Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IRBESARTAN
Generic Health Sdn. Bhd.
IRBESARTAN
2x14tablet Tablets
Lupin Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ I – SARTAN TABLETS Irbesartan (150 mg and 300 mg.) 1 WHAT IS IN THIS LEAFLET 1. What I-SARTAN TABLETS_ _is used for 2. How I-SARTAN TABLETS works 3. Before you use I-SARTAN TABLETS 4. How to use I-SARTAN TABLETS 5. While you are using it 6. Side effects 7. Storage and Disposal of I- SARTAN TABLETS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1. WHAT I-SARTAN TABLETS_ _IS USED FOR I-SARTAN TABLETS_ _is used to treat: to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function 2. HOW I-SARTAN TABLETS_ _ WORKS Irbesartan is in a group of medicines known as angiotensin‑II receptor antagonists. Angiotensin‑II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin‑II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. 3. BEFORE YOU USE I-SARTAN TABLETS - _When you must not use it _ DO NOT USE I-SARTAN TABLETS if you are allergic (hypersensitive) to irbesartan or any other ingredients if you are more than 3 months pregnant. (It is also better to avoid in early pregnancy I-SARTAN TABLETS_ _should not be given to children and adolescents (under 18 years). _ _ _Pregnancy and lactation _ Do not take I-SARTAN TABLETS_ _ if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking I-SARTAN TABLETS, stop taking it immediately and contact your doctor. Your doctor can discuss with you the risks of using it while you are pregnant. Do not take I-SARTAN TABLETS_ _ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Bef Przeczytaj cały dokument
I – SARTAN 150/300 TABLETS (IRBESARTAN 150 MG/300 MG) DESCRIPTION I-SARTAN 150 Tablets 150mg: White to off-white, oval shaped, film coated tablets with thickness between 4.95 to 5.95mm, plain on one side and ‘I2’ on the other side. I-SARTAN 300 Tablets 300mg: White to off-while, oval shaped, film coated tablets with thickness between 6.30 to 7.30mm, plain on one side and ‘I3’ on the other side. COMPOSITION I-SARTAN 150 Tablets 150mg: Each film coated tablet contains: Irbesartan Ph.Eur….150mg I-SARTAN 300 Tablets 300mg Each film coated tablet contains: Irbesartan Ph.Eur….300mg CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses. Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites. Irbesartan does not require metabolic activation for its activity. PHARMACOKINETIC PROPERTIES _Absorption _ Irbesartan is rapidly absorbed from the gastrointestinal tract with an oral bioavailability of 60 to 80%. Peak plasma concentrations of irbesartan occur 1.5 to 2 hours after an oral dose. Irbesartan may be dosed without regards to meals _Distribution _ Irbesartan is about 96% bound to plasma proteins. The volume of distribution is 53 - 93 litres _ _ _Metabolism _ Irbesartan is metabolised in the liver via glucuronide conjugation and oxidation, primarily by the cytochrome P450 isoenzyme CYP2C9, to inactive metabolites. The major circulating metabolite is irbesartan glucuronide (approximately 6%). _ _ _Elimination _ It Przeczytaj cały dokument