Alogliptin and pioglitazone

Name: Alogliptin and pioglitazone

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).

Alogliptin and pioglitazone side effects

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

Stop taking this medicine 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, new or worsening urge to urinate;

  • 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 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.

Uses For alogliptin and pioglitazone

Alogliptin and pioglitazone combination is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Alogliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. Pioglitazone works by helping your body use insulin better. alogliptin and pioglitazone does not help patients who have insulin-dependent or type 1 diabetes.

alogliptin and pioglitazone is available only with your doctor's prescription.

Proper Use of alogliptin and pioglitazone

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.

alogliptin and pioglitazone should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take alogliptin and pioglitazone with or without food.

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

Dosing

The dose of alogliptin and pioglitazone 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 alogliptin and pioglitazone. 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 once a day. The tablet may contain either alogliptin 25 milligrams [mg] plus pioglitazone 15 mg or alogliptin 25 mg plus pioglitazone 30 mg. 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 alogliptin and pioglitazone, 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 alogliptin and pioglitazone

It is very important that your doctor check your progress at regular visits to make sure that alogliptin and pioglitazone 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 alogliptin and pioglitazone. If you had problems ovulating and had irregular periods in the past, alogliptin and pioglitazone 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 trouble breathing, 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 fluid retention (too much water in the body).

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

alogliptin and pioglitazone 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 alogliptin and pioglitazone.

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.

alogliptin and pioglitazone may increase the risk for bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

Using alogliptin and pioglitazone for a long time 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 alogliptin and pioglitazone. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

alogliptin and pioglitazone 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). Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

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. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

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.

alogliptin and pioglitazone may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using alogliptin and pioglitazone.

alogliptin and pioglitazone may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using alogliptin and pioglitazone.

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.

What are some other side effects of Alogliptin and Pioglitazone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Stuffy nose.
  • Runny nose.
  • Sore throat.
  • Back pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Alogliptin and Pioglitazone?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time alogliptin and pioglitazone is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take alogliptin and pioglitazone or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 alogliptin and pioglitazone. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Dosing Hepatic Impairment

There are no dosage adjustments for the combination product provided in the manufacturer’s labeling. See individual agents.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture and humidity.

Adverse Reactions

Percentages as reported with combination product. Also see individual agents.

1% to 10%:

Endocrine & metabolic: Hypoglycemia (≤4%)

Neuromuscular & skeletal: Back pain (4%)

Respiratory: Nasopharyngitis (5%), upper respiratory tract infection (4%)

<1% (Limited to important or life-threatening): Bladder carcinoma (FDA Safety Alert, Dec. 19, 2016), severe arthralgia (FDA Safety Alert, Aug 28, 2015)

Monitoring Parameters

HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2017a]), serum glucose.

Renal function (prior to initiation of therapy then annually or more frequent if necessary); liver enzymes (ALT, AST, alkaline phosphatase, and total bilirubin) prior to initiation in all patients (continue routine periodic monitoring during treatment in patients with liver disease or suspected liver disease).

Signs and symptoms of heart failure; weight gain; signs/symptoms of bladder cancer (dysuria, macroscopic hematuria, dysuria, urinary urgency); ophthalmic exams

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