Expiration date: 05/2020
Description pharmaceutical form:
Tablets: oblong, film-coated white or almost white, at the risk of dividing the one hand.
Drops: clear, colorless to pale yellow solution.
Syrup: clear, colorless to light yellow liquid.
Suction. After oral cetirizine rapidly and well absorbed from the gastrointestinal tract. Maximum concentration level is determined after about 30-60 minutes.
Food intake has no significant effect on the magnitude of the absorption, but in this case, the rate of absorption is reduced slightly.
Distribution. Cetirizine binds to plasma proteins about 93%. Size distribution volume (Va) is low (0.5 l / kg), the drug does not penetrate inside the cell. The drug does not cross the blood-brain barrier.
Metabolism. Cetirizine poorly metabolized in the liver with the formation of active metabolites. At 10 days of administration at a dose of 10 mg drug accumulation was observed.
Withdrawal. Approximately 70% takes place through the kidneys, in largely unaltered.
The magnitude systemic clearance is about 54 ml / min.
After a single administration of a single dose of T1 / 2 value is about 10 hours. In children aged 2 to 12 years the value of T1 / 2 is reduced to 5-6 hours.
If the kidney (Cl creatinine less than 11-31 mL / min) and in patients on hemodialysis (Cl creatinine less than 7 ml / min), the value of T1 / 2 increased by 3 times, Cl reduced by 70%.
Against the background of chronic diseases and elderly patients have an increase in the value of T1 / 2 by 50% and a decrease in clearance of 40%.
Hemodialysis is ineffective.
Description of the pharmacological actions:
Cetirizine belongs to the group of histamine competitive antagonists to block histamine H1-receptors, almost no anticholinergic and antiserotonin activities. It has a pronounced anti-allergic effect, prevents the development and facilitates the allergic reactions. It has antipruritic and protivoekssudativnoe effect. It affects early stage of allergic reactions and also reduces the migration of inflammatory cells inhibits release of mediators involved in the late allergic response. It reduces the permeability of capillaries, prevents tissue swelling, relieves smooth muscle spasm. Removes skin reaction to the introduction of histamine specific allergens and cooling (when cold urticaria). At therapeutic doses, virtually no sedative effect. Against the background of course taking the tolerance does not develop.
Effect of the drug starts after 20 min (50% of patients), after 1 h (95% of patients) and maintained for 24 hours.
- seasonal and perennial allergic rhinitis and conjunctivitis
- itchy allergic dermatitis
- hay fever (hay fever)
- urticaria (including chronic idiopathic)
- Hypersensitivity to the drug
- Children under 6 years (for tablets) and 2 years (syrup) to 1 year (drip).
Precautions: chronic renal failure secondary to severe (requires correction mode), advanced age (perhaps decreased glomerular filtration).
From the digestive system: dry mouth, dyspepsia.
CNS: headache, drowsiness, fatigue, dizziness, agitation, migraine.
Allergic reactions: skin rash, angioedema, urticaria, pruritus.
The drug is generally well tolerated. Side effects are rare and are transient in nature.
Not established clinically significant interactions of cetirizine with other drugs.
Joint reception with theophylline at a dose of 400 mg / day leads to a decrease in the overall clearance of cetirizine (kinetics of theophylline is not changed).
Dosage and administration:
Inside, regardless of meals. The tablets should be swallowed whole with a little water. Before receiving the droplets should be dissolved in water.
The drug Zodac applied by a doctor to avoid complications.
Adults and children over 12 years of age - 1 table. or 20 drops. or 2 mern.lozhechki (10 mg of cetirizine) 1 time per day.
Children from 6 to 12 years - 1 tablet. or 20 drops. or 2 mern.lozhechki (10 mg of cetirizine) 1 time a day or 1/2 Table. 10 or wart. or 1 mern.lozhechke (Cetirizine 5 mg) 2 times a day, morning and evening.
Children from 2 to 6 years - 10 Cap. or 1 mern.lozhechke (5 mg cetirizine) 1 time per day, or 5 cap. mern.lozhechki or 0.5 (2.5 mg of cetirizine), 2 times a day (morning and evening).
Children from 1 year to 2 years - 5 kap. (2, 5 mg of cetirizine), 2 times a day.
Elderly or patients with severe liver and / or kidney drug appointed doctor individually, at a reduced dose.
Elderly patients with normal renal function dose adjustment is required.
If you accidentally pass the time of taking the drug, the next dose should be taken at the earliest opportunity. In the event that the time is approaching the next dose, the next dose should be taken according to the schedule, without increasing the total dose.
For Zodac drug in droplet form, and syrup
Instructions for opening the bottle with safety cap. The vial is closed with a device preventing the opening of its children. The bottle is opened by a strong pressing cover down and then unscrewing it counter-clockwise. After using the vial lid must be firmly re-tighten.
Symptoms: possible drowsiness, lethargy, weakness, fatigue, headache, tachycardia, irritability, urinary retention, dry mouth, constipation (often while taking daily 50 mg of cetirizine).
Treatment: symptomatic therapy. Gastric lavage, the appointment of activated carbon. A specific antidote is not revealed. Hemodialysis is ineffective.
In the period of treatment should refrain from activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
Caution should be exercised in patients with impaired liver and / or kidney disease, and the elderly.
Not recommended simultaneous use of drugs which depress the central nervous system, alcohol.
Note for diabetics: 10 ml of syrup (2 mern.lozhki) contains 3 g of sorbitol, which corresponds to 0.25 XE.
Drops not contain sugars (used as a sweetener saccharin), and therefore may be administered to persons suffering from diabetes.