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Generic Name: alogliptin and pioglitazone (AL oh GLIP tin and PYE oh GLI ta zone)
Brand Names: Oseni

What is Oseni?

Oseni contains a combination of alogliptin and pioglitazone. Alogliptin and pioglitazone are oral diabetes medicines that helps control blood sugar levels.

Oseni is used to treat people with type 2 diabetes. This medicine is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.

Oseni may also be used for purposes not listed in this medication guide.

Important information

You should not use Oseni if you have severe or uncontrolled heart failure, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Oseni can cause or worsen congestive heart failure. Call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

Oseni can also cause pancreatitis. Stop using this medicine and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and loss of appetite.

Before taking this medicine

You should not Oseni if you are allergic to alogliptin or pioglitazone, if you have severe or uncontrolled heart failure. Do not use Oseni if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Oseni is safe for you, tell your doctor if you have:

  • congestive heart failure, history of heart disease;

  • liver disease;

  • kidney disease (or if you are on dialysis);

  • eye problems caused by diabetes;

  • pancreatitis;

  • a history of bladder cancer;

  • gallstones; or

  • a history of alcoholism.

Although Oseni may increase your risk of serious heart problems, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of taking Oseni.

Some women using pioglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking pioglitazone. Talk with your doctor if you are concerned about this possibility.

Oseni may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

It is not known whether Oseni will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether alogliptin and pioglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Oseni is not approved for use by anyone younger than 18 years old.

How should I take Oseni?

Take Oseni exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Oseni with or without food. Follow your doctor's instructions.

Do not break an Oseni tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating.

Keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Oseni is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, vision exams, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Oseni dosing information

Usual Adult Dose for Diabetes Type 2:

Individualize dose based on current regimen and concurrent medical condition:

For patients inadequately controlled on diet and exercise or metformin monotherapy:
-Initial dose: alogliptin-pioglitazone 25 mg/15 mg or 25 mg/30 mg orally once a day
-For patients on alogliptin requiring additional glycemic control:
-Initial dose: alogliptin-pioglitazone 25 mg/15 mg or 25 mg/30 mg orally once a day
For patients on pioglitazone requiring additional glycemic control:
-Initial dose: alogliptin-pioglitazone 25 mg/15 mg, 25 mg/30 mg, or 25 mg/45 mg orally once a day
For patients with congestive heart failure (NYHA Class I or II):
-Initial dose: alogliptin-pioglitazone 25 mg/15 mg orally once a day
For patients switching from individual components:
-Initial dose: Switch to combination product based on current therapy.

Titrate dose based on glycemic response as determined by hemoglobin A1c (HbA1c).
Maximum dose: Alogliptin 25 mg per day; Pioglitazone 45 mg per day.

Comments: When used in combination with insulin or insulin secretagogues such as sulfonylureas, a lower dose of insulin or the insulin secretagogue may be required to minimize the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetess when treatment with both Oseni is appropriate.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking Oseni?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Oseni side effects

Get emergency medical help if you have signs of an allergic reaction to Oseni: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Oseni and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Call your doctor at once if you have:

  • severe or ongoing pain in your joints;

  • pink or red urine, painful or difficult urination, urinating more than usual;

  • changes in your vision;

  • heart problems - shortness of breath (even while, lying down), rapid weight gain, swelling (especially in your feet, legs, or midsection);

  • liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Oseni side effects may include:

  • back pain; or

  • cold symptoms such as stuffy nose, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Oseni?

Tell your doctor if you use insulin. Taking Oseni while you are using insulin may increase your risk of serious heart problems.

Other drugs may increase or decrease the effects of Oseni on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Oseni.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Oseni only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.03. Revision Date: 2016-04-28, 7:53:22 AM.