Few people like allergies, enjoy red eyes, a stuffy nose, inability to breathe, scabies, sneezing and other joys. Few people greet hay fever as an old and beloved friend. Most people try to get rid of intrusive and unpleasant allergy symptoms. Be it seasonal or year-round. The pharmaceutical market offers a huge number of anti-allergy drugs. Today we will talk about the drug Zodak, which is produced in the Czech Republic. This is an effective antihistamine and antiallergic agent that is used for various types of allergies in adults and children over 6 years of age. Zodak is produced in the form of tablets and drops, which can be given to children from 6 months (as prescribed by a doctor and under strict medical supervision).
The active ingredient of the drug is cetirizine, a competitive histamine antagonist. This means that cetirizine binds to histamine receptors, which are mainly involved in the development of allergies, and blocks them. And allergic reactions are thus stopped. Cetirizine affects the early stage of allergic reactions and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in a late allergic reaction. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles.
Today, there is a division of antiallergic drugs into generations. There are only three of them. Zodak belongs to the second.
Second generation drugs have less effect on the central nervous system, since they are selective with respect to receptors. But with selectivity, the effectiveness of anti-allergy drugs disappears when compared with the first generation. Zodak prevents the development and facilitates the course of allergic reactions at any stage of occurrence, has an antiallergic and antipruritic effect. Judging by studies of the effect of Zodak on the human body, the drug is well tolerated and does not cause addiction. If you follow the dosage indicated in the instructions for use and selected by your doctor, you will not experience drowsiness, which is the problem with first-generation antihistamines.
Cetirizine affects the early stage of allergic reactions and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in a late allergic reaction. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles.
Indications
Zodak is usually prescribed for allergic rhinitis
Since Zodak is an antihistamine, it is prescribed for allergies of various origins. Indications for use of Zodak medicine include:
- seasonal and year-round allergic rhinitis and conjunctivitis;
- itchy allergic dermatoses;
- hay fever;
- urticaria (including chronic idiopathic);
- angioedema.
Contraindications
Zodak helps relieve allergic symptoms, reduces the activity of histamine receptors, and helps prevent sneezing and stuffy nose. But even with all the positive features and properties, the medicine has contraindications for use. Please read the list carefully and take Zodak only as directed by your doctor. So, the instructions for use include the following contraindications:
- individual intolerance and hypersensitivity to the components of the drug;
- bronchospasm;
- end-stage renal failure (creatinine clearance <10 ml/min)/severe nephropathy;
- porphyria;
- hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome; children under 6 years of age;
- pregnancy, lactation period.
Zodak is prescribed with caution to elderly patients, as well as to those with a history of moderate to severe chronic renal/liver failure.
It should be remembered that antihistamines of the 1st and 2nd generations often cause drowsiness, which means that while taking Zodak you should not engage in potentially dangerous activities that require attention, concentration and speed of reactions.
Side effects
Judging by studies of the human body's reactions to Zodak, the drug is well and easily tolerated. However, this does not exclude the possibility of possible adverse reactions. The list of undesirable reactions of the body to taking the drug Zodak is quite large, but side effects occur quite rarely and are transient.
One of the side effects of the drug may be Tachycardia
- Blood and lymphatic system disorders: thrombocytopenia.
- Immune system disorders: hypersensitivity reactions, anaphylactic shock.
- Nervous system disorders: headache, drowsiness, fatigue, dizziness, paresthesia, convulsions, motor dysfunction, taste perversion, dyskinesia, dystonia, fainting, tremor, tic, memory impairment, including amnesia.
- Mental disorders: agitation, aggression, confusion, depression, hallucinations, sleep disturbance, suicidal ideation.
- Violations of the organ of vision: disturbances of accommodation, blurred vision, nystagmus.
- Hearing and labyrinthine disorders: vertigo.
- Digestive system disorders: dry mouth, nausea, dyspepsia, diarrhea, abdominal pain.
