Zyrtec 10 mg/ml drops for oral administration, 20 ml dropper bottle

How to take Zyrtec drops

The optimal dose of the drug depends on the age category of the patient:

• from 6 years of age and adults can be given initially 10 drops, and depending on the condition, can be gradually increased to 20 drops;
• at the age of 2-6 years, 5 drops are prescribed 2 times a day, or you can combine them in one dose;
• from 1 to 2 years, no more than 5 drops are prescribed 1-2 times a day;
• from 6 to 12 months you can give 5 drops 1 time per day.

If the medicine is given to children, then the dosage may also be affected not only by age, but also by body weight.

For people with kidney disease, the dosage is determined individually.

Zyrtec 10 mg/ml drops for oral administration, 20 ml dropper bottle

Registration Certificate Holder

UCB FARCHIM (Switzerland)

Dosage form

Medicine - Zyrtec®

Description

Drops for oral administration

colorless, transparent, with the smell of acetic acid.

1 ml

Cetirizine dihydrochloride 10 mg

Excipients

: glycerol, propylene glycol, sodium saccharinate, methylparabenzene, propylparabenzene, sodium acetate, glacial acetic acid, purified water.

10 ml - dark glass dropper bottle (1) - cardboard packs. 20 ml - dark glass dropper bottle (1) - cardboard packs.

Indications

• treatment of symptoms of year-round and seasonal allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia;
• hay fever (hay fever);
• urticaria (including chronic idiopathic urticaria);
• Quincke's edema;
• other allergic dermatoses (including atopic dermatitis), accompanied by itching and rashes.

Contraindications for use

• end-stage renal failure (CC < 10 ml/min);
• pregnancy;
• lactation period (breastfeeding);
• hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
• children under 6 years of age (for tablets);
• children up to 6 months (for drops);
• hypersensitivity to the components of the drug;
• hypersensitivity to hydroxyzine.

Carefully

The drug should be prescribed for chronic renal failure (correction of the dosage regimen is required), for chronic liver diseases, and for elderly patients (due to a possible decrease in glomerular filtration).

pharmachologic effect

Antiallergic drug. Histamine H1 receptor blocker, competitive histamine antagonist, hydroxyzine metabolite. Prevents the development and facilitates the course of allergic reactions, has antipruritic and antiexudative effects.

Affects the early histamine-dependent stage of allergic reactions, limits the release of inflammatory mediators at the late stage of the allergic reaction, reduces the migration of eosinophils, neutrophils and basophils, stabilizes mast cell membranes. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reactions to the introduction of histamine, specific allergens, as well as to cooling (with “cold” urticaria). Reduces histamine-induced bronchoconstriction in mild bronchial asthma.

It has virtually no anticholinergic and antiserotonin effects. In therapeutic doses it has virtually no sedative effect.

After a single dose of cetirizine at a dose of 10 mg, the onset of effect is observed after 20 minutes (in 50% of patients) and after 60 minutes (in 95% of patients), the effect lasts more than 24 hours. During a course of treatment, tolerance to the antihistamine effect of cetirizine does not develop. After stopping treatment, the effect lasts up to 3 days.

Drug interactions

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

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

When administered simultaneously with macrolides and ketoconazole, no changes were noted on the ECG.

When using the drug in therapeutic doses, no data on interaction with alcohol (at a blood alcohol concentration of 0.5 g/l) were obtained. However, the patient should refrain from drinking alcohol during drug therapy to avoid depression of the central nervous system.

Dosage regimen

The drug is prescribed orally.

Adults and children over 6 years old

prescribed at a dose of 10 mg (1 tablet or 20 drops)/day. Adults - 10 mg 1 time/day; children - 5 mg 2 times / day or 10 mg 1 time / day. Sometimes an initial dose of 5 mg may be sufficient to achieve a therapeutic effect.

Children aged 2 to 6 years

prescribed 2.5 mg (5 drops) 2 times/day or 5 mg (10 drops) 1 time/day.

Children aged 1 to 2 years

Prescribe 2.5 mg (5 drops) up to 2 times a day.

Children aged 6 months to 12 months

prescribed 2.5 mg (5 drops) 1 time/day.

For renal failure

and in elderly patients, the dose of the drug should be adjusted depending on the value of CC.

