Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium, Quantity: 41.36 mg (Equivalent: atorvastatin, Qty 40 mg)
Arrotex Pharmaceuticals Pty Ltd
Atorvastatin calcium
Tablet, film coated
Excipient Ingredients: hyprolose; activated attapulgite; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000
Oral
40, 50, 30, 20, 10
(S4) Prescription Only Medicine, (S3) Pharmacist Only Medicine
As an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,Indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see CLINICAL TRIALS, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.
Visual Identification: White, oblong bi-convex tablets; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-09-16
Atorvastatin AMNEAL CMI v7.0 - 1 - ATORVASTATIN AMNEAL Consumer Medicine Information Atorvastatin calcium film coated tablets _ _ WHAT IS IN THIS LEAFLET This leaflet answers some of the more common questions about Atorvastatin AMNEAL. It does not contain all of 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 Atorvastatin AMNEAL against the benefits he/she expects it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. _ _ WHAT IS ATORVASTATIN AMNEAL USED FOR Atorvastatin AMNEAL is used to lower high cholesterol levels. Atorvastatin AMNEAL is also used to help reduce the risk of having a heart attack or stroke in people who have high blood pressure and coronary heart disease (CHD) or who are at risk of CHD. Examples of risk factors for CHD include diabetes, a history of stroke, or small blood vessel disease. WHAT IS CHOLESTEROL? Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for many things, such as building the cell lining, making bile acids (which help to digest food) and some hormones. However, too much cholesterol can be a problem. Cholesterol is present in many foods and is also made in your body by the liver. If your body makes too much cholesterol or you have too much cholesterol in your diet, then your level becomes too high. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol. There are different types of cholesterol. LDL, or low-density lipoprotein, is the 'bad' cholesterol that can block your blood vessels. HDL, or high density lipoprotein, cholesterol is the 'good' cholesterol that is thought to remove the bad cholesterol from the blood vessels. Atorvastatin AMNEAL CMI v7.0 - 2 - When you have high levels of 'bad' cholesterol in your blood, it may begin Baca dokumen lengkapnya
1 AUSTRALIAN PRODUCT INFORMATION – ATORVACHOL (ATORVASTATIN CALCIUM) FILM COATED TABLETS 1 NAME OF THE MEDICINE Atorvastatin calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ATORVACHOL tablets contain atorvastatin calcium equivalent to 10, 20, 40 and 80 mg atorvastatin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ATORVACHOL is available as: 10mg white, oval, biconvex, film-coated tablets. 20mg white, oval, biconvex, film-coated tablets with a breakline on one side. 40mg white, oblong, biconvex, film-coated tablets. 80mg white, oblong, biconvex, film-coated tablets with a breakline on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ATORVACHOL is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated. ATORVACHOL is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see section 5.1 CLINICAL TRIALS, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non- fatal stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking._ _ 2 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE ATORVACHOL can be administered within the dosage range of 10–80 mg/day as a single daily dose. Therapy should be individualised according to the target lipid levels, the recommended goal of therapy and the patient's response. After initiation and/or upon titration of ATORVACHOL, lipid levels should be re-analysed within 4 weeks and dosage adjuste Baca dokumen lengkapnya