Tablets, coated with a shell, Xyzal, 7 or 10 pieces packed in a blister pack, 1 or 2 pods in a cardboard box.

Oral drops Xyzal 10 ml in dark-coloured bottles with a small dropper, in a carton pack of 1 bottle.

Pharmacological action:

Xizal is a medicinal preparation that exhibits antihistamine and antiallergic action. The active ingredient in Xizal is levocetirizine, the R-enantiomer of cetirizine. Levocetirizine competitively blocks H1-histamine receptors, and the pharmacological activity of levocetirizine is almost 2 times greater than that of cetirizine.
Xyzal is added to the histamine-dependent phase of the allergic reaction. In addition, levocetirizine leads to a change in the migration of eosinophils and a decrease in the penetration of the vessel wall. Ksizal also improves the viability of cytokines and mediators of inflammation.

The drug may have anti-verb and anti-exudative effects, ease the overshoot and delay the development of allergic reactions. Levocetirizine practically does not affect cholinergic and serotonin receptors, does not have a significant sedative effect.
After oral administration, levocetirizine is well absorbed in the intestinal tract. Taking the drug at the same time as taking the drug should not lead to a change in the bioavailability and speed of absorption of levocetirizine.

Peak plasma concentration of active speech is reached within 1 year after intake. Equal plasma concentrations are available for other dobu therapy Levocetirizine.

The degree of binding of levocetirizine with plasma proteins reaches 90%, oral bioavailability 100%. An insignificant world is metabolized in organisms. It is excreted most importantly by channels of tubular secretion and glomerular filtration.

Approximately 13% of levocetirizine is excreted by the intestine. The period of drinking varies from 6 to 10 years, depending on the individual characteristics of the patient. In children, the period of administration of levocetirizine shortened.
Patients with impaired function of nirok show an increase in the period of drinking. It is practical not to administer levocetirizine during hemodialysis (during 4-year hemodialysis, no more than 10% levocetirizine should be administered).
The active ingredient of Xyzal passes into breast milk.

Indications before congestion:

Existing indications for symptomatic therapy of patients who suffer from the color and seasonal form of allergic conjunctivitis and rhinitis, I are accompanied by wheezing, swelling of the nasal mucosa, lacrimation, rhinorrhea and hyperemia of the nasal mucosa and con’ junctiv.
Xizal is also prescribed to patients who suffer from polynosis, a chronic form of idiopathic croup, flare-ups and allergic dermatoses, as they are accompanied by visip and severbitis.

Method of administration:

Tablets, coated with shell, Xizal:

Prescription drug for oral administration. It is not recommended to take a pill or to open the pill. Ksizal should be taken directly in the form of a drink, a tablet should be washed down with a small amount of drinking water.

Trivality of the course of treatment and dose of levocetirizine indicates a favorable drug.
Adults and children over 6 years of age are usually given 1 tablet Xyzal per day.
Children younger than 6 years of age are advised to administer the drug in the form of oral droplets.

Patients with reduced function nirok should adjust the dose of levocetirizine:
With creatinine clearance of 30 to 50 ml / min, as a rule, prescribe 1 tablet of the drug Xizal 1 time in 48 years.
When creatinine clearance is 10 to 30 ml/min, as a rule, 1 tablet of Xizal is prescribed once every 72 years.
When creatinine clearance becomes less than 10 ml/min (patients on hemodialysis), levocetirizine does not stop.
With normal function of the liver in patients with a frail age and patients with impaired liver function, the dose of levocetirizine should not be corrected.
Trivality of lust to become from 1 tyzhnya to 6 months in fallow land due to the nature of the disease. In the last few days, the course is continued for up to 12 months under the control of the doctor.

Drops for oral infusion Xizal:

The drug is taken directly in the middle of the intake. If necessary, I will need to dilute a small amount of drops in a small amount of drinking water (no more than 10 ml). The validity of the intake and dose of Xizal depends on the drug.
Adults and children older than 6 years old, as a rule, are prescribed 20 drops of Xizal per dose. The additional dose is recommended to be taken in 1 dose.
Children aged 2 to 6 years, as a rule, are prescribed 5 drops of the drug Ksizal dvіchi per doba.
The maximum recommended additional dose of levocetirizine for adults and children over 6 years of age is 5 mg.
The maximum recommended additional dose of levocetirizine for children aged 2 to 6 years is 2. 5 mg.

