Composition
of 1 tab. : – desloratadine 5 mg; excipients: calcium hydrophosphate dihydrate 61.7 mg; povidone 6.8 mg; calcium stearate 0.7 mg; croscarmellose sodium (primellose) 4.8 mg;microcrystalline cellulose 41 mg; film shell composition: Opadray II white 4 mg, including: polyvinyl alcohol 1.88 mg, macrogol (polyethylene glycol 3350) 0.94 mg, talc 0.7 mg, titanium dioxide 0.48 mg
Pharmacological action
Pharmaceutical group:
anti-allergic agent-H 1-histamine receptor blocker.
Pharmaceutical effect:
Desloratadine Canon is a long-acting antihistamine.
It is the primary active metabolite of loratadine. Inhibits the cascade of reactions of allergic inflammation, including the release of proinflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, release of proinflammatory chemokines (RANTES), production of superoxide anion by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, release of adhesion molecules such as P-selectin, IgE-mediated release of histamine, prostaglandin D2, and of leukotriene C 4.
Thus, it prevents the development and facilitates the course of allergic reactions, has an antipruritic and anti-exudative 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.
The effect of desloratadine begins within 30 minutes after ingestion and lasts for 24 hours.
Pharmacokinetics:
Desloratadine is well absorbed in the gastrointestinal tract. It is determined in blood plasma 30 minutes after ingestion. The maximum concentration is reached on average 3 hours after ingestion. It does not cross the blood-brain barrier.
Binding to plasma proteins is 83-87%. When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg 1 time per day, clinically significant accumulation of the drug is not observed. Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine when used at a dose of 7.5 mg once a day.
Desloratadine is not an inhibitor of CYP3A4 and CYP2D6 and is not a substrate or inhibitor of P-glycoprotein. It is intensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, combined with glucuronide. Only a small portion of the oral dose is excreted by the kidneys (< 2%) and through the intestines ( The elimination half-life is 20-30 hours (27 hours on average).
Indications
-Allergic rhinitis (elimination or relief of sneezing, nasal congestion, nasal mucus discharge, itchy nose, itchy palate, itchy and red eyes, watery eyes);- urticaria (reduction or elimination of skin itching, rash).
Contraindications
-hypersensitivity to any of the substances that make up the drug;- pregnancy and lactation;- age up to 12 years. With caution: severe chronic renal failure.
Side effects
WHO classification of frequency of side effects: very common – ≥1/10 appointments (>10%)common – ≥1/100 to < 1/10 appointments (>1% and < 1/10 appointments (><10%) uncommon – ≥1/1000 to <1/100 appointments (>0.1% and <1/100 appointments (><1%) rare – ≥1/10000 to <1/1000 appointments (>0.01% and <1/1000 appointments (>very rare – <1/10000 appointments (<0.01%)
Immune system disorders Very rare: allergic reactions, including anaphylaxis.
Nervous system disorders often: headache.
Disorders of the heart are very rare: tachycardia, palpitations.
Disorders of the gastrointestinal tract often: dry mouth.
Skin and subcutaneous tissue disorders Very rare: rash.
General disorders and disorders at the injection site often: increased fatigue.
Laboratory and instrumental data are very rare: increased activity of liver enzymes, increased bilirubin concentration.
Interaction
Interaction with other drugs was not detected.
Food intake does not affect the effectiveness of the drug. Desloratadine does not increase the effect of alcohol on the central nervous system.
How to take, course of use and dosage
Inside, regardless of food intake, adults and adolescents from 12 years of age,1 tablet per day. The tablet should be swallowed whole, washed down with water.
Overdose
Symptoms. Taking a dose exceeding the recommended 5 times did not lead to 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 the recommended dose) for 10 days did not cause prolongation of the QT interval and was not accompanied by the appearance of serious side effects.
Treatment. If you accidentally take a large amount of the drug inside, you should immediately consult a doctor. Gastric lavage and activated charcoal are recommended; if necessary, symptomatic therapy is recommended. Desloratadine is not eliminated by hemodialysis, and the effectiveness of peritoneal dialysis has not been established.
Special instructions
Studies of the effectiveness of desloratadine in rhinitis of infectious etiology have not been conducted.
Influence on the ability to drive a car and other mechanical means:
There were no adverse effects on driving or complex technical devices.
Active ingredient
Desloratadine
Dosage form
Tablets
Description
For adults, Children over 12 years of age
Indications
Allergy, Urticaria, Pollinosis, Allergic Conjunctivitis, Dermatitis, Allergic Rhinitis, Diathesis
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