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Levocetirizine, 5 mg, film-coated tablets, 30 pcs.

The pharmacokinetic parameters of levocetirizine change linearly, depending on the dose, and practically do not differ from the pharmacokinetics of cetirizine.

Absorption.

Quickly and completely absorbed when taken orally. Eating does not affect the completeness of absorption, but reduces its speed. Cmax in blood plasma is reached after 0.9 hours and is 270 ng/ml. A constant level of drug concentration is achieved after 2 days of administration.

Distribution.

Binding to blood plasma proteins is 90%. Vd is 0.4 l/kg. Bioavailability reaches 100%. Passes into breast milk.

Metabolism.

Less than 14% of the drug is metabolized in the liver by N- and O-dealkylation to form a pharmacologically inactive metabolite. Due to the low level of metabolism and lack of metabolic potential (the cytochrome system is minimally involved in its metabolism), the interaction of levocetirizine with other drugs seems unlikely.

Excretion.

In adults, T1/2 is (7.9 ± 1.9) hours, and the total clearance is 0.63 ml/min/kg; in young children, T1/2 is shortened. About 85.4% of the dose taken is excreted by the kidneys, and about 12.9% through the intestines.

Special patient groups

Kidney failure.

In case of renal failure (Cl creatinine <40 ml/min), clearance is reduced (in patients on hemodialysis - by 80%), T1/2 is prolonged. Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis procedure.

Children.

Data from a study of the pharmacokinetics of the drug in 14 children aged 6 to 11 years weighing from 20 to 40 kg with a single oral dose of 5 mg of levocetirizine showed that the Cmax and AUC values are approximately twice as high as those in healthy adults when cross-over control. Data obtained during the analysis showed that taking the drug at a dose of 1.25 mg in children aged 6 months to 5 years leads to plasma concentrations corresponding to those in adults when taking 5 mg of the drug once a day.

Elderly patients.

Pharmacokinetic data in elderly patients is limited. When repeated dosing of levocetirizine 30 mg once daily for 6 days in 9 elderly patients (age 65 to 74 years) total clearance was approximately 33% lower than that in younger adults. The distribution of cetirizine racemate has been shown to be more dependent on renal function than on age. This statement may also apply to levocetirizine, because Both drugs, levocetirizine and cetirizine, are excreted primarily in the urine. Therefore, in elderly patients, the dose of levocetirizine should be adjusted depending on renal function.

Comparison of ease of use of Levocetirizine and Cetirizine

This includes dose selection taking into account various conditions and frequency of doses. At the same time, it is important not to forget about the release form of the drug; it is also important to take it into account when making an assessment.

The ease of use of Levocetirizine is approximately the same as that of Cetirizine. However, they are not convenient enough to use.

The drug ratings were compiled by experienced pharmacists who studied international research. The report is generated automatically.

Last update date: 2020-12-04 13:46:33

Comparison of the effectiveness of Levocetirizine and Cetirizine

Levocetirizine is more effective than Cetirizine - this means that the ability of the drug substance to provide the maximum possible effect is different.
For example, if the therapeutic effect of Levocetirizine is more pronounced, then with Cetirizine it is impossible to achieve this effect even in large doses.

Also, the speed of therapy is an indicator of the speed of therapeutic action; Levocetirizine and Cetirizine are also different, as is bioavailability - the amount of a drug substance reaching the site of its action in the body. The higher the bioavailability, the less it will be lost during absorption and use by the body.

Comparison of safety of Levocetirizine and Cetirizine

The safety of a drug includes many factors.

Moreover, it is higher for Levocetirizine than for Cetirizine. It is important where the drug is metabolized: drugs are excreted from the body either unchanged or in the form of products of their biochemical transformations. Metabolism occurs spontaneously, but most often involves major organs such as the liver, kidneys, lungs, skin, brain and others. When assessing the metabolism of Levocetirizine, as well as Cetirizine, we look at which organ is the metabolizing organ and how critical the effect on it is.

The risk-benefit ratio is when the prescription of a drug is undesirable, but justified under certain conditions and circumstances, with the obligatory observance of caution in use. At the same time, Levocetirizine has fewer risks when used than Cetirizine.

Also, when calculating safety, it is taken into account whether only allergic reactions occur or possible dysfunction of the main organs. In other matters, as well as the reversibility of the consequences of the use of Levocetirizine and Cetirizine.