CC can be calculated based on serum creatinine concentration using the following formula:

For men: CC (ml/min) = [140 - age (years)] x body weight (kg)/72 x serum creatinine (mg/dl);

CC for women can be calculated by multiplying the resulting value by a coefficient of 0.85.

Adult patients with renal and hepatic insufficiency

The dose is set according to the following table.
Renal failure KK (ml/min) Dosage regimen
Norm≥8010 mg/day Mild50-7910 mg/dayModerate30-495 mg/daySevere<305 mg every other dayTerminal stage - patients on dialysis<10 The drug is contraindicated

Patients with impaired liver function only

no dosage adjustment is required.

Overdose

Symptoms:

When taking the drug once in a dose of more than 50 mg, confusion, diarrhea, dizziness, increased fatigue, headache, malaise, mydriasis, itching, weakness, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention are possible.

Treatment:

Immediately after taking the drug, you should perform gastric lavage or artificially induce vomiting. It is recommended to prescribe activated carbon and carry out symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective.

Side effect

From the hematopoietic system:

thrombocytopenia.

From the nervous system:

drowsiness, dizziness, headache, aggression, agitation, confusion, depression, hallucinations, insomnia, tic, convulsions, dyskinesia, dystonia, paresthesia, fainting, tremor.

From the side of the organ of vision:

disturbance of accommodation, blurred vision, nystagmus.

From the cardiovascular system:

tachycardia.

From the respiratory system:

rhinitis, pharyngitis.

From the digestive system:

dry mouth, nausea, abdominal pain, diarrhea, liver dysfunction (increased levels of transaminases, alkaline phosphatase, GGT, bilirubin).

From the urinary system:

urination disorder, enuresis.

Allergic reactions:

itching, rash, urticaria, angioedema, increased sensitivity, up to the development of anaphylactic shock.

From the side of metabolism:

increase in body weight.
Other:
fatigue, asthenia, malaise, swelling.

Side effects occur in very rare cases.

special instructions

Children aged 6 months to 6 years

Zyrtec® is prescribed in the dosage form of drops for oral administration at 10 mg/ml.
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 reactions when taking the drug at the recommended dose. But, nevertheless, during the period of taking the drug, it is advisable to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage conditions

Tablets should be stored in their original packaging at a temperature not exceeding 30°C. Drops for oral administration should be stored at a temperature not exceeding 25°C.

Best before date

The shelf life of the drug is 5 years.

The drug should be stored out of the reach of children.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use for renal impairment

Restrictions for impaired renal function - With caution.

Carefully _

the drug should be prescribed for chronic renal failure (moderate or severe), as well as for elderly patients (due to a possible decrease in glomerular filtration).

In case of renal failure, the dose is reduced depending on the QC.

Contraindicated in end-stage renal failure (CC < 10 ml/min).

Use in elderly patients

Restrictions for elderly patients - Use with caution.

Carefully _

the drug should be prescribed to elderly patients (due to a possible decrease in glomerular filtration).

Use in children

Restrictions for children - Contraindicated. Contraindicated in children under 6 years of age (for tablets), in children under 6 months of age (for drops).

Terms of sale

The drug is approved for use as a means of OTC.

Contacts for inquiries

YUSB PHARMA S.A. (Belgium)

YUSB Pharma LLC

105082 Moscow, Perevedenovsky per. 13, p. 21 Tel.; Fax

Contraindications

You should stop taking the drug in the following cases:

• increased susceptibility to any component of the drug;
• kidney disease;
• period of bearing a child;
• lactation period;
• children under 6 months.

Can be used with caution when:

• epilepsy;
• elderly people;
• chronic renal failure;
• tendency to urinary retention.

The medicine in tablet form is also contraindicated in case of galactose allergy and in children under 6 years of age.

Zyrtec 10 mg 20 pcs. film-coated tablets

pharmachologic effect

Antiallergic H1-histamine receptor blocker.

Composition and release form Zirtec 10 mg 20 pcs. film-coated tablets

Tablets - 1 tablet:

• Active ingredient: cetirizine dihydrochloride 10 mg;
• Excipients: microcrystalline cellulose 37.00 mg, lactose monohydrate 66.40 mg, colloidal silicon dioxide 0.60 mg, magnesium stearate 1.25 mg, opadray® Y-1-7000 3.45 mg (hypromellose (E 464) 2.156 mg, titanium dioxide (E 171) 1.078 mg, macrogol 400 0.216 mg).

