Otitis

How to give xyzal to a six month old child. Xyzal for children in drops and tablets

drops for oral administration 5 mg/1 ml: fl. 10 ml or 20 ml 1 pc. Reg. No.: LSR-001308/08

Clinical and pharmacological group:

Histamine H1 receptor blocker. Antiallergic drug

Release form, composition and packaging

Drops for oral administration in the form of an almost colorless, slightly opalescent solution.

Excipients: sodium acetate, acetic acid, propylene glycol, glycerol 85%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharinate, purified water.

10 ml - dark glass bottles with a dropper (1) - cardboard packs.
20 ml - dark glass bottles with a dropper (1) - cardboard packs.

Description of the active components of the drug " Xizal ®»

Pharmacological action

A histamine H1 receptor blocker, an enantiomer of cetirizine, belongs to the group of competitive histamine antagonists. The affinity for histamine H1 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. Prevents the development and facilitates the course of allergic reactions, has an antiexudative, antipruritic effect, and has virtually no anticholinergic and antiserotonin effects. In therapeutic doses it has virtually no sedative effect.

Indications

Symptomatic treatment of allergic diseases and conditions:

- year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis (itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia, nasal congestion);

— hay fever (hay fever);

- urticaria (including chronic idiopathic urticaria);

- Quincke's edema;

- other allergic dermatoses, accompanied by itching and rashes.

Dosage regimen

The drug is prescribed orally during meals or on an empty stomach.

The 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 5 mg (1 tablet or 20 drops).

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

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

For men:

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

For women: obtained value × 0.85

For patients with renal and liver failure dosing is carried out according to the table above.

Patients with liver function disorders only no dosage regimen adjustment is required.

The duration of use depends on the indications. Course of treatment hay fever averages 1-6 weeks. At chronic diseases (year-round rhinitis, atopic dermatitis) the duration of treatment can increase to 18 months.

Side effect

Possible side effects are listed below by body system and frequency of occurrence: often (≥1/10); uncommon (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 cardiovascular system: very rarely - tachycardia.

From the respiratory system: very rarely - dyspnea.

From the digestive system: uncommon - 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.

Contraindications

— end-stage renal failure (creatinine clearance less than 10 ml/min);

- children under 6 years of age (for tablets);

- children under 2 years of age (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 for chronic renal failure (dosage regimen adjustment is required), in elderly patients (with an age-related decrease in glomerular filtration).

Pregnancy and lactation

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

Levocetirizine is excreted in breast milk, so if it is necessary to use the drug during lactation, breastfeeding should be discontinued while taking it.

IN experimental studies Animal studies did not reveal any direct or indirect adverse effects of levocetirizine on the developing fetus (including in the postnatal period), the course of pregnancy and childbirth also did not change.

Use for liver dysfunction

Patients with hepatic insufficiency do not require dose adjustment.

Use for renal impairment

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

Special instructions

The patient should be careful when taking the drug and drinking alcohol at the same time.

Impact on the ability to drive vehicles and operate machinery

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

Overdose

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

Treatment: immediately after taking the drug, perform gastric lavage or induce artificial vomiting. It is recommended to prescribe activated carbon and carry out symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective.

Drug interactions

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

Tablets should be stored out of reach of children, in a dry place at a temperature not exceeding 25°C. Shelf life – 4 years.

Drops for oral administration should be stored out of the reach of children, protected from light at a temperature not exceeding 30°C. Shelf life – 3 years. After opening the bottle, the shelf life is 3 months.

Drug interactions

The interaction of levocetirizine with other drugs has not been studied.

When studying the drug interactions of cetirizine racemate with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam, no clinically significant adverse interactions were identified.

When used simultaneously 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 simultaneous use of levocetirizine with ethanol or drugs that have a depressant effect on the central nervous system, their effect on the central nervous system may be enhanced, although cetirizine racemate has been proven to potentiate the effect of alcohol.

Xyzal belongs to the histamine H1 receptor blockers and is a representative of the group of competitive histamine antagonists. The similarity with histamine H1 receptors in the active component of the drug, levocetirizine, is 2 times greater than that of cetririzine. Xyzal acts on the histamine-dependent stage of the allergic reaction and reduces the movement of eosinophils, reducing vascular permeability and limiting the release of inflammatory mediators.

Dosage form

Xyzal is produced in 2 dosage forms - tablets and drops for oral use. The tablets contain 5 mg of the active ingredient and are coated. Packaged in 7,10,14,20 pieces per package.

