Relief of nose and eye symptoms associated with seasonal and chronic allergic rhinitis and symptoms of chronic idiopathic urticaria in adults and children ≥6 years.
Composition:
1 tabl powl. contains 10 mg of Cetirizine dihydrochloride; the preparation contains lactose.
Action:
Antihistamine - a strong and selective antagonist of histamine H-receptors1. Cetirizine has antiallergic activity in patients with hypersensitivity (atopy) undergoing allergen challenge. It inhibits the influx of cells in the late phase of the inflammatory reaction, eosinophils, to the skin and conjunctiva. It relieves the symptoms of rhinitis and does not affect lung function. It inhibits the reaction leading to the formation of wheals and redness. Maximum steady-state blood levels occur within 1.0 ± 0.5 hours after oral administration. The drug 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.
Contraindications:
Hypersensitivity to Cetirizine, hydroxyzine or other piperazine derivatives or other components of the preparation. Severe renal impairment with creatinine clearance <10 ml / min.
Precautions:
It is not recommended for use in children <6 years. Caution should be used in patients with renal insufficiency (dosage adjustment recommended), epilepsy or risk of seizures and in combination with alcohol. Caution should be exercised in patients with risk factors for urinary retention (eg spinal cord injury, prostatic hyperplasia), because cetirizine may increase the risk of urinary retention. Due to the lactose content, the preparation should not be used 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 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. The following side effects have been reported during post-marketing experience - uncommon: agitation, paresthesia, diarrhea, pruritus, rash, weakness, 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 disturbances, blurred vision, eyeball rotation, angioneurotic edema, drug eruption, painful or difficult urination, involuntary urination. In addition, an unknown frequency was observed: increased appetite, suicidal thoughts, amnesia, memory impairment, dizziness, urinary retention.
Dosage:
Orally. Adults and children> 12 years: 10 mg (1 table) once a day; children 6-12 years: 5 mg (1/2 times table) 2 times a day. In patients with hepatic impairment and in the elderly, no dosage adjustment is necessary. In 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. Swallow with a glass of water.
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