No medicinal interactions of cetyricin with other drugs were noted.
Based on the results of studies of the drug interaction of cetyrizin, in particular studies of the interaction with pseudoephedrine or theophyllin at a dose of 400 mg / day, there were no clinically significant interactions.
The simultaneous use of cetyrizin with alcohol and other drugs that depress the central nervous system can further reduce the concentration and speed of reactions, although cetrizin does not increase the effect of alcohol (at its concentration in the blood of 0.5 g / l).
Uncounter.
SARU.ZODA.17.08.1194a
In view of the potential depressing effect on the central nervous system, caution should be exercised when prescribing the drug Zodak® children under the age of 1 year with the following risk factors for sudden infant death syndrome, such as (but not limited to this list):
- sleep apnea syndrome or sudden infant death syndrome of infants in a brother or sister;
- mother abuse of drugs or smoking during pregnancy ;
- young age of the mother (19 years and younger) ;
- abuse of smoking of a nanny caring for a child (one pack of cigarettes per day or more) ;
- children who regularly fall asleep face down and who are not laid on their backs ;
- premature (gestational age less than 37 weeks) or children born with insufficient body weight (below the 10th percentile from gestational age) ;
- joint use of drugs that have an oppressive effect on the central nervous system. The drug includes methylparabenzene and propyl parabenzene, which can cause allergic reactions, including.h. slow type.
In patients with spinal cord damage, prostate hyperplasia, and also in the presence of other predisposing factors, caution is required to delay urine, t.to. cetirizin can increase the risk of urine retardation. It was recommended to be careful when using cetyrizin simultaneously with alcohol, although there was no clinically significant interaction with alcohol in therapeutic doses (at a blood alcohol concentration of 0.5 g / l). Care should be observed in patients with epilepsy and increased convulsive readiness.
A 3-day washing period is recommended before the appointment of allergological samples due to the fact that blockers N1histamina receptors inhibit the development of skin allergic reactions.
Impact on the ability to drive vehicles and work with mechanisms. In an objective assessment of the ability to drive vehicles and work with mechanisms, no undesirable phenomena were reliably detected when using the Zodak drug® in recommended doses. However, it is advisable for patients with manifestations of drowsiness against the background of taking the drug during treatment to refrain from driving, engaging in potentially dangerous activities or managing mechanisms that require increased attention and speed of psychomotor reactions.
Cetirisin is a metabolite of hydroxisin, belongs to the group of competitive antagonists of histamine and blocks N1- histamine receptors.
In addition to the antihistamine effect, cetyrizin prevents development and facilitates the course of allergic reactions: at a dose of 10 mg 1 or 2 times a day inhibits the late phase of the aggregation of eosinophiles in the skin and conjunctiva of patients exposed to atopia.
Clinical efficiency and safety. Studies in healthy volunteers have shown that cetirisin in doses of 5 or 10 mg significantly inhibits the reaction in the form of rash and redness to inject histamine into the skin at a high concentration, but a correlation with efficiency has not been established. A 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant bronchial asthma of mild to moderate currents shows that taking cetrizin at a dose of 10 mg 1 time per day reduces the symptoms of rhinitis and does not affect the function of the lungs.
The results of this study confirm the safety of the use of cetyrin in patients suffering from allergies and bronchial asthma of the mild and medium-lived course.
A placebo-controlled study showed that taking cetrizin at a dose of 60 mg / day for 7 days did not cause a clinically significant extension of the QT interval. Taking cetyrin in the recommended dose showed an improvement in the quality of life of patients with year-round and seasonal allergic rhinitis.
Children. In a 35-day study involving patients aged 5–12 years, there were no signs of immunity to the antihistamine effect of cetyrizin. The normal reaction of the skin to the histamine was restored within 3 days after the abolition of the drug when it was repeatedly used.
A 7-day placebo-controlled study of cetyricine in the form of syrups involving 42 patients aged 6 to 11 months demonstrated the safety of the drug.
Cetirizin was assigned at a dose of 0.25 mg / kg 2 times a day, which approximately corresponded to 4.5 mg per day (dose range ranged from 3.4 to 6.2 mg per day).
The use of children from 6 to 12 months is possible only by appointment of a doctor and under strict medical supervision.
The pharmaceutical parameters of cetyrizin when used in doses of 5 to 60 mg change linearly.
Suction. Cmax in blood plasma is achieved through (1 ± 0.5) h and is 300 ng / ml.
Various pharmacokinetic parameters, such as Cmax in blood plasma and AUC are homogeneous.
Eating does not affect the completeness of cetyrizin absorption, although its speed decreases. The bioavailability of various dosage forms of cetyrizin (rathering, capsules, tablets) is comparable.
Distribution. Cetirisin on (93 ± 0.3)% binds to blood plasma proteins.
Vd is 0.5 l / kg. Cetirisin does not affect the binding of warfarin with proteins.
Metabolism. Cetirisin is not exposed to extensive primary metabolism.
The conclusion. T1/2 is approximately 10 hours.
When taking the drug in a daily dose of 10 mg for 10 days, cetyrizin cumulation was not observed.
Approximately 2/3 of the accepted dose of the drug is withdrawn with urine in an unchanged form.
Elderly patients. In 16 elderly patients with a single medication in a dose of 10 mg T1/2 was 50% higher, and clearance was 40% lower compared to patients of not old age. The decrease in cetirizin clearance in older patients is probably due to a decrease in the function of the kidneys in this category of patients.
Renal failure. In patients with renal failure of mild severity (Cl creatinine> 40 ml / min), pharmacokinetic parameters are similar to those in healthy volunteers with normal kidney function.
In patients with moderate renal failure and in patients undergoing hemodialysis (Cl creatinine <7 ml / min), when taking the drug inward at a dose of 10 mg T1/2 lengthens 3 times, and the overall clearance is reduced by 70% relative to healthy volunteers with normal kidney function.
For patients with renal failure of moderate or severe degree, a corresponding change in the metering mode is required (see. “Method of application and doses”).
Cetirisin is poorly removed from the body during hemodialysis.
Pediatric failure. In patients with chronic liver diseases (hepatocellular, cholestatic and biliar cirrhosis) with a single medication at a dose of 10 or 20 mg T1/2 increases by about 50%, and clearance is reduced by 40% compared to healthy entities. Correction of the dose is necessary only if the patient with liver failure also has concomitant renal failure.
Children. T1/2 in children from 6 to 12 years old it is 6 hours, from 2 to 6 years old - 5 hours, from 6 months to 2 years old - reduced to 3.1 hours.
Keep out of the reach of children.
The shelf life of the drug Zodak®3 years.Do not apply after the expiration date indicated on the package.
| Drops for taking in | 1 ml |
| active substance : | |
| cetirizina dihydrochloride | 10 mg |
| auxiliary substances : methylparahydroxybenzoate; propylparagydroxybenzoate; glycerol; propylene glycol; sodium sakharinate dihydrate; sodium acetate trihydrate; acetic ice acid; purified water |
Drops for taking inward, 10 mg / ml. 20 ml in a dark glass bottle, stoned with a dropper cork and equipped with a cover with child protection. Each bottle is placed in a cardboard pack.
