Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium
Amneal Pharma Australia Pty Ltd
Rosuvastatin calcium
Registered
ROSUVASTATIN AMNEAL CMI V2.0 1 Rosuvastatin AMNEAL _contains the active ingredient rosuvastatin (as calcium) _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about ROSUVASTATIN AMNEAL. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking ROSUVASTATIN AMNEAL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. What ROSUVASTATIN AMNEAL is used for ROSUVASTATIN AMNEAL is used to lower high cholesterol levels. Even though you may have normal cholesterol, ROSUVASTATIN AMNEAL can also be used to reduce the risk of you having a stroke or heart attack if you are a man 50 or more years old or a women 60 or more years old and have at least 2 risk factors for having a heart attack or stroke, such as high blood pressure, low levels of good cholesterol (HDL), smoking or a family history of premature coronary heart disease. Your doctor may also do a blood test to measure a substance called C Reactive Protein to help decide if you should be given ROSUVASTATIN AMNEAL for this use. _CHOLESTEROL AND TRIGLYCERIDES _ Everyone has cholesterol and triglycerides in their blood. They are fatty substances needed by the body for many things. Triglycerides are an energy source for the body. Cholesterol is used for such things as building cells, making bile acids (which help to digest foods) and making some hormones. There are different types of Cholesterol. Too much of the “bad” cholesterol. Too much of the “bad” cholesterol (LDL) can block the blood vessels that supply your heart and brain with blood, and can cause heart attack, angina and stroke. The “good” cholesterol (HDL) helps to remove the bad cholesterol from the blood vessels. High levels of triglycerides can b Lire le document complet
_Rosuvastatin AMNEAL tablets Product Information Amneal Pharma Australia Pty Ltd _ Rosuvastatin AMNEAL PI v2.0 Page 1 of 22 ROSUVASTATIN AMNEAL _ _ _ROSUVASTATIN (AS CALCIUM) TABLETS _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE Rosuvastatin (as rosuvastatin calcium). The chemical name for rosuvastatin calcium is bis [(_E_)-7- [4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl) amino]pyrimidin-5-yl] (3_R_, 5_S_)-3,5- dihydroxyhept-6-enoic acid] calcium salt. Its structural formula is: (C 22 H 27 FN 3 O 6 S) 2 Ca Molecular weight: 1001.14 CAS No.: 147098-20-2 DESCRIPTION Rosuvastatin calcium is an amorphous solid, which is slightly soluble in methanol, ethanol and water (7.8 mg/mL at 37◦C) and has a pKa of 4.6. Rosuvastatin calcium is the (3_R_,5_S_,6_E_) enantiomer. ROSUVASTATIN AMNEAL film-coated tablets come in four strengths and contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin (as calcium). The tablets also contain: microcrystalline cellulose, crospovidone, calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate, Opadry II Complete film coating system 33G28435 White (ARTG 107124, 5 mg tablet only) and Opadry II Complete film coating system 33G240007 Pink (ARTG 107544, 10 mg, 20 mg and 40 mg tablets only). The tablets are gluten free. PHARMACOLOGY Rosuvastatin is a fully synthetic competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated, with apolipoprotein B (ApoB), into very low density lipoprotein (VLDL) and released into the plasma for delivery to peripheral tissues. VLDL particles are TG-rich. Cholesterol-rich low density lipoprotein (LDL) is _Rosuvastatin AMNEAL tablets Product Information Amneal Pharma Australia Pty Ltd _ Rosuvastatin AMNEAL PI v2.0 Page 2 of 22 formed from VLDL and is cleared primarily through the high affinity LDL receptor in the liver. Rosuvastatin produces its lipid-modifying effec Lire le document complet