7 or 10 tablets per blister pack (blister) [PVC / aluminum foil].

1 blister (7 or 10 tablets each), 2 or 3 blisters (10 tablets each) along with instructions for use are placed in a cardboard box.

Description of the dosage form

White oblong film-coated tablets with biconvex surfaces, with a one-sided score and an engraving “Y” on both sides of the score.

Directions for use and doses

Children from 6 to 12 months: 2.5 mg (5 drops) 1 time per day.

Children from 1 year to 2 years: 2.5 mg (5 drops) up to 2 times a day.

Children from 2 to 6 years: 2.5 mg (5 drops) 2 times a day or 5 mg (10 drops) 1 time a day.

Adults and children over 6 years of age: daily dose - 10 mg (1 tablet or 20 drops).

Adults - 10 mg once a day, children - 5 mg 2 times a day or 10 mg once. Sometimes an initial dose of 5 mg may be sufficient to achieve a therapeutic effect.

For patients with renal failure, the dose is reduced depending on creatinine clearance: with creatinine clearance of 30–49 ml/min - 5 mg once a day, with 10–29 ml/min - 5 mg every other day.

Pharmacodynamics

A competitive histamine antagonist, a metabolite of hydroxyzine, blocks H1 histamine receptors. Prevents the development and facilitates the course of allergic reactions, has antipruritic and antiexudative effects. Affects the “early” histamine-dependent stage of allergic reactions, limits the release of inflammatory mediators at the “late” stage of the allergic reaction, reduces the migration of eosinophils, neutrophils and basophils, stabilizes mast cell membranes. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reactions to the introduction of histamine, specific allergens, as well as to cooling (with cold urticaria). Reduces histamine-induced bronchoconstriction in mild bronchial asthma. It has virtually no anticholinergic and antiserotonin effects.

In therapeutic doses it has virtually no sedative effect. The onset of effect after a single dose of 10 mg of cetirizine is after 20 minutes (in 50% of patients) and after 60 minutes (in 95% of patients), the effect lasts more than 24 hours. During a course of treatment, tolerance to the antihistamine effect of cetirizine does not develop.

After stopping treatment, the effect lasts up to 3 days.

Pharmacokinetics

Rapidly absorbed when taken orally. Cmax in serum is achieved 1 hour after oral administration. Food does not affect the completeness of absorption, but prolongs the absorption process by 1 hour. 93% of cetirizine is protein bound.

The pharmacokinetic parameters of cetirizine have a linear dependence on the dose.

Volume of distribution - 0.5 l/kg. In small quantities, it is metabolized in the liver by O-desalcation to form a pharmacologically inactive metabolite (unlike other H1-histamine receptor blockers, which are metabolized in the liver with the participation of the cytochrome P450 system). Does not accumulate. 2/3 of the drug is excreted unchanged by the kidneys and about 10% in the feces. Systemic Cl - 53 ml/min. T1/2 is 7-10 hours (in children 6-12 years old - 6 hours, 2-6 years old - 5 hours, from 6 months to 2 years - 3.1 hours). In elderly patients, T1/2 increases by 50%, systemic Cl - by 40%.

Practically not removed by hemodialysis.

Passes into breast milk.

Indications for use Zyrtec 10 mg 20 pcs. film-coated tablets

For adults and children from 6 months. and older: treatment of symptoms of year-round and seasonal allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia, hay fever (hay fever); urticaria, including chronic idiopathic urticaria, Quincke's edema; other allergic dermatoses (including atopic dermatitis), accompanied by itching and rashes.

Contraindications

Hypersensitivity to any of the components of the drug or to hydroxyzine.

The drug is not intended for children under 6 months.

Application of Zyrtec 10 mg 20 pcs. film-coated tablets during pregnancy and breastfeeding

Not used during pregnancy and lactation.

special instructions

Due to the potential depressant effect on the central nervous system, caution should be exercised when prescribing Zyrtec® to children aged 6 months to 1 year who have the following risk factors for sudden infant death syndrome, such as (but not limited to):

• sleep apnea syndrome or sudden infant death syndrome in a sibling;
• maternal drug abuse or smoking during pregnancy;
• young maternal age (19 years and younger);
• Smoking abuse by a nanny caring for a child (one pack of cigarettes a day or more);
• children who regularly fall asleep face down and are not placed on their back;
• premature (gestational age less than 37 weeks) or low birth weight (below the 10th percentile of gestational age) children;
• when taking drugs together that have a depressant effect on the central nervous system.

