Nazione: Sudafrica
Lingua: inglese
Fonte: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
DESAWAY (tablet) SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): DESAWAY (tablet) COMPOSITION Each film-coated tablet contains desloratadine 5 mg Sugar free PHARMACOLOGICAL CLASSIFICATION A 5.7.1 Antihistaminics PHARMACOLOGICAL ACTION Desloratadine is a major metabolite of loratadine and is a non-sedating long-acting histamine antagonist with selective peripheral H 1 -receptor antagonist activity. Pharmacodynamics After oral administration, desloratadine selectively blocks peripheral histamine H 1 -receptors. It does not cross the blood- brain barrier to any great extent. Desloratadine has demonstrated in addition to antihistaminic activity, anti-allergic and anti-inflammatory activity from numerous in vitro (mainly conducted on cells of human origin) and in vivo studies. These studies have shown that desloratadine inhibits the broad cascade of events that initiate and propagate allergic inflammation. Pharmacokinetics Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration. Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine is consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The bioavailability of desloratadine is dose proportional over the range of 5 mg to 20 mg. Desloratadine is moderately bound (83% - 87%) to plasma proteins. There is no evidence of clinically relevant drug accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days. INDICATIONS DESAWAY is indicated for the relief of symptoms associated with seasonal allergic rhinitis. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. WARNINGS DESAWAY Leggi il documento completo