|Herstellung:||Takeda Pharmaceuticals America, Inc.|
Duetact is used for treating type 2 diabetes in certain patients. It is used along with diet and exercise. Duetact is a thiazolidinedione and sulfonylurea antidiabetic combination. It lowers blood sugar by making the cells of the body more sensitive to the action of insulin. It also causes the pancreas to release insulin, which helps to lower blood sugar.
Use Duetact as directed by your doctor.
- Take Duetact by mouth with breakfast or the first main meal of the day unless instructed otherwise by your doctor.
- Continue to take Duetact even if you feel well. Do not miss any dose.
- Taking Duetact at the same time each day will help you remember to take it.
- If you miss a dose of Duetact, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Duetact.
Store Duetact at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store Duetact in the bathroom. Keep Duetact out of the reach of children and away from pets.
Active Ingredients Pioglitazone hydrochloride and Glimepiride
Do NOT use Duetact if:
- you are allergic to any ingredient in Duetact
- you have moderate to severe heart failure, liver problems or abnormal liver function tests, certain severe problems associated with diabetes (eg, diabetic ketoacidosis, diabetic coma), moderate to severe burns, or very high blood acid levels (acidosis)
- you have type 1 diabetes
- you are taking bosentan.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Duetact. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to any other sulfonamide medicine such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glipizide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
- if you have a history of kidney, thyroid, heart, or blood vessel problems; anemia, stroke; certain hormonal problems (eg, adrenal or pituitary problems, syndrome of inappropriate secretion of antidiuretic hormone [SIADH]); low blood sodium levels; or low levels of an enzyme called glucose 6-phosphate dehydrogenase (G6PD)
- if you have stomach or bowel problems (eg, stomach or bowel blockage, stomach paralysis), drink alcohol, or have had poor nutrition
- if you have very poor health, a high fever, a severe infection, severe diarrhea, high blood acid levels, or brain or nervous system problems, or have had a severe injury
- if you have a history of bladder cancer, bone fracture, low calcium intake, or weak bones (eg, osteoporosis)
- if you have swelling problems (edema) or certain eye problems (macular edema)
- if you will be having surgery.
Some medicines may interact with Duetact. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Bosentan because liver problems may occur, and the effectiveness of both medicines may be decreased
- Beta-blockers (eg, propranolol) because the risk of low blood sugar may be increased. They may also hide certain signs of low blood sugar and make it more difficult to notice
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), azole antifungals (eg, miconazole, ketoconazole), chloramphenicol, clarithromycin, clofibrate, disopyramide, fenfluramine, fluoxetine, insulin, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), phenylbutazone, probenecid, quinolone antibiotics (eg, ciprofloxacin), salicylates (eg, aspirin), and sulfonamides (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
- Calcium channel blockers (eg, diltiazem), corticosteroids (eg, prednisone), decongestants (eg, pseudoephedrine), diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogens, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, promethazine), phenytoin, rifamycins (eg, rifampin), sympathomimetics (eg, albuterol, epinephrine), or thyroid supplements (eg, levothyroxine) because they may decrease Duetact’s effectiveness, resulting in high blood sugar
- Gemfibrozil because blood sugar may be increased or decreased
- Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Duetact.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Duetact may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Important safety information:
- Duetact may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Duetact with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking Duetact; it may increase the risk of low blood sugar. Rarely, alcohol may interact with Duetact and cause a serious reaction with symptoms such as flushing, nausea, vomiting, dizziness, or stomach pain. Discuss any questions or concerns with your doctor.
- Carry an ID card at all times that says you have diabetes.
- Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.
- Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Duetact exactly as prescribed, tell your doctor.
- It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
- Do not take more than the recommended dose without checking with your doctor.
- Duetact may cause low blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Risk of low blood sugar may be increased by severe or prolonged exercise, drinking alcohol, or skipping meals.
- Duetact contains a sulfonylurea. It may increase the risk of death from heart disease. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition.
- Duetact may cause ovulation in women who have not reached menopause but do not ovulate. To avoid pregnancy, be sure to use effective birth control while using Duetact.
- Duetact may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Duetact. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Tell your doctor or dentist that you take Duetact before you receive any medical or dental care, emergency care, or surgery.
- Duetact may be associated with an increased risk of bladder cancer. Discuss any questions or concerns with your doctor.
- An increased incidence of bone fracture has been reported in women who take Duetact. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.
- Lab tests, including fasting blood sugar, hemoglobin A1c, liver function, and eye exams, may be performed while you use Duetact. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Duetact with caution in the elderly; they may be more sensitive to its effects, especially the risk of heart problems or low blood sugar.
- Duetact should not be used in children; safety and effectiveness in children have not been confirmed.
- Pregnancy and breast-feeding: Duetact may cause harm to the fetus or newborn. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Duetact while you are pregnant. It is not known if Duetact is found in breast milk. Do not breastfeed while taking Duetact.
When used for long periods of time Duetact may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.
All medicines may cause side effects, but many people have no, or minor, side effects.
Check with your doctor if any of these most common side effects persist or become bothersome:
Diarrhea; headache; limb pain; nausea; upper respiratory tract infection; weight gain.
Seek medical attention right away if any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; fever, chills, or persistent sore throat; increased or painful urination; irregular heartbeat; symptoms of heart failure (eg, shortness of breath; sudden unexplained weight gain; swelling of the hands, ankles, or feet); symptoms of liver problems (eg, dark urine, severe or persistent nausea, stomach pain, unexplained vomiting or loss of appetite, yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety, chills, dizziness or drowsiness, headache, increased hunger, increased sweating, tremors); unusual bone pain; unusual bruising or bleeding; unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.