The drug contains excipients methylparabenzene and propylparabenzene, which can cause allergic reactions, including delayed ones.

In patients with spinal cord injury, prostatic hyperplasia, or other predisposing factors to urinary retention, caution is required as cetirizine may increase the risk of urinary retention.

In patients with renal failure, the dosage regimen of the drug should be adjusted.

Due to a possible decrease in renal function in elderly patients, the dosage regimen of the drug should be adjusted.

Caution is recommended when using cetirizine concomitantly with alcohol, as cetirizine may cause increased drowsiness.

Caution should be observed in patients with epilepsy and increased convulsive readiness.

Before prescribing allergy tests, a three-day “washing out” period is recommended due to the fact that H1-histamine receptor blockers inhibit the development of skin allergic reactions.

Read the instructions carefully before you start using the drug. Save the instructions, you may need them again. If you have any questions, consult your doctor. The medicine you are using is intended for you personally and should not be given to others as it may cause harm to them even if they have the same symptoms as you.

Impact on the ability to drive vehicles and operate machinery

Cetirizine can lead to increased drowsiness, therefore, the drug Zyrtec® may affect the ability to drive vehicles and machines.

Overdose

Symptoms (when taking the drug once in a dose of over 50 mg): drowsiness, anxiety, increased irritability, urinary retention, dry mouth, constipation, mydriasis, tachycardia. Treatment: stop taking the drug, empty your stomach, take activated charcoal, consult a doctor immediately.

Side effects of Zirtec 10 mg 20 pcs. film-coated tablets

Drowsiness, headache, dry mouth, rarely - headache, dizziness, migraine, diarrhea, allergic reactions: angioedema, itching, rash, urticaria.

Drug interactions

No pharmacokinetic interaction or clinical effect was observed when co-administered with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, glipizide. When co-administered with theophylline at a dose of 400 mg 1 time per day, a decrease in creatinine Cl by 16% was noted.

When co-administered with macrolides and ketoconazole, no changes were noted on the ECG. When used in therapeutic doses, no data on interaction with alcohol have been obtained (at a blood alcohol concentration of 0.5 g/l). However, it is best to avoid drinking alcohol during treatment with cetirizine.

Negative manifestations and overdose

The most common adverse reactions are:

• headache;
• fatigue;
• dizziness;
• fast fatiguability;
• gagging;
• feeling of dry mouth.

No less common adverse reactions include:

• stomach upset;
• excited state;
• allergies in the form of skin rash;

• abnormal heartbeat;
• weight gain;
• aggressive or depressive behavior;
• disturbed sleep.

The following reactions occur much less frequently:

• taste disturbance;
• tremor;
• fainting;
• deterioration of visual acuity.

An overdose may occur, which is characterized by the above negative reactions in a more pronounced form. With such signs, it is necessary to induce vomiting or rinse the stomach. It is also worth starting treatment based on symptoms

Adverse reactions and overdose

Common negative side effects from taking the drug include:

• headache;
• lethargy;
• dizziness;
• excessive fatigue;
• vomiting, nausea;
• feeling of dryness in the mouth.

Slightly less common:

• stomach upset;
• nervous state;
• allergic skin reaction.

• peripheral edema;
• hives;
• abnormal heart rhythm;
• weight gain;
• aggressive or depressive state;
• disturbed sleep;
• convulsions.

It is extremely rare:

• taste disturbance;
• tremor;
• fainting;
• blurred vision.

There may be cases of overdose, manifested by the adverse reactions described above. In this condition, you need to induce vomiting or rinse the stomach. You can also start symptomatic therapy.

Can I take Zyrtec during pregnancy?

Medical research on the effect of the drug on the body during pregnancy was carried out exclusively on animals. Their results deny the possibility of a negative impact on the developing fetus and the condition of the expectant mother. Due to the lack of necessary data, the medication can be used only after examination by a doctor.

The active ingredient may pass into breast milk. Therefore, if there is a need to take the drug, you should temporarily switch to artificial feeding.

