"The US Food and Drug Administration (FDA) said today that it still believes the type 2 diabetes drug pioglitazone (Actos, Takeda Pharmaceuticals) may pose an increased risk for bladder cancer after updating its review of published resear"...
(rosiglitazone maleate and glimepiride) Tablets
CONGESTIVE HEART FAILURE
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, WARNINGS AND PRECAUTIONS]
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 pKa 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:
Glimepiride is an oral antidiabetic drug of the sulfonylurea class. 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 a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula of glimepiride is:
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)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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;
- pale skin, feeling light-headed, rapid heart rate, trouble concentrating, fever, confusion or weakness;
- changes in your vision;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea,...
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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart problems (e.g., congestive heart failure, heart attack, angina), fluid in your lungs, swelling (edema, fluid retention), kidney disease, thyroid problems, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), mineral imbalance (hyponatremia), anemia,...
Last reviewed on RxList: 12/19/2016
This monograph has been modified to include the generic and brand name in many instances.
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