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Product info: Diabetes
Actos
Actos (PIOGLITAZONE) is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body’s sensitivity to insulin, a natural substance that helps control blood sugar levels. Pioglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).
Actos
Generic Name: pioglitazone hydrochloride
Dosage Form: tablets
Actos®
(pioglitazone hydrochloride) Tablets
WARNING: CONGESTIVE HEART FAILURE
Thiazolidinediones, including Actos, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of Actos, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of Actos must be considered.
Actos is not recommended in patients with symptomatic heart failure. Initiation of Actos in patients with established NYHA Class III or IV heart failure is contraindicated (see CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
Actos (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. Actos is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes). Pharmacological studies indicate that Actos improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Actos improves glycemic control while reducing circulating insulin levels.
Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride belongs to a different chemical class and has a different pharmacological action than the sulfonylureas, metformin, or the ?-glucosidase inhibitors. The molecule contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:
Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.
Actos is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lActose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.
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