Zirtec drops for internal use 1% fl-cap 10ml

Compound

Active substance: cetirizine dihydrochloride - 10 mg. Excipients: glycerol, propylene glycol, sodium saccharinate, methylparabenzene, propylparabenzene, sodium acetate, glacial acetic acid, purified water.

Pharmacokinetics

The pharmacokinetic parameters of cetirizine change linearly.

Suction

After oral administration, the drug is quickly and completely absorbed from the gastrointestinal tract. In adults, after a single dose of the drug in a therapeutic dose, Cmax in plasma is reached after 1±0.5 hours and is 300 ng/ml. Taking the drug with food does not affect the amount of absorption.

Distribution

Cetirizine binds to plasma proteins by 93±0.3%. Vd - 0.5 l/kg.

When taking the drug at a dose of 10 mg for 10 days, no accumulation of cetirizine is observed.

Metabolism

In small quantities, it is metabolized in the liver by O-dealkylation to form a pharmacologically inactive metabolite (unlike other histamine H1 receptor blockers, which are metabolized in the liver with the participation of isoenzymes of the cytochrome P450 system).

Removal

T1/2 in adults is approximately 10 hours. Approximately 2/3 of the dose taken is excreted unchanged by the kidneys.

Pharmacokinetics in special clinical situations

T1/2 in children aged 6-12 years - 6 hours; for children 2-6 years old - 5 hours; for children aged 6 months to 2 years - 3.1 hours.

In elderly patients and patients with chronic liver diseases, with a single dose of 10 mg, T1/2 increases by approximately 50%, and systemic clearance decreases by 40%.

In patients with mild renal failure (creatinine clearance > 40 ml/min), pharmacokinetic parameters are similar to those in patients with normal renal function.

In patients with moderate renal failure and in patients on hemodialysis (creatinine clearance <7 ml/min), when taking the drug orally at a dose of 10 mg, T1/2 increases 3 times, and total clearance decreases by 70% compared to patients with normal renal function, which requires a corresponding change in the dosage regimen.

Cetirizine is practically not removed from the body during hemodialysis.

Indications for use

The use of the drug is indicated in adults and children from 6 months to alleviate:

• nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis: itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;
• symptoms of chronic idiopathic urticaria.

Use in children from 6 to 12 months is possible only as prescribed by a doctor and under strict medical supervision!

Contraindications

• hypersensitivity to cetirizine, hydroxyzine or other piperazine derivatives, as well as any other component of the drug;
• end-stage renal failure (creatinine clearance <10 ml/min);
• children up to 6 months of age (due to limited data on the effectiveness and safety of the use of the drug Zyrtec®).

Carefully:

• chronic renal failure (with creatinine clearance > 10 ml per minute, dosage adjustment is required);
• elderly patients (with an age-related decrease in glomerular filtration);
• epilepsy and patients with increased convulsive readiness;
• patients with predisposing factors to urinary retention (see section “Special instructions”);
• children under 1 year of age;
• when used simultaneously with alcohol (see section “Interaction with other drugs”);
• breastfeeding period;
• pregnancy.

Directions for use and doses

The drug is prescribed orally.

Adults and children over 6 years of age are prescribed at a dose of 10 mg (1 tablet or 20 drops)/day. Adults - 10 mg 1 time/day; children - 5 mg 2 times / day or 10 mg 1 time / day. Sometimes an initial dose of 5 mg may be sufficient to achieve a therapeutic effect.

Children aged 2 to 6 years are prescribed 2.5 mg (5 drops) 2 times a day or 5 mg (10 drops) 1 time a day.

Children aged 1 to 2 years are prescribed 2.5 mg (5 drops) up to 2 times a day.

Children aged 6 months to 12 months are prescribed 2.5 mg (5 drops) 1 time/day.

In case of renal failure and in elderly patients, the dose of the drug should be adjusted depending on the value of CC.

CC can be calculated based on serum creatinine concentration using the following formula:

For men: CC (ml/min) = [140 - age (years)] x body weight (kg)/72 x serum creatinine (mg/dl);

CC for women can be calculated by multiplying the resulting value by a coefficient of 0.85.

For adult patients with renal and hepatic insufficiency, the dose is set according to the following table.

In patients with impaired liver function only, no dosage adjustment is required.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25°C.

