How to give xyzal to a child at six months. New generation antiallergic drug - Xyzal tablets: instructions for use and effectiveness of therapy

One tablet contains

active substance - levocetirizine dihydrochloride 5 mg,

excipients: microcrystalline cellulose,

lactose monohydrate, colloidal silicon dioxide, magnesium stearate,

shell composition: hypromelose (E464), titanium dioxide (E171), macrogol 400.

Description

White or off-white oval film-coated tablets, marked "Y" on one side.

Pharmacotherapeutic group

Systemic antihistamines, piperazine derivatives.

Levocetirizine.

ATX code R06AE09

Pharmacological properties

Pharmacokinetics

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

Suction

After oral administration, the drug is rapidly and completely absorbed from gastrointestinal tract. Eating does not affect the completeness of absorption, although its rate decreases. In adults, after a single dose of the drug at a therapeutic dose (5 mg), the maximum concentration (Cmax) in the blood plasma is reached after 0.9 hours and is 270 ng / ml, after repeated administration at a dose of 5 mg / day - 308 ng / ml. A constant level of concentration is reached after 2 days.

Distribution

Levocetirizine is 90% bound to plasma proteins. The volume of distribution (Vd) is 0.4 l/kg. Bioavailability reaches 100%.

Metabolism

In small quantities (< 14 %) метаболизируется в организме путем N- и О-деалкилирования (в отличие от других антагонистов Н1-гистаминовых рецепторов, которые метаболизируются в печени с помощью системы цитохромов) с образованием фармакологически неактивного метаболита. Деалкилирование, в первую очередь, опосредовано CYP 3A4, во время ароматического окисления участвуют многочисленные и/или неизвестные изоформы CYP. Левоцетиризин не влияет на деятельность изоферментов CYP 1A2, 2С9, 2С19, 2D6, 2Е1 и 3А4 в концентрациях, значительно превышающих пик концентрации, достигнутой при приеме дозы 5 мг.

Due to the low level of metabolism and the lack of metabolic potential, the interaction of levocetirizine with other medicines seems unlikely.

breeding

In adults, the half-life (T1 / 2) is 8 ± 2 hours; in young children, T1 / 2 is shortened. In adults, the total clearance is 0.63 ml / min / kg. Near

85.4% of the accepted dose of the drug is excreted by the kidneys unchanged by glomerular filtration and tubular secretion; about 12.9% - through the intestines.

In patients with renal insufficiency (creatinine clearance (CC)< 40 мл/мин) клиренс препарата уменьшается, а T1/2 удлиняется (так, у больных, находящихся на гемодиализе, общий клиренс снижается на 80 %), что требует соответствующего изменения режима дозирования. Менее 10 % левоцетиризина удаляется в ходе стандартной 4-часовой процедуры гемодиализа.

Pharmacodynamics

The active substance of the drug - levocetirizine, the R-enantiomer of cetirizine, belongs to the group of competitive histamine antagonists, blocks H1-histamine receptors. The affinity for H1 receptors in levocetirizine is 2 times higher than that of cetirizine.

Levocetirizine has an effect on the histamine-dependent stage allergic reactions, and also reduces the migration of eosinophils, reduces vascular permeability, and limits the release of inflammatory mediators.

Levocetirizine prevents the development and facilitates the course of allergic reactions, has an antiexudative, antipruritic effect, practically does not have an anticholinergic and antiserotonin effect. In therapeutic doses, it practically does not have a sedative effect.

The action of the drug begins 12 minutes after taking a single dose in 50% of patients, after 1 hour - in 95% and lasts for 24 hours.

Indications for use

Symptomatic treatment allergic rhinitis(including persistent allergic rhinitis) and urticaria

Dosage and administration

It is used orally with food or on an empty stomach, with a small amount of water, without chewing.

Adolescents 12 years of age and older and adults

Elderly patients

Adult patients with renal insufficiency

Dosing intervals should be individualized according to renal function. Refer to the following table and adjust the dose as indicated below. To use this dosing table, an estimate of the patient's creatinine clearance (CC) in ml/min is required. CC (ml / min) can be estimated from serum creatinine (mg / dl), determined by the following formula:

KK = x mass (kg) (x 0.85 for women)

72 x serum creatinine (mg/dl)

Children with kidney failure

The dose must be adjusted on an individual basis, taking into account the patient's renal clearance and his/her body weight.

