Indications for use:
Therapy of itching and urticaria of various origins, including urticaria accompanied by fever (chronic idiopathic urticaria);
· symptomatic therapy of allergic seasonal rhinitis and year-round allergic rhinitis;
symptomatic treatment of allergic conjunctivitis.
Pharmachologic effect:
Zodak is a 2nd generation antiallergic agent with a prolonged effect. The active substance of the product is cetirizine dihydrochloride, a selective blocker of peripheral H1 receptors. It does not have significant antiserotonin and anticholinergic effects. When used in therapeutic doses, Zodak does not cause sedation, including drowsiness. The active substance of Zodak affects the histamine-dependent – the early phase of allergic reactions, as well as the late cellular phase. Under the action of cetirizine, histamine release from basophils and mast cells is inhibited, and the migration of eosinophils and other cells is reduced. When taking 5-60 mg of cetirizine, linear kinetics are observed. The total volume of distribution is 0.50 l/kg. The half-life of the active substance is 10 hours.
There was no accumulation effect when taking a dose of 10 mg every day for 10 days. The maximum concentration in blood plasma after reaching an equilibrium concentration is 300 ng / ml, which is achieved after 60 ± 30 minutes. Binds to blood proteins 93±0.3% of cetirizine. Has no effect on the binding of warfarin to plasma proteins. It does not undergo active metabolic transformation during the primary passage through the liver. Approximately 2/3 of cetirizine is excreted unchanged in the urine. A study on volunteers revealed no pharmacokinetic differences in both AUC and maximum concentration. There was no difference in pharmacokinetic parameters in adults of different races. The bioavailability of the active substance is the same for all dosage forms of the product: syrup, drops and tablets.
Zodac (Zodak) method of administration and doses:
Zodac-tablets
The tablet is taken with water, regardless of the meal. Do not chew! For adults and children from 12 years old – 10 mg / day (1 tablet) in 1 dose.
In pediatrics: children from 6 to 12 years old – 5 mg / day (1/2 tablet) 2 r / day, it is possible to take 10 mg of Zodak once every day.
Zodak drops
For adults and children from 12 years old – 10 mg (20 drops) 1 r / day. 1 ml of the product contains 20 drops.
In pediatrics: from the first days of life up to 2 years – 5 drops (2.5 mg) 2 r / day; from 2 to 6 years – 5 drops (2.5 mg of cetirizine) 2 r / day, it is possible to use 10 drops (5 mg)
1 r / day; from 6 to 12 years old – 10 drops (5 mg) 2 r / day, it is possible to take 20 drops (10 mg) 1 r / day.
Zodak syrup
For adults and children from 12 years old – 10 mg (2 scoops) 1 r / day. 1 measuring spoon contains 5 ml of Zodak syrup. The spoon is equipped with divisions: ¼ – corresponds to 1.25 ml of syrup and ½ – 2.5 ml.
In pediatrics: from 1 to 2 years – 2.5 mg (half a measuring spoon) 2 r / day; from 2 to 6 years – 2.5 mg (half a measuring spoon) 2 r / day, it is possible to take 5 mg (1 measuring spoon) 1 r / day; from 6 to 12 years old – 5 mg (1 measuring spoon) 2 r / day, it is possible to take 10 mg (2 measuring spoons) 1 r / day.
Treatment of elderly patients
In the case of normally functioning kidneys, there is no need to reduce the dosage.
Treatment of patients with impaired renal function
In moderate or severe impaired renal function, it is necessary to set individual intervals for taking Zodak, which depends on the severity of renal failure: with minor impairments (creatinine clearance – 50-79 ml / min) – there is no need for dose adjustment and change interval between doses; for mild disorders (creatinine clearance 30-49 ml / min) – 5 mg / day as usual; in severe disorders (creatinine clearance ≤ 30 ml / min) – 10 mg 1 time per day after 2 days; in the terminal stage, in the presence of contraindications to hemodialysis (creatinine clearance ≤ 10 ml / min), the appointment of Zodak is contraindicated.
The dose of cetirizine for children with renal insufficiency is calculated individually, based on body weight and creatinine clearance.
Treatment of patients with impaired liver function
There is no need to reduce the dosage.
Zodac (Zodak) contraindications:
General for all dosage forms:
high susceptibility to hydroxyzine or cetirizine in the anamnesis of life or to any other ingredients of Zodac;
· During pregnancy and breastfeeding;
Renal failure with creatinine clearance less than 10 ml/min.
