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Overview: Trijardy XR helps lower blood sugar levels and the risk of dying from heart problems in people with type 2 diabetes. It works by helping your body use sugar better and get rid of extra sugar, salt, and water. Common side effects are diarrhea, constipation, and headache. Notify your healthcare provider if you have severe or frequent episodes of low blood sugar.

Uses

What is Trijardy XR used for?

Trijardy XR (empagliflozin/linagliptin/metformin) is commonly used for the following conditions

  • To help lower blood sugar levels in people with type 2 diabetes
  • To lower the risk of dying from heart problems in people with type 2 diabetes and heart disease (or at high risk for heart disease)

Trijardy XR may also be used for other conditions as determined by your healthcare provider.

How does Trijardy XR work (mechanism of action)?

Trijardy XR works in several ways to lower your blood glucose (sugar). It increases the levels of natural hormones in your body to lower blood sugar by increasing insulin levels, especially after meals. (Insulin is a hormone that helps your body use sugar as a source of energy). It decreases the amount of sugar your body absorbs from things you eat and drink. It reduces the amount of sugar that your liver makes, helps insulin to work better, and helps you get rid of sugar when you pee. 

Trijardy XR lowers the risk of dying from heart problems by helping your body get rid of extra sugar, salt, and water.

How is Trijardy XR supplied (dosage forms)?

Brands and other names

  • Trijardy XR

Dosage forms and strengths

  • 5 mg/2.5 mg/1000 mg extended-release oral tablets
  • 10 mg/5 mg/1000 mg extended-release oral tablets
  • 12.5 mg/2.5 mg/1000 mg extended-release oral tablets
  • 25 mg/5 mg/1000 mg oral extended-release oral tablets

How should I store Trijardy XR?

Trijardy XR should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Trijardy XR?

The most common side effects of Trijardy XR are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Kidney or bladder infections
  • Diarrhea and constipation
  • Headache
  • Stomach flu

There may be other side effects of Trijardy XR that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Trijardy XR?

While less common, the most serious side effects of Trijardy XR are described below, along with what to do if they happen.

Severe Allergic Reactions. Trijardy XR may cause allergic reactions, which can be serious. Stop taking Trijardy XR and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Lactic Acidosis. Trijardy XR may cause lactic acidosis (a buildup of lactic acid in your blood), which can be serious. Stop taking Trijardy XR and get help right away if you have any of the following symptoms of lactic acidosis.

  • General ill feeling
  • Muscle pain
  • Difficulty breathing
  • Drowsiness 
  • Stomach pain

Diabetic Ketoacidosis (DKA). Trijardy XR may cause diabetic ketoacidosis (a serious complication of diabetes). DKA can be life threatening. Stop taking Trijardy XR and get help right away if you have any of the following symptoms of diabetic ketoacidosis.

  • Nausea or vomiting
  • Stomach pain
  • Feeling very tired, woozy, or confused
  • Difficulty breathing
  • Your breath smells fruity or sweet
  • Very high blood sugar levels (higher than 300 mg/dL)

Vitamin B12 Deficiency. Trijardy XR may cause you to have low levels of vitamin B12 in your blood (possibly by decreasing the amount of vitamin B12 your body absorbs from things you eat or drink), which may lead to anemia (low levels of red blood cells). Keep all appointments, including lab appointments, to check your vitamin B12 levels and for anemia. Tell your healthcare provider right away if you have any of the following symptoms of anemia.

  • Unusual weakness or tiredness
  • Cold hands and feet
  • Fast or abnormal heartbeat
  • Pale or yellowish skin
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Shortness of breath

Low Blood Sugar (Hypoglycemia). Trijardy XR can cause hypoglycemia (low blood sugar), especially if used with other diabetes medicines. The doses of the other medicines may need to be changed when taken with Trijardy XR. Call your healthcare provider right away if you have any of the following symptoms of low blood sugar.

  • Headache
  • Crankiness or anxiety
  • Hunger
  • Dizziness or confusion
  • Blurry vision
  • Slurred speech
  • Sweating
  • Feeling jittery or shakiness
  • Fast heartbeat
  • Seizures

Dehydration. Trijardy XR may cause dehydration. Dehydration may lead to low blood pressure, especially when you stand up (orthostatic hypotension) or kidney damage. Call your healthcare provider right away if you have any of the following symptoms of dehydration, low blood pressure, or kidney damage.