Patients with liver failure

Dose adjustment is not required in patients with hepatic impairment alone. In patients with hepatic and renal insufficiency, dose adjustment is recommended (see "Adult Patients with Renal Insufficiency" above).

Duration of use

Periodic allergic rhinitis (symptoms<4 дней/неделю или менее чем 4 недели) должен рассматриваться в зависимости от заболевания и его истории, прием можно остановить только после исчезновения симптомов, и он может быть возобновлен снова, когда появляются симптомы. В случае стойкого аллергического ринита (симптомы>4 days/week and for more than 4 weeks) continuous therapy may be offered to the patient during the period of exposure to allergens. There is clinical experience with levocetirizine 5 mg film-coated tablets with a 6-month treatment period. For chronic urticaria and chronic allergic rhinitis, there is clinical experience with the use of the racemate for up to one year.

Side effects"type="checkbox">

Side effects

In children aged 6-12 years

Headache, drowsiness

Adolescents 12 years of age and older

Headache, drowsiness, dry mouth, fatigue

Post-marketing experience

Hypersensitivity, including anaphylaxis, angioedema, rash, pruritus, urticaria

Increased appetite, nausea, vomiting

Aggression, agitation, hallucinations, depression, insomnia, suicidal thoughts, convulsions, paresthesias, dizziness, syncope, tremor, dysgesia, blurred vision, blurred vision

Palpitations, tachycardia

Hepatitis

Dysuria, urinary retention

Muscle pain

Weight gain, liver dysfunction

Contraindications

Hypersensitivity to any of the components of the drug or piperazine derivatives

Severe chronic renal failure (creatinine clearance less than 10 ml/min)

Children's age up to 6 years

Pregnancy and lactation

Drug Interactions

No interaction studies have been conducted with levocetirizine (including no studies with CYP3A4 inducers); studies of compounds of cetirizine with racemate did not show any clinically significant adverse interactions (with antipyrine, pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). A slight decrease in clearance of cetirizine (16%) was observed in a study with several doses of theophylline (400 mg once a day), while the location of theophylline does not change with the simultaneous use of cetirizine. In a multi-dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the degree of exposure to cetirizine was increased by approximately 40% and the location of ritonavir was slightly altered (-11%), further concomitant with absorption of cetirizine.

The degree of absorption of levocetirizine does not decrease with food intake, although the rate of absorption decreases.

In susceptible patients, concomitant use of cetirizine or levocetirizine and alcohol or other CNS depressants may have central nervous system effects, although racemate cetirizine has not been shown to potentiate the effects of alcohol.

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special instructions

Patients with chronic renal insufficiency and the elderly with moderate to severe renal insufficiency

Correction of the dosing regimen is required (see Dosage and Administration "Adult Patients with Renal Insufficiency").

Xyzal is one of the sought after modern medicines against allergies. It is approved for use in children, and especially for young patients is available in the form of drops. In what cases is it prescribed to babies, how is it dosed and what, if necessary, is it replaced with?

Release form and composition

Ksizal in the form of drops is produced in glass bottles equipped with a dropper. Inside one such vial contains a slightly opalescent or colorless liquid. One bottle holds 10 ml or 20 ml of medicine.

The active substance of this medication is levocetirizine in the form of dihydrochloride. Its content in 1 ml drops is 5 mg. Additionally, the drug includes glycerol, acetic acid, sodium saccharinate and other substances. In pediatrics, this medicine is prescribed for children older than 2 years.

In addition to drops, Ksizal is also available in solid form. These are oval tablets in a white shell, which are sold in 7-20 pieces in one pack. Each such tablet contains 5 mg of levocetirizine. This form of medicine is prescribed for children from the age of 6, since it is impossible to divide the tablet into halves.

Operating principle

The active substance Xyzal blocks receptors for histamine, a substance that acts as the main mediator of allergy. In addition, under the action of the drug, vascular permeability decreases, and the movement of eosinophils is less active. The drug also affects the release of other substances that support the activity of inflammation. As a result of the use of drops, the manifestations of an allergic reaction are reduced, swelling and itching are eliminated.

Indications

Contraindications

The drug is not given to patients with last stage renal failure, as well as hypersensitivity to any ingredient in the drops. Any kidney disease in a child requires close attention of the doctor and a change in dosage when prescribing Ksizal.

Side effects

If you do not exceed the dose of Xyzal, then the sedative effect in most patients does not appear. Only occasionally, when treated with drops, children complain of headaches or abdominal pain.

