Active substanceDesloratadineDesloratadine
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    Active substance: desloratadine - 5.0 mg;

    Excipients: corn starch - 20.0 mg, microcrystalline cellulose (Avicel PH 101) - 49.0 mg, hypromellose (E-6 LV Premium) 3.0 mg; microcrystalline cellulose (Avicel PH 112) 20.0 mg; silicon dioxide colloidal anhydrous - 1.5 mg; butter vegetable hydrogenated - 1.5 mg;

    film sheath: Opapray blue (hypromellose 62.50%, titanium dioxide 30.30%, macrogol-400 6.25%, indigo carmine (E 132) 0.95%) - 3.0 mg.

    Description:

    TObifid biconvex tablets coated with film shell, light-blue color, with an impression of "5" on one side.

    Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker
    ATX: & nbsp

    R.06.A.X   Other antihistamines for systemic use

    R.06.A.X.27   Desloratadine

    Pharmacodynamics:

    Antihistamine is a long-acting drug. Has a selective effect on peripheral H1-receptors. Has anti-allergic action: inhibits the release proinflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, release of pro-inflammatory chemokines (RANTES), production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, isolation of adhesion molecules such as P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4. Thus, it prevents development and facilitates the course of allergic reactions, has antipruritic and antiexcudative action, reduces permeability of capillaries, prevents the development of edema of tissues, spasm of smooth muscles.

    The drug has no effect on the central nervous system (CNS), has no sedative effect and does not affect the rate of psychomotor reactions. In clinico-pharmacological studies of the use of desloratadine in the recommended therapeutic dose there was no longer lengthening of the interval QT on an electrocardiogram (ECG).

    The action of desloratadine begins within 30 minutes after ingestion and lasts for 24 hours.

    Pharmacokinetics:

    Desloratadine is well absorbed in the gastrointestinal tract (GIT): it is detected in the blood plasma 30 minutes after ingestion. The maximum concentration (CmOh) is achieved on average 3 hours after administration.Does not penetrate the blood-brain barrier. The connection with 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 is no clinically significant cumulation of the drug. Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine when administered at a dose of 7.5 mg 1 time per day. Desloratadine is not an inhibitor of isoenzymes CYP3A4 and CYP2D6 and is not a substrate or an inhibitor of P-glycoprotein.

    Intensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, which, in turn, undergoes glucuronidation.

    Output is unchanged kidney less than 2% and through the intestine less than 7%. The half-life (T1/2) on the average is 27 hours.

    Indications:
    • seasonal and year-round allergic rhinitis (elimination or alleviation of sneezing, nasal congestion, mucus discharge from the nose, pruritus in the nose, itching of the palate, itching and redness of the eyes, lachrymation);
    • urticaria (reduction or elimination of itching, rash).
    Contraindications:
    • hypersensitivity to desloratadine, loratadine, as well as any of the components of the drug;
    • pregnancy;
    • lactation period;
    • children under 12 years.
    Carefully:

    Carefully should be used in severe renal failure (creatinine clearance (CK) <30 mL / min).

    Pregnancy and lactation:

    The use of the drug during pregnancy is contraindicated in connection with the lack of data on the safety of the use of desloratadine during pregnancy.

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

    Dosing and Administration:

    Inside, regardless of food intake.

    The tablet should be swallowed whole, not liquid, squeezed with a small amount of water.

    Adults and teenagers over 12 years of age: 1 tablet (5 mg) once a day. Treatment seasonal allergic rhinitis (duration of symptoms less than 4 days a week or less than 4 weeks) should be carried out taking into account anamnesis of the disease, after the disappearance of symptoms treatment can be stopped. If the symptoms recur, the treatment can be resumed.

    When year-round allergic rhinitis (the duration of the manifestation of symptoms for 4 or more days a week and more than 4 weeks) patients can be recommended continuous treatment during periods of exposure to the allergen.

    Side effects:

    According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10000 to <1/1000), very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

    The following undesirable phenomena from the side of the central nervous system (headache, drowsiness, increased fatigue) were encountered approximately at the same frequency as when using a placebo ("dummy").

    From the nervous system

    infrequently: headache;

    rarely: dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions, hallucinations.

    From the side of the cardiovascular system

    rarely: tachycardia, heart palpitations;

    frequency is unknown: extension of the QT interval.

    From the gastrointestinal tract

    infrequently: dry mouth;

    rarely: abdominal pain, nausea, vomiting, indigestion, diarrhea.

    From the liver and biliary tract

    rarely: increased activity of "hepatic" transaminases, increased bilirubin concentration, hepatitis.

    From the skin and subcutaneous tissues

    frequency is unknown: photosensitization.

    From the musculoskeletal and connective tissue

    rarely: myalgia.

    From the immune system

    rarely: anaphylaxis, angioedema, dyspnea, pruritus, rash, urticaria.

    Other

    often: increased fatigue.

    Post-registration period.

    Children

    frequency is unknown: prolongation of QT interval, arrhythmia, bradycardia.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms. In a clinical 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 clinically significant changes.

    Treatment. Recommended gastric lavage, reception of activated charcoal; if necessary, symptomatic therapy.

    It is not excreted when hemodialysis, the effectiveness of peritoneal dialysis is not established.

    Interaction:

    With multiple simultaneous use of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine clinically significant changes in the concentration of desloratadine in blood plasma were not detected.

    Simultaneous use grapefruit juice does not affect the effectiveness of the drug.

    Desloratadine does not increase the effect alcohol on the central nervous system. However, during the post-registration use cases of alcohol and alcohol intolerance were reported. therefore desloratadine Alcohol should be used with caution.

    Special instructions:

    Studies of the effectiveness of the drug in rhinitis of infectious etiology were not conducted.

    Clinical studies have shown that increasing the dose and increasing the frequency of admission does not affect the effectiveness of the drug, so patients should be warned that it is not recommended to increase the dosage or frequency of admission.

    Effect on the ability to drive transp. cf. and fur:

    Consideration should be given to the potential for the development of side effects such as dizziness and drowsiness. When these undesirable phenomena appear, one should refrain from performing these activities.

    Form release / dosage:

    Tablets, film-coated, 5 mg.

    Packaging:For 10 tablets, covered with a film sheath, in Al / Al blister. For 1, 2, 3 or 6 blisters in a pack of cardboard along with instructions for use.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Special precautions for the destruction of unused medicinal product

    There is no need for special precautions when destroying an unused Alestamine®.

    Shelf life:

    2 years. Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003856
    Date of registration:23.09.2016
    Expiration Date:23.09.2021
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp06.07.2017
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