  • Dizziness or lightheadedness
  • Weakness or unusual tiredness
  • Confusion
  • Unsteadiness
  • Peeing less than normal
  • Swelling in your legs, ankles, and feet
  • Loss of appetite/nausea
  • Difficulty catching your breath or chest pain/pressure
  • Seizures

Urosepsis and Pyelonephritis. Trijardy XR may cause pyelonephritis (a kidney infection) or urosepsis (an untreated urinary tract infection that spreads to your kidney). These are serious infections and may need to be treated in the hospital. Get help right away if you have any of the following symptoms of these serious infections.

  • Dark, cloudy, or bloody pee or pee that smells bad
  • Fever and chills
  • Loss of appetite
  • Needing to pee a lot or feeling pain when you pee
  • Pain in your lower back, side, or groin
  • Upset stomach, nausea, and vomiting

Inflammation of the Pancreas (Pancreatitis). Trijardy XR may cause inflammation of the pancreas, which is called pancreatitis. Stop taking Trijardy XR and call your healthcare provider right away if you have symptoms of pancreatitis including vomiting or severe pain in the upper part of your belly that travels to your back.

Heart Failure. Trijardy XR may increase your risk of heart failure. Tell your healthcare provider right away if you have any of the following symptoms of heart failure.

  • Shortness of breath or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, or legs
  • Unusually fast weight gain
  • Unusual tiredness

Severe Joint Pain. Trijardy XR may cause joint pain that can be severe. Call your healthcare provider if you have new or increased joint pain while taking this medicine.

Severe Skin Reactions. Trijardy XR can cause a rare skin reaction called bullous pemphigoid. This reaction may start as an itchy skin rash and large blisters may form on the skin. You may need treatment in a hospital if this reaction happens. Call your healthcare provider right away if you develop a rash or blisters on the skin while taking this medicine.

Necrotizing Fasciitis (Fournier’s Gangrene). Trijardy XR can cause necrotizing fasciitis, which is an aggressive skin and tissue infection that causes some of the tissue involved to die. Necrotizing fasciitis is rare, but very serious, can lead to death, and may require surgery to treat it. Get help right away if you have any of the following symptoms of this serious infection.

  • Pain, redness, tenderness, or swelling of the perineum (of and around the anus and genitals)
  • Fever
  • General feeling of illness or discomfort

Amputations. People who take Trijardy XR may be more likely to have an amputation (limb or part of a limb cut off) than people who do not take Trijardy XR. The toe, part of the foot, or part of the leg were most often involved. Amputations seem more likely in people with diabetes, peripheral artery disease (narrowing of your blood vessels, often in your legs), diabetic foot infections, nerve damage in your legs, or who already had an amputation. Inspect your feet and legs regularly and contact your healthcare provider right away if you have sores, ulcers, or new pain or tenderness, as these may lead to the need for an amputation if not treated.

Warnings & Precautions

Who should not use Trijardy XR?

Allergies to Ingredients. People who are allergic to any of the following should not take Trijardy XR.

  • Empagliflozin
  • Linagliptin
  • Metformin
  • Trijardy XR
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Trijardy XR.

Metabolic Acidosis, Including Diabetic Ketoacidosis. Trijardy XR should not be used in people with acute or chronic metabolic acidosis (when there is too much acid in your blood). Tell your healthcare provider if you have a history of metabolic acidosis or diabetic ketoacidosis.

Kidney Problems. Trijardy XR should not be used to lower your blood sugar if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your healthcare provider may do tests to determine if they are working well enough to take this medicine.

What should I know about Trijardy XR before using it?

Do not take Trijardy XR unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Trijardy XR with other people, even if they have the same condition as you. It may harm them.

Keep Trijardy XR out of the reach of children.

Certain conditions that cause increased stress on your body, like fever, trauma (such as a car accident), infection, or surgery can change the amount of diabetes medicines you need to take to control your diabetes. Talk to your healthcare provider if you have any of these conditions to decide if your medicine needs to be changed.

