Letizen

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

Letizen: instructions for use and reviews

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

Latin name: Letizen

ATX code: R06AE07

Active ingredient: cetirizine (Cetirizine)

Manufacturer: KRKA, d.d. (KRKA, dd) (Slovenia)

Description and photo updated: 2019-29-07

Letizen is an anti-allergic drug, blocker of H ₁ -histamine receptors.

Release form and composition

Dosage forms:

oral solution: transparent colorless liquid with a banana odor [120 ml each in dark glass vials (equipped with a safety insert that regulates the solution flow), in a cardboard box 1 vial complete with a dosing syringe];
film-coated tablets: white, round, slightly biconvex, with a dividing line (10 pcs. in blisters, in a cardboard box 1 or 2 blisters).

Each pack also contains instructions for the use of Letizen.

1 ml of solution contains:

active substance: cetirizine dihydrochloride - 1 mg;
auxiliary components: glycerol, sorbitol, sodium cyclamate, citric acid monohydrate, sodium benzoate, sodium citrate dihydrate, banana flavor, purified water.

1 tablet contains:

active substance: cetirizine dihydrochloride - 10 mg;
auxiliary components: lactose monohydrate, corn starch, povidone, magnesium stearate;
composition of the film shell: Opadray 33G28707 [lactose monohydrate, hypromellose, macrogol 3000, triacetin, titanium dioxide (E171)].

Pharmacological properties

Pharmacodynamics

Letizen is an antiallergic drug, the active ingredient of which is cetirizine, a metabolite of hydroxyzine and a competitive histamine antagonist. The mechanism of action of cetirizine is due to its property of selective blocking of peripheral H ₁ -histamine receptors. As a result of the effect of the drug at the early histamine-dependent stage of allergic reactions, the release of inflammatory mediators of the late stage of the allergic reaction is limited, the migration of eosinophils, basophils and neutrophils is reduced, the membranes of mast cells are stabilized.

The use of Letizen helps to eliminate skin reactions to the administration of histamine, specific allergens, and in case of cold urticaria - to cooling. In patients with mild bronchial asthma, histamine-induced bronchoconstriction decreases.

Along with the antiallergic drug, it has an antipruritic and antiexudative effect, has a weak anticholinergic and antiserotonin effect. Reduces capillary permeability, prevents the development of tissue edema.

While taking therapeutic doses, sedation usually does not occur.

After oral administration, the drug begins to act in 1/3 hour, and reaches its maximum effect after one hour. The action lasts more than 24 hours. Tolerance to the antihistamine action of cetirizine does not develop during the course of treatment, the effect lasts up to 72 hours after taking the last dose of Letizene.

Pharmacokinetics

After taking Letizen inside, cetirizine is absorbed from the gastrointestinal tract (GIT) quickly, its bioavailability in the form of tablets or solution is 70%. The maximum concentration (C _max) in blood plasma is achieved after 1 hour, the equilibrium concentration - after 72 hours of therapy. Simultaneous food intake reduces the rate of absorption, but does not affect the degree of absorption.

For cetirizine in the dose range from 5 to 60 mg, linear pharmacokinetics are characteristic, in the body with prolonged use it does not accumulate.

Plasma protein binding (albumin) - about 93% of the dose taken. The volume of distribution is approximately 0.5 l / kg.

In breast milk, cetirizine is secreted in small amounts.

In the liver, less than 14% of the dose is metabolized, as a result of which a pharmacologically inactive metabolite is formed by O-dealkylation.

The half-life (T _1/2) of the substance is approximately 10 hours. It is excreted unchanged through the kidneys - 2/3, through the intestines in the form of a metabolite - up to 10%.

In old age, T _1/2 is approximately 15 hours, clearance decreases by 40%, mainly as a result of impaired renal function.

In children, the concentration of cetirizine in the blood plasma reaches a higher level, the total clearance is higher than in adults, by 33%, which causes a faster elimination of the drug from the body. T _1/2 in children aged 6-12 years is 6 hours.

