Instructions for Erides syrup 0.5 mg/ml bottle 100 ml
Composition
active ingredient: desloratadine;
1 ml of syrup contains desloratadine 0.5 mg;
Excipients: propylene glycol, non-crystallizing liquid sorbitol, citric acid monohydrate, sodium citrate, sucrose, sodium benzoate (E 211), disodium edetate, banana flavoring, purified water.
Dosage form
Syrup.
Main physicochemical properties: clear yellowish liquid.
Pharmacotherapeutic group
Antihistamines for systemic use.
ATX code R06A X27.
Pharmacological properties
Pharmacodynamics.
Desloratadine is a potent, selective, non-sedating peripheral histamine H1 receptor blocker. Desloratadine is the primary active metabolite of loratadine.
After oral administration, the drug Erides® selectively blocks peripheral H1-histamine receptors, as it almost does not penetrate the blood-brain barrier.
Numerous studies have shown that in addition to antihistamine activity, desloratadine has antiallergic and anti-inflammatory properties. It has been established that the drug Eridez® inhibits the cascade of various reactions that underlie allergic inflammation, namely:
· release of pro-inflammatory cytokines, including IL-4, IL-6, IL-8, IL-13;
· release of pro-inflammatory 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 and allergic cough in animal studies.
The safety of desloratadine in children has been demonstrated in three clinical studies. The drug was administered to children aged 6 months to 11 years who required antihistamine therapy at a daily dose of 1 mg (age group 6 to 11 months), 1.25 mg (age group 1 to 5 years) or 2.5 mg (age group 6 to 11 years). Treatment was well tolerated, as confirmed by the results of clinical laboratory tests, vital signs and ECG data (including QT interval).
In clinical studies, daily administration of desloratadine at a dose of up to 20 mg for 14 days was not accompanied by statistically clinically significant changes in the cardiovascular system. In a clinical pharmacology study, the use of desloratadine at a dose of 45 mg per day (9 times the therapeutic dose) for 10 days did not cause prolongation of the QT interval.
Desloratadine does not cross the blood-brain barrier. At the recommended dose of 5 mg, the incidence of drowsiness did not exceed that in the placebo group. In clinical studies, desloratadine did not affect psychomotor function at doses up to 7.5 mg.
In addition to the conventional division of allergic rhinitis into seasonal and perennial, it can alternatively be classified according to the duration of symptoms into intermittent and persistent. Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days per week or for less than 4 weeks. In the case of persistent allergic rhinitis, symptoms are observed for 4 days or more per week or for a period exceeding 4 weeks.
The clinical efficacy of desloratadine in the treatment of seasonal allergic rhinitis was demonstrated in four placebo-controlled, multiple-dose clinical trials.
In patients with allergic rhinitis, desloratadine effectively relieved the following symptoms: sneezing, nasal discharge and itching, as well as eye irritation, tearing and redness, and itching of the palate.
Pharmacokinetics.
Desloratadine begins to be detected in the blood plasma within 30 minutes after administration and effectively controls symptoms for 24 hours. Desloratadine is well absorbed. The maximum concentration of desloratadine in the blood plasma (Cmax) is achieved on average after 3 hours, the half-life is on average 27 hours. The degree of cumulation of desloratadine corresponds to its half-life (approximately 27 hours) and the frequency of administration (1 time per day). The bioavailability of desloratadine was proportional to the dose in the range from 5 mg to 20 mg.
Desloratadine is moderately (83–87%) bound to plasma proteins. When desloratadine was administered at a dose of 5 mg to 20 mg once daily for 14 days, there was no evidence of clinically significant drug accumulation.
Poor metabolism of desloratadine has been reported in approximately 8% of patients, with significant increases in desloratadine plasma levels and prolonged half-life. The prevalence of poor metabolism may be related to race. This finding is currently considered clinically irrelevant.
When conducting cross-comparative studies with the same dose of drugs, bioequivalence was found in the form of tablets and syrup.
The results of the studies showed that desloratadine does not inhibit CYP3A4 or CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Indication.
To relieve symptoms associated with allergic rhinitis, such as sneezing, nasal discharge, itching, swelling and nasal congestion, as well as itching and redness of the eyes, tearing, itching of the palate and cough.
To relieve symptoms associated with hives, such as itching and rash.
Contraindication
Hypersensitivity to desloratadine or loratadine or to any of the excipients of the medicinal product.
Interaction with other medicinal products and other types of interactions
No clinically significant changes in plasma concentrations of desloratadine were observed with repeated concomitant use with ketoconazole, erythromycin, azithromycin, fluoxetine, or cimetidine. Since the enzyme responsible for the metabolism of desloratadine has not been identified, interactions with other drugs cannot be completely excluded.
Food (fatty high-calorie breakfast) or grapefruit juice do not affect the distribution of desloratadine.
Impact on laboratory test results
The use of the drug Erides® should be discontinued approximately 48 hours before skin tests, as antihistamine drugs may prevent or reduce the manifestations of positive dermatological reactions to irritants.
Application features
In clinical pharmacology studies, desloratadine did not potentiate the following effects of alcohol: impaired psychomotor function and drowsiness. The results of psychomotor tests did not differ significantly in patients taking desloratadine and patients taking placebo, either alone or with alcohol.
In patients with severe renal insufficiency, Erides® should be administered under the supervision of a physician.
Desloratadine should be used with caution in patients with a history of seizures. Children may be more susceptible to developing a new seizure during treatment with desloratadine. The physician should consider discontinuing desloratadine in patients who experience a seizure while taking the drug.