- Cardiac disorders: tachycardia.
- Disorders of the respiratory system, chest and mediastinal organs: rhinitis, pharyngitis.
- Metabolic and nutritional disorders: weight gain.
- Renal and urinary tract disorders: dysuria, enuresis, urinary retention.
- Laboratory and instrumental data: changes in liver function tests, thrombocytopenia.
- Skin and subcutaneous tissue disorders: rash, itching, urticaria, angioedema, persistent erythema.
- General disorders: asthenia, malaise, peripheral edema, increased appetite.
Zodak allergy medicine tablets No. 30
A country
Czech Republic
Country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Cetirizine
Compound
1 tablet contains: cetirizine dihydrochloride 10 mg. Excipients: lactose monohydrate - 73.4 mg, corn starch - 33 mg, povidone 30 - 2.4 mg, magnesium stearate - 1.2 mg. Film-coated tablets are white or almost white, oblong, with risky for dividing on one side.
pharmachologic effect
Cetirizine is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists, blocks histamine H1 receptors, has virtually no anticholinergic and antiserotonin effects. It has a pronounced antiallergic effect, prevents the development and facilitates the course of allergic reactions: at a dose of 10 mg 1 or 2 times a day, it inhibits late phase of eosinophil aggregation in the skin and conjunctiva of patients susceptible to atopy. Has antipruritic and antiexudative effect. Affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in a late allergic reaction. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reactions to the introduction of histamine, specific allergens, as well as to cooling (with cold urticaria). In therapeutic doses, it has virtually no sedative effect. During a course of treatment, tolerance does not develop. The effect of the drug begins after 20 minutes in 50% of patients, after 1 hour in 95% of patients and persists for 24 hours. Clinical efficacy and safety Studies involving healthy volunteers have shown that cetirizine in doses of 5 or 10 mg significantly inhibits the reaction in the form of rash and redness to the introduction of high concentrations of histamine into the skin, but a correlation with effectiveness has not been established. A 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant mild to moderate bronchial asthma showed that taking cetirizine at a dose of 10 mg 1 time / day reduced the symptoms of rhinitis and did not affect lung function. The results of this study confirm the safety of cetirizine in patients suffering from allergies and mild to moderate bronchial asthma. A placebo-controlled study showed that taking cetirizine at a dose of 60 mg/day for 7 days did not cause a clinically significant prolongation of the QT interval. Taking cetirizine at 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 cetirizine. The normal skin reaction to histamine was restored within 3 days after discontinuation of the drug with repeated use. A 7-day placebo-controlled study of cetirizine in syrup dosage form involving 42 patients aged 6 to 11 months demonstrated the safety of the drug. Cetirizine was prescribed at a dose of 0.25 mg/kg 2 times/day, which approximately corresponded to 4.5 mg/day (dose range was from 3.4 to 6.2 mg/day). Use in children aged 6 to 12 months is possible only as prescribed by a doctor and under strict medical supervision.
Indications for use
- seasonal and year-round allergic rhinitis and conjunctivitis; - itchy allergic dermatoses; - hay fever (hay fever); - urticaria (including chronic idiopathic); - Quincke's edema.
