Zodak Express - Instructions For The Use Of Tablets, Price, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Zodak Express

Zodak Express: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Zodac Express

ATX code: R06AE09

Active ingredient: levocetirizine (Levocetirizine)

Manufacturer: Zentiva k.s. (Zentiva, ks) (Czech Republic)

Description and photo update: 2019-05-07

Prices in pharmacies: from 234 rubles.

Buy

Zodak Express - antiallergic agent; blocker of H ₁ -histamine receptors.

Release form and composition

The drug is produced in the form of film-coated tablets: biconvex oblong, almost white or white, with an engraving "e" on one side (10 pcs. In a blister, 2 blisters in a cardboard box; 7 pcs. In a blister, in cardboard box 1 or 4 blisters; each box also contains instructions for the use of Zodak Express).

1 tablet contains:

• active substance: levocetirizine dihydrochloride - 5 mg;
• additional components: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, sodium carboxymethyl starch, magnesium stearate;
• shell: macrogol 6000, hypromellose 2910/5, titanium dioxide (E171), talc.

Pharmacological properties

Pharmacodynamics

Levocetirizine, the active component of Zodac Express, is the (R) -enantiomer of cetirizine, a potent and selective histamine antagonist, blocking H ₁ -histamine receptors, the affinity of which for the latter is 2 times higher than that of cetirizine. After a single dose of levocetirizine, after 4 hours, the binding of H ₁ -histamine receptors was observed by 90% and after 24 hours by 57%.

The active substance affects the histamine-dependent phase of allergic reactions, reduces the migration of eosinophils, weakens the permeability of the vascular walls, and prevents the release of inflammatory mediators.

Levocetirizine prevents the development and reduces the severity of allergic reactions. The agent has an antiexudative and antipruritic effect, practically does not demonstrate antiserotonin and anticholinergic effects. When used in therapeutic doses, it shows almost no sedative effect.

After oral administration of a single dose 12 minutes later, the onset of the drug's action is noted in 50% of patients, and in 95% of patients the duration of the therapeutic effect is 24 hours. Zodak Express does not affect the duration of the QT interval on the electrocardiogram (ECG).

Pharmacokinetics

Pharmacokinetic parameters of levocetirizine vary linearly and do not differ significantly from the pharmacokinetic characteristics of cetirizine, may vary slightly in different patients.

After oral administration of Zodak Express, the active substance is intensively absorbed from the gastrointestinal tract (GIT). Food intake does not affect the completeness of absorption of levocetirizine, however, it helps to reduce its rate. With a single intake of an antiallergic agent at a dose of 5 mg in adults, the maximum plasma concentration (C _max) is 270 ng / ml and is observed after 54 minutes, and when using another 5 mg dose, it reaches 308 ng / ml. Stationary concentration of the active substance in the blood (C _ss) is observed after 48 hours. Levocetirizine binds to plasma proteins by 90%, the volume of distribution (_Vd) is 0.4 l / kg, bioavailability is 100%.

There is no information on the distribution of the drug in the tissues and its passage through the BBB in humans, presumably it is excreted during lactation (since cetirizine and racemate of levocetirizine are found in breast milk). In small amounts (less than 14%), levocetirizine is metabolized in the body by N- and O-dealkylation, in contrast to other antagonists of H ₁ -histamine receptors, for the metabolism of which isoenzymes of cytochrome P ₄₅₀ in the liver are responsible. During biotransformation, a pharmacologically inactive metabolite is formed. Due to the limited metabolism and lack of metabolic suppressive activity, the interaction of levocetirizine with other drugs / substances is unlikely.

The half-life (T _1/2) of the drug in adults is 7.9 ± 1.9 hours; in young children it is shortened. The average observed total clearance in adults is 0.63 ml / min / kg. Approximately 85.4% of the taken dose of the substance is excreted unchanged by the kidneys, through glomerular filtration and intense tubular secretion, approximately 12.9% of the dose through the intestines.

Indications for use

• symptoms of seasonal (intermittent) and perennial (persistent) allergic conjunctivitis and allergic rhinitis, including sneezing, itching, lacrimation, rhinorrhea, nasal congestion, conjunctival hyperemia (therapy);
• urticaria, including chronic idiopathic urticaria;
• pollinosis (hay fever);
• Quincke's edema (as an adjuvant);
• other allergic dermatoses, occurring with itching and rashes.

Contraindications

Absolute:

• end-stage renal failure with creatinine clearance (CC) below 10 ml / min;
• age up to 6 years;
• pregnancy and the period of breastfeeding;
• malabsorption of glucose-galactose, lactase deficiency, congenital galactose intolerance (because the product contains lactose monohydrate);
• hypersensitivity to any component of the drug or to other piperazine derivatives.