Drops for oral use contain 5 ml of the active ingredient in 1 drop and are available in dark glass bottles with a dropper, the capacity of which is 10 and 20 ml.

Description and composition

The active substance of the pharmacological drug Xyzal is levocetrin dihydrochloride. Excipients of the tablets are represented by the following components:

MCC – 30 mg;
Magnesium stearate – 1 mg;
colloidal dioxide – 0.5 mg;
lactose monohydrate – 63.5 mg.

The composition of the film shell of the tablet is represented by the following substances:

titanium dioxide;
macrogoal400;
hypromellose.

The drops contain the following auxiliary compounds:

sodium acetate;
acetic acid;
propylene glycol;
glycerol 85%;
methyl parahydroxybenzoate;
propyl parahydroxybenzoate;
sodium saccharinate;
purified water.

Pharmacological group

The medication belongs to pharmacological drugs with pronounced antiallergic and antihistamine effects. The effect on the body is expressed in the prevention of an allergic reaction, and with the development of an allergy, its course is facilitated. The drug is also characterized by antipruritic and antiexudative effects. The active component of the drug has the following effects:

reduces the permeability of vascular walls;
inhibits eosinophils;
slows down the activity of inflammatory mediators and cytokines.

Levocetirizine has virtually no effect on cholinergic as well as serotonin receptors. There is almost no sedative effect when using Xizal.

Indications for use

Xyzal is used in the following situations:

lacrimation;
sneezing;
hay fever;
chronic;
allergic rhinitis;
seasonal;
nasal congestion;
rhinorrhea;
inflammation of the nasal mucosa;
inflammation of the mucous membranes of the eyes;
Quincke's edema;
dermatosis of allergic origin;
chronic

for adults

The medication should be prescribed exclusively by the treating specialist if indicated. Unauthorized use is unacceptable, as there is a possibility of causing significant harm to the body.

for children

In childhood, Xyzal in tablet form is not used for patients under 6 years of age. The drug in the form of drops for oral use is not recommended for use in children under 2 years of age.

Xyzal cannot be used during pregnancy, as well as during breastfeeding, since there is no information regarding its safety.

Contraindications

A medication with antiallergic effects has a number of absolute contraindications, in the presence of which the patient should not use it. Similar conditions that make it impossible to use Xyzal include the following:

excessive sensitivity to levocetirizine;
renal failure;
hypersensitivity to the auxiliary components of the drug.

Applications and dosages

Specific dosages and the required frequency of administration are determined by the treating specialist. Changing medical prescriptions in any way or skipping appointments is strictly not recommended.

for adults

Xyzal in the form of drops for oral administration in a volume of 10 ml is recommended to be dissolved in clean water and taken using a teaspoon in a volume of up to 20 drops for 1 day.

Tablet Xyzal must be taken on an empty stomach or during a meal. The tablets must be swallowed whole - chewing is prohibited. It is necessary to take the drug with a significant amount of water. The standard dose is 1 tablet 1 time per day.

for children

Xyzal drops for children aged 2 to 6 are prescribed in a dose of 5 drops 2 times a day. Children over 6 years old take drops according to the adult dosage regimen.

The tablets are taken by children from 6 years of age in the same way as adults. When a child takes pills, adult supervision is required.

for pregnant women and during lactation

There is no information regarding the effect on the body of a pregnant woman, as well as on the fetus. It is possible to take Xyzal during pregnancy only after consultation with a doctor and in case of urgent need. During lactation, it is necessary to stop breastfeeding the child, since the effect of the drug on the child’s body has not been studied.

Side effects

The drug Xyzal during use can provoke negative reactions from the body. The main negative effects from the use of pharmacological agents are:

drowsiness;
headaches;
dryness of the oral mucosa;
increased fatigue;
pain in the epigastric region;
asthenic syndrome.

The following body reactions are rarely observed when taking Xyzal:

attacks of nausea;
convulsions;
diarrhea;
rashes;
dyspnea;
dyspnea;
muscle pain;
hepatitis;
hallucinations;
tachycardia.

Also, there were isolated cases of fluctuations in the patient’s weight. Angioedema and anaphylactic edema occurred extremely rarely.

Interaction with other drugs

During a course of treatment using a pharmacological drug in combination with theophylline, there is a possibility of increasing the half-life of the main active substance of Xyzal, lefocetirizine, from the patient’s body.

