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Pharmaceutical group: antiallergic agent - H1-histamine receptor blocker.
Pharmaceutical action: Desloratadine Canon - long-acting antihistamine drug. It is the primary active metabolite of loratadine. Inhibits a cascade of allergic inflammation reactions, including the release of proinflammatory cytokines, including IL-4, IL-6, IL-8, IL-13 interleukins, the release of proinflammatory chemokines (RANTES), the production of superoxide anions by activated polymorphonuclear neutrophils, adhesion, and the manifers, as well as manpaths, and adherents, and manifers, and adolescents, adhesion, and adolescents, adhesion, and adolescents, adhesion, and adherents, aspirant and neutrophilia, adhesion, and human beings, as well as manpaths and adolescent neurotrophins, adhesion, and human therapy; isolation 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 antipruritic and anti-exudative action, reduces capillary permeability, prevents the development of tissue edema, and smooth muscle spasm.
The drug has no effect on the central nervous system, has almost no sedative effect (does not cause drowsiness) and does not affect the speed of psychomotor reactions. Does not cause prolongation of the QT interval on the ECG.
The action of desloratadine begins within 30 minutes after ingestion and lasts 24 hours.
Pharmacokinetics: Desloratadine is well absorbed in the gastrointestinal tract. Determined in blood plasma 30 minutes after ingestion. The maximum concentration is reached on average 3 hours after ingestion. Does not penetrate the blood-brain barrier. Communication with 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, there is no clinically significant cumulation of the drug. Simultaneous ingestion of food or grapefruit juice does not affect the distribution of desloratadine when used at a dose of 7.5 mg 1 time per day.
Desloratadine is not a CYP3A4 and CYP2D6 inhibitor and is not a substrate or P-glycoprotein inhibitor. It is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, coupled with the glucuronide. Only a small part of the ingested dose is excreted by the kidneys (<2%) and through the intestines (<7%). The half-life is 20-30 hours (on average, 27 hours).
- allergic rhinitis (elimination or relief of sneezing, nasal congestion, discharge of mucus from the nose, itching in the nose, itching of the palate, itching and redness of the eyes, tearing);
- urticaria (reduction or elimination of pruritus, rash).
1 tab .:
- desloratadine 5 mg;
excipients: calcium hydrophosphate dihydrate 61.7 mg; Povidone 6.8 mg; calcium stearate 0.7 mg; croscarmellose sodium (primelloza) 4.8 mg; microcrystalline cellulose 41 mg;
film coating composition: Opadry 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.
Desloratadine is marketed under different brands and generic names, and comes in different dosage forms:
|Brand name||Manufacturer||Country||Dosage form|
|Erius||Bayer Pharma AG||Germany||syrup|
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Dosage and Administration
Orally, regardless of the meal, adults and adolescents from 12 years on 1 tablet per day. The tablet should be swallowed whole with water.
WHO classification of the incidence of side effects:
very often - ≥1 / 10 appointments (> 10%)
often from ≥1 / 100 to <1/10 of appointments (> 1% and infrequently from ≥1 / 1000 to 0.1% and rarely from ≥1 / 10000 to 0.01% and very rarely - Immune system disorders
Very rare: allergic reactions, including anaphylaxis.
Nervous system disorders
Infrequently: a headache.
Very rarely: tachycardia, palpitations.
Disorders of the gastrointestinal tract
Infrequently: dry mouth.
Violations of the skin and subcutaneous tissue
Very rare: rash.
General disorders and disorders at the site of administration
Often: increased fatigue.
Laboratory and instrumental data
Very rarely: increased activity of liver enzymes, increased concentration of bilirubin.
- Hypersensitivity to any of the substances that make up the drug;
- pregnancy and lactation;
- age up to 12 years.
With care: severe chronic renal failure.
Interaction with other drugs is not revealed. Eating does not affect the effectiveness of the drug. Desloratadine does not increase the effect of alcohol on the central nervous system.