Patients with impaired creatinine clearance, doses of levocetirizine should be carried out to improve indications of creatinine clearance:
As a rule, prescribe 20 drops of Xizal once every 48 years.
Patients with a creatinine clearance of 10 to 30 ml/min are usually given 20 drops of Xizal once every 72 years.
Do not prescribe levocetirizine to patients who are on hemodialysis.
Patients with a frail age and patients with impaired liver function with normal function need no dose adjustment of levocetirizine.
The duration of therapy, as a rule, becomes from 1 day to 6 months. In other cases, under the close supervision of the doctor, the course of healing can be increased up to 18 months.

Side effects:

Xizal is generally not well tolerated by patients. During the period of Levocetirizine therapy in some patients, the development of the following unimportant effects was noted:
On the side of the organs of sensitivity and the central nervous system: decreased vision, drowsiness, increased stupor, headache, aggression, asthenia, depressive states. In lonely moods, the development of hallucinations and judgment is possible.

On the side of the intestinal tract and liver: discomfort and pain in the epigastric cavity, dryness of the mucous membrane of the mouth, nausea, diarrhea, hepatitis, increased liver enzymes. In lonely cases, a change in the mass of the body was indicated.
Allergic reactions: kropivyanka, sverbizh shkir and visip, anaphylactic shock, angioedema.
Інші: quickened heartbeat, butt, butt, bіl in m’yazah.

Contraindications:

Xizal should not be prescribed to patients with individual hypersensitivity to levocetirizine and similar piperazine.
Coated tablets, Xyzal are not recommended for patients with glucose-galactose malabsorption syndrome, galactosemia and lactase deficiency.
Levocetirizine has not been indicated in patients with severe deficiency in blood function (creatinine clearance less than 10 ml/min).
Xyzal is not recommended for use during pregnancy and lactation.
Tablets, coated with a shell, not vicarious for the delight of children under 6 years of age.
Oral drops are not vicorous for the delight of children up to 2 years of age.

It is recommended to take precautions by prescribing levocetirizine to patients with impaired function, chronic alcoholism, and patients of a frail age.
Patients who drive a car or control potentially unsafe mechanisms should be especially careful during the hour of Levocetirizine therapy.

Vagination:

Levocetirizine should not be used for therapy in women during pregnancy, in connection with the number of reliable data on the infusion of levocetirizine during the period of pregnancy vagity.
In the period of lactation, the drug Xyzal may be used only after the development of nutrition for breastfeeding, but levocetirizine passes into breast milk.

Interaction with other medical problems:

May be able to increase the period of administration of levocetirizine in case of one-hour ingestion with theophylline.
It is not recommended to administer levocetirizine with ethyl alcohol and drugs overnight, as they depress the central nervous system.

Overdose:

Taking high doses of levocetirizine may cause unreasonable restlessness, arousal or drowsiness. Moreover, it is possible to strengthen the manifestation of negligible effects.
There is no specific antidote. When taking high doses of the drug, it is necessary to skip the tube and sign the intake of enterosorbents. If necessary, carry out therapy directed at the symptoms of intoxication.
Hemodialysis with levocetirizine overdose is not effective.

Wash up the savings:

Drops oral Xyzal after saving no more than 2 years after preparation.

Tablets, coated with shell, Xyzal should save no more than 3 years after preparation.

Directly dispensed, the drug is taken in places where the temperature does not exceed 25 degrees Celsius.

Oral droplets should be taken no more than 3 months after the first vial opening.

Ksizal: instructions

XYZAL®
(UA/9127/01/01)

Release form:

tablets, covered with a plaited shell, 5 mg, 7 or 10 tablets in a blister; 1 or 2 blisters in a cardboard box

Stock:

1 tablet levocetirizine dihydrochloride 5 mg

Manufacturer:

Switzerland

Instruction sheet Xyzal film-coated tablets 5 mg №10

Pending

INSTRUCTION

for medical use of the drug

XYZAL ®

(XYZAL®)

Composition of the medicinal product:

active ingredient: levocetirizine;

1 tablet contains levocetirizine dihydrochloride 5 mg;

other ingredients: microcrystalline cellulose, anhydrous colloidal silicon dioxide, lactose monohydrate, magnesium stearate, Opadry® Y-1-7000 (hypromelose (E 464), titanium dioxide (E 171), macrogol 400).

Dosage form.

Film-coated tablets.

Film-coated tablets, white to off-white, oval-shaped, with a Y logo on one side.

Manufacturer’s name and location.

1) Acica Pharmaceuticals S.R.L (primary and secondary packaging, manufacturer responsible for batch release and quality control).

Via Praglia, 15 – 10044 Pianezza (TO), Italy.

2) YUSB Farshim S.A. (manufacturer in bulk).

Z.I. de Planchu, Chemin de Croix Blanche 10, 1630 Bulle, Switzerland.

Pharmacotherapeutic group.

Antihistamines for systemic use. Piperazine derivatives. ATC code R06A E09.

