国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
PHARMAFORTE (MALAYSIA) SDN. BHD.
GLICLAZIDE
100Tablet Tablets
PT DEXA MEDICA
GLUCODEX TABLET Gliclazide (80mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What GLUCODEX is used for 2. How GLUCODEX works 3. Before you use GLUCODEX 4. How to use GLUCODEX 5. While you are using it 6. Side effects 7. Storage and Disposal of GLUCODEX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT GLUCODEX IS USED FOR GLUCODEX is a medicine used to lower blood glucose level in adult patients with type 2 diabetes mellitus when proper diet, physical exercise, and weight loss are not sufficient to control blood glucose. HOW GLUCODEX WORKS GLUCODEX is an antidiabetic agent belongs to a subfamily of medicines called sulfonylureas. It stimulates insulin secretion by the pancreas in the body. Insulin is made by special cells in the pancreas known as beta cells. In type 2 diabetes you either do not make enough insulin for your body`s needs, and/or the cells in your body are not able to use the insulin properly. By stimulating the beta cells in the pancreas, GLUCODEX causing more insulin to be produced and this helps to decrease the amount of sugar in your blood. BEFORE YOU USE GLUCODEX - _When you must not use it_ _ _ Do not take GLUCODEX if: _ _ • You have insulin-dependent diabetes or experienced of diabetes coma. • You are diabetic patients with acidosis (an accumulation of acid in the body) and ketosis (where the body converts fat into energy) complications. • You are about to undergo surgery, or if you have severe trauma or infection. • You have diabetes mellitus which occurred during childhood or growing period. • You have ever had an allergic or hypersensitivity reaction to gliclazide or to other sulfonylureas. _ _ _Pregnancy and lactation _ Do not take GLUCODEX if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take GLUCODEX if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Before you start use it _ _ _ Talk to your doctor or pharmacist 完全なドキュメントを読む
C. LEAFLET GLUCODEX DESCRIPTION : Round, white tablet, flat bevelled edge surfaces, odorless, tasteless, printed a break-line on side I and “DEXA” on side II. COMPOSITION : Each tablet contains :Gliclazide........................................................80 mg ACTION/PHARMACOLOGY : Gliclazide is a hypoglycaemic sulfonylurea which stimulates insulin secretion by the pancreas. Its action on insulin secretation is mainly due to the restoration of the early phase, resulting in a physiological release of insulin.Gliclazide has been reported to increase glucose metabolism at a peripheral level. This extrapancreatic action is not due to a modification in the number of insulin receptor, but may be due to the potentiation of the “post-receptor pathway”. Therefore, gliclazide improves glycaemic control throughout 24 hours. This can normalize fasting and post-prandial blood sugar. In human, apart from having hypoglycaemic effect, gliclazide has been reported to reduce platelet hyperadhesiveness and hyperaggregation and to increase fibrinolytic activity. These factors are important in diabetes mellitus patients with vascular complications. Study in patients with diabetes retinopathy shows that gliclazide can slow down the progression of retinopathy. PHARMACOKINETICS Oral absorption of gliclazide is similar in patients and healthy volunteers, although intersubject variation in time to reach peak plasma concentrations (t max ) and age-related differences in peak plasma concentrations (C max ) and t max have been observed. Single-dose oral administration of gliclazide 40 to 120 mg results in a C max of 2.2 to 8 mg/L within 2 to 8 hours. C max and t max are increased after repeated gliclazide administration, although drug accumulation has not been observed. Steady-state concentrations are achieved after 2 days administration of gliclazide 40 to 120 mg. The volume of distribution of gliclazide in healthy volunteers and patients is low (13 to 24L) which may be partially explained by extensive protein binding (85 to 9 完全なドキュメントを読む