Sometimes babies become weak and drowsy after taking the drug. The same side effects, as nervous excitement, nausea, heart palpitations, muscle pain, itching, diarrhea, convulsions and others, are extremely rare.

Instructions for use

Xyzal in liquid form is taken orally, dripping a certain number of drops of the medication into a teaspoon. The medicine is recommended to drink on an empty stomach or with meals. If necessary, the product can be diluted with a small amount of clean water.

Dose depends on age:

• A child 2-6 years old is given 5 drops at a time. Since the medication is taken twice a day, the daily dosage for such a baby will be 10 drops.
• Children over six years of age should be given 20 drops per day. Also, for such small patients, you can replace the liquid preparation with tablets. The daily dose of such Ksizal will be 1 tablet.

The duration of use of the drug is affected by the diagnosis and course of the disease. For example, if a child has pollinosis, then drops are prescribed for a period of 7 days to 6 weeks, and with atopic dermatitis, the medication is usually taken for a long time (up to 1.5 years).

Overdose

If you give the child drops in a higher dose, this will lead to a restless and agitated state, which will be replaced by periods of drowsiness.

If an overdose is detected, the baby should immediately wash the stomach or induce vomiting, and then give activated charcoal. If the child's condition worsens, seek medical attention.

drug interaction

The drug can be taken along with erythromycin, diazepat, azithromycin and many other drugs. When administered with drugs that depress the central nervous system, it is possible to increase this effect on the brain. The combination with other drugs has not been studied.

Terms of sale and storage

To buy Xyzal drops in a pharmacy, you must first obtain a prescription from a pediatrician, allergist or other specialist. The average price of a bottle with 10 ml of the drug is 400-450 rubles.

You can store the sealed medication at home for 3 years from the date of issue, by finding a dry place for this with a temperature below +30 degrees.

It is also important to ensure that children do not have access to such a place.

Film-coated tablets - 1 tab.:

• excipients: MCC - 30 mg; lactose monohydrate - 63.5 mg; colloidal silicon dioxide - 0.5 mg; magnesium stearate - 1 mg;
• film shell: Opadry Y-1-7000 (hypromellose (E464) - 62.5%, titanium dioxide (E171) - 31.25%, macrogol 400 - 6.25%) - 3 mg.

Film-coated tablets, 5 mg. In PVC/Aluminum foil blister, 7 or 10 pcs. 1 or 2 blisters in a cardboard box.

Drops for oral administration - 1 ml:

• active substance: levocetirizine dihydrochloride - 5 mg;
• excipients: sodium acetate - 5.7 mg; acetic acid - 0.53 mg; propylene glycol - 350 mg; glycerol 85% - 294.1 mg; methyl parahydroxybenzoate - 0.3375 mg; propyl parahydroxybenzoate - 0.0375 mg; sodium saccharinate - 10 mg; purified water - up to 1 ml

Drops for oral administration, 5 mg / ml. In dark glass bottles (Type III, Ph. Eur.) with a nominal capacity of 15 ml, equipped with a LDPE dropper, with a white polypropylene screw cap, childproof, 10 ml. In dark glass bottles (Type III, Ph. Eur.) with a nominal capacity of 20 ml, equipped with a LDPE dropper, with a white polypropylene screw cap, childproof, 20 ml. 1 vial in a cardboard box.

Description of the dosage form

Tablets: oval-shaped, film-coated white or almost white. One side of the tablet is embossed with a "Y" marking.

Drops: Almost colorless, slightly opalescent solution.

pharmachologic effect

Antiallergic, antihistamine.

Pharmacokinetics

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

Suction. After oral administration, the drug is rapidly and completely absorbed from the gastrointestinal tract. Eating does not affect the completeness of absorption, although its rate decreases. In adults, after a single dose of the drug at a therapeutic dose (5 mg), Cmax in blood plasma is 270 ng / ml and is achieved after 0.9 hours, after repeated administration at a dose of 5 mg - 308 ng / ml. Css is reached in 2 days.

Distribution. Levocetirizine is 90% bound to plasma proteins. Vd is 0.4 l/kg. Bioavailability reaches 100%.

Metabolism. In small quantities (

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

In patients with renal insufficiency (Cl creatinine

Pharmacodynamics

Levocetirizine, the active substance of Xyzal®, is the R-enantiomer of cetirizine, which belongs to the group of competitive histamine antagonists and blocks H1-histamine receptors.