Relative (use Zodak Express tablets with extreme caution):

• chronic renal failure (CRF) with CC from 10 to 50 ml / min (a change in the dosage regimen is necessary);
• chronic liver disease (cholestatic, hepatocellular or biliary cirrhosis);
• the presence of predisposing factors for urinary retention (including spinal cord injury, prostatic hyperplasia), since levocetirizine can aggravate the risk of urinary retention;
• elderly age;
• combined intake with alcohol.

Zodak Express, instructions for use: method and dosage

Zodak Express is taken orally. The tablet is swallowed without chewing, whole, with a sufficient amount of liquid. Food intake does not affect the effectiveness of the drug.

Children over 6 years of age, adolescents and adults are recommended to take Zodak Express 1 tablet (5 mg) once a day.

If, after the course of treatment, there is no improvement in the condition, it is necessary to consult a specialist. Antiallergic agent should be used only in accordance with the method of application and in the doses indicated above.

In the treatment of intermittent (seasonal) rhinitis, if the symptoms are less than 4 days a week or their total duration is less than 4 weeks, the course of therapy depends on the duration of the symptoms. Treatment with the drug can be discontinued if the patient's condition improves and resumed against the background of relapse.

In the case of treatment of persistent (year-round) allergic rhinitis with symptoms more than 4 days a week or with a total duration of more than 4 weeks, the course of therapy can be carried out for a long time - throughout the entire period of exposure to allergens.

Clinical experience with the constant use of levocetirizine in the form of film-coated tablets at a dosage of 5 mg in adults is currently less than 6 months.

If the patient is receiving or has recently received other drugs, this should be reported to the attending physician.

You should not use a double dose of Zodak Express when you miss the next dose of the pill, it is recommended to take the next dose after the missed one at the usual time.

Side effects

In the course of clinical studies in patients of both sexes aged 12 to 71 years, the following adverse events were recorded: most often - dry mouth, drowsiness, fatigue, headache; infrequently - abdominal pain, asthenia. In children aged 6 to 12 years, the most common side effects were drowsiness and headache.

With the post-registration use of Zodak Express, the following disorders were observed from the side of systems and organs, the frequency of which is uncertain:

• cardiovascular system: palpitations, angina pectoris, tachycardia, jugular vein thrombosis;
• Gastrointestinal tract: vomiting, diarrhea, nausea;
• hepatobiliary system: hepatitis;
• respiratory system, chest and mediastinal organs: increased symptoms of rhinitis, shortness of breath;
• nervous system: dysgeusia, dizziness, tremor, paresthesia, convulsions, fainting, sinus thrombosis of the dura mater;
• immune system: hypersensitivity reactions, including anaphylactic;
• mental disorders: insomnia, anxiety, agitation, aggressiveness, depression, suicidal thoughts, hallucinations;
• skin and subcutaneous tissues: pruritus, rash, cracks, urticaria, persistent drug erythema, hypotrichosis, photosensitivity, angioedema;
• kidneys and urinary tract: urinary retention, dysuria;
• organ of hearing and labyrinthine disorders: vertigo;
• organ of vision: blurred vision, visual impairment, inflammatory manifestations;
• metabolism and nutritional disorders: increased appetite;
• general disorders: dry mucous membranes, peripheral edema;
• musculoskeletal and connective tissue: arthralgia, myalgia;
• laboratory and instrumental studies: weight gain, abnormal liver function indicators, cross-reactivity.

Overdose

Symptoms of overdose Zodak Express may include: in adults - drowsiness, agitation; in children - anxiety, followed by drowsiness.

With these manifestations, symptomatic or supportive therapy is prescribed. As soon as possible after taking an excessive dose, gastric lavage is performed. Hemodialysis is ineffective.

special instructions

During the period of Zodak Express therapy, you should refrain from drinking ethanol-containing drinks.

Influence on the ability to drive vehicles and complex mechanisms

When using Zodak Express, patients who drive a car or work with other complex and potentially dangerous equipment should refrain from engaging in these activities due to the possible appearance of increased drowsiness during treatment.

Application during pregnancy and lactation

In the course of animal studies, no direct / indirect adverse effects of this antihistamine on the course of pregnancy, childbirth, embryonic, fetal and postnatal development were found. But the use of the drug during pregnancy is contraindicated, since data on the safety of treatment with levocetirizine in pregnant women are practically absent or limited.

Levocetirizine is excreted in breast milk. If it is necessary to take Zodak Express during lactation, it is recommended to stop breastfeeding, since infants have a risk of developing its adverse reactions.

Pediatric use

According to the results of a study of the pharmacokinetics of the drug, in children from 6 to 11 years old with a body weight of 20 to 40 kg after one oral administration of levocetirizine at a dose of 5 mg, the area under the pharmacokinetic curve (AUC) and C _{max were} approximately 2 times higher than those in adult healthy volunteers. The total clearance depending on the body weight in children was 30% higher, and T _{1/2 was} 24% shorter than the corresponding indicators in adults. The data obtained as a result of a retrospective pharmacokinetic analysis showed that in children under 5 years of age, when using the drug at a dose of 1.25 mg, its plasma concentration corresponded to that in adults when taken once a day at a dose of 5 mg.

