Pioglitazone and glimepiride (Oral)

Pioglitazone and glimepiride combination is used with a proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Pioglitazone helps your body use insulin better. Glimepiride triggers the release of insulin from the pancreas, which helps your body convert food into energy.

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

It is very important that your doctor checks your progress during regular visits to ensure 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 who can become pregnant, you should discuss birth control options with your doctor.

If you are gaining weight rapidly, experiencing shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of your hands, wrists, ankles, or feet, contact your doctor immediately. These may be signs 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 the color of the skin on the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these side effects occur, seek emergency help right away.

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

Contact your doctor immediately if you experience blurred vision, decreased vision, or any other change in vision while 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. Inform your doctor right away if you have blood in your urine, a frequent, strong, or increased urge to urinate, painful urination, or pain in your back, lower abdomen, or stomach.

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

This medicine can cause hypoglycemia (low blood sugar). Low blood sugar can also happen 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 (become unconscious). People experience different symptoms with low blood sugar. It is important to learn which symptoms you have 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 to learn which symptoms you have to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

There may come a time when you need emergency help for a problem caused by your diabetes. You should 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 indicates you have diabetes and lists 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.

In deciding to take this medicine, you and your doctor need to consider the risks and benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medications. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. If you are using non-prescription products, read the label or package ingredients carefully.

Pediatric

There are no appropriate studies on how pioglitazone and glimepiride combination affects children. Its safety and effectiveness for kids have not been established.

Geriatric

Current studies have not shown any specific problems for elderly patients that would stop the use of pioglitazone and glimepiride combination. However, older adults are at a higher risk for low blood sugar and age-related kidney issues, which may require careful monitoring and possible dose adjustments.

Breast Feeding

There are no sufficient studies to determine if this medication poses risks to infants when taken during breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are taking this medicine, it is particularly important for your healthcare professional to know if you are also taking any of the following medicines. The interactions listed below are chosen for their significance, but are not all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Abiraterone Acetate
• Acarbose
• Alogliptin
• Aspirin
• Bexagliflozin
• Capecitabine
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Ciprofloxacin
• Delafloxacin
• Desmopressin
• Disopyramide
• Dulaglutide
• Enoxacin
• Entacapone
• Fluconazole
• Furosemide
• Gatifloxacin
• Gemfibrozil
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Ifosfamide
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Isoniazid
• Ivacaftor
• Lanreotide
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lixisenatide
• Lomefloxacin
• Mavacamten
• Metformin
• Methotrexate
• Metolazone
• Metreleptin
• Miconazole
• Moxifloxacin
• Nateglinide
• Nifedipine
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Phenobarbital
• Pioglitazone
• Piperaquine
• Pixantrone
• Polythiazide
• Porfimer
• Pramlintide
• Primidone
• Repaglinide
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Sparsentan
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Tolvaptan
• Topiramate
• Triamterene
• Trovafloxacin
• Voriconazole

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may still be the best treatment option for you. If both medicines are prescribed, your doctor may change the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods because interactions may happen. Using alcohol or tobacco with some medicines can also cause interactions. The following interactions are based on their potential significance and are not all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If used together, your doctor may change the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

Other medical issues may affect how you use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

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

• Bladder cancer, active or
• Diabetic ketoacidosis (high ketones and acid in the blood) or
• Severe heart failure or
• Liver disease, active or
• History of sulfa drug allergy or
• Type I diabetes—Should not be used in these conditions.

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

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

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Anxiety
• bladder pain
• bloody or cloudy urine
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• difficult, burning, or painful urination
• fast heartbeat
• frequent urge to urinate
• headache
• increased hunger
• increased weight
• lower back or side pain
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• swelling of the feet or lower legs
• unusual tiredness or weakness

Less common

• Accidental injury
• loss of appetite
• pain or swelling in the arms or legs without any injury
• pale skin
• stomach pain
• troubled breathing with exertion
• unusual bleeding or bruising
• vomiting
• weight loss
• yellow eyes or skin

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

More common

• Body aches or pain
• cough
• diarrhea
• difficulty with moving
• dryness or soreness of the throat
• ear congestion
• fever
• hoarseness
• joint pain
• loss of voice
• muscle aching or cramping
• muscle pains or stiffness
• runny nose
• sneezing
• stuffy nose
• swollen joints
• tender, swollen glands in the neck
• tooth disorder
• trouble swallowing
• voice changes

Less common

• Dizziness
• itching skin or rash
• lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Duetact

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 2nd Generation Sulfonylurea

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™.

Dosing

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.

Missed Dose

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.

Storage

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.