With mild renal dysfunction with creatinine clearance (CC) more than 40 ml / min, the pharmacokinetics of cetirizine does not change. With moderate renal impairment and in patients on hemodialysis (CC less than 7 ml / min), clearance decreases by 70%, and T _1/2 increases 3 times. Therefore, patients with moderate or severe renal impairment require dose adjustment of Letizen. During hemodialysis, 9.4% of the dose taken is excreted from the body.

With cirrhosis of the liver, against the background of a single dose of cetirizine at a dose of 10 mg or 20 mg, T _1/2 increases by 50%, there is a decrease in clearance by 40% compared with patients with a healthy liver. In liver disease, the dose should be changed only in patients with concomitant renal dysfunction.

Indications for use

seasonal or perennial allergic rhinitis and allergic conjunctivitis;
allergic dermatosis, accompanied by itching;
pollinosis or hay fever;
Quincke's edema;
urticaria, including chronic idiopathic urticaria.

Contraindications

Absolute:

end-stage renal failure (CC less than 10 ml / min), requiring hemodialysis;
syndrome of glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
period of pregnancy;
breast-feeding;
age contraindications: solution - up to 1 year; tablets - up to 6 years;
hypersensitivity to hydroxyzine, cetirizine or auxiliary components of the drug.

Letizen should be taken with caution in patients with chronic renal failure (except for the terminal stage), chronic liver disease, in old age.

Letizen, instructions for use: method and dosage

Oral solution

Letizen solution is taken orally before or after meals, drinking plenty of liquid, preferably in the evening.

For accurate dosing of the drug, you must use the supplied dosing syringe, the volume of which corresponds to 5 ml.

The bottle should be stored with the lid tightly closed.

The recommended dosage of Letizen (taking into account the patient's age):

adults and adolescents over 12 years old: 10 ml once a day;
children 6–12 years old: 5 ml 2 times a day;
children 2–6 years old: 5 ml once a day or 2.5 ml (1/2 dosing syringe) 2 times a day;
children aged 1 to 2 years: 2.5 ml (1/2 dosing syringe) 2 times a day.

The duration of treatment is determined by the doctor individually.

In case of impaired renal function in adult patients, the following dose reduction of Letizen is required, depending on the CC value:

50–79 ml / min: 10 mg once a day;
30–49 ml / min: 5 mg once a day;
10–30 ml / min: 5 mg once every 2 days.

In case of impaired renal function in children, the doctor should prescribe a dose of Letizen, taking into account the child's age, body weight and CC.

Elderly patients and patients with impaired liver function do not require dose adjustment of Letizen.

Film-coated tablets

Letizen tablets are taken orally with a sufficient amount of liquid, regularly, at a convenient time for the patient, preferably in the evening.

Recommended dosage (taking into account the patient's age):

adults and adolescents over 12 years old: 1 tablet (10 mg) once a day;
children from 6 to 12 years old: 1/2 tablet (5 mg) 2 times a day.

The doctor sets the duration of the course of treatment individually.

Elderly patients and patients with impaired liver function do not require dose adjustment of Letizen.

In case of impaired renal function in adults, the dose is set in accordance with the CC indicators:

50–79 ml / min: 1 tablet (10 mg) once a day;
30–49 ml / min: 1/2 tablet (5 mg) once a day;
less than 30 ml / min (no need for hemodialysis): 5 mg every 2 days.

In case of impaired renal function in children over the age of 6 years, it is recommended to use Letizen in the form of an oral solution, adjusting the dose taking into account the CC, age and body weight of the child.

