What is Duetact?

Pioglitazone hydrochloride, a component of glimepiride/pioglitazone hydrochloride, may cause or exacerbate congestive heart failure; monitor patients for signs and symptoms of heart failure after initiation or dose increase. Should heart failure develop, manage according to current standards of care. Consider discontinuation or dose reduction. Glimepiride/pioglitazone hydrochloride is not recommended in patients with symptomatic heart failure and is contraindicated in established NYHA Class III or IV heart failure .

Pioglitazone and glimepiride combination is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Pioglitazone works by helping your body use insulin better. Glimepiride stimulates the release of insulin from the pancreas which will help your body turn food into energy.

This medicine is available only with your doctor's prescription.

Carefully follow the special diet your doctor gave you. This is the most important part of controlling your diabetes and will help the medicine work properly. Exercise regularly and test for sugar in your blood or urine as directed.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine should be taken with the first meal of the day.

If you are taking colesevelam, take it at least 4 hours after taking Duetact™.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • For patients already taking glimepiride alone:
      • Adults—At first, 1 tablet (either pioglitazone 30 milligrams (mg) plus glimepiride 2 mg, or pioglitazone 30 mg plus glimepiride 4 mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than pioglitazone 45 mg plus glimepiride 8 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For patients already taking pioglitazone alone:
      • Adults—At first, 1 tablet (pioglitazone 30 milligrams (mg) plus glimepiride 2 mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than pioglitazone 45 mg plus glimepiride 8 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For patients switching from other diabetes medicines:
      • Adults—At first, 1 tablet (pioglitazone 30 milligrams (mg) plus glimepiride 2 mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than pioglitazone 45 mg plus glimepiride 8 mg per day.
      • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of pioglitazone and glimepiride combination in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pioglitazone and glimepiride combination in the elderly. However, elderly patients are more likely to have hypoglycemia and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving pioglitazone and glimepiride combination.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Aspirin
• Balofloxacin
• Besifloxacin
• Chlorpropamide
• Ciprofloxacin
• Desmopressin
• Disopyramide
• Dulaglutide
• Enoxacin
• Entacapone
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Ifosfamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Isoniazid
• Lanreotide
• Levofloxacin
• Lixisenatide
• Lomefloxacin
• Metformin
• Metreleptin
• Miconazole
• Moxifloxacin
• Nadifloxacin
• Nateglinide
• Nifedipine
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pazufloxacin
• Pefloxacin
• Pioglitazone
• Piperaquine
• Pixantrone
• Prulifloxacin
• Repaglinide
• Rufloxacin
• Sitagliptin
• Sparfloxacin
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Tolvaptan
• Tosufloxacin
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Aminolevulinic Acid
• Atenolol
• Atorvastatin
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Clopidogrel
• Colesevelam
• Esmolol
• Fenugreek
• Furazolidone
• Glucomannan
• Guar Gum
• Iproniazid
• Isocarboxazid
• Ketoconazole
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nialamide
• Nilotinib
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Topiramate
• Tranylcypromine

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland problem (underactive) or
• Glucose 6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem), history of or
• Kidney problems or
• Pituitary gland problem (underactive) or
• Poorly nourished condition or
• Weakened physical condition—Use with caution. May cause side effects to become worse.

• Bladder cancer, active or
• Diabetic ketoacidosis (high ketones and acid in the blood) or
• Heart failure, severe or
• Liver disease, active or
• Sulfa drug allergy, history of or
• Type I diabetes—Should not be used in patients with these conditions.

• Diabetic macular edema (swelling of the back of the eye) or
• Edema (fluid retention or swelling) or
• Heart disease or
• Liver disease—Use with caution. May make these conditions worse.

• Fever or
• Infection or
• Surgery or
• Trauma—Use with caution. These conditions may cause problems with blood sugar control.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a serious heart problem.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

If you have abdominal or stomach pain, dark urine, a loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin, check with your doctor right away. These may be symptoms of a serious liver problem.

Check with your doctor right away if blurred vision, decreased vision, or any other change in vision occurs while you are taking this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may increase the risk for bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

This medicine may increase your risk for bladder cancer if you take it for more than 12 months. Tell your doctor right away if you have blood in the urine, a frequent, strong, or increased urge to urinate, painful urination, or pain in the back, lower abdomen, or stomach.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms of low blood sugar you have in order to treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.