Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
pravastatin sodium, Quantity: 40 mg
Sun Pharma ANZ Pty Ltd
pravastatin sodium
Tablet, uncoated
Excipient Ingredients: lactose; sodium stearylfumarate; iron oxide yellow
Oral
30 tablets
(S4) Prescription Only Medicine
1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (eg; poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. CHOLVASTIN is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. 3. CHOLVASTIN is indicated in patients with unstable angina pectoris see Clinical Trials). 4. CHOLVASTIN is also indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 Years of age or older (see Clinical Trials). 1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (eg; poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. VASTORAN is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. 3. VASTORAN is indicated in patients with unstable angina pectoris see Clinical Trials). 4. VASTORAN is also indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 Years of age or older (see Clinical Trials).
Visual Identification: Dark yellow to yellow coloured, mottled, circular, biconvex, uncoated tablet debossed with P3 on one side and a breakline on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-08-07
CHOLVASTIN CMI V1 May 2011 Page 1 of 9 CHOLVASTIN TABLETS _PRAVASTATIN SODIUM_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CHOLVASTIN (Pravastatin Sodium). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CHOLVASTIN against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT CHOLVASTIN TABLETS ARE USED FOR CHOLVASTIN tablets belong to a group of lipid-lowering medicines called HMG-CoA reductase inhibitors (commonly known as "statins"). They work by lowering lipids (fats) such as cholesterol and triglycerides in your blood when non-medicinal measures, such as a low-fat diet, exercise and lifestyle changes, alone have failed. Cholesterol is a naturally occurring substance in the body necessary for normal growth. However, if there is too much cholesterol in your blood, it can get deposited along the walls of the blood vessels leading to narrowing and even blocking of these vessels (atherosclerosis). This is one of the common causes of heart problems such as chest pain (angina) and heart attack (myocardial infarction). High cholesterol levels have been shown to be associated with increased risk of heart disease. Other factors including high blood pressure, high blood sugar (diabetes), increased weight, lack of exercise and smoking further add to the risk of heart disease. High cholesterol levels in the blood can be brought down and kept down with dietary modifications, exercise and medicines. CHOLVASTIN tablets are used for one or more of the following: If you already have heart disease and raised levels of cholesterol, pravastatin will help reduce your chances of having another heart attack, or a stroke. It will reduce your chances of requiring a Прочитајте комплетан документ
CHOLVASTIN PI V2 Page 1 of 21 CHOLVASTIN ( PRAVASTATIN SODIUM TABLETS ) NAME OF THE MEDICINE Pravastatin Sodium (JAN, USAN, INN). DESCRIPTION Pravastatin is one of a new class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, that reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3- hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. CHOLVASTIN tablets contain pravastatin sodium, which is chemically designated as: _ _ Sodium (3 _R_ ,5 _R_ )-3,5-dihydroxy-7-[(1 _S_ ,2 _S_ ,6 _S_ ,8 _S_ ,8a _R_ )-6-hydroxy-2-methyl-8-[[(2 _S_ )-2- methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Its structure is: Molecular Formula: C 23 H 35 NaO 7 Molecular Weight: 446.52 Pravastatin Sodium is a white to yellowish-white powder or crystalline powder, hygroscopic. It is freely soluble in water and in methanol, soluble in ethanol. CHOLVASTIN tablets contain the following inactive ingredients: lactose anhydrous, sodium stearyl fumarate, ferric oxide yellow. PHARMACOLOGY MECHANISM OF ACTION Pravastatin produces its lipid-lowering effect in two ways. First, as a consequence of its reversible inhibition of HMG-CoA reductase activity, it affects modest reductions in intracellular pools of cholesterol. This results in an increase in the number of LDL- receptors on cell surfaces and enhanced receptor-mediated catabolism and clearance of circulating LDL. Second, pravastatin inhibits LDL production by inhibiting hepatic synthesis of VLDL, the LDL precursor. Clinical and pathologic studies have shown that elevated levels of total cholesterol (Total- CHOLVASTIN PI V2 Page 2 of 21 C), low density lipoprotein cholesterol (LDL-C) and apolipoprotein B (a membrane transport complex for LDL) promote human atherosclerosis. Similarly decreased levels of HDL-cholesterol (HDL-C) and its transport complex, apolipoprotein A, are associated with the development of atheroscler Прочитајте комплетан документ