Blogir-3 syrup 0.5mg/ml vial, 60ml

Composition

1 ml of syrup contains:  active substance:  desloratadine 0.5 mg. Auxiliary substances: 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 action

Pharmacodynamically an antihistamine for long periods. It is the primary active metabolite of loratadine. Selectively blocks the activity of peripheral H1 histamine receptors. Inhibits the release of histamine from mast cells. It inhibits a cascade of allergic inflammatory reactions, including the release of anti-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, and the release of adhesion molecules such as P-selectin. 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. It does not cause prolongation of the QT interval on the ECG. Pharmacokineticsabsorption After oral use, desloratadine is well absorbed in the gastrointestinal tract, is determined in blood plasma 30 minutes after oral use. The maximum concentration of Cmax is reached after approximately 3 h. 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. Metabolizm is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine coupled to glucuronide. It is not an inhibitor of the CYP3A4 and CYP2D6 isoenzymes and is not a substrate or inhibitor of P-glycoprotein. Excretiondezloratadine is excreted 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 T1 / 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 the components of the drug; pregnancy and lactation; age up to 1 year; hereditary disorders of fructose tolerance (due to the presence of sorbitol in the drug). Caution In the presence of severe renal insufficiency, the drug should be taken with caution.

Side effects

In clinical studies in children under 2 years of age, the following adverse events were observed with the drug, the frequency of which was slightly higher than with placebo: diarrhea, fever, insomnia; 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 following adverse events were observed with the drug, the frequency of which was slightly higher than with placebo: increased fatigue, dry mouth, headache. Very rarely, the following side effects were observed: : From the central nervous system: hallucinations, dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions. From the cardiovascular system: tachycardia, palpitations. From the digestive system: abdominal pain, nausea, vomiting, dyspepsia, diarrhea. From the liver and biliary tract: increased activity of liver enzymes, bilirubin content, hepatitis. Musculoskeletal system disorders: myalgia. Allergic reactions: anaphylaxis, angioedema, shortness of breath, pruritus, rash, including urticaria, photosensitization. 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

Interactions with multiple co-use of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine clinically significant changes in the concentration of desloratadine in plasma were not detected. BLOGIR-3® does not enhance the effect of alcohol on the central nervous system. Food intake does not affect the effectiveness of the drug.

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

In clinical trials, no clinically significant adverse effects were observed when desloratadine was administered at a dose of up to 45 mg (9 times the therapeutic dose). Treatment: In case of overdose, standard measures are taken to remove the Active ingredient from the gastrointestinal tract. Symptomatic and supportive care is recommended. Desloratadine is not eliminated by hemodialysis, and the effectiveness of peritoneal dialysis has not been established.

Special instructions

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 mechanicsin the recommended dose, the drug does not affect the ability to drive vehicles or mechanisms. However, in very rare cases, some patients may experience drowsiness while taking desloratadine, which may affect their ability to drive vehicles or operate machinery.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach of children!

Shelf

life is 3 years.

Active ingredient

Desloratadine

Dosage form

solution for oral use

Description

For adults, Children over 1 year old

Indications

Urticaria, Dermatitis, Pollinosis, Runny Nose, Conjunctivitis, Allergy