Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 86.76 mg (Equivalent: atorvastatin, Qty 80 mg)
Arrotex Pharmaceuticals Pty Ltd
atorvastatin calcium trihydrate
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; polysorbate 80; lactose monohydrate; magnesium stearate; calcium carbonate; hyprolose; microcrystalline cellulose; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; PEG-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc
Oral
100
(S4) Prescription 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 to off-white, elliptical, film-coated tablets debossed 'AS80' on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2011-09-23
APO-ATORVASTATIN 1 APO-ATORVASTATIN _Atorvastatin calcium trihydrate _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some of the more common questions about APO- Atorvastatin. 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 this medicine 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Atorvastatin. It contains the active ingredient atorvastatin. Atorvastatin is used to lower high cholesterol levels. It 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). 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. When you have high levels of 'bad' cholesterol in read_full_document
1 AUSTRALIAN PRODUCT INFORMATION – APO-ATORVASTATIN (ATORVASTATIN CALCIUM TRIHYDRATE) TABLETS 1 NAME OF THE MEDICINE Atorvastatin as calcium trihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains atorvastatin calcium trihydrate equivalent to 10 mg, 20 mg, 40 mg and 80 mg atorvastatin. EXCIPIENTS WITH KNOWN EFFECT Contains sugars as lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 10 MG TABLETS White to off-white, elliptical, film-coated tablets debossed ‘AS10’ on one side and plain on the other side. 20 MG TABLETS White to off-white, elliptical, film-coated tablets debossed ‘AS20’ on one side and plain on the other side. 40 MG TABLETS White to off-white, elliptical, film-coated tablets debossed ‘AS40’ on one side and plain on the other side. 80 MG TABLETS White to off-white, elliptical, film-coated tablets debossed ‘AS80’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atorvastatin 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. Atorvastatin 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 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS, PREVENTION OF CARDIOVASCULAR DISEASE) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. 2 These effects do not replace the need to independently control known causes of cardiovascular (CV) mortality and morbidity such as hypertension, diabetes and smoking. 4.2 DOSE AND METHOD OF ADMINISTRATION read_full_document