Talk to your healthcare provider about how to prevent, recognize, and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and diabetes-related problems. 

Trijardy XR can cause ovulation (release of an egg from your ovary) if you have not gone through menopause, even if you do not have regular periods. This can increase your chance of getting pregnant.

People who are 65 years or older can be at greater risk for some side effects from Trijardy XR. Talk to your healthcare provider about your risks if you are in this age group.

You can take Trijardy XR with your morning meal to help decrease the chance you will have an upset stomach.

Do not cut, break, dissolve, or chew Trijardy XR. It should be swallowed whole.

Trijardy XR will cause your pee to test positive for sugar.

What should I tell my healthcare provider before using Trijardy XR?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Trijardy XR is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Medical Conditions. Tell your healthcare provider if you have any of the following. 

  • Kidney or liver problems
  • Gallbladder problems
  • High triglyceride levels
  • Inflammation of the pancreas
  • Heart problems, including congestive heart failure or a heart attack
  • Have an upcoming medical test that uses contrast (a special dye), surgery, or other procedure
  • Stroke
  • Scheduled surgery
  • History of kidney, bladder, or genital yeast infections
  • Difficulty peeing or emptying your bladder
  • Nerve damage or blood flow problems
  • Previous amputation

Other Medicines and Supplements. Trijardy XR may interact with other medicines and supplements. Before taking Trijardy XR, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Risk Factors for Diabetic Ketoacidosis. Tell your healthcare provider if you have any of the following risk factors for diabetic ketoacidosis. Your healthcare provider may monitor you more closely or choose a different medicine for you.

  • Type 1 diabetes or a history of diabetic ketoacidosis
  • Decrease in your insulin dose
  • Serious infection
  • Use a low-salt diet
  • Drink alcohol often or in large amounts
  • Pancreas problems, including a history of pancreatitis or surgery on your pancreas
  • Dehydration
  • Are eating or drinking less than normal
  • Vomiting or diarrhea

Pregnancy. Trijardy XR may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you get pregnant, contact your healthcare provider right away. Talk to your healthcare provider about how to control your blood sugar while you are pregnant. 

Breastfeeding. It is not known if Trijardy XR passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Trijardy XR while breastfeeding.

How can I get more information about Trijardy XR?

For more information about Trijardy XR, you can visit the manufacturer’s website at www.patient.boehringer-ingelheim.com/us/trijardy or call them at 800-542-6257.

Interactions

Does Trijardy XR interact with foods or drinks?

You should take Trijardy XR with your morning meal.

Being on a low-salt diet while taking Trijardy XR may increase your risk of dehydration. See the Side Effects section for more details. 

It is unknown if drinking alcohol will affect Trijardy XR, but alcohol may affect blood sugar levels in people with diabetes. This may interfere with the effect of Trijardy XR. Drinking alcohol often or too much alcohol while taking Trijardy XR may increase your risk of diabetic ketoacidosis. See the Side Effects section for more details. It is best to limit the amount of alcohol you drink.

Does Trijardy XR interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Trijardy XR.

  • A carbonic anhydrase inhibitor, such as topiramate (Topamax), zonisamide (Zonegran), acetazolamide (Diamox), or methimazole
  • Lithium, which is a medicine for certain mental health conditions
  • A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
  • Another medicines for diabetes
  • Ranolazine (Aspruzyo Sprinkle), which is a medicine used for chest pain
  • Vandetanib (Caprelsa), which is a medicine used for thyroid cancer
  • Dolutegravir, which is a medicine used for HIV
  • Cimetidine (Tagamet HB), which is a medicine used for heartburn
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis

Many other medicines can increase your blood sugar and can interfere with the effect of Trijardy XR. Talk to your pharmacist or healthcare provider before starting or stopping other medicines while taking Trijardy XR. You may need to monitor your blood sugar levels more closely during these times.

Some other medicines may alter the blood levels of Trijardy XR. Tell your healthcare provider about all medicines that you take or have recently taken. 

This may not be a complete list of medicines that can interact with Trijardy XR. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Trijardy XR?

If you or someone else has used too much Trijardy XR, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Trijardy XR?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

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