The use of Zodak Express tablets in children under 6 years of age is contraindicated, since this form of release does not allow for dose adjustment of levocetirizine.

With impaired renal function

In the presence of end-stage renal failure with a CC below 10 ml / min, Zodak Express is contraindicated.

The total clearance of levocetirizine depends on the CC, therefore, patients with moderate / severe renal failure require an increase in the interval between doses, taking into account the CC. The total clearance of the active substance against the background of anuria and end-stage renal failure decreases by an average of 80% compared to that in healthy people. In a standard four-hour hemodialysis procedure, less than 10% of levocetirizine is removed.

Patients with chronic renal failure need to adjust the dosage regimen in accordance with QC. For men, the value of the latter can be established based on the level of serum creatinine according to the following formula: CC (ml / min) = [140 - age (years)] × body weight (kg) / [72 × serum creatinine (mg / dl)]. For women, the resulting value must be multiplied by 0.85.

Recommended dosage regimen of Zodac Express in adult patients with impaired renal function (CC in ml / min):

• normal function (CC ≥ 80) and mild chronic renal failure (CC - 50–79): 5 mg once a day;
• moderate chronic renal failure (CC - 30–49): 1 time in 2 days, 5 mg;
• severe chronic renal failure (CC <30): 1 time in 3 days, 5 mg;
• end-stage chronic renal failure (patients on dialysis, CC <10): use is contraindicated.

In case of impaired renal function in children, the dose is changed individually, taking into account the CC and the child's body weight, there are no separate data on the use of Zodak Express in this group of patients.

For violations of liver function

It is required to carry out drug therapy with caution in the presence of chronic liver diseases (including cholestatic, hepatocellular or biliary cirrhosis). In patients from this group, dose adjustment should be carried out only against the background of a decrease in the glomerular filtration rate (GFR), in accordance with the above recommendations.

Use in the elderly

Data on the pharmacokinetics of levocetirizine in elderly patients are limited. With repeated use of the agent in the amount of 30 mg once a day for 6 days in patients aged 65 to 74 years, the total clearance was approximately 33% lower than in adult patients of a younger age. Since levocetirizine is excreted mostly in the urine, it is recommended to change the dose of Zodac Express in the elderly with moderate / severe renal failure.

Drug interactions

The interaction of levocetirizine with other medicinal substances / drugs, including with inducers of the CYP3A4 isoenzyme, has not been studied.

Interaction reactions that are possible with the combined use of cetirizine with certain drugs / substances:

• ritonavir (at a dose of 600 mg 2 times a day): when combined with cetirizine at a daily dose of 10 mg, the exposure of the latter increased by 40%, and the exposure of ritonavir changed slightly (-11%);
• theophylline (in a daily dose of 400 mg): there was a decrease in the total clearance of cetirizine by 16%, the kinetics of theophylline did not change;
• alcohol or drugs that have a depressing effect on the central nervous system (CNS): it is possible to increase the effect on the central nervous system, but there is no evidence that the racemate of cetirizine enhances the effect of alcohol;
• cimetidine, antipyrine, pseudoephedrine, phenazone, erythromycin, ketoconazole, azithromycin, diazepam, glipizide: no clinically significant drug interactions were recorded.

Analogs

Analogs of Zodak Express are: Tsesera, Suprastinex, Levocetirizine-Teva, Levocetirizine Sandoz, Ksizal, Glenzet, Allerway, Alerset-L, etc.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Zodak Express

Most of the reviews about Zodak Express are positive. The drug was highly appreciated by both patients and doctors. Many point to the very rapid development of the therapeutic effect of the antihistamine and its effectiveness in the treatment of various forms of allergy, including the symptoms of seasonal and perennial allergic rhinitis, urticaria, hay fever and allergic dermatoses. They also note a convenient dosing regimen and the fact that Zodak Express is not addictive.

The disadvantages of some patients include the appearance of side effects (most often drowsiness) and a rather short period of action.

Price for Zodak Express in pharmacies

The price of Zodak Express, film-coated tablets, for a package containing 7 pieces, can be 270 rubles, for 28 pieces. - 580 rubles.

Zodak Express: prices in online pharmacies

Drug name Price Pharmacy

Zodak Express 5 mg film-coated tablets 7 pcs. 234 r Buy

Zodak express tablets p.p. 5mg 7 pcs. 239 r Buy

Zodak Express 5 mg film-coated tablets 28 pcs. 440 RUB Buy

Zodak express tablets p.p. 5mg 28 pcs. 455 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!