Mode of application
Before using Zodak®, you should consult your doctor to avoid complications. The drug is taken orally, regardless of food intake. Tablets Tablets should be swallowed whole with a small amount of water. Adults and children over 12 years of age are prescribed 1 tablet. (10 mg of cytirizine) 1 time/day. Children aged 6 to 12 years Zodak® are prescribed, as a rule, 1 tablet. (10 mg of itirizine) 1 time/day or 1/2 tablet. (5 mg of cytirizine) 2 times/day, morning and evening. In patients with renal failure, the dose of the drug should be reduced depending on the CC: for CC 30-49 ml/min - 5 mg 1 time/day; at 10-29 ml/min - 5 mg every other day. When prescribing the drug to elderly patients with renal failure, the dose should be adjusted depending on the value of KK. KK for men can be calculated based on the concentration of serum creatinine, using the following formula: img_f-KK .png CK for women can be calculated by multiplying the resulting value by a coefficient of 0.85. Renal failure CK (ml/min) Dosage regimen Norm ? 80 10 mg/day Mild 50-79 10 mg/day Moderate 30-49 5 mg/day Heavy 10-29 5 mg/day day Terminal stage - patients on hemodialysis 80 10 mg/day Mild 50-79 10 mg/day Moderate 30-49 5 mg/day Severe Interaction No clinically significant interaction of cetirizine with other drugs has been established. Based on the results of studies of drug interaction of cetirizine, in particular, interaction studies with pseudoephedrine or theophylline at a dose of 400 mg/day have not established a clinically significant interaction. Concomitant use of cetirizine with ethanol and drugs that depress the central nervous system may further reduce concentration and reaction speed, although cetirizine does not enhance the effect of ethanol (at its concentration in blood 0.5 g/l).
Side effect
Overview Clinical trial results have demonstrated that cetirizine at recommended doses is associated with minor CNS adverse effects, including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical stimulation of the central nervous system has been reported. Despite the fact that cetirizine is a selective blocker of peripheral H1 receptors and has virtually no anticholinergic effect, isolated cases of difficulty urinating, disturbances of accommodation and dry mouth have been reported. Impaired liver function accompanied by increased activity of liver enzymes and bilirubin. In most cases, adverse events resolved after discontinuation of cetirizine dihydrochloride. List of adverse reactions There is data obtained from double-blind, controlled clinical studies aimed at comparing cetirizine and placebo or other antihistamines used in recommended doses (10 mg 1 time / day for cetirizine) in more than 3200 patients from which a reliable analysis of safety data can be conducted. According to the results of the pooled analysis, in placebo-controlled studies with cetirizine 10 mg, the following adverse reactions were identified with an incidence of 1% or higher: Adverse reactions (WHO terminology) Cetirizine 10 mg (n=3260) Placebo (n=3061) General disorders and disorders at the injection site Fatigue 1.63% 0.95% Nervous system disorders Dizziness 1.10% 0.98% Headache 7.42% 8.07% Digestive system Abdominal pain 0.98 % 1.08% Dry mouth 2.09% 0.82% Nausea 1.07% 1.14% Mental disorders Drowsiness 9.63% 5% Respiratory system Pharyngitis 1.29% 1.34% Although the incidence of drowsiness in the cetirizine group was higher than that in the placebo group, in most cases it is undesirable the event was mild or moderate in severity. Objectively assessed in other studies, it was confirmed that the use of cetirizine at the recommended daily dose in healthy young volunteers does not affect their daily activities. Children: In placebo-controlled studies in children aged 6 months to 12 years, the following adverse events were identified: reactions with a frequency of 1% and higher: Adverse reactions (WHO terminology) Cetirizine (n = 1656) Placebo (n = 1294) Digestive system Diarrhea 1.0% 0.6% Mental disorders Drowsiness 1.8% 1.4% Respiratory system Rhinitis 1.4% 1.1% General disorders and administration site disorders Fatigue 1.0% 0.3% Post-marketing experience In addition to the adverse events identified during clinical trials and described above, the following adverse reactions were observed during post-marketing use of the drug. Based on data from post-marketing use of the drug, adverse events are divided into MedDRA organ system classes and frequency of development. The frequency of development of adverse events was determined as follows: very often (>1/10), often (>1/100, 1/1000, 1/10,000, Contraindications - end-stage renal failure (CC Overdose Clinical picture observed with overdose of cetirizine was due to its effect on the central nervous system. Symptoms: after a single dose of cetirizine at a dose of 50 mg, the following clinical picture was observed - confusion, dizziness, drowsiness, lethargy, stupor, weakness, anxiety, increased irritability, sedation, increased fatigue, malaise , headache, mydriasis, itching, tachycardia, tremor, urinary retention, dry mouth, diarrhea, constipation. Treatment: immediately after taking the drug, it is necessary to perform gastric lavage or induce vomiting. It is recommended to prescribe activated carbon and carry out symptomatic and supportive therapy. A specific antidote is unknown. Hemodialysis is ineffective.
