Χώρα: Νότια Αφρική
Γλώσσα: Αγγλικά
Πηγή: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN CETIRIZINE 1 mg/mL SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): ASPEN CETIRIZINE 1 mg/mL (oral solution) COMPOSITION: Each 1 mL of ASPEN CETIRIZINE 1 mg/mL contains 1 mg cetirizine dihydrochloride. Contains sodium methylparahydroxybenzoate 0,155% m/v and sodium propylparahydroxybenzoate 0,0168% m/v as preservatives. Does not contain sucrose or alcohol. PHARMACOLOGICAL CLASSIFICATION: A 5.7.1 Antihistaminics PHARMACOLOGICAL ACTION: Cetirizine is a metabolite of hydroxyzine. It is a second-generation reversible, competitive inhibitor of histamine at the histamine-1 (H1) receptor. Cetirizine competes with histamine for the H1-receptor site. Cetirizine prevents, but does not reverse, pharmacological responses mediated by histamine, at the H1 receptor. Pharmacokinetics: Cetirizine is well absorbed from the gastro-intestinal tract and peak plasma concentrations are reached within 1 hour after oral administration. Pharmacokinetics are linear, with plasma concentrations increasing proportionately with increasing doses. The terminal half-life in adults is approximately 10 hours; in children aged 6 to 12 years 6 hours; in children aged 2 to 6 years, 5 hours. Cetirizine is eliminated faster in children, and slower in patients with hepatic or renal impairment (creatinine clearance <40 mL/min), with a resultant increase in half-life and decrease in clearance. Cetirizine does not undergo extensive first-pass metabolism. The cumulative urinary excretion represents about two thirds of the dose given in both adults and children. INDICATIONS: ASPEN CETIRIZINE is indicated for symptomatic relief of allergic conditions such as allergic rhinitis, and allergic skin conditions such as urticaria. CONTRA-INDICATIONS: Hypersensitivity to ASPEN CETIRIZINE or any of the ingredients. Hypersensitivity to hydrox Διαβάστε το πλήρες έγγραφο