Држава: Јужноафричка Република
Језик: Енглески
Извор: South African Health Products Regulatory Authority (SAHPRA)
Ucb
ZYRTEC® TABLET 10 mg ZYRTEC® ORAL DROPS 10 mg/mL ZYRTEC® ORAL SOLUTION 1 mg/mL SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): ZYRTEC ® TABLET 10 mg ZYRTEC ® ORAL DROPS 10 mg/mL ZYRTEC ® ORAL SOLUTION 1 mg/mL COMPOSITION: Each film-coated TABLET contains 10 mg Cetirizine dihydrochloride Each 1 mL ORAL DROPS contains 10 mg Cetirizine dihydrochloride Each 1 mL ORAL SOLUTION contains 1 mg Cetirizine dihydrochloride The ORAL DROPS and ORAL SOLUTION contain methylparahydroxybenzoate 0,135% m/v and propylparahydroxybenzoate 0,015% m/v as preservatives. The ORAL DROPS and ORAL SOLUTION do not contain sucrose or alcohol. PHARMACOLOGICAL CLASSIFICATION: A 5.7.1 Antihistaminics PHARMACOLOGICAL ACTION: ZYRTEC ® , a metabolite of hydroxyzine, is an anti-allergic agent with a histamine H 1 receptor antagonism devoid of any significant anticholinergic and antiserotonin effects as demonstrated in experimental and clinical pharmacology. At the present stage of research into the mode of action of cetirizine, the anti-allergic activity seems to be exerted mainly via its effects on the release of certain mediators, such as histamine, together with a selective action on the H 1 receptors. Cetirizine reduces eosinophil recruitment induced by an antigen-antibody reaction. PHARMACOKINETIC PROPERTIES: Peak blood levels of 300 ng/mL are reached within one hour after oral administration of cetirizine. Cetirizine does not undergo extensive first pass metabolism. The terminal half life is approximately 10 hours in adults, 6 hours in children aged 6 to 12 years and 5 hours in children aged 2 to 6 years. These data are consistent with the urinary excretion half-life of the drug. The cumulative urinary excretion represents about two thirds of the dose given in both adults and children. T Прочитајте комплетан документ