Levocetirizine has an effect on the histamine-dependent stage of allergic reactions, and also reduces the migration of eosinophils, vascular permeability, and limits the release of inflammatory mediators.

Levocetirizine prevents the development and facilitates the course of allergic reactions, has antiexudative, antipruritic and practically does not have anticholinergic and antiserotonin effects. In therapeutic doses, it practically does not cause a sedative effect.

Indications for use Ksizal

• treatment of such symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;
• pollinosis (hay fever);
• hives;
• other allergic dermatoses, accompanied by itching and rashes.

Contraindications to the use of Ksizal

For all dosage forms:

• hypersensitivity to levocetirizine or piperazine derivatives, as well as to other components of the drug;
• end-stage renal disease (Cl creatinine
• pregnancy;
• breastfeeding period.

With caution: chronic renal failure (correction of the dosing regimen is necessary); elderly age(possibly decreased glomerular filtration rate); damage spinal cord, prostatic hyperplasia, as well as the presence of other predisposing factors for urinary retention, since levocetirizine may increase the risk of urinary retention; simultaneous use with alcohol (see "Interaction").

For film-coated tablets, in addition:

• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• children under 6 years of age (due to limited data on safety and efficacy).

For oral drops, in addition:

• children under 2 years of age (due to limited data on the efficacy and safety of the drug).

Xyzal Use in pregnancy and children

Preclinical studies have not revealed any direct or indirect adverse effects of levocetirizine on the developing fetus, as well as on development in the postnatal period; the course of pregnancy and childbirth also did not change.

Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy have not been conducted.

The use of the drug during pregnancy is contraindicated.

Levocetirizine is excreted in breast milk, therefore, if necessary, the use of the drug during lactation is recommended to stop breastfeeding.

Xyzal side effects

During clinical trials in males and females aged 12–71 years, often (≥1/100,

From the side immune system: hypersensitivity reactions, including anaphylaxis.

From the side of metabolism and eating disorders: increased appetite.

On the part of the psyche: anxiety, aggression, agitation, insomnia, hallucinations, depression, suicidal thoughts.

From the side nervous system: convulsions, thrombosis of the sinuses of the dura mater, paresthesia, dizziness, fainting, tremor, dysgeusia.

On the part of hearing: vertigo.

On the part of the organ of vision: blurred vision, blurred vision, inflammatory manifestations.

From the CCC: palpitations, tachycardia, jugular vein thrombosis.

From the side respiratory system: shortness of breath, increased symptoms of rhinitis.

From the side digestive system: nausea, vomiting.

Hepatobiliary disorders: hepatitis.

From the side of the kidneys and urinary system: dysuria, urinary retention.

On the part of the skin and soft tissues: angioedema, persistent drug erythema, rash, itching, urticaria, hypotrichosis, cracks, photosensitivity.

From the musculoskeletal system: muscle pain.

General disorders: peripheral edema.

Other: weight gain, changes in liver function tests, cross-reactivity.

If any side effects indicated in the instructions are aggravated or the patient notices other side effects, the doctor should be informed.

drug interaction

The study of the interaction of levocetirizine with other drugs has not been conducted. When studying drug interaction racemate cetirizine with phenazone, pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam, no clinically significant adverse interactions were identified.

With simultaneous administration with theophylline (400 mg / day), the total clearance of cetirizine is reduced by 16% (the kinetics of theophylline does not change).

In a study with simultaneous administration of ritonavir (600 mg 2 times a day) and cetirizine (10 mg / day), it was shown that the exposure of cetirizine increased by 40%, and the exposure of ritonavir changed slightly (−10%).

In some cases, with the simultaneous use of levocetirizine with alcohol or drugs that depress the central nervous system, it is possible to increase their effect on the central nervous system, although it has not been proven that the racemate of cetirizine potentiates the effect of alcohol.

Dosage of Xyzal

Inside, during a meal or on an empty stomach. The film-coated tablets should be swallowed whole with a small amount of water. To take the drug in the form of drops, you should use a teaspoon. If necessary, the dose of the drug can be diluted in a small amount of water immediately before use.

Adults and children over 6 years of age: daily dose is 5 mg (1 tab. or 20 drops) once.

Children from 2 to 6 years: 1.25 mg (5 drops) 2 times a day; daily dose - 2.5 mg (10 drops).

