국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CARVEDILOL
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
CARVEDILOL
10tablet Tablets; 100tablet Tablets; 30tablet Tablets
TORRENT PHARMACEUTICALS LTD.
KARVIL TABLETS _ _ Carvedilol Tablets USP (6.25mg, 25mg) 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET? 1. What Karvil is used for 2. How Karvil works 3. Before you use Karvil 4. How to use Karvil 5. While you are using it 6. Side effects 7. Storage and Disposal of Karvil 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT KARVIL IS USED FOR? Karvil contains a medicine called carvedilol. This belongs to a group of medicines called ‘beta-blockers’. Karvil is used to treat the following: Chronic heart failure. High blood pressure (hypertension). Angina (chest pain or discomfort that happens when your heart isn’t getting enough oxygen). HOW KARVIL WORKS This helps to lower your blood pressure. If you have chronic heart failure, this makes it easier for your heart to pump blood around your body. If you have angina, this will help stop the chest pain. BEFORE YOU USE KARVIL _When you must not use it _ You are allergic (hypersensitive) to carvedilol or any of the other ingredients of Karvil. You have ever had wheezing due to asthma or other lung diseases. You have severe fluid retention (swelling of your hands, ankles and feet) which is being treated by medicines given into one of your veins (intravenously). You have problems with your liver. You have problems with your heart (for example ‘heart block’ or slow heart beat). Karvil is not suitable for some people with certain types of heart problem. You have very low blood pressure. You have a problem with the acid levels in your blood (‘metabolic acidosis’). You have a growth on one of your adrenal glands (‘phaeochromocytoma’). If you are not sure, talk to your doctor or pharmacist before taking Karvil. - _Before you start use Karvil _ Check with your doctor or pharmacist before taking Karvil if: • You have problems with your kidneys. You have diabetes (high blood sugar). You wear contact lenses. You have probl 전체 문서 읽기
Proposed Prescribing Information For the use of a Registered Medical Practitioner or a Hospital or a Laboratory KARVIL TABLETS 6.25 MG AND KARVIL TABLETS 25 MG CARVEDILOL TABLETS USP 6.25 MG AND 25 MG BRAND OR PRODUCT NAME KARVIL TABLETS 6.25 MG KARVIL TABLETS 25 MG NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) KARVIL TABLETS 6.25 MG Each uncoated tablet contains: Carvedilol……...6.25mg KARVIL TABLETS 25 MG Each uncoated tablet contains: Carvedilol……...25mg PRODUCT DESCRIPTION KARVIL TABLETS 6.25 MG White to off-white colored, round, flat, uncoated tablets with break line on one side and plain on other side. KARVIL TABLETS 25 MG White to off-white colored, round, flat, uncoated tablets with break line on one side and plain on other side. DOSAGE FORM Uncoated Tablet PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMICS Carvedilol is a multiple action adrenergic receptor blocker with ά1, β1 and β2 adrenergic receptor blockade properties. Carvedilol has been shown to have organ-protective effects. Carvedilol is a potent antioxidant and a scavenger of reactive oxygen radicals. Carvedilol is racemic, and both R(+) and S(-) enantiomers have the same s-adrenergic receptor blocking properties and antioxidant properties. Carvedilol has antiproliferative effects on human vascular smooth muscle cells. A decrease in oxidative stress has been reported in clinical studies by measuring various markers during chronic treatment of patients with carvedilol. Carvedilol's β-adrenergic receptor blocking properties are nonselective for the β1 and β2- adrenoceptors and are associated with the levorotatory S(-) enantiomer Carvedilol has no intrinsic sympathomimetic activity and (like propranolol) it has membrane stabilising 1 properties. Carvedilol suppresses the renin-angio-tensin-aldosterone system through β- blockade, which reduces the release of renin, thus making fluid retention rare. Carvedilol reduces the peripheral vascular resistance via selective blockade of ά1- adrenoceptors. Carvedilol attenuates the increase in blo 전체 문서 읽기