Relief of nose and eye symptoms associated with seasonal and chronic allergic rhinitis and relief of symptoms of chronic idiopathic urticaria in adults and children from 6 years.
Composition:
1 tabl powl. contains 10 mg of Cetirizine dihydrochloride. The preparation contains lactose.
Action:
An antihistaminic drug, a potent and selective antagonist of histamine H-receptors1. Cetirizine has antiallergic activity in patients with hypersensitivity (atopy) undergoing allergen challenge. The 10 mg dose administered 1-2 times a day inhibits the influx of cells in the late phase of the inflammatory response, eosinophils to the skin and conjunctiva. In patients with allergic rhinitis and concomitant, mild or moderate asthma, cetirizine 10 mg once daily alleviates the symptoms of rhinitis and does not affect lung function. Following oral administration, steady-state peak plasma concentrations occur within 1 ± 0.5 hours. No accumulation of cetirizine has been observed with 10 mg daily doses for 10 days. The drug binds to plasma proteins at 93 ± 0.3%. It does not affect the binding of Warfarin to 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.
Contraindications:
Hypersensitivity to the active substance, any of the excipients, hydroxyzine or piperazine derivatives. Severe renal dysfunction with creatinine clearance less than 10 ml / min.
Precautions:
Caution should be exercised in patients with epilepsy or the risk of seizures and due to the risk of urinary retention - in patients with risk factors for urinary retention (eg damaged spinal cord, prostatic hyperplasia). Caution is advised when using the drug together with alcohol. The use of the film-coated tablet formulation is not recommended in children under 6 years of age, because this pharmaceutical form does not allow for a suitable dose adjustment. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
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, paraesthesia, diarrhea, weakness, malaise, pruritus, rash. Rarely: hypersensitivity reactions, aggressive behavior, confusion, depression, insomnia, hallucinations, convulsions, tachycardia, abnormal liver function (increased transaminases, alkaline phosphatase, γ-GT, bilirubin), edema, weight gain, urticaria. Very rare: thrombocytopenia, anaphylactic shock, tics, taste disturbances, fainting, tremor, dystonia, dyskinesia, disturbances in eye accommodation, blurred vision, eyeball rotation, painful or difficult urination, involuntary urination, angioneurotic edema, drug eruption. Not known: increased appetite, suicidal thoughts, amnesia, impaired memory, dizziness, urinary retention. In addition, the following were observed: drowsiness, headache and dizziness, fatigue, paradoxical agitation o.u.n., dryness of the oral mucosa. In children, the following side effects were observed with a frequency ≥1%: drowsiness, diarrhea, rhinitis and fatigue.
Dosage:
Orally. Adults and adolescents over 12 years: 10 mg once a day. Children 6-12 years: 5 mg twice daily. In patients with impaired renal function, no data describing the relationship between efficacy and safety. In the absence of alternative treatment, the intervals between individual doses must be determined individually depending on renal function. In patients with mild renal insufficiency (creatinine clearance 50-79 ml / min): 10 mg once a day; in patients with moderate renal impairment (creatinine clearance 30-49 ml / min): 5 mg once a day; in patients with severe renal impairment (creatinine clearance <30 ml / min): 5 mg onceevery other day; in patients with end-stage renal disease, 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. The tablets should be swallowed with a glass of liquid.
(C)
