Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
pravastatin sodium, Quantity: 80 mg
Amneal Pharma Australia Pty Ltd
pravastatin sodium
Tablet, uncoated
Excipient Ingredients: croscarmellose sodium; povidone; microcrystalline cellulose; iron oxide yellow; lactose monohydrate; heavy magnesium oxide; magnesium stearate
Oral
30
(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. Pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/L) serum cholesterol levels.,3. Pravastatin is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS).,4. Pravastatin 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, oval shaped, biconvex, mottled uncoated tablets debossed with 'R' on one side and '80' on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2012-10-24
PRAVASTATIN AN CONSUMER MEDICINE INFORMATION Ver 1.0 Page 1 of 5 PRAVASTATIN AN Pravastatin Sodium CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about pravastatin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. ASK YOUR DOCTOR OR PHARMACIST: if there is anything you do not understand in this leaflet, if you are worried about taking your medicine, or to obtain the most up-to-date information All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Keep this leaflet with your medicine. You may want to read it again. WHAT PRAVASTATIN AN IS USED FOR The name of your medicine is PRAVASTATIN AN. It contains the active ingredient, pravastatin sodium. It is used, together with changes in the diet, to treat: people who have high blood cholesterol levels people who have had a heart attack (even if their blood cholesterol levels are normal) people who have had an episode of unstable angina In these people pravastatin can reduce the risk of having a stroke, reduce the risk of further heart disease, or reduce the possibility of needing a bypass operation. It is also used to treat children and adolescent patients aged 8 years and older who have heterozygous familial hypercholesterolaemia (an inherited disorder which produces high blood cholesterol levels). This is in combination with diet and lifestyle changes. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _ _ HOW IT WORKS Pravastatin lowers high blood cholesterol levels (doctors call this hypercholesterolaemia. It is more effective if it is taken with a cholesterol lowering diet. If you have had a heart at Đọc toàn bộ tài liệu
_Pravastatin AN tablets Product Information _ _ Amneal Pharma Australia Pty Ltd _ Pravastatin AN PI v2.0 Page 1 of 21 PRAVASTATIN AN _ _ _(PRAVASTATIN SODIUM TABLETS) _ _ _ PRODUCT INFORMATION _ _ NAME OF THE MEDICINE The name of this medicine is pravastatin sodium. CHEMICAL NAME: 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. MOLECULAR FORMULA: C 23 H 35 O 7 Na MOLECULAR WEIGHT: 446.52 CAS REGISTRY NUMBER: _[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 sodium is white to yellowish white crystalline powder. It is freely soluble in water, methanol, glacial acetic acid & soluble in ethanol. PRAVASTATIN AN is available as tablets containing 10, 20, 40 & 80 mg of pravastatin sodium. _PRAVASTATIN AN 10_ Yellow, capsule shaped, biconvex, mottled uncoated tablets with notched sides at double bisect, debossed with ‘R’ on one side and ‘10’ on the other side. _PRAVASTATIN AN 20_ Yellow, capsule shaped, biconvex, mottled uncoated tablets with notched sides at double bisect, debossed with ‘R’ on one side and ‘20’ on the other side. _Pravastatin AN tablets Product Information _ _ Amneal Pharma Australia Pty Ltd _ Pravastatin AN PI v2.0 Page 2 of 21 _PRAVASTATIN AN 40_ Yellow, capsule shaped, biconvex, mottled uncoated tablets debossed with ‘R’ on one side and ‘40’ on the other side. _PRAVASTATIN AN 80_ Yellow, oval shaped, biconvex, mottled uncoated tablets debossed with ‘R’ on one side and ‘80’ on the other side. PRAVASTATIN AN tablets contain the following inactive ingredients: lactose, povidone, microcrystalline cellul Đọc toàn bộ tài liệu