Blogir-3 syrup 0.5mg/ml bottle, 120ml

Composition

1 ml of syrup contains:

active ingredient: desloratadine 0.5 mg.

excipients: propylene glycol – 150,0 mg, sorbitol – 150,0 mg, hypromellose – 3.5 mg, Sucralose – 2.0 mg, sodium citrate – 1,26 mg, flavor, tutti-Frutti (flavouring substances, propylene glycol E 1520) – 0.75 mg, citric acid 0.5 mg, water – q. s.

Pharmacological properties

Pharmacotherapeutic group: anti-allergic agent – N₁– histamine receptor blocker.

ATX code: R06AX27

Pharmacological properties

Pharmacodynamics

Non-sedative long-acting antihistamine. It is the primary active metabolite of loratadine. Selectively blocks the activity of peripheral_H1 histamine receptors. Inhibits the cascade of allergic inflammatory reactions, including the release of anti-inflammatory cytokines, including interleukins IL‑4, IL-6, IL-8, IL‑13, the release of anti-inflammatory chemokines, the production of superoxide anions by activated polymorphonuclear neutrophils, the adhesion and chemotaxis of eosinophils, the release of adhesion molecules such as P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4. Thus, it prevents the development and facilitates the course of allergic reactions, has an antipruritic and antiexudative effect, reduces capillary permeability, prevents the development of tissue edema, smooth muscle spasm.

The drug does not affect the central nervous system, has almost no sedative effect (does not cause drowsiness) and does not affect the speed of psychomotor reactions. In clinical and pharmacological studies of the use of desloratadine at the recommended therapeutic dose, there was no prolongation of the QT interval on the ECG.

The effect of desloratadine begins within 30 minutes after ingestion and continues for 24 hours.

Pharmacokinetics

Suction

After oral use, desloratadine is well absorbed in the gastrointestinal tract, and is detected in blood plasma 30 minutes after oral use. The maximum concentration C_max is reached after approximately 3 hours.

Distribution

The binding of desloratadine to plasma proteins is 83-87%. When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg once a day, there were no signs of clinically significant accumulation of desloratadine. Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine (when taken at a dose of 7.5 mg once a day). It does not cross the blood-brain barrier.

Metabolism

It undergoes intensive metabolism in the liver by hydroxylation to form 3-OH-desloratadine, combined with glucuronide. It is not an inhibitor of the CYP3A4 and CYP2D6 isoenzymes and is not a substrate or inhibitor of P-glycoprotein.

Deduction

Desloratadine is eliminated from the body as a glucuronide compound and in small amounts (less than 2%) by the kidneys and through the intestines (less than 7%) in unchanged form. The T_{1/2 half}-life averages 27 hours.

Indications

-allergic rhinitis (elimination or relief of sneezing, nasal congestion, mucus discharge from the nose, itching in the nose, itching of the palate, itching and redness of the eyes, lacrimation);

– urticaria (reduction or elimination of skin itching, rash).

Use during pregnancy and lactation

The use of BLOGIR-3® syrup during pregnancy is contraindicated due to the lack of clinical data on the safety of its use during this period.

Desloratadine is excreted in breast milk, so the use of the drug during breastfeeding is contraindicated.

Contraindications

Hypersensitivity to desloratadine, other components of the drug or loratadine; pregnancy and lactation; age up to 1 year; hereditary disorders of fructose tolerance (due to the presence of sorbitol in the drug). With caution: In the presence of severe renal insufficiency, the drug should be taken with caution. Desloratadine should be used with caution in patients with a history of seizures.

Side effects

In clinical studies in children under 2 years of age, the following adverse events were observed when using the drug, the frequency of which was slightly higher than when using placebo (from ≥1/100 to

In children aged 2 to 11 years, the frequency of side effects was the same as with placebo.

In adults and adolescents over 12 years of age, the incidence of side effects was slightly higher compared to placebo (from ≥1/100 to: increased fatigue (1.2%), dry mouth (0.8%), headache (0.6%).

The frequency of adverse reactions is classified according to the recommendations of the World Health Organization (WHO): very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (

From the side of the psyche: very rarely – hallucinations; frequency unknown-abnormal behavior, aggression.

