Relief of nose and eye symptoms associated with seasonal and chronic allergic rhinitis; alleviation of symptoms of chronic idiopathic urticaria in adults and children aged ≥6 years.
Composition:
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, cetirizine has antiallergic activity, inhibits the influx of cells in the late phase of the inflammatory reaction, eosinophils, to the skin and conjunctiva. Cetirizine is well absorbed from the gastrointestinal tract; food prolongs absorption, but does not affect the bioavailability of the drug. It binds approximately 93% to plasma proteins. It is slightly metabolised in the liver and excreted mainly in unchanged form in the urine. T0,5 in the blood is about 10 hours in adults, in children - 5 hours.
Contraindications:
Hypersensitivity to cetirizine, hydroxyzine, piperazine derivatives or other components of the preparation. Severe renal impairment (creatinine clearance below 10 ml / min).
Precautions:
Caution is recommended in combination with alcohol. Caution is advised when using patients with epilepsy, risk of seizures or risk factors for urinary retention (eg damaged spinal cord, prostatic hyperplasia). Due to the lactose content, patients with hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose should not use this preparation. It is not recommended to use the preparation in the form of tablets. powl. 10 mg in children under 6 years, 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, as cetirizine is excreted in human milk.
Side effects:
Uncommon: agitation, paresthesia, diarrhea, pruritus, rash, weakness, malaise. Rarely: hypersensitivity reactions, aggression, confusion, depression, hallucinations, insomnia, convulsions, tachycardia, increased transaminases, alkaline phosphatase, GGTP and increased bilirubin, urticaria, edema, weight gain. Very rare: thrombocytopenia, anaphylactic shock, tics, dysgeusia, dyskinesia, dystonia, fainting, tremor, angioneurotic edema, drug eruption, accommodation disorder, blurred vision, eyeball rotation, painful or difficult urination, involuntary urination. Not known: increased appetite, suicidal thoughts, amnesia, memory impairment, urinary retention, dizziness. In addition, the following were observed: drowsiness, fatigue, headache, pharyngitis, nausea, abdominal pain, dryness of the oral mucosa. In children (up to 12 years), diarrhea, drowsiness, rhinitis and fatigue were observed.
Dosage:
Orally. Adults and adolescents over 12 years: 10 mg once a day. Children 6-12 years: 5 mg twice daily. In renal insufficiency with a creatinine clearance of 30-49 ml / min 5 mg administered once a day; <30 ml / min - 5 mg every 48 h. In children with renal insufficiency, the dose should be determined based on creatinine clearance, age and body weight. The tablets should be taken with a glass of liquid. The tablet can be divided into two equal doses.
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