special instructions
Patients with impaired renal function, liver function and elderly patients should consult a doctor before taking the drug. In patients with spinal cord damage, prostatic hyperplasia, as well as in the presence of other factors predisposing to urinary retention, caution is required, because Cetirizine may increase the risk of urinary retention. Caution is recommended when using cetirizine concomitantly with alcohol, although at therapeutic doses no clinically significant interaction with ethanol was noted (at a blood ethanol concentration of 0.5 g/l). Caution should be observed in patients with epilepsy and increased convulsive readiness. Before prescribing allergy tests, a three-day “wash-out” period is recommended due to the fact that blockers of histamine H1 receptors inhibit the development of skin allergic reactions. Use in pediatrics Due to the potential depressant effect on the central nervous system, caution should be exercised when prescribing Zodak® to children under 1 year of age with the presence of the following risk factors for sudden infant death syndrome, such as (but not limited to): - sleep apnea syndrome or sudden infant death syndrome in a brother or sister; - maternal drug abuse or smoking during pregnancy; - young age of the mother (19 years and younger); - smoking abuse of the nanny caring for the child (1 pack of cigarettes per day or more); - children who regularly fall asleep face down and who are not placed on their back; - premature infants (gestational age less than 37 weeks ) or children born with insufficient body weight (below the 10th percentile of gestational age); - when taking drugs together that have a depressant effect on the central nervous system. The drug contains excipients methylparabenzene and propylparabenzene, which can cause allergic reactions, incl. delayed type. Effect on the ability to drive vehicles and operate machinery. An objective assessment of the ability to drive vehicles and operate machinery did not reliably reveal any adverse events when using the drug Zodak® in recommended doses. However, for patients with symptoms of drowsiness while taking the drug during the treatment period, it is advisable to refrain from driving a car, engaging in potentially hazardous activities, or operating machinery that requires increased concentration and speed of psychomotor reactions.
Storage conditions
Room temperature
Zodak instructions for use
The drug is prescribed orally, regardless of food intake. Zodak is available in two dosage forms - tablets and drops. The choice of which form to take the drug depends on the age of the patient. Children from 6 months to 2 years of age are not prescribed tablets; for them, the preferred form is drops, which must be dissolved in water before taking. Adults are prescribed both tablets and drops for allergies. Film-coated tablets should be swallowed whole with a small amount of water.
Adults and children over 12 years of age: 1 tablet or 20 drops (10 mg cetirizine). Children from 6 to 12 years old: 1 tablet or 20 drops (10 mg of cetirizine) once a day or 10 drops (5 mg of cetirizine) 2 times a day, morning and evening.
Children from 2 to 6 years: 1/2 tablet or 10 drops (5 mg of cetirizine) 1 time per day or 5 drops (2.5 mg of cetirizine) 2 times per day, morning and evening.
Children from 1 to 2 years: 5 drops (2.5 mg of cetirizine) 2 times a day.
If the patient has a history of renal failure, then the dose is reduced depending on creatinine clearance (CC): with creatinine clearance 30-49 ml/min – 5 mg once a day; at 10-29 ml/min – 5 mg every other day.
If you miss a tablet or drops, the next dose should be taken as soon as possible. If the time for the next dose is approaching, the dose should be taken as scheduled, without increasing the total amount of the drug taken.
Zodak - instructions for use in video format
Pregnancy and lactation
The drug is prohibited during pregnancy and lactation
Zodak is forbidden to be taken by women who are preparing to become a mother, as well as throughout the entire period of lactation, since the main active ingredient enters the child’s body with milk. And this can negatively affect the development of the baby’s psyche.
