Oseni

Generic Name: alogliptin and pioglitazone (Oral route)

al-oh-GLIP-tin BEN-zoe-ate, pye-oh-GLI-ta-zone hye-droe-KLOR-ide

Oral route(Tablet)

May cause or worsen congestive heart failure, is not recommended in patients with symptomatic heart failure, and is contraindicated in patients with established NYHA Class III or IV heart failure. Monitor patients for signs and symptoms of heart failure after initiation or dose increases. If heart failure occurs, consider dose reduction of pioglitazone in the alogliptin/pioglitazone combination or discontinue pioglitazone and manage according to current standards of care .

Commonly used brand name(s)

In the U.S.

  • Oseni

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Alogliptin

Chemical Class: Pioglitazone

Uses For Oseni

Alogliptin and pioglitazone combination is used to treat high blood sugar levels caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In patients with type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your blood. Chronic high blood sugar can lead to serious health problems in the future.

Slideshow: Flashback: FDA Drug Approvals 2013

Many people can control type 2 diabetes with diet alone or diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of alogliptin and pioglitazone you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.

Alogliptin and pioglitazone combination does not help patients who have insulin-dependent or type 1 diabetes, because they cannot produce insulin from their pancreas. Their blood sugar is best controlled with insulin injections.

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

Before Using Oseni

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of alogliptin and pioglitazone combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alogliptin and pioglitazone combination in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cobicistat
  • Elvitegravir
  • Ifosfamide
  • Nifedipine
  • Piperaquine
  • Pixantrone
  • Tolvaptan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone Acetate
  • Atorvastatin
  • Bitter Melon
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fenugreek
  • Gemfibrozil
  • Glucomannan
  • Guar Gum
  • Ketoconazole
  • Levonorgestrel
  • Medroxyprogesterone Acetate
  • Mestranol
  • Nilotinib
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Psyllium
  • Rifampin
  • Topiramate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol, excessive use of or
  • Gallbladder stones or
  • Pancreas problems, history of—Use with caution. May increase risk for getting pancreatitis (swelling and inflammation of the pancreas).
  • Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history with other dipeptidyl peptidase-4 (DPP-4) inhibitors—Use with caution. May increase the risk of this condition occurring again.
  • Bladder cancer, active or
  • Diabetic ketoacidosis (high ketones and acid in the blood) or
  • Heart failure, severe or
  • Kidney disease, severe or
  • Type 1 diabetes—Should not be used in patients with these conditions.
  • Diabetic macular edema (swelling of the back of the eye) or
  • Edema (fluid retention) or
  • Liver disease—Use with caution. May make these conditions worse.
  • Fragile bones (especially in women)—Use with caution. This medicine may increase the risk for fractures.
  • Kidney disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Oseni

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to 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.

You may take this medicine with or without food.

Swallow the tablet whole. Do not crush, break, or chew it.

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:
      • Adults—At first, one tablet (either alogliptin 25 milligrams [mg] plus pioglitazone 15 mg or alogliptin 25 mg plus pioglitazone 30 mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than alogliptin 25 mg plus pioglitazone 45 mg per day.
      • Children—Use is not recommended.
      • For patients switching from a combination of alogliptin and pioglitazone as separate tablets:
        • Adults—The starting dose is the same dose of alogliptin and pioglitazone that you are already taking. Your doctor may adjust your dose as needed. However, the dose is usually not more than alogliptin 25 mg plus pioglitazone 45 mg per day.
        • Children—Use is not recommended.

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.

Precautions While Using Oseni

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Certain women may be at an increased risk for pregnancy while taking this medicine. If you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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.

Using this medicine longer than 12 months may increase your risk for bladder cancer. Tell your doctor right away if you have blood in the urine, a frequent, strong, or increased urge to urinate, painful urination, or pain in the back, lower abdomen, or stomach.

Check with your doctor right away if blurred vision, decreased vision, or any other change in vision occurs while you are taking this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take alogliptin with another type of diabetes medicine (eg, insulin, glimepiride, glipizide, glyburide, or metformin). Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly.

Symptoms of low blood sugar include anxiety, behavior changes similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.

If symptoms of low blood sugar occur, check your blood sugar level. If you have low blood sugar, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Glucagon is a medicine that is used in emergency situations when severe symptoms, such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. The members of your family should also know how to use glucagon.

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 diet plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), loss of appetite, sleepiness, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness (passed out), or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

There may be a time when you need emergency help for a problem caused by your diabetes. You need to 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 says you have diabetes with a list of 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.

Oseni Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common
  • Anxiety
  • blurred vision
  • chest pain
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • decreased urine output
  • depression
  • dilated neck veins
  • dizziness
  • extreme fatigue
  • fast heartbeat
  • headache
  • increased hunger
  • irregular breathing
  • irregular heartbeat
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
  • weight gain
Rare
  • Blistering, peeling, or loosening of the skin
  • bloating
  • blood in the urine
  • constipation
  • cough
  • darkened urine
  • diarrhea
  • difficulty with swallowing
  • feeling of discomfort
  • fever
  • frequent, strong, or increased urge to urinate
  • hives
  • indigestion
  • inflammation of the joints
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • muscle aches
  • pain in the back, lower abdomen, or stomach
  • painful urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swollen lymph glands
  • vomiting
  • yellow eyes or skin
Incidence not known
  • Change in vision
  • general feeling of tiredness or weakness
  • light-colored stools
  • stomach pain, continuing

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

Less common
  • Back pain
  • body aches or pain
  • ear congestion
  • loss of voice
  • sneezing
  • stuffy or runny nose

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.

See also: Side effects (in more detail)

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