Important information about excipients.
The medicine contains sorbitol, which can have a mild laxative effect. The energy value of 1 g of sorbitol is 2.6 kcal. The medicine Eridez® contains 49 g of sucrose per 100 ml, so it should be used with caution in patients with diabetes.
Use during pregnancy or breastfeeding
A large amount of data on the use of desloratadine during pregnancy (more than 1000 cases) indicate the absence of teratogenic, fetotoxic effects and adverse effects on the newborn. Animal studies have not revealed direct or indirect adverse effects on reproductive function. As a precautionary measure, it is preferable to avoid the use of the drug Eridez® during pregnancy.
Desloratadine passes into breast milk, therefore, nursing women are advised to decide whether it is necessary to discontinue breastfeeding or to avoid the use of the drug, taking into account the benefit of breastfeeding for the child and the benefit of the drug for the mother.
Fertility: There are no data on the effect on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Clinical trial data indicate that desloratadine has no or negligible influence on the ability to drive or use machines. Patients should be advised that most people do not experience drowsiness. It should be noted that individual responses to medications may vary. Patients are advised not to engage in activities requiring mental alertness, such as driving or operating machinery, until they have determined how they respond to the medication.
Method of administration and doses
To eliminate symptoms associated with allergic rhinitis (including intermittent and persistent) and urticaria, the drug Erides® is used regardless of meals in the following doses:
Adults and adolescents (≥12 years): 10 ml of syrup (5 mg desloratadine) once daily.
Treatment of intermittent allergic rhinitis (presence of symptoms less than 4 days per week or less than 4 weeks) should be carried out taking into account the anamnesis: stop after the disappearance of symptoms and resume after their reappearance. In persistent allergic rhinitis (presence of symptoms more than 4 days per week or more than 4 weeks), treatment should be continued throughout the entire period of contact with the allergen.
Children.
The efficacy and safety of Eridez® syrup in children under 6 months of age have not been established. The drug is not recommended for use in children under 6 months of age for the treatment of chronic idiopathic urticaria and in children under 12 months of age for the treatment of allergic rhinitis. The following dosage regimen is used for treatment:
- children aged 6 to 11 months: 2 ml of syrup (1 mg of desloratadine) once a day;
- aged 6 to 11 years: 5 ml of syrup (2.5 mg of desloratadine) once a day.
Overdose
In case of overdose, standard measures are taken to remove unabsorbed active substance, and symptomatic treatment is applied.
When desloratadine was used in doses up to 45 mg (9 times the recommended dose) in clinical studies in adults and adolescents, no clinically significant effects were observed.
Desloratadine is not removed by hemodialysis, and its removal by peritoneal dialysis has not been established.
Adverse reactions
In clinical trials in indications including allergic rhinitis and chronic idiopathic urticaria, adverse reactions were reported 3% more frequently in patients receiving 5 mg daily than in patients receiving placebo. The most frequently reported adverse reactions compared to placebo were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%). In clinical trials of Eridez® in children aged 2 to 11 years, the incidence of adverse reactions was similar in both the syrup and placebo groups. In children aged 6 to 23 months, the most frequent adverse reactions (compared to placebo) were diarrhea (3.7%), fever (2.3%), and insomnia (2.3%).
There is a risk of psychomotor hyperactivity (abnormal behavior) associated with the use of desloratadine (which may manifest as anger and aggression, as well as agitation).
In the post-marketing period, the following events were observed (frequency unknown): QT prolongation, arrhythmia and bradycardia.
Other adverse reactions that have been reported very rarely during post-marketing experience are listed in the table below. The frequency of adverse reactions is classified as follows: very common (≥ 1/10), common (≥ 1/100) - uncommon (≥ 1/1,000 - cannot be estimated from the available data).
On the part of the organs of vision: frequency unknown - dry eyes.
Gastrointestinal: common - dry mouth; common (for children under 2 years of age) - diarrhea; rare - abdominal pain, nausea, vomiting, dyspepsia, diarrhea.
From the liver and biliary tract: rare - increased liver enzymes, increased bilirubin, hepatitis; frequency unknown - jaundice.
From the side of metabolism: frequency unknown - increased appetite.
From the nervous system: frequent - headache; frequent (for children under 2 years of age) - insomnia; rare - dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.
On the part of the psyche: rare - hallucinations; frequency unknown - abnormal behavior, aggression.
Cardiovascular system: rare - tachycardia, palpitations, QT prolongation, supraventricular tachyarrhythmia.
Skin and subcutaneous tissue disorders: frequency unknown - photosensitivity.
Musculoskeletal and connective tissue disorders: rare – myalgia.
General disorders and administration site conditions: common - fatigue; common (for children under 2 years of age) - fever; rare - hypersensitivity reactions (anaphylaxis, angioedema, shortness of breath, itching, rash, urticaria); frequency unknown - asthenia.
Laboratory indicators: frequency unknown - weight gain.
Desloratadine has little or no penetration into the central nervous system. When used at the recommended adult dose of 5 mg, there was no increase in the incidence of drowsiness compared to placebo. In clinical studies, Eridez® at a single daily dose of 7.5 mg had no effect on psychomotor performance.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
After first opening the bottle, store for no more than 90 days.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
100 ml in a bottle closed with a tamper-evident cap, 1 bottle with a measuring cup in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business
Ukraine, 02093, Kyiv, Boryspilska St., 13.
