Active substanceLoratadinLoratadin
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  • Dosage form: & nbsppills
    Composition:

    One tablet contains:

    active substance: loratadine in terms of 100% - 10 mg;

    Excipients: lactose monohydrate 110 mg, cellulose microcrystalline 75 mg, calcium stearate 2 mg, carboxymethyl starch sodium 3 mg.

    Description:

    Tablets are white or almost white, flat-cylindrical, with a bevel.

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

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

    R.06.A.X.13   Loratadin

    Pharmacodynamics:

    H1-histamine receptor blocker (long-acting). Suppresses the release of histamine and leukotriene C4 from mast cells. Prevents development and facilitates the course of allergic reactions. It has antiallergic, antipruritic, antiexudative action. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasms of smooth muscles. The antiallergic effect develops after 30 minutes, reaches a maximum after 8-12 hours and lasts for 24 hours. It does not affect the central nervous system (because it does not penetrate the blood-brain barrier) and is not addictive.

    Pharmacokinetics:

    Quickly and completely absorbed in the gastrointestinal tract. Time to reach the maximum concentration in the blood plasma after taking the drug - 1,3-2,5 h; intake of food slows it down for 1 hour. The maximum concentration of the drug in the blood plasma in the elderly increases by50%, with alcoholic liver damage - with increasing severity of the disease. The connection with plasma proteins is 97%. Metabolized in the liver with the formation of an active metabolite descarbotoxyloratadine with the participation of cytochrome isoenzymes CYP3A4 and to a lesser extent CYP2D6. The equilibrium concentration of loratadine and metabolite in plasma is reached by 5 days of administration. Does not penetrate the blood-brain barrier. The half-life of loratadine is 3-20 hours (an average of 8.4), the active metabolite is 8.8-92 hours (an average of 28 hours); in elderly patients, respectively, 6.7-37 hours (an average of 18.2 hours) and 11-38 hours (17.5 hours). With alcohol damage to the liver, the elimination half-life increases in proportion to the severity of the disease. It is excreted by the kidneys and with bile. In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically does not change.

    Indications:

    Allergic rhinitis (seasonal and year-round), conjunctivitis, hay fever, urticaria (including chronic idiopathic), angioedema, itching dermatoses; pseudoallergic reactions caused by the release of histamine; allergic reactions to insect bites.

    Contraindications:

    Hypersensitivity, lactation period, children with body weight less than 30 kg, lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

    Carefully:

    Hepatic insufficiency, pregnancy.

    Pregnancy and lactation:

    Use during pregnancy is only possible when the intended benefit to the mother exceeds the potential risk to the fetus. For the duration of treatment, breastfeeding should be stopped (penetrates into breast milk).

    Dosing and Administration:

    Inside. Adults and children with a body weight of more than 30 kg - 10 mg once a day.

    For patients with renal insufficiency or with impaired liver function, the initial dose should be 10 mg every other day.

    Side effects:

    In adults: headache, fatigue, dry mouth, drowsiness, nausea, gastritis, allergic reactions (rash), anaphylaxis, alopecia, liver dysfunction, tachycardia.

    Children: headache, increased nervous excitability, sedation.

    Overdose:

    Symptoms: drowsiness, tachycardia, headache.

    Treatment: gastric lavage, reception of activated carbon. It is not excreted by hemodialysis.

    Interaction:

    Erythromycin, cimetidine and ketoconazole when combined with loratadine increase the concentration of loratadine in blood plasma, without causing clinical manifestations and without affecting the data of electrocardiography.

    Inductors of microsomal oxidation (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the effectiveness of loratadine.

    Loratadine does not enhance the effect of alcohol on the central nervous system.

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

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Tablets 10 mg.

    Packaging:

    For 7 or 10 tablets in a planar cell package.

    1 or 3 contour mesh packages together with instructions for use in a pack of cardboard.

    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years. Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N003765 ​​/ 02
    Date of registration:06.10.2009 / 14.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.03.2018
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