Active substanceLoratadinLoratadin
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains: active substance - loratadine-10 mg;

    Excipients - lactose (milk sugar), magnesium stearate, corn starch.

    Description:Tablets are white or white with a yellowish hue of color, flat-cylindrical with a bevel.
    Pharmacotherapeutic group:Antiallergic - H1 histamine receptor blocker
    ATX: & nbsp

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

    R.06.A.X.13   Loratadin

    Pharmacodynamics:

    The blocker of H1-gistaminovyh receptors (long-acting). Suppresses the release of histamine and leukotriene C4 from mast cells. Prevents development and facilitates the course of allergic reactions. Has anti-allergic, antipruritic, anti-exsudative 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. Does not affect the central nervous system and is not addictive (because it does not penetrate the blood-brain barrier).

    Pharmacokinetics:

    Quickly and completely absorbed in the gastrointestinal tract. The maximum concentration of loratadine and its active metabolite in blood plasma is achieved in 1,3 - 2,5 hours after taking one tablet, and the food intake slows it down by 1 hour. The maximum concentration of loratadine and its active metabolite in the elderly increases by 50%, with alcoholic liver damage - with an increase in the severity of the disease,

    The connection with plasma proteins is 97%.

    Loratadine is metabolized in the liver with the formation of an active metabolite of descabroxetoxyloratadine with the participation of cytochrome isoenzymes CYP3A4 and to a lesser extent CYP2D6.

    The equilibrium concentration (Css) loratadine and metabolite in plasma is reached on the 5th day of administration.

    Does not penetrate the blood-brain barrier.

    The half-life of loratadine is 3-20 hours (an average of 8.4 hours), 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 (an average of 17.5 hours). In alcoholic liver damage, the half-life period increases in proportion to the severity of the disease.

    It is excreted by the kidneys and through the intestines.

    In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically does not change.

    Indications:

    Allergic rhinitis (seasonal, year-round), conjunctivitis, hay fever, urticaria, including chronic idiopathic, Quincke's edema, pseudoallergic reactions, itchy dermatoses, allergic reactions to insect bites.

    Contraindications:

    Hypersensitivity to any of the components of the drug, lactation period, children weighing up to 30 kg,patients with violations of the liver in connection with a possible violation of the clearance of loratadine.

    Pregnancy and lactation:

    The use of the drug during pregnancy is possible if the intended benefit to the mother exceeds the potential risk to the fetus.

    Loratadin is excreted in breast milk, so when prescribing the drug during lactation it is necessary to resolve the issue of stopping breastfeeding.

    Dosing and Administration:

    Inside. Adults and children over 12 years: 10 mg (1 tablet) 1 time per day. The daily dose is 10 mg.

    Children with a body weight of more than 30 kg - 10 mg (1 tablet) 1 time per day. The daily dose is 10 mg.
    Side effects:

    The undesirable phenomena listed below, when using loratadine were found with the frequency ≥2% and approximately at the same frequency as with the placebo ("dummies"),

    In adults: headache, fatigue, dry mouth, drowsiness, gastrointestinal disorders (nausea, gastritis), as well as allergic reactions in the form of rashes. In addition, there were rare reports of anaphylaxis, alopecia, impaired liver function, palpitation, tachycardia.

    Children rarely: headache, nervousness, sedation.

    Overdose:

    Symptoms of an overdose: drowsiness, tachycardia, headache. In case of an overdose, you should consult a doctor and take measures to remove the drug from the gastrointestinal tract and reduce absorption - gastric lavage, reception of activated charcoal.

    Interaction:

    Inhibitors CYP3A4 (including ketoconazole, erythromycin), inhibitors CYP3A4 and CYP2D6 cimetidine, etc.) increase the concentration of loratadine in the blood. Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) reduce effectiveness.

    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:

    10, 20, 30, 40 or 50 tablets in cans for orange glass medicines with a triangular aureole.

    10,20, 30,40 or 50 tablets in cans for polymeric drugs with a screw neck and screw caps.

    10 tablets in a contoured cell pack of PVC film and aluminum foil or packaging material.

    Each bank, 1, 2, 3, 4 or 5 contour mesh packages together with instructions for use - in a pack of cardboard.

    Storage conditions:

    List B. In a dry, protected from light place, at a temperature of no higher than 25 ° С. Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N000654 / 02
    Date of registration:14.08.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.01.2018
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