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AVANDAMET (METFORMIN HYDROCHLORIDE, ROSIGLITAZONE MALEATE) TABLETS: PATIENT COUNSELING INFORMATION

Instructions

Patients should be informed of the following:

  • The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the Warnings and Precautions sections, should be explained to patients. Patients should be advised to discontinue AvandaMet immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of AvandaMet (Rosiglitazone Maleate and Metformin), gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
  • Avoid excessive alcohol intake, either acute or chronic, while receiving AvandaMet.
  • AvandaMet (Rosiglitazone Maleate and Metformin) tablets is not recommended for patients with symptoms of heart failure.
  • Patients with more severe heart failure (NYHA Class III or IV) cannot start AvandaMet as the risks exceed any potential benefits in such patients.
  • Results of a set of clinical studies suggest that treatment with rosiglitazone is associated with an increased risk for myocardial ischemic events, such as angina or myocardial infarction (heart attack), especially in patients taking insulin or nitrates. Because this risk has not been confirmed or excluded in different long-term trials, definitive conclusions regarding this risk await completion of an adequately-designed cardiovascular outcome study.
  • AvandaMet is not recommended for patients who are taking insulin.
  • AvandaMet (Rosiglitazone Maleate and Metformin HCl) is not recommended for patients who are taking nitrates.
  • There are multiple medications available to treat type 2 diabetes. The benefits and risks of each available diabetes medication should be taken into account when choosing a particular diabetes medication for a given patient.
  • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with AvandaMet or any other oral antidiabetic drug.
  • Management of type 2 diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes but also in maintaining the efficacy of drug therapy.
  • It is important to adhere to dietary instructions and to regularly have blood glucose, glycosylated hemoglobin (HbA1c), renal function, and hematologic parameters tested. It can take 2 weeks to see a reduction in blood glucose and 2 to 3 months to see the full effect of AvandaMet (Rosiglitazone Maleate and Metformin HCl) tablets.
  • Blood will be drawn to check their liver function prior to the start of therapy and periodically thereafter per the clinical judgment of the healthcare professional. Patients with unexplained symptoms of nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine should immediately report these symptoms to their physician.
  • Patients who experience an unusually rapid increase in weight or edema or who develop shortness of breath or other symptoms of heart failure while on AvandaMet should immediately report these symptoms to their physician.
  • Therapy with AvandaMet (Rosiglitazone Maleate and Metformin Hydrochloride), like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking this medication. Thus, adequate contraception in premenopausal women should be recommended. This possible effect has not been specifically investigated in clinical studies so the frequency of this occurrence is not known.

    Manufactured and distributed by GlaxoSmithKline pharmaceutical company and its divisions.

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