Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
Irbesartan
Sanofi-Aventis Australia Pty Ltd
Irbesartan
IRBESARTAN WINTHROP ® _irbesartan_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Irbesartan Winthrop. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the benefits of you taking this medicine against the risks 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 IRBESARTAN WINTHROP IS USED FOR Irbesartan Winthrop is used to lower high blood pressure, which doctors call hypertension. Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. There are often no symptoms of high blood pressure. The only way of knowing that you have high blood pressure is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, such as stroke, heart disease and kidney failure. Irbesartan Winthrop is also used in the treatment of kidney disease in patients with high blood pressure and type 2 diabetes. _HOW IRBESARTAN WINTHROP_ _WORKS_ Irbesartan Winthrop belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to narrow. Irbesartan Winthrop blocks angiotensin-II and therefore widens your blood vessels, making it easier for your heart to pump blood throughout your body. This helps to lower your blood pressure. Irbesartan Winthrop also slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Your doctor may have prescribed Irbesartan Winthrop Կարդացեք ամբողջական փաստաթուղթը
PRODUCT INFORMATION February 2017 Irbesartan Winthrop - irbesartan irbesartan-winthrop-ccdsv14-piv6-27feb17 1 PRODUCT INFORMATION IRBESARTAN WINTHROP ® NAME OF THE MEDICINE AUSTRALIAN APPROVED NAME Irbesartan: 2-butyl-3-[(2'-(1 _H_ -tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-diazaspiro[4.4]non-1-en-4- one. CHEMICAL STRUCTURE The chemical structure of irbesartan is: The empiric formula is C 25 H 28 N 6 O and the molecular weight, 428.5. The CAS registry number for irbesartan is: CAS-138402-11-6. DESCRIPTION Irbesartan is a white, to practically white powder that is less than 0.1mg/mL soluble in water and slightly soluble in alcohol and methylene chloride. Irbesartan is a nonpeptide angiotensin II receptor (AT 1 subtype) antagonist. It is available as 75, 150 or 300 mg film-coated tablets for oral administration. The white, biconvex oval shaped tablets are debossed with a heart on one side and 2871 (75 mg) or 2872 (150 mg) or 2873 (300 mg) engraved on the other side. The inactive ingredients are: carnauba wax, croscarmellose sodium, hypromellose, lactose, macrogol 3000, magnesium stearate, microcrystalline cellulose, silicon dioxide, and titanium dioxide. N N O (CH 2 ) 3 CH 3 N N N N H PRODUCT INFORMATION February 2017 Irbesartan Winthrop - irbesartan irbesartan-winthrop-ccdsv14-piv6-27feb17 2 PHARMACOLOGY PHARMACODYNAMICS Irbesartan is a specific antagonist of angiotensin II receptors (AT 1 subtype). Angiotensin II is an important component of the renin-angiotensin system and is involved in the pathophysiology of hypertension and in sodium homeostasis. Irbesartan does not require metabolic activation for its activity. Irbesartan blocks the potent vasoconstrictor and aldosterone-secreting effects of angiotensin II by selective antagonism of the angiotensin II (AT 1 subtype) receptors localized on vascular smooth muscle cells and in the adrenal cortex. It has no agonist activity at the AT 1 receptor and a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor (a receptor that has Կարդացեք ամբողջական փաստաթուղթը