From the central nervous system: often-headache, insomnia (in children under 2 years); very rarely-dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.

From the cardiovascular system: very rarely – tachycardia, palpitations; frequency unknown-prolongation of the QT interval.

From the digestive system: often-dry mouth, diarrhea (in children under 2 years); very rarely-abdominal pain, nausea, vomiting, dyspepsia, diarrhea.

From the liver and biliary tract: very rarely-increased activity of liver enzymes, increased bilirubin concentration, hepatitis; frequency unknown-jaundice.

Musculoskeletal disorders: very rare – myalgia.

Skin and subcutaneous tissue disorders: frequency unknown-photosensitization.

From the side of metabolism and nutrition: frequency unknown-increased appetite.

General disorders: often-increased fatigue, fever (in children under 2 years of age); very rarely-anaphylaxis, angioedema, shortness of breath, itching, rash, including urticaria; frequency unknown – asthenia.

Laboratory and instrumental data: frequency unknown – weight gain.

Post-registration period.

Children: frequency unknown – QT interval prolongation, arrhythmia, bradycardia, abnormal behavior, aggression.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

There were no clinically significant interactions in studies when co-administered with ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine.

Simultaneous food intake or consumption of grapefruit juice does not affect the effectiveness of the drug.

BLOGIR-3® does not enhance the effect of alcohol on the central nervous system, however, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, desloratadine should be used with caution at the same time as alcohol.

How to take, course of use and dosage

Inside, regardless of food intake, with a small amount of water.

Children aged 1 to 5 years: 1.25 mg (2.5 ml of syrup) 1 time a day; children aged 6 to 11 years: 2.5 mg (5 ml of syrup) 1 time a day; adults and adolescents from 12 years: 5 mg (10 ml of syrup) 1 time a day.

For seasonal (intermittent) allergic rhinitis (with symptoms lasting less than 4 days a week or less than 4 weeks a year), it is necessary to assess the course of the disease. If symptoms disappear, the drug should be discontinued, and if symptoms reappear, the drug should be resumed.

In case of year-round (persistent) allergic rhinitis (if there are symptoms lasting more than 4 days a week or more than 4 weeks a year), the drug should be taken during the entire period of exposure to the allergen.

Overdose

Symptoms: Taking a dose 5 times higher than the recommended dose did not cause any symptoms. In clinical trials, daily use of desloratadine in adults and adolescents at a dose of up to 20 mg for 14 days was not accompanied by statistically or clinically significant changes in the cardiovascular system. In a clinical and pharmacological study, the use of desloratadine at a dose of 45 mg per day (9 times higher than recommended) for 10 days did not cause prolongation of the QT interval and was not accompanied by the appearance of serious side effects.

Treatment: in case of accidental ingestion of a large amount of the drug, you should immediately consult a doctor; gastric lavage, taking activated charcoal is recommended; if necessary, symptomatic therapy.

Desloratadine is not eliminated by hemodialysis, and the effectiveness of peritoneal dialysis has not been established.

Special instructions

Caution should be exercised when using the drug in patients with a history of seizures, especially in children. You should stop using the drug in case of seizures.

Use in pediatrics

The efficacy and safety of BLOGIR-3® syrup in children under 1 year of age has not been established.

In most cases, rhinitis in children under 2 years of age is infectious in nature.Studies of the effectiveness of desloratadine in rhinitis of infectious etiology have not been conducted.

Differential diagnosis between allergic rhinitis and rhinitis of other origin in children under 2 years of age presents certain difficulties. When making a differential diagnosis, you should pay attention to the presence or absence of foci of infection or structural abnormalities of the upper respiratory tract, conduct a thorough medical history, examination, as well as appropriate laboratory tests and skin tests.

Influence on the ability to drive vehicles and mechanisms

The potential for side effects such as dizziness and drowsiness should be taken into account. If the described adverse events occur, you should refrain from performing these types of activities.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach of children!

Shelf

life is 3 years.

Do not use after the expiration date.

Active ingredient

Desloratadine

Dosage form

oral solution