Zodak for children
Before giving Zodak to a child, you should consult your doctor.
The use of Zodak for children is limited only by the age of young patients and the dosage form of the drug itself. It is important to remember that you cannot prescribe anything for yourself or your child. It is necessary to consult with a pediatrician, follow the regimen and dosage indicated by him and described in the instructions. In children, Zodak effectively copes with severe allergy symptoms. As for the dosage form, tablets can be used for children over 6 years of age, drops are used for babies from 6 months under the strict supervision of a doctor.
Interaction of Zodak with other medications
Combining Zodak with alcohol is not recommended
Since Zodak is a medicinal product, its combination with other medications should be regulated by a doctor and the instructions for use. Therefore, you need to talk with your doctor about possible combinations. So, if the patient takes medications containing theophylline (bronchodilators), then the frequency of side effects may increase. The simultaneous use of Zodak and drugs that affect and depress the central nervous system is not recommended. The same applies to alcohol. It is better not to drink alcoholic beverages during treatment with Zodak.
Zodak drops for oral administration 10 mg/ml 20 ml dropper bottle 1 pc. in Moscow
The pharmacokinetic parameters of cetirizine when taken in doses from 5 to 60 mg change linearly.
Suction
Tmax in blood plasma is (1±0.5) hours, and Cmax is 300 ng/ml.
Pharmacokinetic parameters such as plasma Cmax and AUC are uniform. Food intake does not affect the complete absorption of cetirizine, although its rate decreases. The bioavailability of different dosage forms of cetirizine is comparable.
Distribution
Cetirizine is (93±0.3)% bound to blood plasma proteins. Vd is 0.5 l/kg. Cetirizine does not affect the protein binding of warfarin.
Metabolism
Cetirizine does not undergo extensive first-pass metabolism.
Removal
T1/2 is approximately 10 hours.
When taking cetirizine at a daily dose of 10 mg for 10 days, no accumulation was observed.
Approximately 2/3 of the dose taken is excreted unchanged in the urine.
Special patient groups
Elderly.
In 16 elderly people, with a single dose of cetirizine at a dose of 10 mg, T1/2 was 50% higher, and clearance was 40% lower compared to non-elderly people.
The decreased clearance of cetirizine in elderly patients is likely due to decreased renal function in this category of patients.
Kidney failure.
In patients with mild renal failure (Cl creatinine >40 ml/min), pharmacokinetic parameters are similar to those in healthy volunteers with normal renal function.
In patients with moderate renal failure and patients on hemodialysis (Cl creatinine <7 ml/min), when taking cetirizine orally at a dose of 10 mg, T1/2 is extended by 3 times, and total clearance is reduced by 70% relative to healthy volunteers with normal nocturnal function.
For patients with moderate or severe renal insufficiency, an appropriate change in the dosage regimen is required (see "Dosage and Administration").
Cetirizine is poorly removed from the body during hemodialysis.
Liver failure.
In patients with chronic liver diseases (hepatocellular, cholestatic and biliary cirrhosis), with a single dose of cetirizine at a dose of 10 or 20 mg, T1/2 increases by approximately 50%, and clearance decreases by 40% compared to healthy subjects. Dose adjustment is only necessary if the patient with hepatic insufficiency also has concomitant renal insufficiency.
Children.
T1/2 in children from 6 to 12 years is 6 hours, from 2 to 6 years - 5 hours, from 6 months to 2 years - reduced to 3.1 hours.
Analogs
Choosing an allergy drug is a joint effort between the patient and the doctor. It is not always easy or quick, but only together is it possible to find an effective and safe remedy against allergies. The analogues listed below, as well as the drug in question, reduce the severity of allergies, improve the patient’s well-being, and can be taken both in courses and as an emergency medicine.
