Relief of nose and eye symptoms associated with seasonal and chronic allergic rhinitis. Relief of symptoms of chronic idiopathic urticaria. Table. powl. can be used in adults and children aged ≥6 years; oral drops and oral solution - in adults and children aged ≥2 years.
Composition:
1 tabl powl. contains 10 mg of Cetirizine dihydrochloride; Table. contain lactose. 1 ml of oral drops contains 10 mg cetirizine dihydrochloride (1 drop contains 0.5 mg cetirizine dihydrochloride); drops contain p-hydroxybenzoates.1 ml oral solution contains 1 mg cetirizine dihydrochloride; the solution contains sorbitol and p-hydroxybenzoates.
Action:
Cetirizine, a metabolite of hydroxyzine, is a potent and selective antagonist of peripheral histamine H-receptors1. In addition, it has antiallergic activity, inhibits the influx of cells in the late phase of the inflammatory reaction, eosinophils, to the skin and conjunctiva. It inhibits the reaction leading to the formation of wheals and redness. It relieves the symptoms of rhinitis and does not affect lung function. The maximum steady-state cetirizine concentration occurs within 1.0 ± 0.5 hours after oral administration. It binds to plasma proteins in about 93 ± 0.3%. The first pass metabolism is not significantly affected. About 2/3 of the dose is excreted unchanged in the urine. Final T0,5 is about 10 hours; it is shorter in children.
Contraindications:
Hypersensitivity to cetirizine, hydroxyzine, piperazine derivatives or other components of the preparation. Severe renal impairment (creatinine clearance <10 ml / min).
Precautions:
Drops of oral and oral solution do not use in children <2 years. Table. powl. do not use in children <6 years. The preparation should be used with caution in patients with risk factors for urinary retention (eg with injured spinal cord, prostatic hyperplasia), with renal insufficiency (dose modification indicated), with epilepsy or risk of seizures and in combination with alcohol. Due to the lactose content, tabl. powl. should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. Due to the sorbitol content, the oral solution should not be used in patients with hereditary fructose intolerance. Due to the content of p-hydroxybenzoates, oral drops and oral solution may cause allergic reactions (also of late type).
Pregnancy and lactation:
Animal studies do not indicate any harmful effects of cetirizine on pregnancy or on the health of the fetus and / or newborn. Caution should be exercised when cetirizine is administered to pregnant or breastfeeding women (the drug is excreted in human milk).
Side effects:
The following may occur: drowsiness, fatigue, headache and dizziness, abdominal pain, dry mouth, nausea, sore throat. In children with a frequency of ≥1%, diarrhea, drowsiness, rhinitis, and tiredness were observed. In addition, the following side effects have been reported post-marketing - uncommon: agitation, paresthesia, diarrhea, pruritus, rash, asthenia, malaise; rare: hypersensitivity reactions, aggressive behavior, confusion, depression, hallucinations, insomnia, convulsions, tachycardia, abnormal liver function (increased ALT, alkaline phosphatase, GGT, increased bilirubin), urticaria, edema, weight gain; very rare: thrombocytopenia, anaphylactic shock, tics, taste disturbances, syncope, tremor, dystonia, dyskinesia, accommodation disorder, blurred vision, eyeball rotation, angioneurotic edema, drug eruption, painful or difficult urination, involuntary urination; frequency unknown: increased appetite, suicidal thoughts, vertigo, drowsiness, amnesia, memory impairment, urinary retention.
Dosage:
Orally. Adults and adolescents> 12 years: 10 mg (1 table or 10 ml oral solution or 20 drops) once a day; children 6-12 years: 5 mg (1/2 tablesl.or 5 ml oral solution or 10 drops) twice daily; children 2-6 years: 2.5 mg (2.5 ml oral solution or 5 drops) twice daily. In patients with hepatic impairment and in the elderly, no dosage adjustment is necessary. In adult patients with renal insufficiency, the dosage depends on the creatinine clearance (CCr) - CCr = 50-79 ml / min: 10 mg once a day; CCr = 30-49 ml / min: 5 mg once a day; CCr <30 ml / min: 5 mg every other day; CCr <10 ml / min: do not use. In children with renal impairment, the dose should be determined individually based on the creatinine clearance, age and weight of the patient. Table. the powl can be divided into halves along the incision. The oral solution can be taken without dilution. Drops should be measured on a spoon or diluted in water and taken orally immediately after preparation.
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