Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Atorvastatin calcium trihydrate 21.65mg equivalent to atorvastatin 20 mg
PSM Healthcare Ltd trading as API Consumer Brands
Atorvastatin calcium trihydrate 21.65 mg (equivalent to atorvastatin 20 mg)
20 mg
Film coated tablet
Active: Atorvastatin calcium trihydrate 21.65mg equivalent to atorvastatin 20 mg Excipient: Butylated hydroxyanisole Colloidal silicon dioxide Croscarmellose sodium Sepifilm LP 010 Magnesium stearate Mannitol Microcrystalline cellulose Purified water Sodium carbonate Sodium laurilsulfate
Prescription
Ind-Swift Laboratories Limited
Indicated as an adjunct to diet to reduce elevated total-C, LDL-C and TG levels in patients with primary hypercholesterolaemia or mixed dyslipidaemia where the primary abnormality is either elevated cholesterol or triglycerides when response to diet and other non-pharmacological measures is inadequate. Atorvastatin tablet is also indicated to reduce total-C and LDL-C in patients with heterozygous and homozygous familial hypercholesterolaemia.
Package - Contents - Shelf Life: Blister pack, Alu-Alu cold form laminate & aluminium foil, calendar pack of 4 x 7 strips - 28 tablets - 18 months from date of manufacture stored at or below 25°C
2016-07-05
ATORVASTATIN 10mg, 20mg, 40mg, 80mg film-coated tablets (Pharmacare®) 1 ATORVASTATIN 10MG, 20MG, 40MG & 80MG FILM-COATED TABLETS (PHARMACARE®) _Atorvastatin (as Atorvastatin calcium)_ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the more common questions about 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 Atorvastatin 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 ATORVASTATIN IS USED FOR Atorvastatin is used to lower high cholesterol levels. Atorvastatin 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. When you have high levels of 'bad' cholesterol i Διαβάστε το πλήρες έγγραφο
Page 1 of 24 NEW ZEALAND DATA SHEET ATORVASTATIN 10MG, 20MG, 40MG & 80MG FILM-COATED TABLETS (PHARMACARE®) (AS A TORVASTATIN CALCIUM) NAME OF MEDICINE Atorvastatin 10mg, 20mg, 40mg & 80mg film-coated Tablets (Pharmacare®) (as Atorvastatin calcium) Atorvastatin 10mg, 20mg, 40mg & 80mg film-coated Tablets (Pharmacare®) contain the active ingredient atorvastatin calcium. The structural formula of atorvastatin calcium is shown below: NHC N O CH CH 3 CH 3 CH 2 CH 2 CH 2 CH 2 CH CH C O O - F •Ca •3H O 2 2+ OH OH Chemical name: Molecular formula: Molecular weight: 2 [R-(R*,R*)]-2-(4-fluorophenyl)-ß, -dihydroxy-5-(1- methylethyl)-3-phenyl-4-[(phenylamino) carbonyl] -1H-pyrrole-1- heptanoic acid, calcium salt (2:1) (C 33 H 34 FN 2 O 5 ) 2 Ca.3H 2 O 1209.42 CAS registry number: 134523-03-8 DESCRIPTION Atorvastatin calcium is a white to off-white crystalline powder that is practically insoluble in a q u e o u s s o l u t i o n s o f pH 4 a n d below. Atorvastatin c a l c i u m i s very slightly soluble in distilled water, pH 7.4 phosphate buffer and acetonitrile, slightly soluble in ethanol and freely soluble in methanol. A t o r v a s t a t i n 1 0 m g , 2 0 m g , 4 0 m g & 8 0 m g f i l m - c o a t e d t a b l e t s ( P h a r m a c a r e ® ) contain 10 mg, 20 mg, 40 mg o r 80 mg o f atorvastatin (as atorvastatin calcium), and the following inactive ingredients: Bulk tablets: Mannitol, Sodium lauryl sulphate, Colloidal anhydrous silica, Anhydrous sodium carbonate, Butyl hydroyanisole, Microcrystalline cellulose, Croscarmellose sodium and Magnesium stearate. Film coat: Hypromellose, Microcrystalline cellulose and Stearic acid. Page 2 of 24 PHARMACOLOGY PHARMACODYNAMICS Atorvastatin and its metabolites are responsible for pharmacological activity in humans. The liver is its primary site of action and the principal site of cholesterol synthesis and LDL clearance. Drug dose rather than systemic drug concentration correlates better with LDL-C reduction. Individualisation of drug dose should be based on therapeutic Διαβάστε το πλήρες έγγραφο