It is undesirable to consume alcohol-containing products during a course of medication treatment, as well as medications that have a depressing effect on the functioning of the central nervous system, since there is a possibility of an uncontrolled increase in the intensity of their effect on the patient’s body.

Special instructions

While using the medication, it is advisable to refrain from driving vehicles and other machinery, as well as from activities that require increased concentration. This is due to the fact that the pharmacological agent can affect the quality, clarity and speed of psychomotor reactions.

Overdose

In case of an overdose of Xyzal, there is a high probability of developing a certain symptomatic picture, which varies depending on the age group of the patient. In adults, sleepiness increases. Patients in the pediatric age group may experience the following conditions:

excessive irritability;
causeless anxiety;
excessive excitability;
drowsiness.

If an overdose is suspected, gastric lavage is required first. In the future, supportive and symptomatic therapy is necessary. There is no specific antidote to the active component of the drug.

Storage conditions

Tablet Xyzal and in the form of drops must be stored in a place inaccessible to direct sunlight. The room temperature should not exceed 25 °C. The shelf life of tablet Xizal is 3 years, and drops for oral use are valid for 2 years from the date of release. An opened bottle cannot be used after 3 months from opening.

Analogues

The medication has analogues that are characterized by similar medicinal effects. But, replacing a drug prescribed by a doctor with any analogue without prior consultation with a specialist is not recommended.

The main active component of the drug is levocetirizine dihydrochloride. The medicine is also produced in the form of drops and tablets. Characterized by antiallergic and antihistamine properties. In the drops form it is prohibited for children under 2 years of age, in tablet form - for children under 6 years of age. During pregnancy and breastfeeding, it is not recommended to use unless absolutely necessary, since its effect has not been studied during these periods. valid for 3 years from the date of manufacture. Belongs to the category of non-prescription pharmacological agents.

Price

The cost of Xizal is on average 456 rubles. Prices range from 260 to 794 rubles.

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. Food intake 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 achieved after 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 cytochrome P450 isoenzymes) to form a pharmacologically inactive metabolite. Due to its low metabolic rate and lack of metabolic potential, interactions between levocetirizine and other drugs are unlikely.

Removal

In adults it is 7.9±1.9 hours, 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 failure (creatinine clearance less than 40 ml/min), the clearance of levocetirizine decreases and T1/2 increases (in patients on hemodialysis, the total clearance decreases by 80%), which requires a corresponding change in the dosage regimen. Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis procedure.

In young children, T 1/2 is shortened.

Release form

White or almost white film-coated tablets, oval; with embossed "Y" marking 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) - cardboard packs.
7 pcs. - blisters (2) - cardboard packs.
10 pcs. - blisters (1) - cardboard packs.
10 pcs. - blisters (2) - cardboard packs.

Dosage

The drug is prescribed orally during meals or on an empty stomach.

The 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 of age: daily dose 5 mg (1 tablet or 20 drops).

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

For men:

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

For women: obtained value × 0.85

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

Patients with impaired liver function alone do not require dosage adjustment.

The duration of use depends on the indications. The course of treatment for hay fever is on average 1-6 weeks. For chronic diseases (year-round rhinitis, atopic dermatitis), the duration of treatment can increase to 18 months.

Overdose

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

Treatment: immediately after taking the drug, perform gastric lavage or induce artificial vomiting. It is recommended to prescribe activated carbon and carry out symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective.

Interaction

The interaction of levocetirizine with other drugs has not been studied.

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

Side effects

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 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.

Metabolism: very rarely - weight gain.

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

Indications

Symptomatic treatment of allergic diseases and conditions:

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

Contraindications

end-stage renal failure (creatinine clearance less than 10 ml/min);
children under 6 years of age (for tablets);
children under 2 years of age (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.

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

Features of application

Use during pregnancy and breastfeeding

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

Levocetirizine is excreted in breast milk, so if it is necessary to use the drug during lactation, breastfeeding should be discontinued while taking it.

Experimental studies on animals did not reveal any direct or indirect adverse effects of levocetirizine on the developing fetus (including in the postnatal period), the course of pregnancy and childbirth also did not change.

Use for liver dysfunction

Patients with hepatic insufficiency do not require dose adjustment.

Use for renal impairment

Contraindicated in end-stage renal failure (creatinine clearance less than 10 ml/min).

For patients with chronic renal failure, with a CC of 49-30 ml/min, the dose is reduced by 2 times (1 tablet every other day), with a CC of 29-10 ml/min, the dose is reduced by 3 times (1 tablet, 1 time every 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 of age: daily dose 5 mg (1 tablet 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 value of CC.

