国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE
HEALOL PHARMACEUTICALS SDN. BHD.
DESLORATADINE
1 X 60 ml
GRACURE PHARMACEUTICALS LTD.
DESTACURE Desloratadine Syrup 2.5mg/5ml _Consumer Medication Information Leaflet (RiMUP) _ 1 WHAT IS IN THIS LEAFLET 1. What _Destacure Syrup _ is used for 2. How _Destacure Syrup _ works _3._ _ _ Before you use _Destacure Syrup _ _4._ _ _ How to use _Destacure Syrup _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Destacure Syrup _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS _DESTACURE SYRUP _USED FOR _Destacure Syrup _ is indicated for the rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness. _Destacure Syrup _ is also indicated for the relief of symptoms associated with urticarial such as the relief of itching and the size and number of hives. HOW _DESTACURE SYRUP _WORKS _Destacure Syrup _ contains desloratadine is a non-sedating, long- acting histamine antagonist with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system. Desloratadine has demonstrated anti- allergic properties from in vitro studies. These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8 and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells. The clinical relevance of these observations remains to be confirmed. BEFORE YOU USE _DESTACURE SYRUP _ - _When you must not use it _ • If you have an allergy to desloratadine, loratadine or any other ingredients of this product. • If you have poor kidney function. • In children under one year of age. • If you are pregnant; trying to get pregnant or think you may be pregnant. • If you are breast-feeding. - _Before you start to use it _ _ _ Please make sure you have understood the explanation g 阅读完整的文件
For the use only of a registered Medical Practitioner or a Hospital or a Laboratory DESTACURE (DESLORATADINE SYRUP 2.5MG/5ML) COMPOSITION: Each 5ml contains: Desloratadine 2.5mg DESCRIPTION: Destacure is orange coloured syrupy liquid. It contains Desloratadine as active ingredient and Sucrose, Glycerol, Propylene Glycol, Disodium Edetate, Citric Acid Monohydrate, Color Sunset Yellow Supra, Sodium Benzoate, Sodium Citrate, Ess. Mix Fruit and Purified Water as excipients. PHARMACODYNAMICS / PHARMACOKINETICS: _PHARMACODYNAMIC PROPERTIES:_ Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27 _Mechanism of action_ Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system. Desloratadine has demonstrated antiallergic properties from _in vitro_ studies. These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells. The clinical relevance of these observations remains to be confirmed. _PHARMACOKINETIC PROPERTIES:_ _Absorption:_ From already published literature it is concluded that desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration in adults and adolescents. 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 was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg. _Distribution:_ Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of clinical 阅读完整的文件