solution (1.25 mg of desloratadine) once daily;
Children aged 6 to 11 years: 5 mL of oral solution (2.5 mg of desloratadine) once daily.

Overdose.

In case of overdose, standard measures aimed at removing the unabsorbed active substance should be initiated, along with symptomatic treatment.

When desloratadine was administered at doses up to 45 mg (9 times higher than the recommended dose), no clinically significant effects were observed.

Desloratadine is not removed by hemodialysis; the possibility of its removal by peritoneal dialysis has not been established.

Adverse Reactions

During clinical trials of PSYLO-ALLERGO at the recommended dose of 5 mg once daily according to the indications, including allergic rhinitis and chronic idiopathic urticaria, the incidence of adverse events was 3% higher compared to placebo. The most common adverse events (compared to placebo) were increased fatigue (1.2%), dry mouth (0.8%), and headache (0.6%).

In children aged 2 to 11 years, the number of adverse reactions was similar in both the oral solution group and the placebo group. In children aged 6 to 23 months, the most common adverse events (compared to placebo) were diarrhea (3.7%), fever (2.3%), and insomnia (2.3%).

Very rarely, hypersensitivity reactions (including anaphylaxis and rash), tachycardia, palpitations, psychomotor hyperactivity, seizures, increased liver enzyme activity, elevated bilirubin levels, and hepatitis have been reported.

There is a risk of psychomotor hyperactivity (abnormal behavior) associated with desloratadine use, which may manifest as irritability, aggression, and agitation.

In the post-marketing period, the following events have been observed (frequency unknown): QT interval prolongation, arrhythmia, and bradycardia.

Other adverse effects reported very rarely during the post-marketing period are listed in the table below. The frequency of adverse reactions is classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), and frequency not known.

Desloratadine hardly penetrates into the central nervous system. When used at the recommended adult dose of 5 mg, no increase in the incidence of somnolence was observed compared to the placebo group. In clinical studies, the drug administered as a single daily dose of 7.5 mg did not affect psychomotor performance.

If any adverse reactions occur, consult a physician.

Shelf life. 3 years.

Shelf life after opening the bottle – 2 months.

Storage conditions. Store in the original packaging at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging. 150 ml in amber glass bottles closed with a child-resistant cap, supplied with a dosing spoon or a dosing device in the form of a syringe, in a cardboard box.

Availability. Over-the-counter.

Manufacturer (batch release).

STADA Arzneimittel AG, Germany.

Manufacturer's address and place of business.

Stadstrasse 2-18, 61118 Bad Vilbel, Germany.