Duration of taking the drug: in the treatment of seasonal (intermittent) rhinitis (the presence of symptoms less than 4 days a week or their total duration is less than 4 weeks), the duration of treatment depends on the nature of the disease; treatment can be stopped when symptoms disappear and resumed when symptoms appear. In the treatment of year-round (persistent) allergic rhinitis (presence of symptoms more than 4 days a week and their total duration of more than 4 weeks), treatment is possible during the entire period of exposure to allergens. There is clinical experience with the continuous use of Xyzal tablets in adult patients for up to 6 months.

Overdose

Symptoms: drowsiness (in adults), agitation and anxiety, followed by drowsiness (in children).

Treatment: gastric lavage or the appointment of activated charcoal, if little time has passed after taking the drug. Symptomatic and supportive therapy is recommended. There is no specific antidote. Hemodialysis is ineffective.

Precautionary measures

Methyl parahydroxybenzoate and propyl parahydroxybenzoate, which are part of drops for oral administration, can cause allergic reactions (possibly delayed type).

Impact on ability to drive vehicles and work with machinery. Levocetirizine may cause increased drowsiness, therefore Xyzal® may affect the ability to drive or operate machinery. During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

The blocker of histamine H 1 receptors, the enantiomer of cetirizine, belongs to the group of competitive histamine antagonists. The affinity for histamine H 1 receptors in levocetirizine is 2 times higher than that of cetirizine.

Levocetirizine has an effect on the histamine-dependent stage of allergic reactions, and also reduces the migration of eosinophils, reduces vascular permeability, and limits the release of inflammatory mediators. It prevents the development and facilitates the course of allergic reactions, has an anti-exudative, antipruritic effect, practically does not have an anticholinergic and antiserotonin effect. In therapeutic doses, it practically does not have a sedative effect.

Pharmacokinetics

Suction

The pharmacokinetic parameters of levocetirizine change linearly and practically do not differ from the pharmacokinetics of cetirizine. After oral administration, levocetirzine is rapidly absorbed from the gastrointestinal tract. Eating does not affect the degree of absorption, although its rate decreases. After a single oral administration at a therapeutic dose, Cmax in blood plasma in adults is reached after 0.9 hours and is 207 ng / ml, after repeated administration at a dose of 5 mg / day - 308 ng / ml. Bioavailability is 100%.

Distribution

C ss is reached in 2 days. The binding of levocetirizine to plasma proteins is 90%.
V d is 0.4 l / kg.

Metabolism

Less than 14% is metabolized in the liver by N- and O-dealkylation (unlike other histamine H1 receptor blockers, which are metabolized in the liver with the participation of isoenzymes of the cytochrome P450 system) with the formation of a pharmacologically inactive metabolite. Due to the low metabolic rate and the lack of metabolic potential, the interaction of levocetirizine with other drugs is unlikely.

breeding

In adults, it is 7.9 ± 1.9 hours, the total clearance is 0.63 ml / min / kg. About 85.4% of the dose is excreted unchanged by the kidneys by glomerular filtration and tubular secretion; about 12.9% is excreted through the intestines.

Pharmacokinetics in special clinical situations

In patients with renal insufficiency (CC less than 40 ml / min), the clearance of levocetirizine decreases, and T 1/2 increases (in patients on hemodialysis, the total clearance is reduced by 80%), which requires an appropriate change in the dosing regimen. Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis session.

In children younger age T 1/2 shortened.

Release form

Tablets, film-coated white or almost white, oval; embossed with "Y" on one side.

Excipients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

Shell composition: Opadry Y-1-7000 (hypromellose, titanium dioxide (E171), macrogol 400).

7 pcs. - blisters (1) - packs of cardboard.
7 pcs. - blisters (2) - packs of cardboard.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.

Dosage

The drug is administered orally during a meal or on an empty stomach.

Tablets are taken with a small amount of water, without chewing.

Drops for oral administration are taken with a teaspoon. If necessary, the dose of the drug can be diluted in a small amount of water immediately before use.

Adults and children over 6 years old: daily dose of 5 mg (1 tab. or 20 drops).

Since levocetirizine is excreted by the kidneys, when prescribing the drug to elderly patients and patients with renal insufficiency, the dose should be adjusted depending on the size of the CC.

