Relief of nose and eye symptoms associated with seasonal and chronic allergic rhinitis and symptoms of chronic idiopathic urticaria in adults and children aged ≥6 years.
Composition:
1 tabl powl. contains 10 mg of Cetirizine dihydrochloride and 80.62 mg of lactose.
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. Cetirizine is bound to plasma proteins in approximately 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 the active substance, to any of the excipients, hydroxyzine or other piperazine derivatives. Severe renal impairment with creatinine clearance <10 ml / min.
Precautions:
Use with caution in patients with renal impairment (dose modification recommended), epilepsy or risk of seizures and in combination with alcohol and in patients with risk factors for urinary retention (eg damaged spinal cord, prostatic hyperplasia). Due to the lactose content, do not use in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Animal studies do not indicate any harmful effects of pregnancy on the course of pregnancy, embryonic and / or fetal development - use caution in pregnancy. Cetirizine is excreted in breast milk - use caution when breastfeeding.
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 in post-marketing experience: uncommon: agitation, paresthesia, diarrhea, pruritus, rash, asthenia, malaise; rare: hypersensitivity reactions, aggressive behavior, confusion, depression, hallucinations, insomnia, convulsions, tachycardia, abnormal liver function (increased ALT, AST, ALP, 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: amnesia, impaired memory, increased appetite, thoughts of suicide, dizziness, urinary retention.
Dosage:
Orally. Adults and adolescents> 12 years: 10 mg (1 table) once a day; children 6-12 years: 5 mg (1/2 times table) 2 times a day.Special groups of patients. 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. The use of coated tablets is not recommended in children <6 years because this pharmaceutical form does not allow for appropriate dosage adjustments.Way of giving. Table. should be swallowed with a glass of liquid. Table. the powl can be divided into halves along the incision.
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