Relief of nose and eye symptoms that occur in the course of seasonal and perennial rhinitis and symptoms of chronic idiopathic urticaria in adults and adolescents and children from the age of 6 years.
Composition:
1 tabl powl. contains 10 mg of Cetirizine dihydrochloride. The preparation contains lactose.
Action:
Antihistamine. A potent and selective antagonist of peripheral H-receptors1. In addition to the antagonistic effect on H-receptors1, cetirizine has antiallergic properties: at a dose of 10 mg once or twice daily, it inhibits the influx of cells in the late phase of the allergic reaction, eosinophilia, in the skin and conjunctiva of atopic patients exposed to the allergen. The steady-state maximum concentration in plasma is achieved within 1.0 ± 0.5 hours. During cetirizine administration in daily doses of 10 mg for 10 days, no accumulation in the body was observed. Food does not reduce the rate of absorption of Cetirizine, but reduces its absorption rate. The degree of binding to plasma proteins is 93 ± 0.3%. Cetirizine does not significantly undergo first-pass metabolism. Approximately 1-3 doses are excreted unchanged in urine. T0,5 in the final phase is about 10 hours.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients, to hydroxyzine or to any piperazine derivative. Severe renal dysfunction with creatinine clearance below 10 ml / min. Patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose should not take the preparation.
Precautions:
Caution is advised in patients with epilepsy and in patients at risk of convulsions. Application of tabl. powl. it is not recommended in children under the age of 6, because this pharmaceutical form does not allow for appropriate dosage adjustments.
Pregnancy and lactation:
Data on the use of cetirizine in pregnant women are limited. As a precautionary measure, it is recommended to avoid the use during pregnancy. The use of cetirizine during breastfeeding should be avoided.
Side effects:
The following adverse reactions have been reported in clinical trials with a frequency of 1% or greater: fatigue, dizziness, headache, abdominal pain, dry mouth, nausea, drowsiness, pharyngitis. There have been post-marketing reports: uncommon: psychomotor agitation, paraesthesia, diarrhea, pruritus, rash, asthenia, malaise; rare: hypersensitivity, aggression, disorientation, depression, hallucinations, insomnia, convulsions, movement disorders, tachycardia, liver dysfunction (increased transaminases, alkaline phosphatase and GGT, and increased bilirubin), urticaria, edema, weight gain. Very rare: thrombocytopenia, anaphylactic shock, tics, dysgeusia, syncope, tremor, dystonia, dyskinesias, dysgeusia, syncope, tremor, dystonia, dyskinesias, accommodation disorder, blurred vision, eyeball rotation, angioedema, drug-induced rash, painful or impaired urination, involuntary urination. Side effects are reported with a frequency of 1% or morechildren between 6 and 12 years of age: diarrhea, drowsiness, rhinitis, fatigue.
Dosage:
Orally. Adults and adolescents over 12 years: 10 mg (1 tablet) once a day. Children from 6 to 12 years: 5 mg (half tables) 2 times a day. There is no need to reduce the dose in elderly patients if their renal function is normal. Since cetirizine is mainly excreted via the kidneys, if there is no alternative treatment option, the interval between doses should be determined individually depending on the degree of kidney function.Dose modification in adult patients with impaired renal function. Patients with mild renal impairment (creatinine clearance 50-79 ml / min): 10 mg once daily; patients with moderate renal impairment (creatinine clearance 30-49 ml / min): 5 mg once daily; patients with severe renal impairment (creatinine clearance <30 ml / min): 5 mg every 2 days; patients with end-stage renal disease - dialysis patients (creatinine clearance <10 ml / min) - do not use. In children and adolescents with renal impairment, the dose should be adjusted individually based on the creatinine clearance, age and weight of the patient. The tablets should be swallowed with a glass of water.
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