For men:

CC (ml / min) \u003d × body weight (kg) / 72 × serum creatinine (mg / dl)

For women: measured value × 0.85

For patients with renal and hepatic insufficiency, dosing is carried out according to the table above.

Patients with impaired liver function only do not need to adjust the dosing regimen.

The duration of use depends on the indications. The course of treatment for hay fever is an average of 1-6 weeks. At chronic diseases(perennial rhinitis, atopic dermatitis) the duration of treatment can be increased up to 18 months.

Overdose

Symptoms: drowsiness (in adults), agitation and anxiety, followed by drowsiness (in children).

Treatment: immediately after taking the drug, perform a gastric lavage or induce artificial vomiting. The appointment of activated charcoal, symptomatic and supportive therapy is recommended. There is no specific antidote. Hemodialysis is ineffective.

Interaction

The study of the interaction of levocetirizine with other drugs has not been conducted.

When studying the drug interaction of racemate cetirizine with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam, no clinically significant undesirable interaction was detected.

With simultaneous use with theophylline (400 mg / day), the total clearance of cetirizine is reduced by 16%, the pharmacokinetic parameters of theophylline do not change.

In some cases, with the simultaneous use of levocetirizine with ethanol or drugs that have a depressant effect on the central nervous system, it is possible to increase their effect on the central nervous system, although it has been proven that the racemate of cetirizine potentiates the effect of alcohol.

Side effects

Possible side effects are listed below by body systems and frequency of occurrence: often (≥1 / 10); infrequently (from ≥1 / 100 to<1/10); редко (от ≥1/1000 до <1/100); очень редко (от ≥1/10 000 до < 1/1000).

From the side of the central nervous system: infrequently - headache, fatigue, drowsiness; rarely - asthenia; very rarely - aggression, agitation, convulsions, hallucinations, depression, visual impairment.

From the side of the cardiovascular system: very rarely - tachycardia.

From the respiratory system: very rarely - dyspnea.

From the digestive system: infrequently - dry mouth; rarely - abdominal pain; very rarely - nausea, diarrhea, hepatitis, changes in liver function tests.

From the musculoskeletal system: very rarely - myalgia.

From the side of metabolism: very rarely - weight gain.

Allergic reactions: very rarely - itching, rash, urticaria, angioedema, anaphylaxis.

Indications

Symptomatic therapy of allergic diseases and conditions:

• year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis (itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia, nasal congestion);
• pollinosis (hay fever);
• urticaria (including chronic idiopathic urticaria);
• angioedema;
• other allergic dermatoses, accompanied by itching and rashes.

Contraindications

• terminal stage of renal failure (CC less than 10 ml / min);
• children's age up to 6 years (for tablets);
• children's age up to 2 years (for oral drops);
• pregnancy;
• hypersensitivity to the components of the drug, especially in patients with galactosemia or severe lactose intolerance (for tablets);
• hypersensitivity to levocetirizine or piperazine derivatives.

With caution, the drug should be used in chronic renal failure (correction of the dosing regimen is required), in elderly patients (with an age-related decrease in glomerular filtration).

Application features

Use during pregnancy and lactation

Adequate and strictly controlled clinical studies on the safety of the drug in pregnant women have not been conducted, so Ksizal ® should not be prescribed during pregnancy.

Levocetirizine is excreted in breast milk, therefore, if it is necessary to use the drug during lactation, breastfeeding should be discontinued at the time of administration.

In experimental studies on animals, no direct or indirect adverse effects of levocetirizine on the developing fetus (including in the postnatal period) were revealed, the course of pregnancy and childbirth also did not change.

Application for violations of liver function

Patients with hepatic impairment do not require dose adjustment.

Application for violations of kidney function

Contraindicated in the end stage of renal failure (CC less than 10 ml / min).

For patients with chronic renal failure with CC 49-30 ml / min, the dose is reduced by 2 times (1 tab. every other day), with CC 29-10 ml / min, the dose is reduced 3 times (1 tab. 1 time in 3 days ).

Use in children

Contraindicated in children under 6 years of age (for tablets); in children under 2 years of age (for oral drops).

Children over 6 years old: daily dose of 5 mg (1 tab. or 20 drops).

Children aged 2 to 6 years: 1.25 mg (5 drops) 2 times / day; daily dose - 2.5 mg (10 drops).

Use in elderly patients

Since levocetirizine is excreted by the kidneys, when prescribing the drug to elderly patients, the dose should be adjusted depending on the size of the CC.

special instructions

The patient should be careful when taking the drug and the simultaneous use of alcohol.

