Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
pravastatin sodium, Quantity: 20 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, uncoated
Excipient Ingredients: croscarmellose sodium; magnesium stearate; povidone; microcrystalline cellulose; lactose monohydrate; iron oxide yellow; magnesium oxide
Oral
3 tablets, 100 tablets, 30 tablets
(S4) Prescription Only Medicine
As an adjunct to diet for the treatment of hypercholesterolemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. PRAVACHOL is indicated in patients with previous myocardial infarction and average (normal) serum cholesterol levels (see CLINICAL TRIALS). INDICATIONS AS AT 23 JANUARY 2004: As an adjunct to diet for the treatment of hypercholesterolemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. PRAVACHOL is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. PRAVACHOL is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS). PRAVACHOL 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 TRAILS).
Visual Identification: Yellow capsule shaped bi-convex tablet with a "20" engraved on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2000-03-06
160517 PRAVACHOL CMI V1 Page 1 of 3 PRAVACHOL ® _pravastatin sodium _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET The information in this leaflet will answer some of the questions you may have about _PRAVACHOL_. This leaflet does not tell you everything about the medicine. 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. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. You should read this leaflet carefully before starting _PRAVACHOL_ and keep it in a safe place to refer to later. WHAT IS IT 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. _ _ It 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. It 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 are also being given immunosuppressive medicine. It is used to treat long-term (chronic) conditions so it is important that you take your _PRAVACHOL_ every day. It is not addictive or habit Soma hati kamili
1 AUSTRALIAN PRODUCT INFORMATION PRAVACHOL (PRAVASTATIN SODIUM) TABLETS 1 NAME OF THE MEDICINE PRAVACHOL (Pravastatin Sodium). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PRAVACHOL 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 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. PRAVACHOL tablets are available in 10mg, 20mg, 40mg and 80mg. Excipients of known effect: lactose. For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PRAVACHOL is available as yellow capsule shaped biconvex tablets containing 10mg, 20mg, 40mg or 80mg pravastatin sodium. The 10mg tablet (8.8 x 4.4mm) is engraved “10” on one side, the 20mg tablet (11.0 x 5.5mm) is engraved “20” on one side, the 40mg tablet (14.0 x 7.0mm) is engraved “40” on one side, the 80mg tablet (17.6 x 8.8mm) is engraved “80” on one side. The tablets are supplied in blister packs containing 30 tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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 2. PRAVACHOL is indicated in patients with previous myocardial infarction including those who have normal (4.0 – 5.5 mmol/L) serum c Soma hati kamili