Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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AP LORATADINE SYRUP SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): AP LORATADINE SYRUP COMPOSITION Each 5 mL of AP LORATADINE SYRUP contains: 5 mg of Loratadine as active 0,1% m/v Sodium Benzoate as preservative PHARMACOLOGICAL CLASSIFICATION A.5.7.1 Antihistaminics PHARMACOLOGICAL ACTION Loratadine is a second generation histamine (H1)-receptor antagonist. Loratadine exerts its action by competing with histamine for H1-receptor sites on effector cells. It prevents, but does not reverse responses mediated by histamine. Loratadine does not cross the blood-brain barrier to any extent. Pharmacokinetics: After oral administration, loratadine is well absorbed from the gastrointestinal tract and peak plasma concentrations are reached within 1,5 hours. Ingestion of food may enhance the absorption of loratadine. Loratadine undergoes extensive first pass metabolism via the cytochrome P-450 system. The major metabolite, desloratadine, is active. Loratadine is 97% protein bound, while desloratadine is less extensively protein bound (73% to 77%). The mean elimination half-lives for loratadine and desloratadine are 8,4 and 28 hours respectively. INDICATIONS AP LORATADINE SYRUP is indicated for the relief of symptoms associated with seasonal allergic rhinitis and chronic urticaria. CONTRA-INDICATIONS Hypersensitivity to AP LORATADINE SYRUP or to any ingredients of this preparation. Cross sensitivity to other antihistamines. Porphyria. WARNINGS Safety of AP LORATADINE SYRUP in the elderly has not been established. Safety of AP LORATADINE SYRUP in children under two years of age has not been established. AP LORATADINE SYRUP should be used with caution in patients with: • Severe liver impairment, as reduced clearance of loratadine may occur. Dosage adjustment may be needed (See Read the complete document