البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE
APEX PHARMACY MARKETING SDN. BHD.
DESLORATADINE
1x10tablet Tablets; 3X10tablet Tablets
IND-SWIFT LIMITED
_Consumer Medication Information Leaflet (RiMUP) _ _ _ AVORIUS 5MG TABLET DESLORATADINE 5MG 1 WHAT IS IN THIS LEAFLET 1. What Avorius is used for 2. How it works 3. Before you use Avorius 4. How to use Avorius 5. While you are using it 6. Side effects 7. Storage and Disposal of Avorius 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision WHAT AVORIUS IS USED FOR Avorius is used for the rapid relief of symptoms associated with seasonal 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. Avorius is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. HOW IT WORKS Avorius is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. BEFORE YOU USE AVORIUS When you must not use it Do not use Avorius if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Avorius or to loratadine. Before you start to use it Efficacy and safety of Avorius Tablets in children under 12 years of age have not been established. The use of desloratadine is not recommended in breast- feeding women and during pregnancy. Talk to your doctor, pharmacist or nurse before taking desloratadine if you have medical or familial history of seizures. Taking other medicines Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE AVORIUS How much to use Adults and adolescents (12 years of age and over): _ _ one tablet once a day. When to use it Swallow the tablet whole with water, with or without food. How long to use it Continue taking your medicine for as long as your doctor tells you. Do not stop taking it unless your doctor tells you to - even if you feel bette اقرأ الوثيقة كاملة
COMPOSITION Desloratadine……………………………………………………………………… 5mg PRODUCT DESCRIPTION Light blue colored, round shaped, biconvex, film coated tablets with both side plain. PHARMACODYNAMICS PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27 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. PHARMACOKINETICS 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. Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days. The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products can not be fully excluded. Desloratadine does not inhibit CYP3A4 _in vivo, _ and _in vitro _ studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a s اقرأ الوثيقة كاملة