País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
HOVID BERHAD
MONTELUKAST SODIUM
30tablet Tablets; 10tablet Tablets
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ HOVID - MONTELUKAST CHEWABLE TABLET 4MG Montelukast (4 mg) 1 WHAT IS IN THIS LEAFLET 1. What Hovid-Montelukast is used for 2. How Hovid-Montelukast works 3. Before you use Hovid-Montelukast 4. How to use Hovid-Montelukast 5. While you are using Hovid- Montelukast 6. Side effects 7. Storage and Disposal of Hovid- Montelukast 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT HOVID-MONTELUKAST IS USED FOR It is used to: • prevent and treat asthma in patients 2 to 5 years old • relieve day and night symptoms of seasonal allergic rhinitis (hay fever) in patients 2 to 5 years old HOW HOVID-MONTELUKAST WORKS This medicine is a leukotriene receptor antagonist. It blocks substances in your lungs that narrows and swells your airways. The substance is called leukotriene. By blocking leukotrienes, your asthma symptoms will improve and this helps prevents asthma attacks. It also improves hay fever symptoms. BEFORE YOU USE HOVID-MONTELUKAST _ _ _- When you must not use it _ Do not take this medicine if: • you or your child is allergic to montelukast • you or your child are already taking any medicine containing montelukast • you or your child is/ are galactose intolerance, have Lapp lactase deficiency or glucose-galactose malabsorption If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor. _- Before you start to use it _ Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may interact with Hovid-Montelukast. _ _ Tell your doctor if: • you are pregnant or plan to get pregnant • you are breastfeeding or plan to breastfeed. _ _ _- Taking other medicines_ Talk to your doctor or pharmacist if you are taking any other medicines in any form including any that you buy or obtained without a prescription from pharmacy, supermarket or health food shop. Some medicines may interf Leia o documento completo
DESCRIPTION Oval, pink mottled uncoated tablet, shallow convex faces, with "HD" embossed on one face. COMPOSITION Montelukast Sodium which is equivalent to Montelukast 4 mg. ACTIONS AND PHARMACOLOGY The cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT 1 ) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions and are associated with symptoms of allergic rhinitis. Intranasal challenge with CysLTs has been shown to increase nasal airway resistance and symptoms of nasal obstruction. Montelukast is a potent, orally active compound that significantly improves parameters of asthmatic inflammation. Based on biochemical and pharmacological bioassays, it binds with high affinity and selectivity to the CysLT 1 receptor (in preference to other pharmacologically important airway receptors such as the prostanoid, cholinergic, or ß-adrenergic receptor). Montelukast potently inhibits physiologic actions of LTC 4 , LTD 4 and LTE 4 at the CysLT 1 receptor without any agonist activity. PHARMACOKINETICS ABSORPTION: Montelukast is rapidly absorbed following oral administration. After administration of the 4 mg chewable tablet to paediatric patients 2 to 5 years of age in the fasted state, Cmax is achieved 2 hours after administration. The mean Cmax is 66% higher while mean Cmin is lower than in adults receiving a 10 mg tablet. DISTRIBUTIO Leia o documento completo