Rosiglitazone & Glimepiride

Rosiglitazone/glimepiride is a prescription medication used to treat type 2 diabetes. It is a single tablet containing two different medications, glimepiride and rosiglitazone. Glimepiride belongs to a group of drugs called sulfonylureas. It can help your body release more of its own insulin. Rosiglitazone belongs to a group of drugs called thiazolidinediones. It can help your body respond better to insulin. These medicines can work together to help control your blood sugar.

This medication comes in tablet form and is usually taken once a day, with your first main meal.

Common side effects include new or worse heart failure, headache, and cold symptoms.

Rosiglitazone/glimepiride is a prescription medication used to treat type 2 diabetes. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Rosiglitazone & Glimepiride may be found in some form under the following brand names:

• Avandaryl

Rosiglitazone/glimepiride may cause serious side effects. See "Precautions" section.

The most common side effects with rosiglitazone/glimepiride include:

• cold-like symptoms
• headache

This is not a complete list of rosiglitazone/glimepiride side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Rosiglitazone/glimepiride and certain other medicines can affect each other and may lead to serious side effects including high or low blood sugar, or heart problems. Especially tell your doctor if you take:

• insulin.
• any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

Know the medicines you take. Keep a list of all your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is alright to take rosiglitazone/glimepiride with other medicines.

In 2010 the FDA severely restricted the use of rosiglitazone/glimepiride, due to the risk of "cardiovascular events" such as heart attacks and strokes. After thorough review and analysis of the research, the FDA announced, in 2013, that there is not an increased risk of cardiovascular events, compared to treatment with standard diabetes medications. Use of this medication is no longer restricted.

Rosiglitazone/glimepiride may cause serious side effects, including:

• New or worse heart failure. Rosiglitazone, one of the two drugs that make up rosiglitazone/glimepiride, can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough.
  • If you have severe heart failure, you cannot start rosiglitazone/glimepiride.
  • If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, rosiglitazone/glimepiride may not be right for you.

Call your doctor right away if you have any of the following:

• swelling or fluid retention, especially in the ankles or legs
• shortness of breath or trouble breathing, especially when you lie down
• an unusually fast increase in weight
• unusual tiredness
• Myocardial Infarction (“Heart Attack”). Rosiglitazone, one of the medicines in rosiglitazone/glimepiride, may raise the risk of heart attack. The risk of having a heart attack may be higher in people who take rosiglitazone/glimepiride with insulin. Most people who take insulin should not also take rosiglitazone/glimepiride.
  • Symptoms of a heart attack can include the following:
  • chest discomfort in the center of your chest that lasts for more than a few minutes, or that goes away or comes back
  • chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Call your doctor or go to the nearest hospital emergency room right away if you think you are having a heart attack.

• People with diabetes have a greater risk for heart problems. It is important to work with your doctor to manage other conditions, such as high blood pressure or high cholesterol.

• Low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. This can happen if you skip meals, drink alcohol, use another medicine that lowers blood sugar, exercise (particularly hard or long), or if you have certain medical problems. Call your doctor if low blood sugar levels are a problem for you.
• Weight gain. Rosiglitazone, one of the medicines in rosiglitazone/glimepiride, can cause weight gain that may be due to fluid retention or extra body fat. Weight gain can be a serious problem for people with certain conditions including heart problems. See “Drug Precautions".
• Liver problems. It is important for your liver to be working normally when you take rosiglitazone/glimepiride. Your doctor should do blood tests to check your liver before you start taking rosiglitazone/glimepiride and during treatment as needed. Call your doctor right away if you have unexplained symptoms such as:
  • nausea or vomiting
  • stomach pain
  • unusual or unexplained tiredness
  • loss of appetite
  • dark urine
  • yellowing of your skin or the whites of your eyes.
• Macular edema (a diabetic eye disease with swelling in the back of the eye). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly. Very rarely, some people have had vision changes due to swelling in the back of the eye while taking rosiglitazone, one of the medicines in rosiglitazone/glimepiride.
• Fractures (broken bones), usually in the hand, upper arm or foot. Talk to your doctor for advice on how to keep your bones healthy.
• Low red blood cell count (anemia).
• Ovulation (release of egg from an ovary in women) leading to pregnancy. Ovulation may happen in premenopausal women who do not have regular monthly periods. This can increase the chance of pregnancy. 

