Zyrtec drops for oral administration 10mg / ml, 10ml

• Treating symptoms of perennial and seasonal allergic rhinitis and allergic conjunctivitis (such as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia);

• Hay fever (hay fever);

• Hives;

• Allergic dermatoses, incl. atopic dermatitis, accompanied by itching and rashes.

Inside.

Children over 6 years old and adults: the initial dose is 5 mg (1/2 tab. Or 10 drops) once a day, if necessary, it can be increased to 10 mg (1 tab. Or 20 drops) once a day. Sometimes an initial dose of 5 mg (1/2 table. Or 10 drops) may be sufficient to achieve a therapeutic effect. The daily dose is 10 mg (1 tab. Or 20 drops).

Children from 6 to 12 months: 2.5 mg (5 drops) once a day.

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

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

For patients with renal insufficiency, the dose is reduced depending on creatinine clearance: with Cl creatinine 30Ц49 ml / min - 5 mg once a day, with 10Ц29 ml / min - 5 mg every other day.

Since ZyrtecЃ is excreted from the body by the kidneys, when prescribing the drug to patients with renal insufficiency and elderly patients, the dose should be adjusted depending on the creatinine clearance value.

For children with renal insufficiency, the dose is adjusted taking into account creatinine clearance and body weight.

Patients with impaired liver function alone do not need to adjust the dosage regimen.

Drops for oral administration are 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.

For all dosage forms

• hypersensitivity to cetirizine, hydroxyzine or piperazine derivatives, as well as other components of the drug;

• end-stage renal disease (Cl creatinine <10 ml / min)

• pregnancy;

• period of breastfeeding.

With caution: chronic renal failure (with Cl creatinine> 10 ml / min, dosage adjustment is required); old age (a decrease in glomerular filtration is possible); epilepsy and patients with increased convulsive readiness; patients with predisposing factors for urinary retention (see 'Special instructions').

For film-coated tablets, additionally:

• hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

• children under 6 years of age.

For drops additionally:

• children's age up to 6 months (in view of the limited data on the effectiveness and safety of drugs).

With care: children under 1 year of age.

pharmachologic effect

Antiallergic drug. A blocker of histamine H1 receptors, a competitive antagonist of histamine, a metabolite of hydroxyzine. Prevents the development and facilitates the course of allergic reactions, has an antipruritic and antiexudative effect.

Affects the early histamine-dependent stage of allergic reactions, limits the release of inflammatory mediators at the late stage of an allergic reaction, reduces the migration of eosinophils, neutrophils and basophils, stabilizes the membranes of mast cells. Reduces capillary permeability, prevents the development of tissue edema, relieves smooth muscle spasm. 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.

Virtually no anticholinergic and antiserotonin action. In therapeutic doses, it has practically no sedative effect.

After a single dose of cetirizine at a dose of 10 mg, the onset of the 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 the course of treatment, tolerance to the antihistamine effect of cetirizine does not develop. After stopping treatment, the effect persists for up to 3 days.

Side effect

From the hematopoietic system: thrombocytopenia.

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

From the side of the organ of vision: violation of accommodation, blurred vision, nystagmus.

On the part of 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, hypersensitivity, up to the development of anaphylactic shock.

From the side of metabolism: an increase in body weight.

Others: fatigue, asthenia, malaise, edema.

Side effects develop in very rare cases.

Application during pregnancy and lactation

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

Application in children

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

Use in elderly patients

The drug should be prescribed with caution to elderly patients (due to a possible decrease in glomerular filtration). Special instructions For children aged 6 months to 6 years, ZyrtekЃ is prescribed in a dosage form of drops for oral administration of 10 mg / ml.

Influence on the ability to drive vehicles and use mechanisms

An objective assessment of the ability to drive vehicles and control mechanisms 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 of attention and speed of psychomotor reactions.

Overdose

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

Treatment: immediately after taking the drug, gastric lavage should be performed or vomiting should be induced artificially. The appointment of activated carbon, symptomatic and supportive therapy is recommended. There is no specific antidote. Hemodialysis is ineffective.

Drug interactions

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

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

With the simultaneous appointment with macrolides and ketoconazole, no changes in the ECG were noted.

When using the drug in therapeutic doses, data on the interaction with alcohol (with a blood alcohol concentration of 0.5 g / l) were not obtained. However, the patient should refrain from drinking alcohol during drug therapy in order to avoid depression of the central nervous system.