In adults and children aged 6 years and older: Cetirizine is indicated for the relief of nose and eye symptoms associated with seasonal and chronic allergic rhinitis and to relieving symptoms of chronic idiopathic urticaria.
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, it has an anti-allergic effect: in patients with hypersensitivity (atopy) subjected to allergen challenge, a dose of 10 mg 2 times a day inhibits the inflow to the skin and conjunctiva of the cells of the late phase inflammatory reaction. The drug suppresses the reaction leading to the formation of wheals and redness, alleviates the symptoms of rhinitis and does not affect the lung function. The maximum steady-state cetirizine concentration occurs within 1 ± 0.5 hours after oral administration. Cetirizine is bound to plasma proteins in approximately 93 ± 0.3%. The first pass metabolism is not significantly affected. Approx. 2/3 of the dose is excreted unchanged in the urine. Final T0,5 is about 10 hours; is shorter in children: in children 6-12 years T0,5 is about 6 hours.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients, hydroxyzine or piperazine derivatives. Severe renal dysfunction with creatinine clearance less than 10 ml / min. Patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose should not take this preparation.
Precautions:
Caution is advised when co-administering cetirizine with alcohol or drugs that inhibit O.u.n. Caution is advised when using in patients with epilepsy and in patients at risk of convulsions. Coating tablets are not recommended for use in children below 6 years of age because this dosage form does not allow dose adjustment.
Pregnancy and lactation:
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Caution should be exercised when prescribing cetirizine to pregnant women. Cetirizine is excreted in human milk at concentrations of 25-90% of plasma drug concentration - caution should be exercised when prescribing cetirizine in breast-feeding women.
Side effects:
Side effects occurring in clinical trials with a frequency of 1% or more: drowsiness, headache, dizziness, fatigue, abdominal pain, dry mouth, nausea, pharyngitis. Adverse reactions occurring in clinical trials in children from 6 months to 12 years with a frequency of 1% or more: diarrhea, drowsiness, rhinitis, fatigue. Side effects reported after the medicine has been marketed. Uncommon: agitation, paraesthesia, 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 impairment.
Dosage:
Orally. Adults and adolescents over 12 years: 10 mg once a day. Children 6-12 years: 5 mg twice daily. There are no data available to indicate that the dose should be reduced in elderly patients if their renal function is normal. There are no data on the relationship between efficacy and safety in patients with impaired renal function.In the absence of alternative treatment, the intervals between individual doses must be determined individually depending on renal function. Mild kidney problems - creatinine clearance 50-79 ml / min: 10 mg once a day. 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 failure, dialysis patients - creatinine clearance <10 ml / min: use contraindicated. In children with impaired renal function, the dose should be determined individually based on the creatinine clearance, age and body weight of the patient. No dose adjustment is necessary in patients with hepatic impairment. Table. take it with a glass of water. Table. they are divisible.
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