Active substanceCetirizineCetirizine
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  • Dosage form: & nbspsyrup
    Composition:

    Active substance:

    cetirizine dihydrochloride 5 mg / 5 ml

    Excipients:

    Methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, propylene glycol, sorbitol, sodium saccharinate dihydrate, sodium acetate trihydrate, acetic acid ice, flavoring banana, purified water.

    Description:Transparent, from colorless to light yellow color syrup.
    Pharmacotherapeutic group:Anti-allergic agent-H1-histamine receptor blocker
    ATX: & nbsp

    E.06.A.E.07   Cetirizine

    Pharmacodynamics:

    Cetirizine belongs to the group of competitive antagonists of histamine, blocks H1-gistamine receptors, practically does not have anticholinergic and antiserotonin action. Has a pronounced anti-allergic effect, prevents development and facilitates the course of allergic reactions. Has antipruritic and anti-exsudative effect. Affects the early stage of / allergic reactions, and also reduces the migration of inflammatory cells; oppresses' the selection of mediators involved in a late allergic reaction. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasm of smooth muscles. Eliminates the skin reaction to the administration of histamine, specific allergens, and also to cooling (with cold urticaria). In therapeutic doses, it practically does not have a sedative effect. Against the background of the course, tolerance does not develop.

    The effect of the drug begins in 20 minutes (in 50% of patients), after 1 hour (in 95% of patients), and persists for 24 hours.

    Pharmacokinetics:

    Suction: after oral administration cetirizine quickly and well absorbed from the gastrointestinal tract. The maximum level of concentration is determined after about 30-60 minutes.

    Eating does not have a significant effect on the amount of absorption, but in this case, the rate of absorption is slightly reduced.

    Distribution: Cetirizine binds to blood plasma proteins by about 93%. The value of the volume of the distribution (Vd) is low (0.5 l / kg), the preparation does not penetrate into the cell.

    The drug does not penetrate the blood-brain barrier.

    Metabolism: Cetirizine is poorly metabolized in the liver with the formation of an inactive metabolite.

    At 10-day application in a dose of 10 mg accumulation of the drug is not observed. Excretion: approximately 70% of the kidneys are mostly unchanged. The system clearance is about 54 ml / min.

    After a single dose of a single dose, the half-life is about 10 hours. In children aged 2 to 12 years, the half-life is reduced to 5-6 hours.

    If the renal function is impaired (creatinine clearance is less than 11-31 ml / min) and hemodialysis patients (creatinine clearance less than 7 ml / min), the half-life period increases by 3 times, the clearance decreases by 70%.

    Against the backdrop of chronic diseases and in elderly patients there is an increase in the half-life of 50% and a decrease in clearance by 40%.

    Hemodialysis is ineffective.

    Indications:

    - Seasonal and all-the-year-round allergic rhinitis and conjunctivitis;

    - Itching allergic dermatoses;

    - Pollinosis (hay fever);

    - Hives (including chronic idiopathic);

    - Edema Quincke.

    Contraindications:Hypersensitivity to the components of the drug. Children under 2 years. Pregnancy, lactation.
    Carefully:Chronic renal failure of moderate to severe severity (correction of dosing regimen required), elderly age (glomerular filtration may be reduced).
    Dosing and Administration:

    Inside, regardless of food intake.

    Adults and children over 12 years of age: 2 measuring spoons of ZODAK (10 mg cetirizine) once a day.

    Children from 6 to 12 years: 2 measuring spoons (10 mg cetirizine) once a day or 1 measuring spoon (5 mg cetirizine) 2 times a day - morning and evening.

    Children from 2 to 6 years: 1 measuring spoon (5 mg cetirizine) once a day or 1/2 measuring spoon (2.5 mg cetirizine) 2 times a day - in the morning and in the evening.

    Poi of kidney failure should reduce the recommended dose in 2 times.

    In case of violation of liver function it is necessary to select a dose individually, especially carefully with simultaneous renal failure.

    Elderly patients with normal renal function, no dose adjustment is required.

    Instructions for opening the vial with a safety lid.

    The bottle is closed with a lid with a safety device that prevents its opening by children. The bottle opens when the lid is pressed hard down and then unscrewed against the clockwise direction. After use, the lid of the vial must be tightened again firmly.

    Side effects:

    From the digestive system: dry mouth, indigestion.

    From the side of the central nervous system: headache, drowsiness, fatigue, dizziness, agitation, migraine.

    Allergic reactions: skin rash, angioedema, hives, itching.

    The drug is usually well tolerated. Adverse events occur rarely and have a transient nature.

    Overdose:

    Symptoms: possible drowsiness, inhibition, weakness, headache, tachycardia, increased irritability, retention of urination, fatigue (most often with the intake of 50 mg of cetirizine per day).

    Treatment: conduct symptomatic therapy. A specific antidote has not been identified. Hemodialysis is ineffective. The stomach is washed, Activated carbon.

    Interaction:

    Clinically significant interactions of cetirizine with other drugs have not been established.

    Joint reception with theophylline (400 mg / day) leads to a decrease in the total clearance of cetirizine (the kinetics of theophylline does not change).

    Special instructions:

    It is not recommended simultaneous use of drugs that depress the central nervous system, alcohol.

    Indication for patients with diabetes mellitus:

    10 ml of syrup (2 scoops) contains 3.0 g of sorbitol, which corresponds to a 0.25 bread unit.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Syrup 5 mg / 5 ml.
    Packaging:To 100 ml in a bottle of dark glass. Each bottle, complete with a measuring spoon, together with instructions for use, is placed in a cardboard box.
    Storage conditions:

    Does not require special storage conditions.

    Keep out of the reach of children!

    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-000432
    Date of registration:07.06.2011
    Expiration Date:Unlimited
    Date of cancellation:2017-10-24
    The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic
    Manufacturer: & nbsp
    ZENTIVA, k.s. Czech Republic
    Representation: & nbspZENTIVA PHARMA, LLCZENTIVA PHARMA, LLC
    Information update date: & nbsp24.10.2017
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