1 tabl powl. contains 10 mg of Cetirizine dihydrochloride. The preparation contains lactose.
Action:
Cetirizine - a metabolite of hydroxyzine is a potent and selective antagonist of peripheral histamine H-receptors1. In addition, it has an anti-allergic effect - it inhibits the influx of cells in the late phase of the inflammatory reaction, especially 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. Cmax in steady-state blood occurs within +/- 0.5 hours. Cetirizine is approximately 93% bound to plasma proteins. 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 and is shorter in children.
Contraindications:
Hypersensitivity to the preparation ingredients, hydroxyzine or piperazine derivatives. Patients with severe renal impairment (creatinine clearance <10 ml / min). Patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Precautions:
Take caution while taking cetirizine with alcohol. Caution is advised when using in patients with epilepsy and in patients at risk of convulsions. Cetirizine may affect the results of skin tests (they should be carried out after 3 days of discontinuation of the drug). In patients with moderate or severe renal impairment, lower doses of cetirizine should be used. The use of the drug in the form of 10 mg film-coated tablets is not recommended in children under the age of 6, because this pharmaceutical form does not allow for a suitable dose adjustment.
Pregnancy and lactation:
Caution should be exercised when using the preparation in pregnant and breast-feeding women. Cetirizine is excreted in human milk at concentrations of 0.25-0.90 plasma concentrations (depending on the time of sampling after administration).
Side effects:
Uncommon: agitation, paresthesia, diarrhea, pruritus, rash, weakness, malaise. Rarely: hypersensitivity reactions, aggressive behavior, confusion, depression, hallucinations, insomnia, movement disorders, tachycardia, abnormal liver function (increased transaminases, alkaline phosphatase, GGT and increased bilirubin), urticaria, edema, weight gain. Very rare: thrombocytopenia, anaphylactic shock, tics, dysgeusia, syncope, tremor, dystonia, dyskinesia, accommodation disorder, blurred vision, eyeball rotation, angioneurotic edema, drug eruption, painful or difficult urination, involuntary urination. Frequency unknown: amnesia, memory problems. In addition, you may experience: drowsiness, fatigue, headache and dizziness, paradoxical nervous system stimulation, dry mouth. In children (up to 12 years) the following side effects were observed with a frequency ≥1%: diarrhea, drowsiness, rhinitis and fatigue.
Dosage:
Orally. Adults and adolescents over 12 years of age: 10 mg (1 tablet) once a day. Children 6-12 years old: 5 mg twice daily (half a tablet twice daily). In patients with hepatic impairment and in the elderly, no dosage adjustment is necessary. Dose modification in adult patients with impaired renal function - mild renal dysfunction (creatinine clearance 50-79 ml / min): 10 mg once daily; moderate renal impairment (creatinine clearance 30-49 ml / min): 5 mg once a day; severe renal impairment (creatinine clearance <30 ml / min): 5 mg every other day; end-stage renal disease, dialysis patients (<10 ml / min): use contraindicated. In children with renal impairment, the dose should be determined individually based on creatinine clearance, age and body weight.The tablets should be swallowed with a glass of water.
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