Generic Name: alogliptin/pioglitazone (AL-oh-GLIP-tin/PYE-oh-GLI-ta-zone)
Brand Name: Oseni
Thiazolidinedione antidiabetics such as Oseni may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Oseni should not be used to treat patients with moderate to severe heart failure. You will be monitored for signs of heart failure when you start Oseni and when your dose increases. Contact your doctor at once if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden, unexplained weight gain. Your doctor may need to stop your medicine or change your dose.
Oseni is used for:
Treating type 2 diabetes in certain patients. It is used along with diet and exercise.
Oseni is a dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione combination. It works by increasing the amount of insulin released by your body and decreasing the amount of sugar made by your body. It also helps make your body more sensitive to the action of insulin.
Do NOT use Oseni if:
- you are allergic to any ingredient in Oseni
- you have bladder cancer or moderate to severe heart failure
- you have type 1 diabetes
- you have high blood or urine ketone levels (diabetic ketoacidosis)
- you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone
Contact your doctor or health care provider right away if any of these apply to you.
Before using Oseni:
Some medical conditions may interact with Oseni. 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 a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, saxagliptin)
- if you have a history of liver or kidney problems, abnormal liver function tests, heart problems (eg, congestive heart failure [CHF]), inflammation of the pancreas (pancreatitis), stones in your gallbladder (gallstones), bladder cancer, or eye or vision problems (eg, macular edema)
- if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis)
- if you have swelling problems (edema)
- if you have a history of alcohol abuse
Some MEDICINES MAY INTERACT with Oseni. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Gemfibrozil, insulin, or oral antidiabetic medicines (eg, glipizide) because the risk of low blood sugar may be increased
- Rifampin because it may decrease Oseni's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Oseni 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.
How to use Oseni:
Use Oseni as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Oseni comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Oseni refilled.
- Take Oseni by mouth with or without food.
- Swallow Oseni whole. Do not break or cut before swallowing.
- Take Oseni on a regular schedule to get the most benefit from it. Taking Oseni at the same time each day will help you remember to take it.
- Continue to take Oseni even if you feel well. Do not miss any doses.
- If you miss a dose of Oseni, 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 Oseni.
Important safety information:
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Oseni exactly as prescribed, tell your doctor.
- Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Oseni.
- 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 your dose or take more than the recommended dose without checking with your doctor.
- Oseni may cause low blood sugar levels when it is used along with insulin or other oral diabetic medicines. 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 such as table sugar, honey, candy, orange juice, or nondiet 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.
- Oseni may cause ovulation in women who have not reached menopause but do not ovulate. Be sure to use effective birth control while using Oseni.
- Tell your doctor or dentist that you take Oseni before you receive any medical or dental care, emergency care, or surgery.
- Oseni may be associated with an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.
- An increased incidence of bone fracture has been reported in women who take Oseni. 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.
- Severe and sometimes fatal liver problems have been reported in patients taking Oseni. Call your doctor right away if you have symptoms of liver problems (eg, dark urine; stomach pain; unexplained nausea, vomiting, or loss of appetite; yellowing of the skin or eyes). Discuss any questions or concerns with your doctor.
- Severe and sometimes fatal inflammation of the pancreas (pancreatitis) has been reported in patients taking Oseni. Discuss any questions or concerns with your doctor. Contact your doctor immediately if you develop severe or persistent stomach or back pain with or without nausea or vomiting.
- Lab tests, including fasting blood sugar, hemoglobin A1c, eye examinations, and kidney and liver function, may be performed while you use Oseni. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Oseni should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oseni while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Oseni.
Possible side effects of Oseni:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; cold-like symptoms; headache; muscle aches; runny or stuffy nose; sore throat.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; symptoms of low blood sugar (eg, anxiety, chills, increased hunger, headache, increased dizziness or drowsiness, tremors); symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); unusual bone pain; 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. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Oseni:
Store Oseni between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Oseni out of the reach of children and away from pets.
- If you have any questions about Oseni, please talk with your doctor, pharmacist, or other health care provider.
- Oseni is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Oseni or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Oseni. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Oseni. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Oseni.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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- Drug class: antidiabetic combinations