Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
pioglitazone hydrochloride, Quantity: 33.069 mg (Equivalent: pioglitazone, Qty 30 mg)
Arrotex Pharmaceuticals Pty Ltd
Pioglitazone hydrochloride
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; hyprolose; magnesium stearate; carmellose calcium
Oral
28
(S4) Prescription Only Medicine
Treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise:,as monotherapy,as dual therapy to improve glycaemic control,- in combination with metformin or sulfonylurea,- in combination with insulin,as triple therapy to improve glycaemic control,- in combination with metformin and sulfonylurea
Visual Identification: White to off-white, round, flat faced, bevel edge, uncoated tablets debossed with '32' on one side and 'H' on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2011-12-16
AURO-PIOGLITAZONE CONSUMER MEDICINE INFORMATION Ver 1.1 Page 1 of 4 AURO-PIOGLITAZONE 15, 30 & 45 Pioglitazone hydrochloride CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AURO- PIOGLITAZONE. It does not contain all the available information and does not take the place of talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking AURO-PIOGLITAZONE 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 THIS MEDICINE. You may need to read it again. WHAT AURO-PIOGLITAZONE USED FOR AURO-PIOGLITAZONE is a tablet that is used to improve the action of the body's naturally produced insulin. AURO-PIOGLITAZONE is used in the management of type 2 diabetes not controlled by diet. AURO-PIOGLITAZONE helps to control the level of glucose in your blood when you have type 2 diabetes. This is the 'adult onset' type of diabetes and is controlled by diet, certain oral medications and occasionally insulin. This medicine is also called pioglitazone hydrochloride and belongs to a group of medicines called glitazones. Glitazones decrease insulin resistance. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. AURO-PIOGLITAZONE can be used alone (when diet and exercise is not enough to treat your diabetes) or together with other anti-diabetic medicines. This medicine is available only with a doctor's prescription. The use of AURO-PIOGLITAZONE has not been studied in children. BEFORE YOU TAKE AURO-PIOGLITAZONE WHEN YOU MUST NOT TAKE AURO-PIOGLITAZONE DO NOT TAKE AURO- PIOGLITAZONE IF: • you have heart failure requiring treatment. Talk to your doctor if you have heart failure • you have type 1 diabetes or diabetic ketoacidosis (often caused by very high blood glucose levels) • you have an allergy to any medicine Đọc toàn bộ tài liệu
Product Information: AURO-PIOGLITAZONE (Pioglitazone Tablets 15, 30 & 45 mg) Ver 1.2 Page 1 of 19 PRODUCT INFORMATION AURO-PIOGLITAZONE 15 (15 MG PIOGLITAZONE AS HYDROCHLORIDE) AURO-PIOGLITAZONE 30 (30 MG PIOGLITAZONE AS HYDROCHLORIDE) AURO-PIOGLITAZONE 45 (45 MG PIOGLITAZONE AS HYDROCHLORIDE) NAME OF THE MEDICINE The active ingredient in AURO-PIOGLITAZONE tablets is pioglitazone hydrochloride. CHEMICAL NAME: (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione hydrochloride _ _ MOLECULAR FORMULA: C 19 H 20 N 2 O 3 S. HCl MOLECULAR WEIGHT: 392.90 CAS REGISTRY NUMBER: _[112529-15-4] _ DESCRIPTION Pioglitazone is off-white to pale yellow colour powder. It is soluble in methanol, practically insoluble in water. AURO-PIOGLITAZONE is available as tablets containing 15, 30 & 45 mg pioglitazone as hydrochloride. AURO-PIOGLITAZONE tablets contain the following inactive ingredients: Lactose, carmellose calcium, hydroxypropylcellulose and magnesium stearate. PHARMACOLOGY Pioglitazone is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycaemic control while reducing circulating insulin levels. Fasting and postprandial glycaemic control are improved in patients with type 2 diabetes mellitus. The decreased insulin resistance produced by pioglitazone results in lower blood glucose concentrations, lower plasma insulin levels and lower HbA 1c values. Product Information: AURO-PIOGLITAZONE (Pioglitazone Tablets 15, 30 & 45 mg) Ver 1.2 Page 2 of 19 MODE OF ACTION Pioglitazone is a thiazolidinedione antidiabetic agent that depends on the presence of insulin for its unique mechanism of action. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Unlike sulfonylureas, pioglitazone is not a Đọc toàn bộ tài liệu