What is glimepiride and pioglitazone?

Glimepiride and pioglitazone is a combination of two oral diabetes medicines that help control blood sugar levels.

Glimepiride and pioglitazone is for people with type 2 diabetes. Glimepiride and pioglitazone is sometimes given with other diabetes medications when greater blood sugar control is needed.

This medication is not for treating type 1 diabetes.

Glimepiride and pioglitazone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about glimepiride and pioglitazone?

You should not use this medicine if you have severe or uncontrolled heart failure, or if you have bladder cancer. Do not use this medicine if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Glimepiride and pioglitazone is not for treating type 1 diabetes.

Glimepiride and pioglitazone 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.

What should I discuss with my health care provider before taking glimepiride and pioglitazone?

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

To make sure glimepiride and pioglitazone is safe for you, tell your doctor if you have:

• congestive heart failure or heart disease;

• fluid retention;

• a history of bladder cancer;

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency

• eye problems caused by diabetes;

• a history of heart attack or stroke; or

• liver disease.

Taking glimepiride and pioglitazone may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with this medicine.

This medication may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

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

FDA pregnancy category C. Do not use glimepiride and pioglitazone 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 while using this medication.

Some women using glimepiride and pioglitazone 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 pioglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take glimepiride and pioglitazone?

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 glimepiride and pioglitazone 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, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. 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 medication dose or schedule without your doctor's advice.

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

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

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at . A glimepiride and pioglitazone 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).

What should I avoid while taking glimepiride and pioglitazone?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

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

Glimepiride and pioglitazone side effects

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.

Stop using this medicine and call your doctor at once if you have:

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

• pink or red urine, painful or difficult urination, urinating more than usual;

• pale skin, easy bruising or bleeding;

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

• changes in your vision; or

• sudden unusual pain in your hand, arm, or foot.

Common side effects may include:

• weight gain;

• diarrhea; or

• cold symptoms such as stuffy nose, sinus pain, 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 .

See also: Side effects (in more detail)

Glimepiride and pioglitazone dosing information

Usual Adult Dose for Diabetes Type 2:

The initial dosage of glimepiride recommended for this patient with diabetes mellitus type II is based on the patient's current regime of pioglitazone and /or sulfonylurea.

For patients currently on glimepiride monotherapy, glimepiride-pioglitazone may be initiated at 30 mg/2 mg or 30 mg/4 mg tablet strengths once daily, and adjusted after assessing adequacy of therapeutic response.

For patients currently on pioglitazone monotherapy, glimepiride-pioglitazone may be initiated at 30 mg-2 mg or 30 mg-4 mg tablet strengths once daily, and adjusted after assessing adequacy of therapeutic response.

For patients currently on a different sulfonylurea monotherapy or switching from combination therapy of pioglitazone plus a different sulfonylurea (e.g. glyburide, glipizide, chlorpropamide, tolbutamide, acetohexamide), glimepiride-pioglitazone should be limited initially to a starting dose of 30 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.

For patients switching from combination therapy of pioglitazone plus glimepiride as separate tablets, glimepiride-pioglitazone may be initiated with 30 mg/2 mg or 30 mg/4 mg tablet strengths based on the dose of pioglitazone and glimepiride already being taken. Patients who are not controlled with 15 mg of pioglitazone in combination with glimepiride should be carefully monitored when switched to glimepiride-pioglitazone.

What other drugs will affect glimepiride and pioglitazone?

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

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with glimepiride and pioglitazone, especially:

• gemfibrozil; or

• rifampin.

This list is not complete and many other medicines can increase or decrease the effects of glimepiride and pioglitazone on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.