Avandaryl contains a combination of glimepiride and rosiglitazone, two oral diabetes medicines that help control blood sugar levels.

Avandaryl is for people with type 2 diabetes. This medication is not for treating type 1 diabetes.

Avandaryl is not recommended for use with insulin. Taking Avandaryl while you are using insulin may increase your risk of serious heart problems.

You should not use Avandaryl if you have severe or uncontrolled heart failure, or if you are allergic to sulfa drugs. Do not use this medicine if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Avandaryl can cause or worsen congestive heart failure. Stop using this medicine and call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

Take Avandaryl exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Avandaryl with your first meal of the day.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your Avandaryl dose or dosing schedule without your doctor's advice.

Use Avandaryl regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

This medicine is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, vision exams, and special medical care. Follow your doctor's instructions very closely.

Store Avandaryl at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Usual Adult Dose of Avandaryl for Diabetes Type 2:

Individualize dose based on safety, efficacy, and prior therapy; asses the risk versus benefit of initiating with combination therapy versus monotherapy

Initial dose: rosiglitazone 4 mg/glimepiride 1 mg orally once a day
-Patients receiving a sulfonylurea or rosiglitazone: May consider a starting dose of rosiglitazone 4 mg/glimepiride 2 mg orally once a day
-Patients receiving rosiglitazone and glimepiride as individual components: Initial dose is the combination product containing the same dose of each component

Dose Titration: Individualize based on glycemic response and safety concerns for each component.
-Patients switching from rosiglitazone: Titrate glimepiride after 1 to 2 weeks in increments of no more than 2 mg; following increase, rosiglitazone may be titrated after 1 to 2 weeks
-Patients switching from sulfonylurea: Titrate rosiglitazone after 8 to 12 weeks; allow 2 to 3 months to see full effect of increase before further titration

Maximum dose: rosiglitazone 8 mg/glimepiride 4 mg

Comments: Take with first meal of the day.
-Monitor closely for fluid related adverse events, particularly with rosiglitazone initiation and titration.
-If hypoglycemia occurs, dose reduction of the glimepiride component may be necessary.

Use: To improve glycemic control in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise.

You should not use Avandaryl if you are allergic to glimepiride or rosiglitazone, or:

• if you have advanced heart failure;

• if you are allergic to sulfa drugs; or

• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Avandaryl is safe for you, tell your doctor if you have:

• congestive heart failure, heart disease, a history of heart attack or stroke;

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);

• eye problems caused by diabetes;

• liver disease or kidney disease; or

• a adrenal or pituitary gland disorder.

Women may be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Avandaryl. Talk with your doctor if you are concerned about this possibility.

Do not use Avandaryl if you are pregnant. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant.

Some women using Avandaryl have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

It is not known whether glimepiride and rosiglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Avandaryl.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An Avandaryl overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

Avoid drinking alcohol. It can lower your blood sugar.

Avoid exposure to sunlight or tanning beds. This medication can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to Avandaryl: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• chest pain or heavy feeling, pain spreading to the arm or jaw, nausea, sweating, general ill feeling;

• pale skin, easy bruising or bleeding, weakness;

• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• changes in your vision; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Avandaryl side effects may include:

• headache; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor if you use insulin. Taking Avandaryl while you are using insulin may increase your risk of serious heart problems.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin;

• heart or blood pressure medicine; or

• cholesterol-lowering medicine.

This list is not complete. Many other medicines can increase or decrease the effects of Avandaryl on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.