Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE
SYNERRV SDN BHD
DESLORATADINE
10 x 10 Tablets; 5 x 10 Tablets; 1 x 10 Tablets
IND-SWIFT LIMITED
_Consumer Medication Information Leaflet (RiMUP) _ SYNERRV DESLORATADINE 5 Desloratadine Tablets 5mg 1 WHAT IS IN THIS LEAFLET 1. What _SYNERRV _ _DESLORATADINE _ is used for _2._ _ _ How _SYNERRV _ _DESLORATADINE _ works _ _ _3._ _ _ Before you use _SYNERRV _ _DESLORATADINE _ _4._ _ _ How to use _SYNERRV _ _DESLORATADINE _ _5._ _ _ While you are using _SYNERRV DESLORATADINE _ 6. Side effects 7. Storage and Disposal of _SYNERRV DESLORATADINE _ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT _SYNERRV _ _DESLORATADINE _IS USED FOR _SYNERRV DESLORATADINE _ relieves symptoms associated with allergic rhinitis(inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. _SYNERRV DESLORATADINE _ is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep. HOW _SYNERRV _ _DESLORATADINE _WORKS _SYNERRV DESLORATADINE _ is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. BEFORE YOU USE _SYNERRV _ _DESLORATADINE _ _-_ _ _ _When you must not use it _ • Do not use _SYNERRV _ _DESLORATADINE _ if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of _SYNERRV _ _DESLORATADINE _ or to loratadine. _-_ _ _ _Before you start to use it _ _-_ _ _ Talk to your doctor or pharmacist before taking _SYNERRV DESLORATADINE _ if you have medical or familial history of seizures. Efficacy and safety of _SYNERRV _ _DESLORATADINE _ in children under 12 years of age have not been established. _Pregnancy and breast-feeding _ • Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-feeding. • If you are pregnant or nursing a baby, Belgenin tamamını okuyun
SYNERRV DESLORATADINE 5 Desloratadine Tablets 5mg COMPOSITION: Each film coated tablet contains: Desloratadine 5mg Colours: Indigo Carmine and Titanium Dioxide Excipients q.s. PRESENTATION: Light blue colored, round shaped, biconvex, film coated tablets with both sides plain. PROPERTIES: Desloratadine is used as antihistaminic, to be administered orally. The chemical name of Desloratadine is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta [1,2- b]pyridine Its emperical formula is C 19 H 19 ClN 2 and molecular weight is 310.8. Structural formula is as shown: CLINICAL PHARMACOLOGY : PHARMACODYNAMICS : 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. 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. PHARMACOKINETICS AND DRUG METABOLISM: ABSORPTION Desloratadine plasma concentrations can be detected within 30 minutes of 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 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 clinically relevant medicine accumulatio Belgenin tamamını okuyun