Best before date

5 years.
After opening 3 months. Do not take after expiration date.

special instructions

Due to the potential depressant effect on the central nervous system, caution should be exercised when prescribing Zyrtec® to children aged 6 months to 1 year who have the following risk factors for sudden infant death syndrome, such as (but not limited to):

• sleep apnea syndrome or sudden infant death syndrome in a sibling;
• maternal drug abuse or smoking during pregnancy;
• young maternal age (19 years and younger);
• Smoking abuse by a nanny caring for a child (one pack of cigarettes a day or more);
• children who regularly fall asleep face down and are not placed on their back;
• premature (gestational age less than 37 weeks) or low birth weight (below the 10th percentile of gestational age) children;
• when taking drugs together that have a depressant effect on the central nervous system.

The drug contains excipients methylparabenzene and propylparabenzene, which can cause allergic reactions, including delayed ones.

In patients with spinal cord injury, prostatic hyperplasia, or other predisposing factors to urinary retention, caution is required as cetirizine may increase the risk of urinary retention.

In patients with renal failure, the dosage regimen of the drug should be adjusted (see section "Dosage and Administration").

Due to a possible decrease in renal function in elderly patients, the dosage regimen of the drug should be adjusted (see section "Dosage and Administration").

Caution is recommended when using cetirizine concomitantly with alcohol, as cetirizine may cause increased drowsiness.

Caution should be observed in patients with epilepsy and increased convulsive readiness.

Before prescribing allergy tests, a three-day “cold” urticaria is recommended). Reduces histamine-induced bronchoconstriction in mild bronchial asthma.

It has virtually no anticholinergic and antiserotonin effects. In therapeutic doses it has virtually no sedative effect.

After a single dose of cetirizine at a dose of 10 mg, the onset of effect is observed after 20 minutes (in 50% of patients) and after 60 minutes (in 95% of patients), the effect lasts more than 24 hours. During a course of treatment, tolerance to the antihistamine effect of cetirizine does not develop. After stopping treatment, the effect lasts up to 3 days.

Side effects

From the hematopoietic system: thrombocytopenia.

From the nervous system: drowsiness, dizziness, headache, aggression, agitation, confusion, depression, hallucinations, insomnia, tic, convulsions, dyskinesia, dystonia, paresthesia, fainting, tremor.

From the organ of vision: impaired accommodation, blurred vision, nystagmus.

From the cardiovascular system: tachycardia.

From the respiratory system: rhinitis, pharyngitis.

From the digestive system: dry mouth, nausea, abdominal pain, diarrhea, impaired liver function (increased levels of transaminases, alkaline phosphatase, GGT, bilirubin).

From the urinary system: urinary disorder, enuresis.

Allergic reactions: itching, rash, urticaria, angioedema, increased sensitivity, up to the development of anaphylactic shock.

Metabolism: weight gain.

Other: fatigue, asthenia, malaise, swelling.

Side effects occur in very rare cases.

Use during pregnancy and breastfeeding

Pregnancy

Data on the use of cetirizine during pregnancy are limited (300-1000 pregnancy outcomes). However, no cases of developmental defects, embryonic and neonatal toxicity with a clear cause-and-effect relationship were identified.

Experimental studies in animals have not revealed any direct or indirect adverse effects of cetirizine on the developing fetus (including in the postnatal period), pregnancy and postnatal development.

During pregnancy, cetirizine can be prescribed after consultation with a doctor, if the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Cetirizine should not be used during breastfeeding, because Cetirizine is excreted in breast milk. Cetirizine is excreted into breast milk in an amount of 25-90% of the concentration in the blood plasma, depending on the time of sampling after taking the drug.

Adverse reactions associated with cetirizine may occur in infants.

During breastfeeding, it is used after consultation with a doctor, if the expected benefit to the mother outweighs the potential risk to the child.

Fertility

Available data on the effects on human fertility are limited, but no adverse effects on fertility have been identified in animal studies.

Before using the drug, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor.

Interaction

Concomitant use with azithromycin, cimetidine, erythromycin, ketoconazole or pseudoephedrine does not affect the pharmacokinetic parameters of cetirizine. No pharmacokinetic interactions were observed. According to in vitro tests, cetirizine does not interfere with the protein binding effect of warfarin.

Concomitant use of azithromycin, erythromycin, ketoconazole, theophylline and pseudoephedrine did not reveal significant changes in clinical laboratory parameters, vital signs and ECG.