Influence on the ability to drive vehicles and control mechanisms

An objective assessment of the ability to drive vehicles and work with mechanisms did not reliably reveal any adverse events when prescribing the drug at the recommended dose. However, during the period of treatment, it is advisable to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Some facts about the product:

Instructions for use

Price in the online pharmacy site: from 344

Some facts

Xyzal is an anti-allergic drug that belongs to the group of agents that block histamine receptors in the body, which thereby prevents the development of the negative effects that it provokes. The action of the drug is due to levocetirizine, a histamine antagonist that facilitates the course of allergic reactions by reducing itching and inflammation.

Levocetirizine is a representative of the latest innovative antihistamines, has high rates of absorption by the body and long-term effectiveness, because one dose of the drug lasts for twenty-four hours.

Such high rates of pharmacological efficacy are the reason for the development of many drugs based on levocetirizine. The Swiss pharmaceutical corporation UCB Farchim, which has a long history and established itself as a manufacturer of innovative medicines, is engaged in the production and distribution of Xyzal, which was established in 2008. To date, the company's products have already conquered the markets of twenty-eight countries, the company continues its active development, gaining popularity in the domestic pharmaceutical market.

Dosage form and pharmacological properties

Xyzal is produced and distributed as white, oval, film-coated tablets taken by mouth. Tablets are placed in aluminum blisters, each of which can contain seven or ten tablets. The drug package contains one aluminum blister of ten tablets or one or two blisters of seven tablets. The drug is also produced in drops for oral use, placed in a vial in the amount of ten milliliters.

The composition of one tablet of Xyzal includes five milligrams of levocetirizine, supplemented with other components: lactose monohydrate, magnesium stearate, colloidal silicon dioxide, macrogol, and titanium dioxide. Additional components of the drops are propylene glycol, sodium acetate, glycerol, acetic acid, sodium saccharinate, and purified water.

The package with the drug also contains instructions for use, containing information about the composition, indications for use, possible adverse reactions, method and shelf life of the drug.

Indications for use

The use of Xyzal is recommended in the treatment of allergic reactions that occur seasonally or year-round. Levocetirizine is also used for conjunctivitis, accompanied by sneezing, tearing, nasal congestion; with hay fever; urticaria; various types of allergic dermatoses. The drug can be prescribed as a separate drug for monotherapy of these diseases, as well as one of the components of combination therapy.

Method of application and dosage

Xyzal is administered orally, a tablet with medicinal components is swallowed and washed down with water before or after a meal, not chewed or crushed. In the form of drops, it is taken undiluted in a teaspoon. The recommended daily dosage of the drug is one tablet or twenty drops taken at a time. When taking the drug by children, it is better to reduce the daily dose by half. Special instructions for admission exist for people with impaired kidney and liver function, as well as for the elderly. They need to take levocetirizine, based on clear instructions from the doctor, carefully monitoring single doses of the drug. The medication should be taken depending on the manifestation or disappearance of allergy symptoms.

Overdose and side effects

In case of an overdose, symptoms may appear: sleep disturbance, irritability, nervousness, mood swings. Infrequent side effects after taking the drug are headache, overwork, dry mouth, convulsions, anxiety, heart palpitations, weight gain. If the side effects reported by the instructions do not go away, and the patient's condition worsens, you should seek help from a doctor.

Contraindications for use

Do not use the drug in the presence of increased susceptibility to levocetirizine, which is part of the drug, acute stage of renal failure, lactose intolerance. Pregnant women, children, the elderly, patients diagnosed with brain damage, urinary retention should be used with caution. No other contraindications have been identified.

Interaction with alcohol and drugs

It is advisable not to combine the drug with alcohol to achieve the maximum therapeutic effect. No adverse drug interactions were found when the drug was combined with other drugs.

Analogues

Klizal has substitutes used in the treatment of allergic diseases. Among them, Alergolik, Aleron, Zenaro, Levrizin, Tsezer, Tsetrilev, Egizin, Tsetrinal, Zodak, Amertil and others should be noted.

Terms of sale and storage

It is dispensed without a doctor's prescription from the patient. It is necessary to store the pharmaceutical agent in a place with limited access for children, the temperature in which does not exceed 30 degrees Celsius. The shelf life of the drug is 3 years. It is not recommended to use after the expiration date indicated on the package.