Active material: Cetirizine
When ATH: R06AE07
CCF: Gistaminovыh blocker H1-receptors. Allergy medication
ICD-10 codes (testimony): H10.1, J30.1, J30.3, L20.8, L23, L24, L28.0, L29, L30.0, L50, T78.3
When CSF: 13.01.01.02
Manufacturer: ZENTIVA a.s. (Czech Republic)
Zodak: dosage form, composition and packaging
◊ Drops for intake clear, colorless to pale yellow.
|1 ml (20 drops)|
|cetirizine digidrohlorid||10 mg|
Excipients: methylparaben, propyl, glycerol, propylene glycol, sodium saccharin, sodium acetate, glacial acetic acid, Purified water.
20 ml – vials of dark glass (1) a cover-dropper – packs cardboard.
◊ Syrup clear, colorless to pale yellow.
|5 ml (1 mern. l.)|
|cetirizine digidrohlorid||5 mg|
Excipients: methylparaben, propyl, glycerol, propylene glycol, Sorbitol liquid, sodium saccharin, sodium acetate, glacial acetic acid, Banana flavor, Purified water.
100 ml – vials of dark glass (1) complete with a scoop – packs cardboard.
Zodak: pharmachologic effect
Allergy medication, gistaminovыh blocker H1-receptors. Cetirizine belongs to the group of competitive antagonists of histamine. It has a pronounced anti-allergic effect, prevents and facilitates the allergic reactions. It has antipruritic and antiexudativ effect. It affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; inhibits release of mediators, involved in the late allergic reaction. Decreases capillary permeability, prevents the development of edema, relieves smooth muscle spasm. Eliminates skin reaction to the introduction of histamine, specific allergens, and cooling (when cold urticaria).
Virtually no anticholinergic action and antiserotoninovogo.
At therapeutic doses substantially no sedative effect. Against the background of course taking the tolerance does not develop.
Preparation action begins 20 m (in 50% patients) or via 1 no (in 95% patients) and maintained for a 24 no.
After oral cetirizine is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax plasma is determined approximately 30-60 m. Food intake has no significant effect on the value of removals, however, in this case, the rate of absorption is reduced insignificantly.
The binding of cetirizine plasma proteins is approximately 93%. The value Vd Low - 0.5 l / kg. Cetirizine does not penetrate into the cell. Do not cross the BBB.
Cetirizine poorly metabolized in the liver with the formation of active metabolites.
At 10 days of administration at a dose 10 mg cumulation is not observed.
After a single administration of a single dose of T1/2 is about 10 no. About 70% excreted by the kidneys in a largely unaltered. The value of systemic clearance is about 54 ml / min.
Pharmacokinetics in special clinical situations
Children between the ages of 2 to 12 T years1/2 is reduced to 5-6 no.
If the kidney function (KK from 11 to 31 ml / min) and patients, hemodialysis (CC less than 7 ml / min), T1/2 increases 3 times, ground clearance is reduced by 70%.
Against the background of chronic diseases and elderly patients noted an increase in T1/2 on 50% and a decrease in the clearance 40%.
Cetirizine does not appear in hemodialysis.
- seasonal and perennial allergic rhinitis and conjunctivitis;
- itchy allergic dermatoses;
- pollen disease (hay fever);
- hives (incl. chronic idiopathic);
Zodak: dosing regimen
The drug is prescribed inside, regardless of the meal. Before receiving the drops dissolve in water.
Adults and children over 12 years – by 10 mg cetirizine (20 drops or 2 measuring spoons syrup) 1 time / day, daily, preferably in the evening.
Children from 6 to 12 years – by 10 mg cetirizine (20 drops or 2 measuring spoons syrup) 1 once a day or 5 mg cetirizine (10 drops or 1 scoop) 2 times / day – in the morning and in the evening.
Children from 2 to 6 years – by 5 mg cetirizine (10 drops or 1 spoonful of syrup) 1 time / day or 2.5 mg cetirizine (5 drops or 1/2 measuring spoon syrup) 2 times / day – in the morning and in the evening.
Children from 1 to 2 years – by 2.5 mg (5 drops) 2 times / day.
At renal failure recommended dose should be reduced in 2 times.
At hepatic dysfunction the dose should be adjusted individually, reducing it to 5 mg / day or less, with extreme caution with simultaneous renal failure.
Elderly patients with normal renal function dose adjustment is required.
The vial is closed with a safety device, preventing its opening children. The bottle is opened under strong pressure lid down and then unscrewing it counter-clockwise. After use, you must re-cap the bottle tightly tighten.
Zodak: side effects
From the digestive system: dry mouth, dyspepsia.
CNS: headache, drowsiness, fatiguability, dizziness, excitation, migraine.
Allergic reactions: skin rash, angioedema, hives, itching.
The drug is generally well tolerated. Side effects are rare and have a transitory nature.
- Children up to age 1 year (Drops for oral administration);
- Children up to age 2 years (syrup);
- hypersensitivity to the drug.
FROM caution is used in chronic renal failure secondary to severe (requires correction mode), in elderly patients (may decrease glomerular filtration rate).
Zodak: Pregnancy and lactation
The drug is contraindicated in pregnancy and lactation.
Zodak: Special instructions
Not recommended simultaneous reception of medicines, providing a depressing effect on the central nervous system, and drinking.
Note for diabetics
Drops for oral administration do not contain sugar (It is used as a sweetener saccharin), Therefore, this formulation may be administered to patients with diabetes.
IN 10 ml syrup (2 measuring spoons) contains 3 g sorbitol, corresponding 0.25 HE.
Effects on ability to drive vehicles and management mechanisms
In the period of treatment should refrain from activities potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Symptoms: possible drowsiness, lethargy, weakness, headache, tachycardia, irritability, urinary retention, fatiguability (more when receiving cetirizine 50 mg / day).
Treatment: gastric lavage, appointment of activated carbon, symptomatic therapy. The specific antidote is not identified. Hemodialysis nyeeffyektivyen.
Zodak: drug interaction
Not found clinically significant interactions of cetirizine with other drugs.
Combined use of theophylline (400 mg / day) It reduces the total clearance of cetirizine (The kinetics of theophylline is not changed).
Zodak: terms of dispensing from pharmacies
The drug is resolved to application as an agent Valium holidays.
Zodak: terms and conditions of storage
The drug should be stored out of reach of children at or below 25 ° C. Shelf life of the drug in the form of drops for oral administration - 2 year, in the form of a syrup - 3 year.