Duetact

Duetact (pioglitazone/glimepiride) is a combination of two oral diabetes medicines that help control blood sugar levels. Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Glimepiride is in a class of medications called sulfonylureas. It works by causing the pancreas to release insulin, which helps to lower blood sugar.

Pioglitazone and glimepiride are usually taken together once a day with breakfast or the first main meal of the day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Duetact exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of pioglitazone/glimepiride and gradually increase your dose. Your doctor will probably tell you not to take pioglitazone/glimepiride if your blood sugar is too high. Follow these directions carefully. Do not change the dose of your medication without talking to your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

More common:

• headache
• muscle pain
• stomach upset

Less common:

• bloating
• chest pain
• dark urine
• diarrhea
• dizziness
• fast or irregular heartbeat
• fever
• general feeling of discomfort or illness
• light-colored stools
• loss of appetite
• nausea
• skin rash
• sweating
• troubled breathing
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• yellowing of the skin or eyes

Rare:

• blurred vision
• change in near or distance vision
• decreased urination
• eye pain
• increased hunger
• increased thirst
• increased urination
• loss of consciousness
• lower back or side pain
• nervousness
• pounding in the ears
• seizures
• severe or continuing diarrhea
• severe stomach pain
• sudden decrease in the amount of urine
• swelling of the eyes, face, lips, hands, feet, ankles, or lower legs
• weight gain

Incidence not known:

• blue or purple skin discoloration
• bruising
• confusion
• decreased awareness or responsiveness
• depression
• drowsiness
• fast or irregular heartbeat
• inability to speak
• increased bleeding or bruising
• irritability
• joint or muscle pain
• memory problems
• mental or mood changes
• numbness or tingling in the hands, feet, or lips
• pain in the arms or legs
• red or purple spots on the skin
• shortness of breath
• slurred speech
• sudden severe headache or vomiting
• unexplained weight loss
• vision problems

Some side effects of pioglitazone/glimepiride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• More common:

Body aches or pain

• Less common:

Anxiety

For Healthcare Professionals

Applies to pioglitazone/glimepiride: oral tablet

General

The most frequently reported adverse events included upper respiratory tract infection, sinusitis, and pharyngitis.[Ref]

Cardiovascular

Very common (10% or more): Edema (up to 13.7%), hypertension (up to 13.1%)

Common (1% to 10%): Myocardial infarction, stroke, heart failure, angina pectoris

Uncommon (0.1% to 1%): Cardiac arrhythmia, atrial fibrillation

Rare (less than 0.1%): Cardiac arrest, bundle branch block, ventricular fibrillation, ventricular tachycardia

Frequency not reported: Flushing, hypotension, postural hypotension

Postmarketing reports: Palpitations

Hypersensitivity