Oseni treats Type 2 Diabetes. Do not break or cut Oseni tablets before swallowing.
Oseni 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.
Oseni comes in tablet form and is usually taken once daily, with or without food. Do not break or cut Oseni tablets before swallowing.
Some of the common side effects of Oseni include stuffy or runny nose and sore throat, back pain, and cold-like symptoms.
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Side Effects of Oseni
Oseni can cause other serious side effects. See "Oseni Precautions."
The most common side effects of Oseni include:
- cold-like symptoms (upper respiratory tract infection)
- stuffy or runny nose and sore throat
- increase in blood pressure
- back pain
- urinary tract infection
- shaking or feeling jittery
- fast heartbeat
- change in vision
- change in mood
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 Oseni. 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 Oseni drug interactions. Ask your doctor or pharmacist for more information.
Oseni can cause serious side effects, including:
- Do not take Oseni 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, Oseni 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 Oseni, may cause pancreatitis which may be severe. Certain medical conditions make you more likely to get pancreatitis.
- stones in your gallbladder (gallstones)
- a history of alcoholism
- kidney problems
- liver problems
Stop taking Oseni 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 Oseni. You should not take Oseni 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
- fast heartbeat
- change in vision
- change in mood
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 Oseni. This can increase your chance of getting pregnant.
- have severe heart failure
- are allergic to alogliptin, pioglitazone or any ingredient in Oseni or have had a serious allergic (hypersensitivity) reaction to alogliptin or pioglitazone.
Symptoms of a serious allergic reaction to Oseni 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 Oseni and contact your doctor or go to the nearest hospital emergency room right away.
Oseni Food Interactions
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet when receiving Oseni.
Before receiving Oseni, tell your doctor if you:
- have heart failure
- have a type of diabetic eye disease that causes swelling of the back of the eye (macular edema)
- have kidney or liver problems
- have or have had inflammation of the pancreas (pancreatitis)
- have or have had cancer of the bladder
- have other medical conditions
- are pregnant or plan to become pregnant. It is not known if Oseni can harm your unborn baby. Talk to your doctor about the best way to control your blood sugar while you are pregnant or if you plan to become pregnant.
- are a premenopausal woman, who does not have periods regularly or at all. Oseni may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking Oseni. Tell your doctor right away if you become pregnant while taking Oseni.
- are breastfeeding or plan to breastfeed. It is not known whether Oseni passes into your breast milk and if it can harm your baby. You should not take Oseni if you breastfeed your baby. Talk with your doctor about the best way to feed your baby if you are taking Oseni.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Oseni and Pregnancy
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.
Oseni and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether Oseni 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 Oseni.
- Take Oseni exactly as your doctor tells you to take it.
- Take Oseni 1 time each day with or without food.
- Do not break or cut Oseni tablets before swallowing.
- Your doctor may need to change your dose of Oseni to control your blood glucose. Do not change your dose unless told to do so by your doctor.
- If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose, and take the next dose at your regular time. Do not take 2 doses of Oseni at the same time.
- If you take too much Oseni, call your doctor or go to the nearest hospital emergency room right away.
- If your body is under stress, such as from fever, infection, accident, or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away.
- Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.
- Your doctor may do certain blood tests before you start Oseni and during treatment as needed. Your doctor may change your dose of Oseni based on the results of your blood tests due to how well your kidneys are working.
- Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
- Your doctor should check your eyes regularly while you take Oseni.
The Oseni dose your doctor recommends will depend on several factors including:
- the medications you are currently taking
- other medical conditions you have
- how well Oseni works for you
- how well you tolerate the medication (side effects)
If you take too much Oseni, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
- Store Oseni at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep container tightly closed and protect from moisture and humidity.
- Keep Oseni and all medicines out of the reach of children.
Oseni FDA Warning
WARNING: CONGESTIVE HEART FAILURE
- Thiazolidinediones, including pioglitazone, which is a component of Oseni, cause or exacerbate congestive heart failure in some patients.
- After initiation of Oseni, 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 Oseni must be considered.
- Oseni is not recommended in patients with symptomatic heart failure.
- Initiation of Oseni in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.