Comparison of side effects of Levocetirizine and Cetirizine

Side effects or adverse events are any adverse medical event that occurs in a subject after administration of a drug.

Levocetirizine has almost the same level of adverse events as Cetirizine. They both have few side effects. This implies that the frequency of their occurrence is low, that is, the indicator of how many cases of an undesirable effect of treatment are possible and registered is low. The undesirable effect on the body, the strength of influence and the toxic effect of Levocetirizine are similar to Cetirizine: how quickly the body recovers after taking it and whether it recovers at all.

Levocetirizine ()

Safety data obtained from the study of cetirizine The following adverse reactions were observed:

Rarely (³ 1/10000, < 1/1000)

Mild and temporary adverse events such as fatigue, impaired concentration, drowsiness, headache, dizziness, agitation, dry mouth and gastrointestinal disorders (constipation) occurred. In some cases, hypersensitivity reactions and angioedema have been observed. Isolated cases of seizures, photosensitivity reactions, liver damage, anaphylactic shock, circulatory disorders, deafness, malaise, itching, vasculitis, visual disturbances and nightmares have also been reported.

Clinical trial data

Clinical studies showed that 14.7% of patients taking levocetirizine 5 mg experienced adverse reactions compared to 11.3% of patients in the placebo group. 95% of these adverse reactions were mild or moderate. In clinical trials, the rate of discontinuation due to adverse reactions was 0.7% (4/538) in patients randomized to receive levocetirizine 5 mg and 0.8% (3/382) in patients randomized to placebo. The following adverse reactions were identified in patients (n=538) who participated in the clinical study and used levocetirizine at recommended doses (5 mg once daily):

With a frequency of 1 -10%

Adverse reactions	Levocetirizine 5 mg (n=538)	Placebo (n=382)
Drowsiness	5,6%	1,3%
Dry mouth	2,6%	1,3%
Headache	2,4%	2,9%
Fatigue	1,5%	0,5%
Asthenia	1,1%	1,3%

Although the incidence of somnolence in the levocetirizine group was higher than that in the placebo group, most cases of somnolence were mild or moderate in severity.

Uncommon (0.1-1%): abdominal pain.

Post-registration studies

During post-registration use of levocetirizine, the following side effects were observed:

Immune system disorders: hypersensitivity reactions, including anaphylaxis.

Metabolic and nutritional disorders: increased appetite.

Mental disorders: anxiety, aggression, agitation, depression, hallucinations, insomnia, suicidal ideation, nightmares.

Nervous system disorders: convulsions, dural sinus thrombosis, paresthesia, dizziness, vertigo, fainting, tremor, dysgeusia.

Visual disorders: inflammatory manifestations, blurred vision, blurred vision, involuntary movement of the eyeballs (nystagmus).

Cardiac disorders: angina pectoris, tachycardia, palpitations.

Vascular disorders: jugular vein thrombosis.

Disorders of the respiratory system, chest and mediastinal organs: shortness of breath, increased symptoms of rhinitis.

Skin and subcutaneous tissue disorders: angioedema, exanthema, hypotrichosis, itching, rash, fissures, urticaria, photosensitivity/toxicity, persistent drug erythema.

General disorders: ineffectiveness of the product and its interactions, dry mucous membranes.

Gastrointestinal disorders: nausea, vomiting.

Disorders of the liver and biliary tract: hepatitis.

Disorders of the kidneys and urinary system: dysuria, urinary retention.

Musculoskeletal and connective tissue disorders: muscle pain, arthralgia.

General disorders and disorders at the injection site: swelling.

Laboratory and instrumental data: increase in body weight, changes in liver function tests, cross-reactivity.

Description of selected adverse reactions

A small number of patients experienced pruritus after discontinuation of levocetirizine.
If you experience the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Comparison of addiction between Levocetirizine and Cetirizine

Like safety, addiction also involves many factors that must be considered when evaluating a drug.

So, the totality of the values of such parameters as “syndrome o” in Levocetirizine is quite similar to the similar values in Cetirizine. Withdrawal syndrome is a pathological condition that occurs after the cessation of intake of addictive or dependent substances into the body. And resistance is understood as initial immunity to a drug; in this it differs from addiction, when immunity to a drug develops over a certain period of time. The presence of resistance can only be stated if an attempt has been made to increase the dose of the drug to the maximum possible. At the same time, Levocetirizine has a fairly low “syndrome” value, just like Cetirizine.