Alogliptin & Pioglitazone

Alogliptin/pioglitazone is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. It is a combination of two prescription medications, alogliptin and pioglitazone. Alogliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by stopping the DPP-4 enzyme from removing a hormone that is responsible for telling your body to release insulin after you eat. This allows insulin to be released, which lowers blood sugar. Pioglitazone belongs to a group of drugs called thiazolidinediones. It lowers blood sugar by helping your body use its natural insulin better.

Alogliptin/pioglitazone comes in tablet form and is usually taken once daily, with or without food. Do not break or cut alogliptin/pioglitazone tablets before swallowing.

Some of the common side effects of alogliptin/pioglitazone include stuffy or runny nose and sore throat, back pain, and cold-like symptoms.

Alogliptin/pioglitazone is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

The alogliptin/pioglitazone dose your doctor recommends will depend on several factors including:

• the medications you are currently taking
• other medical conditions you have
• how well alogliptin/pioglitazone works for you
• how well you tolerate the medication (side effects)

The maximum recommended daily dose is 25 mg alogliptin and 45 mg pioglitazone.

WARNING: CONGESTIVE HEART FAILURE

• Thiazolidinediones, including pioglitazone, which is a component of alogliptin/pioglitazone, cause or exacerbate congestive heart failure in some patients.
• After initiation of alogliptin/pioglitazone, 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 pioglitazone in alogliptin/pioglitazone must be considered.
• Alogliptin/pioglitazone is not recommended in patients with symptomatic heart failure.
• Initiation of alogliptin/pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.

Alogliptin/pioglitazone can cause serious side effects, including:

• Do not take alogliptin/pioglitazone if you have severe heart failure.
• If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, alogliptin/pioglitazone may not be right for you. 

​Call your doctor right away if you have any of the following:

• swelling or fluid retention, especially in the ankles or legs
• shortness of breath or trouble breathing, especially when you lie down
• an unusually fast increase in weight
• unusual tiredness

2. Inflammation of the pancreas (pancreatitis). Alogliptin, one of the medicines in alogliptin/pioglitazone, may cause pancreatitis which may be severe. Certain medical conditions make you more likely to get pancreatitis.

• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• kidney problems
• liver problems

Stop taking alogliptin/pioglitazone and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

3. Liver problems. Call your doctor right away if you have symptoms, such as:

• nausea or vomiting
• stomach pain
• unusual or unexplained tiredness
• loss of appetite
• dark urine
• yellowing of your skin or the whites of your eyes

4. Broken bones (fractures). Usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy.

5. Bladder cancer. There may be an increased chance of having bladder cancer when you take alogliptin/pioglitazone. You should not take alogliptin/pioglitazone if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:

• blood or a red color in your urine
• an increased need to urinate
• pain while you urinate

• shaking or feeling jittery
• sweating
• fast heartbeat
• change in vision
• hunger
• headache
• change in mood
• confusion
• dizziness

7. Diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly.

8. Release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take alogliptin/pioglitazone. This can increase your chance of getting pregnant.

• have severe heart failure
• are allergic to alogliptin, pioglitazone or any ingredient in alogliptin/pioglitazone or have had a serious allergic (hypersensitivity) reaction to alogliptin or pioglitazone. 

​Symptoms of a serious allergic reaction to alogliptin/pioglitazone may include:

• swelling of your face, lips, throat, and other areas on your skin
• difficulty with swallowing or breathing
• raised, red areas on your skin (hives)
• skin rash, itching, flaking or peeling

If you have these symptoms, stop taking alogliptin/pioglitazone and contact your doctor or go to the nearest hospital emergency room right away.

Alogliptin/pioglitazone can cause other serious side effects. See "Alogliptin & Pioglitazone Precautions."

The most common side effects of alogliptin/pioglitazone include:

• cold-like symptoms (upper respiratory tract infection)
• stuffy or runny nose and sore throat
• diarrhea
• increase in blood pressure
• headache
• back pain
• urinary tract infection

• shaking or feeling jittery
• sweating
• fast heartbeat
• change in vision
• hunger
• headache
• change in mood
• confusion
• dizziness

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of alogliptin/pioglitazone. For more information, ask your doctor or pharmacist. 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:

• atorvastatin (Lipitor)
• gemfibrozil (Lopid)
• hormonal contraceptives (birth control pills, patches, rings, implants, and injections)
• insulin or other medications to treat diabetes
• ketoconazole (Nizoral)
• midazolam (Versed)
• nifedipine (Procardia)
• rifampin (Rifadin, Rifater, in Rifamate)

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

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.

This medication 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 whether alogliptin/pioglitazone passes into your breast milk and if it can harm your baby. You should not take alogliptin/pioglitazone if you breastfeed your baby. Talk with your doctor about the best way to feed your baby if you are taking alogliptin/pioglitazone.