Zodac

It is shown in adults and children with 6 months and older to facilitate :

- nasal and eye symptoms of year-round (persisting) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis: itching, sneezing, nasal congestion, rhinorea, tearing, conjunctival hyperemia ;

- symptoms of chronic idiopathic urticaria.

Inside, dig into a spoon or dissolve in water.

The amount of water for dissolving the drug must correspond to the amount of fluid that the patient (especially the child) is able to swallow. The solution should be taken immediately after preparation.

Adults. 10 mg (20 drops) 1 time per day. Sometimes an initial dose of 5 mg (10 drops) can be enough if this allows satisfactory control of the symptoms.

Elderly age. In elderly patients with normal kidney function, there is no need to reduce the dose.

Violation of the function of the kidneys. When prescribing the drug to patients with impaired renal function, in the case when alternative treatment cannot be prescribed, the dose should be adjusted depending on the value of Cl creatinine, since cetyrizin is removed from the body mainly by the kidneys.

The Cl creatinine indicator for men can be calculated based on the concentration of serum creatinine in the blood plasma according to the following formula:

Cl creatinine, ml / min = (140 - age, years) × body weight, kg) / (72 × Cl creatinine_serum, mg / dl).

Cl creatinine for women can be calculated by multiplying the value obtained by a coefficient of 0.85.

Violation of liver function. Patients with impaired liver function do not need to correct the dosing mode. In patients with impaired liver function and kidneys, dosing correction is recommended (see. table above).

Children. The use of children from 6 to 12 months is possible only by appointment of a doctor and under strict medical supervision. Children from 6 to 12 months — 2.5 mg (5 drops) 1 time a day; from 1 year to 6 years — 2.5 mg (5 drops) 2 times a day; from 6 to 12 years — 5 mg (10 drops) 2 times a day; over 12 years old — 10 mg (20 drops) 1 time a day, sometimes the initial dose is 5 mg (10 drops) may be enough, if this allows satisfactory control of the symptoms.

Children with renal failure are adjusted for Cl creatinine and body weight.

Instructions for opening a bottle

The bottle is closed with a lid with a safety device that prevents children from opening it. The bottle opens when the lid is pressed heavily down, followed by screwing it off counterclockwise. After using the bottle cover, you must screw it tight again.

hypersensitivity to cetyrizin, hydroxysine or piperazine derivatives, as well as other components of the drug ;

terminal stage of renal failure (Cl creatinine <10 ml / min);

pregnancy;

children under 6 months of age (due to limited data on efficiency and safety).

With caution : chronic renal failure (Cl creatinine> 10 ml / min, metering regimen correction is required); elderly patients (with an age-related decrease in SCF); epilepsy and patients with increased convulsive readiness; patients with predisposing factors to urinary delay (infection of the spinal cord, prostate hyperplasia); period of breastfeeding.

Data obtained in clinical trials (review)

Clinical research has shown that the use of cetyrizin in recommended doses leads to the development of minor undesirable effects from the central nervous system, including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical stimulation of the central tax system was recorded.

Despite the fact that cetirisin is a selective blocker of peripheral N₁receptors and practically does not have an anti-cholinergic effect, isolated cases of urination difficulties, impaired accomodation and dry mouth were reported.

Liver function disorders were reported, accompanied by increased activity of liver enzymes and bilirubin. In most cases, undesirable phenomena were resolved after the cessation of the intake of dihydrochloride cetyrizin.

List of unwanted side reactions

There is evidence obtained from double blind controlled clinical trials aimed at comparing cetyrin and placebo or other antihistamines used in recommended doses (10 mg 1 time per day for cetyrizin) in more than 3200 patients, on the basis of which a reliable analysis of data can be carried out safety.

According to the results of the combined analysis, in placebo-controlled studies when using cetyrizin at a dose of 10 mg, the following unwanted reactions were detected with a frequency of 1% or higher:

Although the incidence of drowsiness in the cetrizin group was higher than that in the placebo group, in most cases this undesirable phenomenon was mild or moderate.

An objective assessment conducted in other studies confirmed that the use of cetyrizin in the recommended daily dose in healthy young volunteers does not affect their daily activity.