Levocetirizine is an active stable R-enantiomer of cetirizine, belonging to the group of competitive histamine antagonists. Pharmacological action is due to the blocking of H1-histamine receptors. The affinity for H1-histamine receptors in levocetirizine is 2 times higher than that of cetirizine. It affects the histamine-dependent stage of the development of an allergic reaction, reduces the migration of eosinophils, vascular permeability, and limits the release of inflammatory mediators. It prevents the development and suppresses the course of allergic reactions, has anti-exudative, antipruritic, anti-inflammatory effects, almost no anticholinergic and antiserotonin effects.

Pharmacokinetic parameters of levocetirizine are linear and almost do not differ from those of cetirizine.

Absorption. After oral administration, the drug is rapidly and extensively absorbed. The degree of absorption of the drug does not depend on the dose and does not change with food intake, but the maximum concentration (Cmax) of the drug decreases and reaches its maximum value later. Bioavailability reaches 100%.

In 50% of patients, the effect of the drug develops 12 minutes after a single dose, and in 95% – after 0.5-1 hour. Smakh in blood serum is reached in 50 minutes after single intake of a therapeutic dose. The equilibrium concentration in the blood is reached after 2 days of taking the drug. Cmax is 270 ng/ml after a single dose and 308 ng/ml after repeated use at a dose of 5 mg, respectively.

Division. There is no information on the distribution of the drug in human tissues, as well as on the penetration of levocetirizine through the blood-brain barrier. In animal studies, the highest concentration is recorded in the liver and kidneys, and the lowest – in the tissues of the central nervous system. The volume of distribution is 0.4 l / kg. Plasma protein binding – 90%.

Biotransformation. About 14% of levocetirizine is metabolized in the human body. The metabolic process includes oxidation, N- and O-dealkylation and coupling with taurine. Dealkylation primarily occurs with the participation of cytochrome CYP 3A4, while numerous and (or) indefinite isoforms of CYP are involved in the process of oxidation. Levocetirizine does not affect the activity of cytochrome isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, 3A4 at concentrations significantly higher than the maximum after a dose.

5 mg orally. Given the low degree of metabolism and the lack of ability to inhibit metabolism, the interaction of levocetirizine with other substances (and vice versa) is unlikely.

Output. Excretion of the drug occurs mainly due to glomerular filtration and active tubular secretion. The plasma half-life in adults (T1 / 2) is 7.9 + 1.9 hours. The half-life of the drug is shorter in young children. The total clearance in adults is 0.63 ml / min / kg. Basically, the excretion of levocetirizine and its metabolites from the body occurs with urine (an average of 85.4% of the drug dose is excreted). Only 12.9 is excreted with faeces% of the drug dose.

Apparent body clearance of levocetirizine correlates with creatinine clearance. Therefore, in patients with moderate to severe renal impairment, it is recommended to select the intervals between doses of levocetirizine, taking into account creatinine clearance. With anuria in end-stage kidney disease, the total body clearance of patients, compared with the total body clearance of individuals without such disorders, is reduced by about 80%. The amount of levocetirizine excreted during a standard 4-hour hemodialysis procedure was < 10%.

Indications for use.

Symptomatic treatment of allergic rhinitis (including perennial allergic rhinitis) and urticaria.

Contraindications.

Hypersensitivity to levocetirizine or to any other component of this dosage form, or to any piperazine derivatives.

Severe CKD (creatinine clearance < 10 ml/min).

Rare hereditary disorders of galactose intolerance, lactase deficiency or impaired absorption of glucose and galactose.

Appropriate safety precautions for use. Use with caution in patients with chronic renal failure (dosage adjustment is needed) and in elderly patients with renal insufficiency (glomerular filtration may be reduced). During the use of the drug should refrain from alcohol.

In patients with certain factors that provoke urinary retention (eg, spinal cord injury, prostatic hyperplasia), attention should be paid to prescribing the drug, since levocetirizine may increase the risk of urinary retention.

Special reservations.

Use during pregnancy or lactation.

Levocetirizine is contraindicated for use during pregnancy. Cetirizine passes into breast milk, therefore, if necessary, the use of the drug, breast-feeding should be discontinued.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms. You should refrain from driving vehicles or working with other mechanisms for the period of treatment with the drug.

Children. The drug in the form of tablets should not be used in children under 6 years of age, since this dosage form does not allow for the necessary correction of the dosing regimen. This category of patients is recommended to use levocetirizine in a dosage form suitable for use in pediatrics.

Dosage and administration.

The drug is prescribed for adults and children from 6 years old orally in a daily dose of 5 mg.

1 time per day. Take the tablet with or without food. The tablet must be swallowed whole with a small amount of water.