Jentadueto

Pronunciation

Generic Name: linagliptin and metformin (LIN a GLIP tin and met FOR min)
Brand Names: Jentadueto

What is Jentadueto?

Jentadueto contains a combination of linagliptin and metformin. Linagliptin and metformin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Linagliptin works by regulating the levels of insulin your body produces after eating.

Jentadueto is used to treat type 2 diabetes. This medicine is not for treating type 1 diabetes.

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

Important information

You should not use Jentadueto if you have ever had a severe allergic reaction to linagliptin. Do not use this medicine if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before you take Jentadueto, tell your doctor if you have liver disease, a serious infection, heart disease, a history of pancreatitis, if you have recently had a heart attack, or if you are over 80 years old and have not recently had your kidney function checked.

Slideshow: Flashback: FDA Drug Approvals 2013

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Jentadueto.

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Before taking this medicine

You should not use Jentadueto if you are allergic to metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet) or linagliptin (Onglyza), or:

  • if you have ever had a severe allergic reaction (breathing problems, swelling, severe skin rash) to linagliptin;

  • if you have kidney disease; or

  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Jentadueto. Be sure your caregivers know ahead of time that you are using this medication.

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

  • liver disease;

  • heart disease;

  • a serious infection called sepsis;

  • a history of pancreatitis;

  • if you have recently had a heart attack; or

  • if you are over 80 years old and have not recently had your kidney function checked.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

FDA pregnancy category B. Jentadueto is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether linagliptin and metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Jentadueto.

How should I take Jentadueto?

Take Jentadueto exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Take Jentadueto twice daily with meals, unless your doctor tells you otherwise.

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

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

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 Jentadueto dose or dosing schedule without your doctor's advice.

Your doctor may have you take extra vitamin B12 while you are taking metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

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

Store at room temperature away from moisture and heat.

Jentadueto dosing information

Usual Adult Dose for Diabetes Type 2:

Patients currently not treated with metformin, initiate treatment with 2.5 mg linagliptin/500 mg metformin orally twice daily

Patients already treated with metformin, start with 2.5 mg linagliptin and the current dose of metformin taken at each of the two daily meals (e.g., a patient on metformin 1000 mg twice daily would be started on 2.5 mg linagliptin/1000 mg metformin orally twice daily with meals).

Patients already treated with the individual components found in Jentadueto may be switched to the combination containing the same doses of each component (linagliptin and metformin).

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). 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).

An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What should I avoid while taking Jentadueto?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Jentadueto side effects

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

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as:

  • muscle pain or weakness;

  • numb or cold feeling in your arms and legs;

  • trouble breathing;

  • feeling dizzy, light-headed, tired, or very weak;

  • stomach pain, nausea with vomiting; or

  • slow or uneven heart rate.

Call your doctor at once if you have:

  • swelling, rapid weight gain;

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, and fast heart rate;

  • the first sign of any skin rash, flaking or peeling of the skin; 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 Jentadueto side effects may include:

  • cough, sore throat

  • sinus pain, stuffy nose;

  • upset stomach, diarrhea; or

  • weight gain.

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 Jentadueto?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Jentadueto, especially:

  • rifampin.

You may be more likely to have hypoglycemia (low blood sugar) if you take Jentadueto with other drugs that can lower blood sugar, such as:

  • exenatide (Byetta);

  • probenecid (Benemid);

  • aspirin or other salicylates (including Pepto Bismol);

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • sulfa drugs (Bactrim, SMX-TMP, SMZ-TMP, and others);

  • a monoamine oxidase inhibitor (MAOI); or

  • insulin or other oral diabetes medications.

These lists are not complete and there are many other medicines that can increase or decrease the effects of linagliptin and metformin on lowering your blood sugar. This includes prescription, over-the-counter, vitamin, 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 Jentadueto.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Jentadueto only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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 absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. 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 1996-2014 Cerner Multum, Inc. Version: 1.03. Revision Date: 2014-08-11, 8:06:28 AM.

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