In a study of co-administration of theophylline (400 mg per day) and cetirizine (20 mg per day), a small but statistically significant increase in 24-hour AUC (area under the curve) was found by 19% for cetirizine and 11% for theophylline. In addition, maximum plasma levels increased to 7.7% and 6.4%, respectively, for cetirizine and theophylline. At the same time, the clearance of cetirizine decreased by -16%, and by -10% in the case of theophylline, when cetirizine was taken by patients who had previously received treatment with theophylline. However, pretreatment with cetirizine did not significantly affect the pharmacokinetic parameters of theophylline.

After a single dose of cetirizine 10 mg, the effect of alcohol (0.8%o) was not significantly enhanced; a statistically significant interaction with 5 mg diazepam was demonstrated in one of 16 psychometric tests.

Concomitant administration of 10 mg cetirizine per day with glipizide resulted in a slight decrease in glucose levels. This effect is not clinically significant. However, it is recommended to take it separately - glipizide in the morning and cetirizine in the evening.

The degree of absorption of cetirizine is not reduced by simultaneous ingestion of food, although absorption slows down by 1 hour.

In a multiple-dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), cetirizine exposure was increased by approximately 40%, while ritonavir exposure was slightly changed (-11%) due to concomitant use of cetirizine. .

If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Zyrtec®.

Overdose

Symptoms observed after apparent overdose of drugs affected the central nervous system or were associated with a possible anticholinergic effect. Symptoms that occurred after taking at least five times the recommended daily dose included the following: confusion, diarrhea, fatigue, headache, malaise, mydriasis, itching, restlessness, sedation, somnolence, stupor, tachycardia, tremor, urinary retention.

Treatment:

There is no specific antidote.

In case of overdose, symptomatic or supportive treatment is recommended. Gastric lavage and/or activated charcoal may be effective if the overdose has occurred recently. Cetirizine is partially eliminated by dialysis.

Impact on the ability to drive vehicles and operate machinery

Cetirizine can lead to increased drowsiness, therefore, the drug Zyrtec® may affect the ability to drive vehicles and machines.

special instructions

The medicine can be stored for 5 years from the date of its release. It should be stored in a dry and dark place away from children, at a temperature of +8...+15 degrees.

It should not be taken in parallel with alcohol, as alcohol-containing drinks increase the risk of negative effects on the central nervous system.

If the patient has serious spinal cord injuries, then before taking it you should consult a specialist, since the use of the medicine may worsen the situation.

In the first couple of hours after using the medication, you should not drive a car or operate other dangerous mechanisms.

Zyrtec drops for oral administration 10 mg/ml 20 ml 1 piece

In patients with spinal cord injury, prostatic hyperplasia, as well as in the presence of other factors predisposing to urinary retention, caution is required, because Cetirizine may increase the risk of urinary retention.

It is recommended to be careful when using cetirizine concomitantly with alcohol, although at therapeutic doses no clinically significant interaction with ethanol was observed (at a blood ethanol concentration of 0.5 g/l).

Caution should be observed in patients with epilepsy and increased convulsive readiness.

Before prescribing allergy tests, a three-day “washing out” period is recommended due to the fact that histamine H1 receptor blockers inhibit the development of skin allergic reactions.

Use in pediatrics

Due to the potential depressant effect on the central nervous system, caution should be exercised when prescribing Zodak to children under 1 year of age who have the following risk factors for sudden infant death syndrome, such as (but not limited to):

sleep apnea syndrome or sudden infant death syndrome in a brother or sister,

maternal drug abuse or smoking during pregnancy,

young mother's age (19 years and younger),

Smoking abuse by a nanny caring for a child (1 pack of cigarettes per day or more),

Children who regularly fall asleep face down and are not placed on their back

premature (gestational age less than 37 weeks) or low birth weight (below the 10th percentile of gestational age) children,

when taking drugs together that have a depressant effect on the central nervous system.

The drug contains excipients methylparabenzene and propylparabenzene, which can cause allergic reactions, incl. slow type.

Impact on the ability to drive vehicles and machinery

An objective assessment of the ability to drive vehicles and operate machinery did not reliably reveal any adverse events when using the drug Zodak in recommended doses. However, for patients with symptoms of drowsiness while taking the drug during the treatment period, it is advisable to refrain from driving a car, engaging in potentially hazardous activities, or operating machinery that requires increased concentration and speed of psychomotor reactions.