Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Repaglinide
Novo Nordisk Pharmaceuticals Pty Ltd
Medicine Registered
NovoNorm ® Page 1 of 5 NovoNorm-cmi13.doc NOVONORM ® _Repaglinide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHAT NOVONORM ® IS USED FOR .. 1 BEFORE YOU TAKE NOVONORM ® ... 1 HOW TO TAKE NOVONORM ® ......... 2 WHILE YOU ARE TAKING NOVONORM ® .................................................... 3 SIDE EFFECTS ................................. 4 AFTER USING NOVONORM ® ........... 4 PRODUCT DESCRIPTION ................. 4 FURTHER INFORMATION ................. 5 This leaflet answers some common questions about NovoNorm ® . It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. All medicines have risks and benefits. Your doctor has weighed the risks of you taking NovoNorm ® 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 NOVONORM ® IS USED FOR NovoNorm ® is used to control blood glucose levels in patients with type 2 diabetes mellitus. This type of diabetes is also known as non- insulin-dependent diabetes mellitus (NIDDM) or maturity onset diabetes. NovoNorm ® is used when diet and exercise are not enough to control your blood glucose level. NovoNorm ® can be used alone, or together with insulin or other medicines for treating diabetes. NovoNorm ® lowers high blood glucose levels by helping your pancreas to produce more insulin. This medicine is only available with a doctor’s prescription. There is no evidence that NovoNorm ® is addictive. BEFORE YOU TAKE NOVONORM ® _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE NOVONORM ® IF: 1. You have an allergy to NovoNorm ® or any of the ingredients listed at the en Soma hati kamili
Product Information NovoNorm-pi12.doc Page 1 of 13 PRODUCT INFORMATION NOVONORM NAME OF THE MEDICINE Repaglinide. Repaglinide has one asymmetric centre. Repaglinide is the pure enantiomer named Benzoic acid, 2-ethoxy-4-[2-[[3-methyl-1-[2-(1-piperidinyl) phenyl] butyl] amino] -2-oxoethyl] -, (S)(+) -. The CAS number for repaglinide is 135062-02-1. Structure: H 3 C CH CH 3 CH 2 CH 3 CH 2 C N H N H C O O CH 2 C OH O DESCRIPTION Repaglinide is a white to off-white powder with needle shaped crystals. It is slightly soluble in aqueous acid, very slightly soluble in aqueous base and freely soluble in methanol and ethanol. The pKa values are pKa 1 (acid) = 3.9; pKa 2 (amine) = 6.0. Molecular formula: C 27 H 36 N 2 O 4 . Molecular weight: 452.6 NovoNorm tablets also contain poloxamer, povidone, meglumine, maize starch, calcium hydrogen phosphate anhydrous, microcrystalline cellulose, glycerol, water, polacrilin potassium and magnesium stearate as inactive ingredients. The 1.0 mg tablets also contain iron oxide yellow and the 2.0 mg tablets contain iron oxide red as colouring agents. PHARMACOLOGY PHARMACODYNAMICS Repaglinide is a novel short-acting oral hypoglycaemic agent structurally unrelated to the sulphonylurea drugs. It lowers blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect which is dependent upon functioning beta cells in the pancreatic islets. Product Information NovoNorm-pi12.doc Page 2 of 13 Repaglinide closes ATP-dependent potassium channels in the -cell membrane by binding to sites which are pharmacologically distinguishable from the sulphonylurea binding sites. This depolarises the -cell and leads to an opening of the calcium channels. The resulting increased calcium influx induces secretion from the -cell. The pharmacology of repaglinide differs from other oral hypoglycae Soma hati kamili