国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Fimasartan Potassium Trihydrate
ZUELLIG PHARMA SDN BHD
Fimasartan Potassium Trihydrate
30tablet Tablets
Boryung Corporation
_Consumer Medication Information Leaflet (RiMUP) _ KANARB ® Fimasartan Potassium trihydrate/ Fimasartan (60 mg, 120 mg) 1 WHAT IS IN THIS LEAFLET 1. What Kanarb ® is used for 2. How Kanarb ® works 3. Before you use Kanarb ® 4. How to use Kanarb ® 5. While you are using it 6. Side Effects 7. Storage and disposal of Kanarb ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1. WHAT KANARB ® IS USED FOR Kanarb ® (Fimasartan potassium trihydrate) is indicated for the treatment of essential hypertension. 2. HOW KANARB ® WORKS Kanarb ® is an angiotensin II receptor antagonist, which selectively binds to the AT 1 receptor with a high affinity, giving very potent anti-hypertensive effect. 3. BEFORE YOU USE KANARB ® - _When you must not use it _ _ _ Kanarb ® is contraindicated in the following patients: a) Patients who are hypersensitive to any component in this product b) Pregnant or nursing mothers c) Hemodialysis patients (no experience in this population) d) Patients with moderate to severe hepatic impairment e) Patients with hepatobiliary obstruction f) Patients with diabetes or renal impairment (GFR <60 mL/min) who are taking aliskiren g) Patients with diabetic nephropathy who are taking angiotensin converting enzyme (ACE) inhibitors h) Patients with genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose- galactose malabsorption (since Kanarb ® contains lactose) i) Drugs directly acting on the rennin- angiotensin system may cause injury or death to the developing fetus when administered to a pregnant woman during the second and third trimesters. Therefore, Kanarb ® should be discontinued when pregnancy is detected in female patients. - _Taking other medicines _ _ _ A) _POTASSIUM _ _SUPPLEMENTS _ _AND _ _POTASSIUM-SPARING _ _ DIURETICS_: Serum potassium can be increased by Kanarb ® and other drugs that exert effects on the renin- angiotensin system when co- administered with potassium- sparing diuretics (e.g., spirinolactone), pota 阅读完整的文件
0422/ 말레이시아 _Read package insert carefully before use._ _Consult your doctor for more information._ _Prescription medicine only. Keep out of reach of children._ Brand or Product Name Kanarb ® Film Coated Tablets 60mg and 120mg Name and Strength of Active Substance(s) Fimasartan 60 mg contains 66.01 mg of fimasartan potassium trihydrate (or 60 mg as fimasartan potassium. Fimasartan 120 mg contains 132.02 mg of fimasartan potassium trihydrate (or 120 mg as fimasartan potassium. Product Description Kanarb ® Film Coated Tablet 60mg is a yellow film-coated hexagonal tablet, the front side of which is engraved with “FMS6”. The backside of Kanarb ® Film Coated Tablet 60mg is engraved with “BR” and there is a split line in the middle. Kanarb ® Film Coated Tablet 120 mg is an orange film-coated hexagonal tablet, the front side of which is engraved with “FMS12”. The backside of Kanarb ® Film Coated Tablet 120mg is engraved with “BR” and there is a split line in the middle. Pharmacodynamics/Pharmacokinetics _Pharmacokinetic Characteristics of Fimasartan_ _Absorption_ Time to peak plasma concentration (Tmax) following single oral administration of fimasartan at doses of 20 – 480 mg in healthy subjects ranged 0.5 – 3 hours with the terminal half-life (t1/2) being 5 – 16 hours. Similar results were obtained in patients with hypertension, i.e., Tmax ranged 0.5 – 1.3 hours and t1/2 were 7 – 10 hours following fimasartan administration at doses 20 – 180 mg. Several subjects showed a second peak, and the total systemic exposure as assessed by the area under the concentration-time curve was linear (i.e., dose-independent). Accumulation index was 1.20 – 1.26 and 1.02 – 1.08 for healthy subjects and patients, respectively. The absolute bioavailability of fimasartan in healthy subjects following 60 mg oral administration compared to 30 mg intravenous infusion was estimated to be 19%. These results support the notion that oral fimasartan is rapidly absorbed, have linear pharmacokinetic pro 阅读完整的文件