For tablets – age up to 6 years.
For syrup – age up to 1 year.
Zodac (Zodak) side effects:
Unlike antihistamine products of previous generations, which belong to the group of H1 receptor antagonists, the active substance of Zodac penetrates the blood-brain barrier in a non-cordial amount, so the development of a sedative effect is not pronounced or expressed in a very mild degree. Although the action of cetirizine is selective at peripheral H1 receptors, the anticholinergic effect is weak, however, there have been reports of eye accommodation disturbances, urinary difficulties, paradoxical stimulation of the central nervous system and a feeling of dry mouth.
From the side of the central and peripheral nervous system: fatigue, drowsiness, dizziness and headache; paradoxical stimulation of the nervous system – in isolated cases.
On the part of the hepatobiliary system: an increase in the content of bilirubin and the activity of liver enzymes (the indicated side effects are transient and disappeared after the withdrawal of the product).
Pregnancy:
Zodak is contraindicated in pregnancy in all trimesters. If Zodak is prescribed to a nursing mother, breastfeeding is temporarily stopped.
Overdose:
If the recommended dose of Zodac is exceeded, symptoms develop, mainly associated with changes in the central nervous system, and anticholinergic effects of cetirizine are also likely. As a result of exceeding the dose by 5 times, there are reports of the following overdose symptoms: diarrhea, excitement, dizziness, nausea, fatigue, dilated pupils, headache, itching, sedation, nervousness, drowsiness, tachycardia, stupor, tremor and urinary retention.
No specific antidote has been identified. In case of overdose, supportive and symptomatic therapy is used. Immediately after taking a large dose, gastric lavage is recommended. Hemodialysis is not effective because cetirizine mostly binds to blood proteins.
Use with other medicinal products:
Studies of the pharmacokinetic parameters of the interaction of cetirizine with cimetidine, pseudoephedrine, ketoconazole, azithromycin and erythromycin have not been identified. There is a non-cardinal decrease in the clearance of cetirizine up to 16% when combined with multiple doses of theophylline at a dosage of 400 mg / day. Moreover, with this combination, the excretion of theophylline does not change.
Studies of pharmacodynamic parameters in the combination of cetirizine with glipizide, diazepam, azithromycin, theophylline, ketoconazole, erythromycin and pseudoephedrine did not reveal adverse clinically significant interactions. Thus, the combination of the drug with ketoconazole or macrolides did not cause clinically significant changes in the electrocardiographic profile. It was also found that the active substance of Zodak does not affect the ability of warfarin to bind blood proteins. With simultaneous ingestion of food with cetirizine, the volume of absorption does not change, but the rate of absorption decreases.
Release form:
Zodak tablets – 10 mg, 5; ten; thirty; 60; 90 pcs. in a blister pack. Tablets are white, oblong, biconvex, scored on 1 side.
Zodak drops for internal use – 10 mg in 1 ml, in 20 ml vials. Drops are transparent, colorless or with a slight yellow tint.
Zodak syrup – 5 mg / ml, in a bottle of 100 ml. The syrup is clear, colorless or with a slight yellow tint. It has a characteristic banana smell.
Storage conditions:
At room temperature. Approved for over-the-counter dispensing.
Zodac (Zodak) composition:
Zodak tablets
Active substance: cetirizine dihydrochloride.
Inactive substances: corn starch, lactose monohydrate, povidone, hydroxypropyl methylcellulose, titanium dioxide, talc, magnesium stearate, macrogol, dimethicone emulsion.
Zodak drops
Active substance: cetirizine.
Inactive substances: propylparaben, methylparaben, glycerol 85%, sodium acetate, sodium saccharin, acetic acid, propylene glycol, purified water.
Zodak syrup
Active substance: cetirizine dihydrochloride.
Inactive substances: propylparaben, methylparaben, propylene glycol, glycerol 85%, sorbitol syrup, sodium acetate, sodium saccharin, banana flavor, acetic acid, purified water.
Additionally:
Tests have shown that Zodak has no clinically significant interaction with alcohol (in the case of a blood alcohol content of 0.5 g / l). However, it is not recommended to drink alcohol while taking Zodak. It is recommended to be careful for people whose activities are associated with increased demands for attention and quick reactions (drivers, machinists, maintenance of mechanisms, work at height, etc.). Also, they should not exceed the dose prescribed by the doctor.
Attention!
Before using the medication“Zodac (Zodak)” must be consulted with a doctor.
The instructions are provided solely for familiarization with “Zodac “.