País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
glimepiride
Arrow Pharma Pty Ltd
Glimepiride
Registered
APO- GLIMEPIRIDE - Consumer Medicine Information Page 1 of 6 APO- GLIMEPIRIDE _glimepiride _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APO- GLIMEPIRIDE. It does not contain all of the available information. 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 this medicine against the benefits this medicine is expected to have for you. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT APO- GLIMEPIRIDE IS USED FOR _ _ The name of your medicine is APO-GLIMEPIRIDE. It contains the active ingredient, glimepiride. It is used to control blood glucose in patients with Type II diabetes mellitus. This type of diabetes is also known as non-insulin-dependent diabetes mellitus (NIDDM) or maturity onset diabetes. Glimepiride is used when diet and exercise are not enough to control your blood glucose. Glimepiride can be used alone, or together with insulin or other medicines for treating diabetes. _HOW IT WORKS _ Glimepiride belongs to a group of medicines called sulphonylureas. Glimepiride lowers high blood glucose by increasing the amount of insulin produced by your pancreas. If your blood glucose is not properly controlled, you may experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose). Hypoglycaemia (low blood glucose) can occur suddenly. Signs may include: • Weakness, trembling or shaking • Sweating • Lightheadedness, dizziness, headache or lack of concentration • Tearfulness or crying • Irritability • Hunger • Numbness around the lips and tongue If not treated prompted, these may progress to: • Loss of co-ordination • Slurred speech • Confusion • Loss of consciousness or seizures Hyperglycaemia (high blood glucose) usually occurs more slowly than low blood glucose. Signs of high blood glucose may incl Leer el documento completo
APO-GLIMEPIRIDE TABLETS- Product Information Page 1 of 10 PRODUCT INFORMATION APO-GLIMEPIRIDE NAME OF THE MEDICINE APO-Glimepiride AUSTRALIAN APPROVED NAME Glimepiride CHEMICAL STRUCTURE APO-Glimepiride tablets contain glimepiride which is a member of the sulfonylurea group of oral antidiabetic agents. Chemical Name: _trans_-1-{4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]- phenylsulfonyl}-3-(4-methylcyclohexyl)urea. Structural Formula: Molecular Formula: C 24 H 34 N 4 O 5 S Molecular Weight: 490.63 CAS Registry Number: 93479-97-1 DESCRIPTION Glimepiride is a white odourless, crystalline powder, practically insoluble in methanol and water, slightly soluble in ethanol and sparingly soluble in methylene chloride. Each APO-Glimepiride tablet contains glimepiride as active ingredient and the excipients: lactose, microcrystalline cellulose, sodium starch glycollate, povidone, magnesium stearate, iron oxide red (1 mg tablets only), iron oxide yellow (2 mg and 3 mg tablets only) and indigo carmine (2 mg and 4 mg tablets only). PHARMACOLOGY PHARMACODYNAMICS _Mechanism of Action _ _ _ Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentrations. The primary mechanism of action of glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion in the rhythm of meals. In addition, extrapancreatic effects (e.g. reduction of basal hepatic glucose production and increased peripheral tissue sensitivity to insulin and glucose uptake) may also play a limited role in the activity of glimepiride. APO-GLIMEPIRIDE TABLETS- Product Information Page 2 of 10 In nonfasting diabetic patients, the hypoglycaemic action of a single dose of glimepiride persists for 24 hours. Evidence from _in vitro_ and animal studies suggests that there is lower glucagon secretion with glimepiride than glibenclami Leer el documento completo