Active substanceFexofenadineFexofenadine
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  • Dosage form: & nbspfilm-coated tablets
    Composition:1 tablet contains:
    Active substance:

    fexofenadine hydrochloride

    - 120 mg

    - 180 mg

    Excipients:



    microcrystalline cellulose

    - 125 mg

    - 187 mg

    corn starch pregelatinized starch

    - 53 mg

    - 80 mg

    Silica colloidal dioxide (aerosil)

    - 8 mg

    - 12 mg

    Povidone (Kollidon 30)

    - 2 mg

    - 3 mg

    crospovidone (Kollidon CL-M)

    - 80 mg

    - 120 mg

    sodium croscarmellose

    - 8 mg

    - 12 mg

    magnesium stearate

    - 4 mg

    - 6 mg

    Excipients for the shell

    Opapray II (series 85)



    polyvinyl alcohol partially hydrolyzed

    - 8 mg

    - 12 mg

    macrogol 3350 (polyethylene glycol 3350)

    - 4.0 mg

    - 6.06 mg

    talc

    3.0 mg

    - 4.44 mg

    titanium dioxide

    - 4.65 mg

    - 6.96 mg

    dye sunset yellow aluminum varnish

    - 0.15 mg

    - 0.23 mg

    iron dye yellow oxide

    - 0.08 mg

    - 0.12 mg

    dye iron oxide red

    - 0.12 mg

    - 0.19 mg

    Average weight of coated tablet

    420 mg

    - 630 mg

    Description:

    The tablets covered with a film membrane of a brownish-pink color, biconvex, oblong with rounded ends, with a risk. Two layers are visible on the cross-section.

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

    R.06.A.X.26   Fexofenadine

    Pharmacodynamics:

    Fexofenadine is a non-sedating blocker H1-histamine receptors, is a pharmacologically active metabolite of terfenadine.

    The antihistamine effect manifests itself 1 hour after admission, reaches a maximum after 6 hours and lasts for 24 hours. With repeated application, there is no development of tolerance. It has no holino-and adrenoblokiruyuschego action, almost no sedative effect.Does not cause changes in the function of calcium and potassium channels, the interval QT in therapeutic doses.

    Pharmacokinetics:

    After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. Time to reach the maximum concentration in plasma (TFROMmax) is 2.6 hours after administration. The average plasma concentration in healthy subjects after single oral administration at a dose of 60 mg - 209 ng / ml, the equilibrium concentration (Css) after repeated administration - 286 ng / ml. The average value of the maximum concentration (Cmax) after taking 180 mg - approximately 494 ng / ml, after taking 120 mg - 289 ng / ml, after taking 60 mg - 131 ng / ml.

    Pharmacokinetics is practically linear with daily intake in the dose range of 60-180 mg. Connection with plasma proteins - 60-70% (mainly with albumin and alpha-1-acid glycoprotein). It does not penetrate the blood-brain barrier (GEB), it is secreted into breast milk.

    The half-life (T1/2) after repeated admission - 14.4 hours, the area under the pharmacokinetic curve of the concentration versus time (AUC) - 1521 μg / l / h, clearance - 3,4 ml / min / kg.

    In patients with moderate (creatinine clearance (CC) 41-80 ml / min) and severe (11-40 ml / min) renal failure T1/2 increases by 59 and 72%, respectively; in patients on hemodialysis, T1/2 increases by 31%. It is exposed (5% of the dose) to partial extrahepatic metabolism.

    Mostly (80%) is excreted with bile, 10% with unchanged kidneys.

    Patients 65 years of age or older T1/2 does not change, the concentration in the blood increases, but this does not affect the tolerability of the drug. Against the background of renal dysfunction and hemodialysis CmOh increases and T1/2 lengthens.

    The pharmacokinetic parameters of fexofenadine in patients with liver diseases vary slightly.

    Indications:Seasonal allergic rhinitis, chronic urticaria.
    Contraindications:

    Hypersensitivity to fexofenadine or other components of the drug, children under 12 years of age, pregnancy, the period of breastfeeding.

    Carefully:In chronic renal failure, with hepatic insufficiency.
    Pregnancy and lactation:
    The use of the drug during pregnancy and breastfeeding is contraindicated.

    If you need to use the drug during breastfeeding, breastfeeding should be discarded.

    Dosing and Administration:

    Inside.

    With seasonal allergic rhinitis, 120 mg once a day.

    For chronic urticaria, 180 mg once a day.

    The recommended daily dose for patients with chronic renal failure is 60 mg once.

    Side effects:

    From the gastrointestinal tract: nausea.

    From the skin and subcutaneous tissues: allergic reactions, urticaria, in some cases - skin rash, skin itching, angioedema.

    From the central nervous system: dizziness, headache, drowsiness; rarely - fatigue, nervousness, sleep disturbance, insomnia.

    From the respiratory system: in some cases - dyspnea.

    Overdose:

    Symptoms: dizziness, headache, drowsiness, nausea and dry mouth.

    Treatment: in the case of an overdose, it is recommended to perform gastric lavage, setting cleansing enemas, taking enterosorbents (activated charcoal). Symptomatic and supportive therapy is recommended. Hemodialysis is ineffective.

    Interaction:

    When combined with erythromycin or ketoconazole, the concentration of fexofenadine in plasma increases 2-3 times.Reception of aluminum-or magnesium-containing antacids 15 minutes before fexofenadine intake leads to a decrease in bioavailability of the latter (the time interval between their intake should be at least 2 hours).

    Does not interact with omeprazole, with drugs metabolized in the liver.

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

    When taking the drug, it is possible to perform works that require a high concentration of attention and speed of psychomotor reactions (with the exception of people who have a non-standard reaction to drugs). Thus, before starting to operate vehicles, servicing moving mechanisms and engaging in other potentially dangerous activities requiring increased attention and speed of psychomotor reactions, it is first necessary to check the individual reaction to the drug.

    Form release / dosage:Tablets, film-coated, 120 mg and 180 mg.
    Packaging:

    For 10, 15, 20 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 1, 2 or 3 contour squares, together with the instructions for use, are placed in a pack of cardboard.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-000895
    Date of registration:19.09.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp25.04.2017
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