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using this medication.

Before starting rosiglitazone/glimepiride, ask your doctor about what the choices are for diabetes medicines and what the expected benefits and possible risks are for you in particular.

Before taking rosiglitazone/glimepiride, tell your doctor about all your medical conditions, including if you:

• have heart problems or heart failure.
• have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin and should not be treated with rosiglitazone/glimepiride.
• have a type of diabetic eye disease called macular edema (swelling of the back of the eye).
• have liver problems. Your doctor should do blood tests to check your liver before you start taking rosiglitazone/glimepiride and during treatment as needed.
• had liver problems while taking Rezulin (troglitazone), another medicine for diabetes.
• have kidney problems. If people with kidney problems use rosiglitazone/glimepiride, they may need a lower dose of the medication.
• have glucose 6-phosphate dehydrogenase (G6PD) deficiency. This condition runs in families. People with G6PD deficiency who take glimepiride (one of the medicines in this combination product) may develop hemolytic anemia (fast breakdown of red blood cells).
• are pregnant or plan to become pregnant. Rosiglitazone/glimepiride should not be used during pregnancy. It is not known if rosiglitazone/glimepiride can harm your unborn baby. You and your doctor should talk about the best way to control your diabetes during pregnancy. If you are a premenopausal woman (before the “change of life”) who does not have regular monthly periods, rosiglitazone/glimepiride may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking rosiglitazone/glimepiride. Tell your doctor right away if you become pregnant while taking rosiglitazone/glimepiride.
• are breastfeeding or planning to breastfeed. It is not known if rosiglitazone/glimepiride passes into breast milk. You should not use rosiglitazone/glimepiride while breast-feeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if rosiglitazone/glimepiride passes into breast milk. You should not use rosiglitazone/glimepiride while breastfeeding.

• Take rosiglitazone/glimepiride exactly as prescribed. Your doctor may need to change your dose until your blood sugar is better controlled.
• Take rosiglitazone/glimepiride by mouth one time each day with your first main meal.
• It usually takes a few days for rosiglitazone/glimepiride to start lowering your blood sugar. It may take 2 to 3 months to see the full effect on your blood sugar level.
• If you miss a dose of rosiglitazone/glimepiride, take it as soon as you remember unless it is time to take your next dose. Take your next dose at the usual time. Do not take double doses to make up for a missed dose.
• If you take too much rosiglitazone/glimepiride, call your doctor or poison control center right away.
• Test your blood sugar regularly as your doctor tells you.
• Your doctor should do blood tests to check your liver before you start rosiglitazone/glimepiride and during treatment as needed. Your doctor should also do regular blood sugar tests (for example, “A1c”) to monitor your response to rosiglitazone/glimepiride.
• Call your doctor if you get sick, get injured, get an infection, or have surgery. Rosiglitazone/glimepiride may not control your blood sugar levels during these times. Your doctor may need to stop rosiglitazone/glimepiride for a short time and give you insulin to control your blood sugar level.
• Diet and exercise can help your body use its blood sugar better. It is important to stay on your recommended diet, lose extra weight, and get regular exercise while taking rosiglitazone/glimepiride.

The recommended starting rosiglitazone/glimepiride dose is 4 mg/1 mg taken once daily with the first meal of the day.

If necessary, your doctor may decide to slowly increase your dose to a maximum dosage of 8 mg/4 mg once a day.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store rosiglitazone/glimepiride at room temperature, 59° to 86° F (15° to 30° C). Keep rosiglitazone/glimepiride in the container it comes in. Keep the container closed tightly.
• Safely, throw away rosiglitazone/glimepiride that is out of date or no longer needed.
• Keep rosiglitazone/glimepiride and all medicines out of the reach of children.

WARNING: CONGESTIVE HEART FAILURE 

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. 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.