Avandaryl (Rosiglitazone Maleate and Glimepiride) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Avandaryl

Oral Diabetes Prescription Medications »

What are oral diabetes medications and how do they work?

Insulin is a hormone produced by cells in the pancreas called beta cells. Insulin helps the body use blood glucose (a type of sugar) for energy. People with type 2 diabetes do not make enough insulin and/or their bodies do not respond well to it, leading to elevated blood sugar levels. Oral diabetes medications bring blood sugar levels into the normal range through a variety of ways.

For what conditions are diabetes pills used?

Oral diabetes medications are only used to treat type 2 or non-insulin-dependent diabetes. Patients with type 1 diabetes are dependent on insulin for their treatment.

Are there differences among types of oral diabetes medications?

Medications that increase insulin production

The earliest oral diabetes drugs were the sulfonylureas. These work by stimulating the pancreas to produce more insu...

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AVANDARYL
(rosiglitazone maleate and glimepiride) Tablets

WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see WARNINGS AND PRECAUTIONS]. After initiation of AVANDARYL, 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 current standards of care. Furthermore, discontinuation or dose reduction of AVANDARYL must be considered.
AVANDARYL is not recommended in patients with symptomatic heart failure. Initiation of AVANDARYL in patients with established NYHA Class III or IV heart failure is contraindicated. [See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS.]
A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared rosiglitazone to placebo, showed rosiglitazone to be associated with an increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo,showed a statistically non-significant increased risk of myocardial infarction, and a statistically non-significant decreased risk of death. There have been no clinical trials directly comparing cardiovascular risk of rosiglitazone and ACTOS® (pioglitazone, another thiazolidinedione), but in a separate trial, pioglitazone (when compared to placebo) did not show an increased risk of myocardial infarction or death. [See WARNINGS AND PRECAUTIONS]
Because of the potential increased risk of myocardial infarction, AVANDARYL is available only through a restricted distribution program called the AVANDIA-Rosiglitazone Medicines Access Program. Both prescribers and patients need to enroll in the program. To enroll, call 1-800-AVANDIAorvisitwww.AVANDIA.com. [See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION

AVANDARYL contains 2 oral antidiabetic drugs used in the management of type 2 diabetes: rosiglitazone maleate and glimepiride.

Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the alpha-glucosidase inhibitors. Chemically, rosiglitazone maleate is (±)-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, (Z)-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable. The molecular formula is C₁₈H₁₉N₃O₃S•C₄H₄O₄. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122° to 123°C. The pK_a values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range. The structural formula of rosiglitazone maleate is:

Rosiglitazone maleate Structural Formula Illustration

Glimepiride is an oral antidiabetic drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder. Chemically, glimepiride is 1 - [[p-[2-(3 -ethyl-4-methyl-2-oxo-3 -pyrroline-1 -carboxamido)ethyl]phenyl] sulfonyl] -3 -(trans-4-methylcyclohexyl)urea with a molecular weight of 490.62. The molecular formula for glimepiride is C₂₄H₃₄N₄O₅S. Glimepiride is practically insoluble in water. The structural formula of glimepiride is:

Glimepiride Structural Formula Illustration

AVANDARYL is available for oral administration as tablets containing rosiglitazone maleate and glimepiride, respectively, in the following strengths (expressed as rosiglitazone maleate/glimepiride): 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2 mg, and 8 mg/4 mg. Each tablet contains the following inactive ingredients: Hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and 1 or more of the following: Yellow, red, or black iron oxides.

What are the possible side effects of glimepiride and rosiglitazone (Avandaryl)?

Stop using glimepiride and rosiglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
vision problems;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill...

Read All Potential Side Effects and See Pictures of Avandaryl »

What are the precautions when taking rosiglitazone maleate and glimepiride (Avandaryl)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to rosiglitazone or glimepiride; or to other "glitazones" (e.g., pioglitazone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Promptly talk with your doctor or pharmacist about the benefits and possible risks of this medication, even if you have been taking it for awhile, especially if you have heart problems. Do not stop taking it unless directed to do so.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: type 1 diabetes (insulin-dependent diabetes), very high...

Read All Potential Precautions of Avandaryl »

Last reviewed on RxList: 12/5/2011
This monograph has been modified to include the generic and brand name in many instances.