País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Candesartan cilexetil
Aurobindo Pharma Australia Pty Ltd
Candesartan cilexetil
AURO-CANDESARTAN™ 4, 8, 16 AND 32 CONSUMER MEDICINE INFORMATION Candesartan cilexetil tablets WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about AURO-CANDESARTAN. It does not contain all the information that is known about AURO-CANDESARTAN. 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 AURO- CANDESARTAN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT AURO-CANDESARTAN IS USED FOR Candesartan cilexetil is a type of medicine called an angiotensin II - receptor antagonist (or blocker). AURO-CANDESARTAN is used to treat high blood pressure, also called hypertension. AURO-CANDESARTAN is also used to treat heart failure. It is used in combination with other medicines to treat your condition. HYPERTENSION: All people have blood pressure. This pressure helps to push blood all around your body. Your blood pressure changes during the day, depending on how busy you are or how you are feeling. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. Regular blood pressure checks are the only way of knowing that you have hypertension. There are usually no symptoms of hypertension and you may feel fine. If hypertension is not treated, serious health problems such as stroke or heart attack and heart or kidney failure may occur. AURO-CANDESARTAN lowers blood pressure by dilating (expanding) small blood vessels from the heart, letting the blood be pumped around the body more easily. HEART FAILURE: Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack and does not mean that the heart stops working. Heart failure may start off wit Leer el documento completo
Page 1 of 14 PRODUCT INFORMATION AURO-CANDESARTAN 4, 8, 16 AND 32 TABLETS NAME OF THE MEDICINE Active ingredient: candesartan cilexetil Chemical name: (1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2′-(1H- tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate. CAS number: 145040-37-5 Molecular weight: 611 Molecular formula: C 33 H 34 N 6 O 6 Chemical structure: DESCRIPTION It is a white or almost white powder and is practically insoluble in water, freely soluble in methylene chloride and slightly soluble in anhydrous ethanol. Three polymorphic forms have been identified; crystal form I, crystal form II and an amorphous form. Crystalline form I is used in AURO- CANDESARTAN. AURO-CANDESARTAN is available as tablets containing 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil. AURO-CANDESARTAN tablets contain the following inactive ingredients: lactose, carmellose calcium, hydroxypropylcellulose, magnesium stearate, aluminium magnesium silicate, propylene glycol, iron oxide red (8 mg only) & iron oxide yellow (16 & 32 mg only). PHARMACOLOGY PHARMACODYNAMICS Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a significant role in the pathophysiology of hypertension, heart failure and other cardiovascular disorders. It also has an important role in the pathogenesis of end organ hypertrophy and damage. The major physiological effects of angiotensin II, such as vasoconstriction, aldosterone stimulation, regulation of salt and water homeostasis and stimulation of cell growth, are mediated via the type 1 (AT 1 ) receptor. Page 2 of 14 Candesartan is a prodrug suitable for oral use. It is rapidly converted to the active drug, candesartan, by ester hydrolysis during absorption from the gastrointestinal tract. Candesartan is an angiotensin II receptor antagonist, selective for AT 1 receptors, with tight binding to and slow dissociation from the receptor. It has no agonist activity. Candesartan does not inhibit angiotensin converting enzyme (ACE), Leer el documento completo