Avandamet (Rosiglitazone Maleate and Metformin HCl) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Avandamet

Diabetes Prevention »

Introduction to diabetes prevention

I'm pretty lucky in my office practice. I have friendly patients who are usually already fairly well informed about their disease. They are also generally willing to have discussions about therapies and options.

What I have noticed (much to my delight) is that there are a growing number of patients coming to me for evaluation BEFORE they actually have developed diabetes, wanting to know how to prevent it. Most of them have seen family members with diabetes go through the process of diagnosis and management. As our attitude towards disease changes, and we learn to focus on prevention, I have more and more to discuss with these patients. Ultimately, I hope to see a paradigm shift where our focus is primarily on prevention of chronic diseases such as diabetes. For now, I hope this review provides some information to those of you wanting to make healthy lifestyle changes, and that it encourages you to open up a...

Read the Diabetes Prevention article »

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AVANDAMET
(rosiglitazone maleate and metformin hydrochloride) Tablets

WARNINGS

ROSIGLITAZONE MALEATE: 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 AVANDAMET, 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 AVANDAMET must be considered.
AVANDAMET is not recommended in patients with symptomatic heart failure. Initiation of AVANDAMET 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, AVANDAMET 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-AVANDIA orvisitwww.AVANDIA.com. [See WARNINGS AND PRECAUTIONS.]

METFORMIN HYDROCHLORIDE: LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. [See WARNINGS AND PRECAUTIONS.]
Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. [See WARNINGS AND PRECAUTIONS.]
If acidosis is suspected, discontinue AVANDAMET and hospitalize the patient immediately [see WARNINGS AND PRECAUTIONS.].

DRUG DESCRIPTION

AVANDAMET contains 2 oral antidiabetic drugs: rosiglitazone maleate and metformin hydrochloride.

Rosiglitazone maleate is an oral antidiabetic agent, which acts primarily by increasing insulin sensitivity. Rosiglitazone improves glycemic control while reducing circulating insulin levels. 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

Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antidiabetic agents. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C₄H₁₁N₅•HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula of metformin hydrochloride is:

Metforniin hydrochloride Structural Formula Illustration

AVANDAMET is available for oral administration as film-coated tablets containing rosiglitazone maleate and metformin hydrochloride equivalent to: 2 mg rosiglitazone with 500 mg metformin hydrochloride (2 mg/500 mg), 4 mg rosiglitazone with 500 mg metformin hydrochloride (4 mg/500 mg), 2 mg rosiglitazone with 1,000 mg metformin hydrochloride (2 mg/1,000 mg), and 4 mg rosiglitazone with 1,000 mg metformin hydrochloride (4 mg/1,000 mg). Inactive ingredients are: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone 29-32, sodium starch glycolate, titanium dioxide, and 1 or more of the following: Red and yellow iron oxides.

What are the possible side effects of metformin and rosiglitazone (Avandamet)?

Stop using metformin 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:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance;
feeling short...

Read All Potential Side Effects and See Pictures of Avandamet »

What are the precautions when taking rosiglitazone maleate and metformin hcl (Avandamet)?

Before taking rosiglitazone/metformin, tell your doctor or pharmacist if you are allergic to it; or to other "glitazones" such as 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: kidney disease, history of liver disease, conditions that may cause a low...

Read All Potential Precautions of Avandamet »

Last reviewed on RxList: 12/2/2011
This monograph has been modified to include the generic and brand name in many instances.