Special instructions

The patient should be careful when taking the drug and drinking alcohol at the same time.

Impact on the ability to drive vehicles and operate machinery

1 tablet of the drug contains 5 mg Levocetirizine dihydrochloride .

1 ml of liquid medicine contains 5 mg of active substance.

Excipients included in Xizal:

sodium acetate ;
sodium saccharinate;
propylene glycol;
85%;
methyl parahydroxybenzoate;
propyl parahydroxybenzoate;
acetic acid;
purified water.

The film coating of the tablets consists of macrogol 400 and opdray Y-1-7000.

Release form

Xyzal is available in two dosage forms:

In the form 5 mg tablets, covered with a film shell. Xyzal tablets are available in 7, 10, 14 and 20 pieces in one package.
In the form drops for oral administration. Xyzal drops are available in 10 and 20 ml bottles. Dark colored bottles with a dropper.

Pharmacological action

Xyzal is a drug with a pronounced antiallergic and antihistamine effect. Blocking effect on histamine receptors in the human body levocetirizine twice as high as .

The drug has an effect on antihistamine phase of the allergic reaction .

The effect of the drug on the patient’s body is that it prevents the development of allergies, when an allergic reaction occurs, it facilitates its course, has antiexudative And antipruritic effect .

Active component of the drug levocetirizine :

reduces the permeability of vascular walls;
slows down eosinophils ;
inhibits the activity of inflammatory mediators and cytokines .

Levocetirizine has virtually no effect on serotonin and cholinergic receptors.

There is practically no sedative effect when taking Xyzal.

Pharmacodynamics and pharmacokinetics

When taken orally, the medicine is well absorbed from the gastrointestinal tract. In this case, minor problems may occur. When taking the medicine with food, the level of bioavailability and rate of absorption do not change.

The maximum concentration of levocetirizine in the blood plasma is achieved 1 hour after taking the drug. Clinical effect persists for more than 24 hours. The half-life of the drug in adult patients ranges from 6 to 10 hours, in children it is slightly shorter.
About 13 percent of the drug leaves the body through the intestines, approximately 85% is excreted by the kidneys. In patients suffering from renal failure, the half-life of the drug is prolonged. In patients undergoing hemodialysis, no more than 10% of the active substance is excreted.

Main component of the drug levocetirizine tends to pass into breast milk.

Indications for use

The main indications for the use of Xizal are:

the patient has itching;
sneezing;
lacrimation ;
nasal congestion;
inflammation of the mucous membranes of the nose and eyes (conjunctiva);
seasonal or chronic And ;
rhinorrhea ;
in chronic form ;
allergic dermatoses .

Contraindications

The drug is contraindicated in patients with hypersensitivity to, as well as to other components that make up the drug. Xyzal is not prescribed to people with severe symptoms.

Special instructions

Instructions for use of Xizal (Method and dosage)

Dosage of drops:

for children from 2 to 6 years old, 5 drops are prescribed 2 times a day;
Children over 6 years of age and adults take up to 20 drops per day, in one dose.

Xizal tablets instructions for use for adults and children over 6 years of age:

take on an empty stomach or with meals;
swallow without chewing;
drink with water.

Dosage – 1 tablet 1 time per day.

For children

Xyzal in tablets, film-coated, is contraindicated in children under 6 years of age.

Overdose

In case of an overdose of the drug, the following symptoms may be observed:

in adults - ;
in children - increased irritability , excitability , turning into drowsiness.

If an overdose of the drug occurs, it is recommended that the patient first perform gastric lavage or induce artificial vomiting. Next, you need to carry out supportive and symptomatic therapy. It is indicated for treatment in case of drug overdose.

There is no specific antidote for drug poisoning.

Interaction

When using Xyzal together with theophylline half-life may increase levocetirizine from the body.

It is not recommended to drink alcohol or drugs that depress the central nervous system during treatment with Xyzal, since an uncontrolled increase in their effect on the human body is possible.

Terms of sale

The drug Xyzal is available in pharmacies with a prescription.

Storage conditions

AND pills, And drops The drug Xyzal should be stored in a dark place, inaccessible to children, where the temperature is maintained no higher than 25 degrees C.

Best before date

Xizal tablets stored in the shell for no more than 3 years from the date of manufacture.