Pregnancy and Lactation
Desloratadine Canon is not recommended to be taken during pregnancy, since no relevant clinical studies have been conducted and the safety of use during pregnancy has not been established.
Desloratadine penetrates into breast milk, so women who are breastfeeding should not take the drug Desloratadine Canon.
Studies of the effectiveness of desloratadine in rhinitis infectious etiology has not been conducted.
Influence on the ability to drive a car and other mechanical means:
Adverse effects on driving or complex technical devices were noted.
Symptoms Receiving a dose exceeding the recommended 5 times, did not lead to the appearance of any symptoms. During clinical trials, daily use of desloratadine in a dose of up to 20 mg for 14 days in adults and adolescents was not accompanied by statistically or clinically significant changes in the cardiovascular system. In a clinical pharmacological study, the use of desloratadine at a dose of 45 mg per day (9 times 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. In case of accidental ingestion of a large amount of the drug should immediately consult a doctor. Recommended gastric lavage, taking activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted by hemodialysis, the effectiveness of peritoneal dialysis has not been established.
- Brand name: Desloratadine
- Active ingredient: Desloratadine
- Dosage form: pills, film coated white or almost white, round, biconvex; the cross section is almost white or white with a creamy or white with a pinkish tinge.
- Manufacturer: Canonpharma
- Country of Origin: Russia
- Prevalence of desloratadine poor metabolizer phenotype in healthy Jordanian males
- Structural characterization of in vitro rat liver microsomal metabolites of antihistamine desloratadine using LTQ-Orbitrap hybrid mass spectrometer in combination with online hydrogen/deuterium exchange HR-LC/MS
- Prevalence of the slow metabolizer (SM) phenotype and single dose pharmacokinetics (PK) of desloratadine (DCL) in a population of healthy adults
- Pharmacokinetics (PK) of multiple oral doses of desloratadine (DCL) and fexofenadine (FEX) in a population of healthy adults identified phenotypically as desloratadine slow metabolizers (DSMS)
- Disposition of desloratadine in healthy volunteers
- High-performance liquid chromatographic method for the bioequivalence evaluation of desloratadine fumarate tablets in dogs
- Determination of desloratadine in drug substance and pharmaceutical preparations by liquid chromatography
- Orthogonal extraction/chromatography and UPLC, two powerful new techniques for bioanalytical quantitation of desloratadine and 3-hydroxydesloratadine at 25 pg/mL
- Simultaneous determination of loratadine and desloratadine in pharmaceutical preparations using liquid chromatography with a microemulsion as eluent
- Simultaneous determination of rupatadine and its metabolite desloratadine in human plasma by a sensitive LC–MS/MS method: Application to the pharmacokinetic study in healthy Chinese volunteers
- Rapid separation of desloratadine and related compounds in solid pharmaceutical formulation using gradient ion-pair chromatography
- Corrigendum to “A validated stability indicating UPLC method for desloratadine and its impurities in pharmaceutical dosage forms” [J. Pharm. Biomed. Anal. 51 (2010) 736–742]
- Desloratadine reduces nasal congestion in patients with intermittent allergic rhinitis
- The pharmacologic profile of desloratadine: a review
- Decongestant efficacy of desloratadine in patients with seasonal allergic rhinitis
- Desloratadine in the treatment of chronic idiopathic urticaria
- Comparison of the effects of desloratadine 5-mg daily and placebo on nasal airflow and seasonal allergic rhinitis symptoms induced by grass pollen exposure
- Therapeutic points of intervention and clinical implications: role of desloratadine
- Twenty-four-hour activity and consistency of activity of levocetirizine and desloratadine in the skin
- Inhibition of cytokine generation and mediator release by human basophils treated with desloratadine
- Effects of fexofenadine and desloratadine on subjective and objective measures of nasal congestion in seasonal allergic rhinitis
- Once-daily desloratadine improves the signs and symptoms of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled study
- Improvements in simulated real-world relevant performance for patients with seasonal allergic rhinitis: impact of desloratadine
- Form I of desloratadine, a tricyclic antihistamine