Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
pravastatin sodium, Quantity: 10 mg
Lupin Australia Pty Limited
pravastatin sodium
Tablet, film coated
Excipient Ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; 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-Lupin, 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. Pravastatin-Lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/L) serum cholesterol levels. 3. Pravastatin-Lupin is indicated in patients with unstable angina pectoris (see Clinical Trials). 4. Pravastatin-Lupin is indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 years and older (see Clinical Trials).
Visual Identification: yellow coloured, capsule shaped, biconvex, film coated tablets debossed with '10' on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-07-07
PRAVASTATIN LUPIN ® Pravastatin sodium CONSUMER MEDICINE INFORMATION This medicine your doctor has prescribed for you is called _PRAVASTATIN LUPIN_. The information in this leaflet will answer some of the questions you may have about _PRAVASTATIN LUPIN_. This leaflet does not tell you everything about _PRAVASTATIN LUPIN_. 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 _PRAVASTATIN LUPIN _and keep it in a safe place to refer to later. WHAT IS PRAVASTATIN LUPIN USED FOR? _PRAVASTATIN LUPIN _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 _PRAVASTATIN LUPIN _can reduce the risk of further heart disease, reduce the possibility of needing a bypass operation, or reduce the risk of having a stroke. _PRAVASTATIN LUPIN _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. _PRAVASTATIN LUPIN _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. _PRAVASTATIN LUPIN _may be used to lower lipids in heart or kidney transplant patients, who are also being given immunosuppressive medicine. _PRAVASTATIN LUPIN _is used to treat long- term ( Izlasiet visu dokumentu
PRAVASTATIN-LUPIN TABLETS NAME OF THE MEDICINE: PRAVASTATIN SODIUM EMPIRICAL FORMULA: C 23 H 35 NaO 7 MOLECULAR WEIGHT: 446.52 CAS: 81131-70-6. 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. Pravastatin is designated chemically as:_ _(3_R_, 5_R_)-7-[(1_S_, 2_S_, 6_S_, 8_S_, 8a_R_)-1, 2, 6, 7, 8, 8a-Hexahydro-6-hydroxy-2-methyl- 8-[(_S_)-2- methylbutyryloxy-1-naphthyl]]-3, 5-dihydroxyheptanoic acid, sodium salt. Pravastatin sodium is an odourless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin-Lupin tablets contain the following inactive ingredients: lactose, crospovidone, sodium bicarbonate, silica - colloidal anhydrous, magnesium stearate, Opadry 03F52262 yellow, water-purified. PHARMACOLOGY: 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-C), low density lipoprotein cholesterol (LDL-C) and apolipoprotein B (a membrane transport complex for LDL) promote human atherosclerosis. Similarly decreased levels of HDL-chole Izlasiet visu dokumentu