Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
simvastatin, Quantity: 10 mg
Dr Reddys Laboratories Australia Pty Ltd
Simvastatin
Tablet
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; citric acid; ascorbic acid; butylated hydroxyanisole; pregelatinised maize starch; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black
Oral
28 tablet, 100 tablet, 7 tablet, 90 tablet, 10 tablet, 5 tablet, 60 tablet, 30 tablet
(S4) Prescription Only Medicine
SIMVASTATIN-DRLA is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with SIMVASTATIN-DRLA, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. SIMVASTATIN-DRLA is indicated in patients at high risk of CHD (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. SIMVASTATIN-DRLA is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena
Visual Identification: brown coloured, round, biconvex, film coated tablets debossed 'RDY' on one side and '198' on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-06-01
SIMVASTATIN-DRLA _Simvastatin _ CONSUMER MEDICINE INFORMATION PAGE 1 OF 6 Simvastatin-DRLA_CMI_v02_January, 2012 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SIMVASTATIN- DRLA. 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 SIMVASTATIN-DRLA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SIMVASTATIN- DRLA IS USED FOR? SIMVASTATIN-DRLA helps to lower cholesterol and triglyceride levels. SIMVASTATIN-DRLA is used in people who have coronary heart disease (CHD) or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease). SIMVASTATIN-DRLA may be used in these people, regardless of their cholesterol level to: • help prolong life by reducing the risk of a heart attack • reduce the risk of stroke • reduce the need for surgery to increase blood flow to the heart • reduce the need for hospitalisation due to angina. _CHOLESTEROL _ Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem. Your body makes cholesterol, but it also comes from food. Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body. However, if you eat a diet high in fat your body may not keep this balance and your cholesterol levels rise. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol. When you have high levels of cholesterol, it may 'stick' to the inside of your Læs hele dokumentet
Dr Reddy’s Laboratories (Australia) Pty Ltd Product Information SIMVASTATIN-DRLA_PI_v03_Mar, 2013 Page 1 of 21 PRODUCT INFORMATION SIMVASTATIN-DRLA TABLETS Simvastatin is a lipid-lowering agent derived synthetically from a fermentation product of Aspergillusterreus. NAME OF THE MEDICINE Simvastatin is described chemically as [1_S_-[1α, 3α, 7β, 8β (2_S_*,4_S_*),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7- dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2_H_-pyran-2-yl) ethyl]-1-naphthalenyl 2,2-dimethylbutanoate. Its empirical formula is C 25 H 38 O 5 and its molecular weight is 418.57. Its structural formula is: Simvastatin chemical abstract number is - CAS−79902-63-9 DESCRIPTION Simvastatin is a whitecrystalline powder, practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Each tablet for oral administration contains either 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following non-medicinal ingredients: butylatedhydroxyanisole, ascorbic acid, citric acid-anhydrous, cellulose-microcrystalline, starch-pregelatinised maize, magnesium stearate, lactose, hypromellose, hydroxypropylcellulose, titanium dioxide, iron oxide red C177491, iron oxideyellowC177492, iron oxideblackC177499. PHARMACOLOGY CLINICAL PHARMACOLOGY The involvement of low-density lipoprotein-cholesterol (LDL-C) in atherogenesis has been well documented in clinical and pathological studies, as well as in many animal experiments. Epidemiological studies have established that high LDL-C and low high-density lipoprotein-cholesterol (HDL-C) are both risk factors for coronary heart disease (CHD). After oral ingestion, simvastatin, which is an inactive lactone, is hydrolysed to the corresponding β- hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3- methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which catalyses an early and rate-limiting step in the biosynthesis of cholesterol. As a result, in clinical studies simvastatinreduced total plasma cholesterol (total-C), LDL-C and very low-de Læs hele dokumentet