Analogues of the active substance cetirizine
Analogues: Allertek, Letizen, Zetrinal, Alerza, Parlazin, Cetirizine, Zintset, Cetrin, Zirtec, Suprastin, Claritin.
Zodak or Suprastin?
Both Zodak and Suprastin are antihistamines. They are primarily distinguished by the active substance in the composition and the generation of the drugs themselves. So Suprastin belongs to the first generation, which is characterized by the occurrence of drowsiness after administration. And Zodak is a medicine of the second generation. More selective with regard to blocking histamine receptors. Suprastin increases appetite, the activity of the bronchial glands, dilates the bronchi and peripheral vessels. Therefore, if a patient has bronchospasm or laryngospasm, then Suprastin is contraindicated for him.
Both drugs cope well with allergic reactions of the body. Suprastin quickly relieves allergy symptoms, fights its more severe manifestations, skin itching, and with additional therapy for Quincke's edema. The Zodak effect is weaker, but longer lasting, reaching several hours. Another advantage of Zodak is another dosage form - drops. They are convenient for children, elderly patients and those who cannot or do not like to swallow tablets. As for children, the prescription and use of any medication, including antiallergic medications, must be accompanied by a mandatory consultation with a pediatrician.
Both drugs are approved for children. Suprastin - from 3 years, Zodak - from 6 months. It is believed that Zodak is safer for children. Both Zodak and Suprastin are prohibited for use during pregnancy and breastfeeding. These antihistamines have more modern analogues that cause fewer side effects. Suprastin and Zodak are used most successfully in adults during seasonal exacerbations.
ZODAK film-coated tablets 10 mg No. 30
Zodak - antiallergic. Pharmacodynamics Cetirizine belongs to the group of competitive histamine antagonists, blocks H1-histamine receptors, and has virtually no anticholinergic and antiserotonin effects. It has a pronounced antiallergic effect, prevents the development and facilitates the course of allergic reactions. Has antipruritic and antiexudative effect. Affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in a late allergic reaction. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reactions to the introduction of histamine to specific allergens, as well as to cooling (with cold urticaria). In therapeutic doses it has virtually no sedative effect. During the course of treatment, tolerance does not develop. The effect of the drug begins after 20 minutes (in 50% of patients), after 1 hour (in 95% of patients) and persists for 24 hours. Pharmacokinetics Absorption. After oral administration, cetirizine is quickly and well absorbed from the gastrointestinal tract. Tmax - approximately 30–60 minutes. Food intake does not have a significant effect on the amount of absorption, but in this case the rate of absorption is slightly reduced. Distribution. Cetirizine is approximately 93% bound to plasma proteins. The Vd value is low (0.5 l/kg), the drug does not penetrate into the cell. The drug does not penetrate the BBB. Passes into breast milk. Metabolism. Cetirizine is poorly metabolized in the liver to form an inactive metabolite. With 10-day use at a dose of 10 mg, no accumulation of the drug is observed. Excretion. Approximately 70% - through the kidneys, mostly unchanged. The systemic clearance is about 54 ml/min. After a single dose, the T1/2 value is about 10 hours. In children aged 2 to 12 years, the T1/2 value decreases to 5–6 hours. Hemodialysis is ineffective. Pharmacokinetics in special groups of patients Patients with impaired renal function. In case of impaired renal function (Cl creatinine below 11–31 ml/min) and in patients on hemodialysis (Cl creatinine less than 7 ml/min), the T1/2 value increases 3 times, Cl decreases by 70%. Elderly patients and patients with chronic diseases. Against the background of chronic diseases and in elderly patients, there is an increase in T1/2 by 50% and a decrease in Cl by 40% Additionally for film-coated tablets Patients with chronic liver diseases (hepatocellular, cholestatic and biliary cirrhosis). In patients with liver cirrhosis, there is an increase in T1/2 by 50% and a decrease in total clearance by 40% (adjustment of the dosage regimen is required only with a concomitant decrease in glomerular filtration rate).
