Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Pravastatin sodium 20mg; ; ;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Pravastatin sodium 20 mg
20 mg
Tablet
Active: Pravastatin sodium 20mg Excipient: Croscarmellose sodium Iron oxide yellow Lactose monohydrate Magnesium oxide Magnesium stearate Microcrystalline cellulose Povidone
Aluminium foil, blister, 30 tablets
Prescription
Prescription
Biocon Limited
1. In hypercholesterolemic patients without clinically evident coronary heart disease, PRAVACHOL is indicated as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. 2. PRAVACHOL is indicated for the reduction of elevated total and LDL-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. 3. PRAVACHOL is indicated as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease.
Package - Contents - Shelf Life: Aluminium foil, blister - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Blister pack, - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light
1998-03-05
NEW ZEALAND CONSUMER MEDICINE INFORMATION PRAVACHOL ® _Pravastatin sodium _ CONSUMER MEDICINE INFORMATION This medicine your doctor has prescribed for you is called _PRAVACHOL_. The information in this leaflet will answer some of the questions you may have about _PRAVACHOL_. This leaflet does not tell you everything about _PRAVACHOL_. Your doctor and pharmacist have been provided with full information and can answer any questions you may have. This leaflet is no substitute for talking with your doctor or pharmacist. You should follow all advice from your doctor when being treated with this medicine. This information is not intended to replace your doctor's advice. You should read this leaflet carefully before starting _PRAVACHOL_ and keep it in a safe place to refer to later. WHAT IS PRAVACHOL USED FOR? _PRAVACHOL_ is used to treat people who have had a heart attack or an episode of unstable angina, or who have high blood cholesterol levels. In these people _PRAVACHOL_ can reduce the risk of further heart disease, reduce the possibility of needing a bypass operation, or reduce the risk of having a stroke. _ _ _PRAVACHOL_ lowers high blood cholesterol levels (Doctors call this hypercholesterolaemia). It is also used if your cholesterol levels are normal if you have had a heart attack or an episode of unstable angina. _PRAVACHOL_ is used to treat heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older as an adjunct to diet and lifestyle changes. If you have had a heart attack, an episode of unstable angina or you have too much cholesterol in your blood, then you have an increased risk of a blood clot forming in your blood vessels and causing a blockage. Blood vessels that become blocked in this way can lead to further heart disease, angina or stroke. _PRAVACHOL_ may be used to lower lipids in heart or kidney transplant patients, who Les hele dokumentet
PRAVACHOL- New Zealand Datasheet Page 1 of 17 DATA SHEET PRAVACHOL _PRAVASTATIN TABLETS 10MG, 20MG, 40MG _ PRESENTATION PRAVACHOL is available as yellow capsule shaped tablets containing 10mg, 20mg or 40mg of PRAVASTATIN sodium. Inactive ingredients are lactose, povidone magnesium oxide microcrystalline cellulose, croscarmellose sodium yellow iron oxide and magnesium stearate. USES _ _ _ACTIONS _ PRAVACHOL (PRAVASTATIN Sodium, Squibb), designated chemically as (3R,5R)-7- [(1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-Hexahydro-6-hydroxy-2-methyl-8-[(S)-2- methylbutyryloxy-1-naphthyl]]-3,5-dihydroxyheptanoic acid, sodium salt, 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 catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. As with other lipid-lowering therapy, PRAVACHOL is not indicated when hypercholesterolaemia is due to hyperalphalipoproteinaemia (elevated HDL-C). The efficacy of pravastatin has not been evaluated in patients with combined elevated Total-C and hypertriglyceridaemia (>5.64 mmols/L) who may also have elevated intermediate density lipoproteins. PRAVACHOL produces its lipid-lowering effect in two ways. First, as a consequence of its reversible inhibition of HMG-CoA reductase activity, it effects 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. In vitro and animal studies have shown that PRAVASTATIN, a hydrophilic HMG-CoA reductase inhibitor, is tissue selective such that inhibitor activity is highest in those tissues with the highest rates of cholesterol synthesis, such as the lier and ileum (Table 1). PRAVACHOL- Les hele dokumentet