Duetact

Duetact is a prescription medication used to treat Type 2 Diabetes. It is used in combination with diet and exercise. It is available as a single product containing 2 medications—pioglitazone and glimepiride. 

Pioglitazone belongs to a class of drugs called thiazolidinediones. It helps the body control blood sugar levels by making the body more sensitive to insulin. Glimepiride is in a different class of drugs called sulfonylureas. It causes the pancreas to make more insulin and helps the body to use insulin more efficiently. This helps to control blood sugar. 

Duetact is available as a tablet and is taken once daily, with the first meal of the day.

Common side effects of Duetact include hypoglycemia, upper respiratory tract infection, increased weight, and lower limb swelling. 

Duetact may cause low blood sugar, also known as hypoglycemia. This can reduce your ability to concentrate or react. Do not drive or operate heavy machinery until you know how Duetact affects you, or if you are having any signs or symptoms of hypoglycemia.

Duetact is a prescription medication used to treat Type 2 Diabetes. It is used in combination with diet and exercise. This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Takeda Pharmaceuticals America, Inc.

Serious side effects have been reported with Duetact. See the Duetact "Precautions" section for more information.

Common side effects of Duetact include the following:

• Low blood sugar
• Infection of the upper airways
• Weight increase
• Swelling of the lower limbs
• Headache
• Urinary tract infection
• Diarrhea
• Nausea

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

Tell your doctor if you have any side effect that bothers you or that does not go away. 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, and herbal supplements. Especially tell your doctor if you take:

• Medications that block the enzyme CYP2C8 such as gemfibrozil (Lopid), fluvoxamine (Luvox), ketoconazole (Nizoral), trimethoprim (Bactrim, Septra, Primsol, Proloprim).

• Medications that increase the activity of the enzyme CYP2C8 or CYP2C9, such as rifampin (Rifadin, Rimactane, Rifamate, Rifater).
• Oral miconazole.
• Colesevelam. Take Duetact at least 4 hours before colesevelam.

This is not a complete list of Duetact drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Duetact including the following:

• Congestive heart failure (CHF). Some patients on Duetact may experience CHF, in which the heart cannot pump the blood at a normal rate and blood backs up into the lungs and body. Tell your doctor if you have any signs of congestive heart failure including the following:
  • Weight gain
  • Shortness of breath
  • Swelling of feet, legs, abdomen
  • Dizziness
  • Persistent cough
  • Needing to sleep upright or with an extra pillow
  • Irregular heart rate
• Hypoglycemia. Duetact can lower blood sugar. Tell your doctor if you have any signs of hypoglycemia including:
  • Shakiness
  • Confusion
  • Dizziness
  • Difficulty speaking
  • Feeling anxious or weak
• Hypersensitivity. Severe allergic reaction can occur while taking this medication. Notify your doctor of any signs or symptoms including:
  • Hives
  • Itching or swelling of skin, mouth, lips, tongue, or throat
  • Shortness of breath, wheeze, chest pain or tightness
  • Weak pulse, dizziness or passing out
  • Vomiting, diarrhea, or cramping
• Liver problems. Tell your doctor if you have any abdominal pain in the right upper abdominal area, dark urine, yellowing of the skin or whites of the eyes, fatigue, or loss of appetite.
• Swelling.
• Fractures.
• Anemia. Because Duetact can decrease your red blood cell levels, notify your doctor if you are feeling weak, dizzy, fatigued, become pale, or have any shortness of breath or chest pain.
• Macular edema. Duetact can cause a serious eye problem. Notify your doctor of any vision changes. 
• Ovulation. Some premenopausal women who do not ovulate may begin to ovulate while on Duetact. This may increase the likelihood of pregnancy and appropriate contraception should be used.
• Bladder cancer. Do not use this medication if you have, or have had, bladder cancer. Notify your doctor if you experience any blood in your urine or painful urination.

Do not take Duetact if you:

• are allergic to Duetact or to any of its ingredients
• have New York Heart Association (NYHA) Class III or IV heart failure
• have type 1 diabetes
• have diabetic ketoacidosis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Duetact, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Duetact, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to pioglitazone, glimepiride, any ingredients of Duetact, or sulfa drugs
• Nave heart failure
• Have kidney problems
• Have Type I Diabetes or have had ketoacidosis
• Have a vision problem called macular degeneration
• Have liver problems
• Have, or have had, bladder cancer
• Are pregnant, or are planning to become pregnant
• Are breastfeeding
• Are premenopausal and have no periods, or irregular periods
• Have a genetic condition known as G6PD deficiency

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories—A, B, C, D, and X—are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Duetact falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well–controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Duetact crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Duetact.

Take Duetact exactly as prescribed by your doctor.

Duetact comes in tablet form and is taken once daily with the first main meal of the day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Duetact at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• The condition being treated
• Other medical conditions you have
• Other medications you are taking
• How you respond to this medication
• Your age
• Kidney function

The recommended starting dose of Duetact (pioglitazone/glimepiride) is 30mg/2mg or 30mg/4mg once daily.  The dose may be increased gradually depending on your response.

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

• Store Duetact at room temperature.
• Protect this medication from moisture and humidity.
• Keep this and all medicines out of the reach of children.
• Keep all appointments with your doctor and the laboratory.
• When beginning treatment, pay close attention to increases in weight, and signs or symptoms of low blood sugar.

FDA WARNING

CONGESTIVE HEART FAILURE

• Thiazolidinediones, including pioglitazone cause or exacerbate congestive heart failure in some patients.
• After initiation of Duetact and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of Duetact must be considered.
• Duetact is not recommended in patients with symptomatic heart failure.
• Initiation of Duetact in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.