Children

In placebo-controlled studies in children aged 6 months to 12 years, the following undesirable reactions were identified with a frequency of 1% and above:

Experience in post-registration use

In addition to the undesirable phenomena identified during the clinical studies and described above, the following unwanted reactions were observed as part of the post-restrictive use of the drug.

Unwanted phenomena are presented below in the classes of the organ system MedDRA and frequency of development, based on data on the post-restrictive use of the drug.

The frequency of development of undesirable phenomena was determined as follows: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10000, <1/1000); very rarely (<1/10000).

From the blood and lymphatic system : very rarely - thrombocytopenia.

From the side of the immune system : rarely - hypersensitivity reactions; very rarely - anaphylactic shock.

Metabolic and nutritional disorders : frequency unknown - increase in appetite.

From the psyche : infrequently - excitement; rarely - aggression, confusion, depression, hallucinations, sleep disturbance; very rarely - tick; frequency unknown - suicidal ideas.

From the side of the nervous system : infrequently - pastezia; rarely - cramps; very rarely - perversion of taste, dyskinesia, dystonia, fainting, tremor; frequency unknown - memory impairment, including.h. amnesia.

From the side of the body of view : very rarely - impaired accomodality, blurred vision, nystagmus.

From the side of the hearing organs : frequency unknown - vertigo.

From the side of the MSS : rarely - tachycardia.

From the digestive system : infrequently - diarrhea.

Hepatobiliary disorders : rarely - a change in functional liver samples (increased activity of transaminases, SchF, GGT and bilirubin).

From the side of the skin : infrequently - skin rash, skin itching; rarely - urticaria; very rarely - angioneurotic swelling, persistent medicinal erythema.

From the urinary system : very rarely - dysuria, enuresis; frequency unknown - urine delay.

General disorders : infrequently - asthenia, malaise; rarely - peripheral edema.

Research: rarely - increasing body weight.

Notification of side reactions : of great importance is the system of notification of suspected side reactions after registration of the drug.

This allows continuous monitoring of the benefit / risk ratio of the drug.

The clinical picture observed during an overdose of cetyrizin was due to its influence on the central nervous system.

Symptoms : after a single intake of cetrizin at a dose of 50 mg, the following clinical picture was observed: confusion, diarrhea, dizziness, increased fatigue, headache, malaise, midriasis, skin itching, anxiety, sedative effect, drowsiness, stupor, tachycardia, tremor, urine delay.

Treatment: immediately after taking the drug, it is necessary to wash the stomach or induce vomiting. The appointment of activated carbon, symptomatic and supportive therapy are recommended. There is no specific antidote. Hemodialysis is ineffective.

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. C_max in blood plasma is achieved through (1 ± 0.5) h and is 300 ng / ml.

Various pharmacokinetic parameters, such as C_max 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.

V_d 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. T_1/2 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 T_1/2 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 T_1/2 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 T_1/2 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. T_1/2 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.

• Anti-allergic agent - H₁histamov receptors blocker [H₁antihistamines]

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).

Keep out of the reach of children.

Do not apply after the expiration date indicated on the package.

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.

Pregnancy. When analyzing prospective data, more than 700 cases of pregnancy outcomes did not reveal cases of formation of malformations, embryonic and neonatal toxicity with a clear causal relationship.

Experimental studies on animals did not reveal any direct or indirect adverse effects of cetrizin on a developing fetus (including.h. postnatal period), pregnancy and postnatal development. Adequate and strictly controlled clinical studies on the safety of the use of the drug during pregnancy were not conducted, so the drug Zodak^® should not be used during pregnancy.

Breastfeeding. Cetirisin stands out with breast milk at a concentration of 25 to 90% of the concentration of the drug in the blood plasma, depending on the time after appointment. During breastfeeding, they are used after consultation with the doctor if the intended benefit for the mother exceeds the potential risk for the child.

Fertility. Available data on the effect on human fertility are limited, but no negative impact on fertility has been identified.

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.

• H10.1 Acute atopic conjunctivitis
• J30 Vasomotor and allergic rhinitis
• J30.1 Allergic rhinitis caused by pollen of plants
• L29 Zud
• L30.9 Unspecified dermatitis
• L50 Hives
• L50.1 Idiopathic urticaria
• T78.3 Angioneurotic edema

Drops : transparent, from colorless to light yellow.