Side effects

from the upper and lower respiratory tract: often - pharyngitis, rhinitis;
from the central and peripheral nervous system: often - dizziness, headache; rarely - drowsiness, migraine; extremely rarely - change or loss of taste, insomnia, aggressiveness, hallucinations, confusion, paresthesia, dyskinesia, convulsions, fainting, agitation, confusion, dystonia, tremors, tics, depression;
on the part of the cardiovascular system: extremely rarely - tachycardia;
from the digestive system: often - nausea, dryness of the oral mucosa; rarely - abdominal pain; extremely rarely - diarrhea, liver functional disorders (increased activity of transaminases, gamma-glutamyltransferase, alkaline phosphatase, bilirubin content);
from the urinary system: extremely rarely - dysuria, enuresis;
on the part of the sense organs: extremely rarely - blurred vision, violation of accommodation, nystagmus;
dermatological reactions: extremely rarely - itching, skin rash, urticaria;
allergic reactions: extremely rarely - hypersensitivity reactions, angioedema, anaphylactic shock;
laboratory parameters: thrombocytopenia;
others: often - weakness; extremely rarely - general malaise, asthenia, weight gain, edema of the lower extremities.

Overdose

symptoms: diarrhea, general malaise, drowsiness, dizziness, itching, confusion, headache, mydriasis, anxiety, confusion, lethargy, urinary retention, tachycardia, tremor, stupor;
treatment: no specific antidote. Requires immediate gastric lavage, induction of vomiting, intake of activated carbon. Ensuring careful monitoring of the function of the cardiovascular and respiratory system. Appointment of symptomatic or supportive therapy. Hemodialysis is ineffective.

special instructions

An accidentally missed dose of Letizen can be taken later than the set time, if this does not mean taking a double dose.

Recommendations regarding the preferred intake of cetirizine in the evening are due to the fact that in some cases it can cause drowsiness.

During the period of treatment, it is necessary to refrain from drinking alcoholic beverages.

High doses of Letizen solution can contribute to the development of headaches and gastrointestinal disorders due to the presence of glycerol in the composition.

The content of sorbitol in 1 ml of solution is 450 mg, and lactose monohydrate in 1 tablet is 75 mg.

Influence on the ability to drive vehicles and complex mechanisms

During the period of application of Letizen, it is not recommended to engage in potentially hazardous types of work, the performance of which requires increased attention or speed of psychomotor reactions due to the fact that the drug can cause drowsiness.

Application during pregnancy and lactation

The use of Letizen is contraindicated during pregnancy and during breastfeeding.

Pediatric use

Age contraindications for the use of Letizen for the treatment of children: in the form of a solution - up to 1 year, in the form of tablets - up to 6 years.

With impaired renal function

The use of Letizen is contraindicated in end-stage renal failure (CC less than 10 ml / min), requiring hemodialysis sessions.

With caution, only after consulting a doctor, Letizen should be used in patients with chronic renal failure.

The dose of the drug should be set taking into account the patient's QC.

For violations of liver function

Letizen should be used with caution in patients with chronic liver disease. No dose adjustment is required.

Use in the elderly

Care should be taken when using Letizen in old age. No dose adjustment is required.

Drug interactions

With simultaneous use with myelotoxic agents, the manifestation of Letizen's hematotoxicity increases.

There is a 16% decrease in the total clearance of cetirizine with concomitant therapy with theophylline at a daily dose of 400 mg, the pharmacokinetic parameters of theophylline do not change.

Taking therapeutic doses of cetirizine in combination with macrolides or ketoconazole does not cause any changes in the electrocardiogram.

A clinically significant interaction of the drug with ethanol, cimetidine, pseudoephedrine, ketoconazole, azithromycin, erythromycin, diazepam or glipizide has not been established.

Analogs

The analogs of Letizen are: Cetirizine, Cetirizine Sandoz, Cetirizin-Akrikhin, Cetirizin-Teva, Tsetrin, Cetirinax, Alerza, Zirtek, Zinset, Zodak, Parlazin, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 30 ° C.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Letizene

Reviews of Letizene are controversial. According to doctors, the effectiveness and safety of the drug is much higher than average. Patients were divided. Among those who noted a good antiallergic effect of the drug, mainly against the background of its use, there were no undesirable effects, but some patients indicated the development of severe drowsiness and other side effects.

In some reviews, it was reported that taking Letizen tablets did not have any therapeutic effect.

Price for Letizen in pharmacies

Due to the lack of the drug in the pharmacy chain, the price of Letizen is unknown.

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!

Letizen - Instructions For Use, Price, Analogs, Reviews, Tablets

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Letizen

Release form and composition