Ksizal drops should be stored no longer than 2 years from the date of manufacture indicated on the packaging. An opened bottle of drops cannot be stored for more than 3 months.

Xyzal analogues (if individual intolerance)

Level 4 ATX code matches:

Instead of Xizal, its analogues can be used for the same indications: , Eltset, Cesera, .

Eisica Pharmaceuticals S.r.l. YUSB Pharma S.A. USB Pharma S.p.A. YUSB Farshim S.A. YUSB Farshim S.A./ Eisika Pharmaceuticals S.r.l.

Country of origin

Italy Switzerland Switzerland/Italy

Product group

Antiallergic drugs

Histamine H1 receptor blocker. Antiallergic drug

Release forms

10 - blisters (1) - cardboard packs. 10 ml - dark glass bottles with a dropper (1) - cardboard packs. 10 ml - dark glass bottles with a dropper (1) - cardboard packs. 20 ml - dark glass bottles with a dropper (1) - cardboard packs. 7 - blisters (1) - cardboard packs. 7 - blisters (1) - cardboard packs. 7 - blisters (2) - cardboard packs. 7 - blisters (2) - cardboard packs.

Description of the dosage form

Drops for oral administration in the form of an almost colorless, slightly opalescent solution. Drops for oral administration in the form of an almost colorless, slightly opalescent solution. Film-coated tablets

Pharmacological action

The histamine H1 receptor blocker, an enantiomer of cetirizine, belongs to the group of competitive histamine antagonists. The affinity for histamine H1 receptors of 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. Prevents the development and facilitates the course of allergic reactions, has an antiexudative, antipruritic effect, and has virtually no anticholinergic and antiserotonin effects. In therapeutic doses it has virtually no sedative effect.

Pharmacokinetics

Absorption 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. Food intake does not affect the degree of absorption, although its rate decreases. After a single oral administration in 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/ml - 308 ng/ml. Bioavailability is 100%. Css distribution is achieved after 2 days. The binding of levocetirizine to plasma proteins is 90%. Vd 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 cytochrome P450 isoenzymes) to form a pharmacologically inactive metabolite. Due to its low metabolic rate and lack of metabolic potential, interactions between levocetirizine and other drugs are unlikely. Elimination in adults is 7.9±1.9 hours, 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 cases In patients with renal failure (creatinine clearance less than 40 ml/min), the clearance of levocetirizine decreases and T1/2 increases (in patients on hemodialysis, the total clearance decreases by 80%), which requires a corresponding change in the dosage regimen. Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis procedure. In young children, T1/2 is shortened.

Special conditions

The patient should be careful when taking the drug and drinking alcohol at the same time. Effect on the ability to drive vehicles and operate machinery. An objective assessment of the ability to drive vehicles and operate machinery did not reliably reveal any adverse events when the drug was prescribed at the recommended dose. However, during the treatment period, it is advisable to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Compound

1 ml of levocetirizine dihydrochloride 5 mg Excipients: sodium acetate, acetic acid, propylene glycol, glycerol 85%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharinate, purified water. Levocetirizine dihydrochloride 5 mg Excipients: sodium acetate, acetic acid, propylene glycol, glycerol 85%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharinate, purified water. Levocetirizine dihydrochloride 5 mg Excipients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. Shell composition: opadry Y-1-7000 (hypromellose, titanium dioxide (E171), macrogol 400).

Xizal indications for use

Symptomatic treatment of allergic diseases and conditions: - year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis (itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia, nasal congestion); - hay fever (hay fever); - urticaria (including chronic idiopathic urticaria); - Quincke's edema; - other allergic dermatoses, accompanied by itching and rashes.

Xizal contraindications

- end-stage renal failure (creatinine clearance less than 10 ml/min); - children under 6 years of age (for tablets); - children under 2 years of age (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. The drug should be used with caution in chronic renal failure (correction of the dosage regimen is required), in elderly patients (with an age-related decrease in glomerular filtration).

Xyzal dosage

5 mg 5 mg/ml

Xyzal side effects

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

Drug interactions

The interaction of levocetirizine with other drugs has not been studied. When studying the drug interactions of cetirizine racemate with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam, no clinically significant adverse interactions were identified. When used simultaneously 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 simultaneous use of levocetirizine with ethanol or drugs that have a depressant effect on the central nervous system, their effect on the central nervous system may be enhanced, although cetirizine racemate has been proven to potentiate the effect of alcohol.

Overdose

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

Storage conditions

keep away from children

Information provided