Uses

What is Xigduo XR used for?

Xigduo XR (dapagliflozin/metformin) is commonly used to help lower blood sugar levels in people with type 2 diabetes.

Xigduo XR is also used in people with type 2 diabetes and chronic (long-term) kidney disease, heart failure, or heart disease (or at high risk for heart disease) to prevent the following complications.

  • Worsening kidney problems
  • Need for urgent treatment or hospital admission for heart failure
  • Dying from heart problems

Xigduo XR is not used to treat type 1 diabetes. 

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

How does Xigduo XR work (mechanism of action)?

Xigduo XR works in different ways to help keep your blood glucose (sugar) from getting too high.

  • Xigduo XR decreases the amount of glucose your body absorbs from things you eat and drink. 
  • Xigduo XR reduces the amount of glucose that your liver makes. 
  • Xigduo XR also helps your body’s own insulin to work better. (Insulin is a hormone that helps your body use glucose as a source of energy.)
  • Xigduo XR helps your body get rid of sugar when you pee.
  • Xigduo XR lowers the risk of complications from heart failure, diabetes and heart disease, and worsening kidney problems by helping your body get rid of extra sugar, salt, and water.

How is Xigduo XR supplied (dosage forms)?

Xigduo XR is available in the following dosage forms that are taken by mouth.

  • 2.5 mg dapagliflozin/1000 mg metformin extended-release oral tablets
  • 5 mg dapagliflozin/500 mg metformin extended-release oral tablets
  • 5 mg dapagliflozin/1000 mg metformin extended-release oral tablets
  • 10 mg dapagliflozin/500 mg metformin extended-release oral tablets
  • 10 mg dapagliflozin/1000 mg metformin extended-release oral tablets

How should I store Xigduo XR?

Xigduo XR oral tablets 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 Xigduo XR?

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

  • Yeast infection of the vagina or penis
  • Common cold symptoms
  • Kidney or bladder infections
  • Diarrhea
  • Headache

There may be other side effects of Xigduo 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 Xigduo XR?

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

Severe Allergic Reactions. Xigduo XR may cause allergic reactions, which can be serious. Stop taking Xigduo 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

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

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

Lactic Acidosis. Xigduo XR may cause lactic acidosis (a buildup of lactic acid in your blood), which can be serious. Stop using Xigduo 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

Dehydration. Xigduo 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
  • Extreme thirst

Urosepsis and Pyelonephritis. Xigduo 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

Low Blood Sugar (Hypoglycemia). Xigduo XR can cause low blood sugar, especially when combined with insulin or other medicines that increase your insulin levels. Low blood sugar can be serious and may lead to death. You may need a lower dose of your other diabetes medicine to reduce your risk of hypoglycemia. Do not take Xigduo XR and call your healthcare provider right away if you have any of the following symptoms of hypoglycemia.

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

Necrotizing Fasciitis (Fournier’s Gangrene). Xigduo XR can cause necrotizing fasciitis (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

Vitamin B12 Deficiency. Xigduo 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). Your healthcare provider will likely use lab tests 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

Broken Bones. Xigduo XR may increase your risk of a fracture (broken bone). Discuss your medical history with your healthcare provider so your risk of fracture can be assessed.

Warnings & Precautions

Who should not use Xigduo XR?

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

  • Dapagliflozin
  • Farxiga
  • Metformin
  • Fortamet
  • Glumetza
  • Any other medicine that contains metformin
  • Any of the ingredients in the specific product dispensed

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

Kidney Problems and Chronic Kidney Disease. Xigduo XR should not be used to treat chronic kidney disease if you have polycystic kidney disease or take or have recently taken a medicine for your kidney disease that lowers your body’s ability to fight infection, such as prednisone.

Kidney Problems. Xigduo XR should not be used 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.

Metabolic Acidosis, Including Diabetic Ketoacidosis. Xigduo XR should not be used in people with acute or chronic metabolic acidosis. Tell your healthcare provider if you have a history of metabolic acidosis or diabetic ketoacidosis.

What should I know about Xigduo XR before using it?

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

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

Keep Xigduo XR out of the reach of children.

You may sometimes notice something in your stool (poop) that looks like the tablet. This is normal and should not cause concern.

Do not chew, cut, or crush Xigduo XR tablets, they should be swallowed whole.

Xigduo 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.

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.

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

People who have kidney problems can be at greater risk for some side effects from Xigduo XR. Talk to your healthcare provider about your risks if you have kidney problems.

Take Xigduo XR in the morning with food to help decrease the chance you will have an upset stomach.

Xigduo XR will cause your pee to test positive for glucose (sugar).

Your healthcare provider will run lab tests to see how well your kidneys are working and make sure you are not dehydrated before starting Xigduo XR.

What should I tell my healthcare provider before using Xigduo 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 Xigduo XR is right for you.

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

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. Your healthcare provider may want you to monitor for ketones (acids made in your liver) if you are taking Xigduo XR.
  • Decrease in your insulin dose
  • Serious infection
  • Low-salt diet. Your healthcare provider may suggest you stop using a low-salt diet.
  • Ketogenic diet (high fat/low carbohydrate)
  • Drink alcohol often or in large amounts
  • Pancreas problems, including a history of pancreatitis or surgery on your pancreas.
  • Dehydration
  • Eating or drinking less than normal
  • Vomiting or diarrhea

Risk factors for lactic acidosis. Tell your healthcare provider if you have any of the following risk factors for lactic acidosis. Your healthcare provider may monitor you more closely or choose a different medicine for you. 

  • Kidney problems
  • Liver problems
  • Heart problems, including congestive heart failure or a heart attack
  • Drink alcohol often or in large amounts
  • Have an upcoming medical test that uses contrast (a special dye), surgery, or other procedure
  • Dehydration 
  • Severe infection
  • Stroke

History of genital yeast infections. Tell your healthcare provider if you have a history of genital (penis or vagina) yeast infections. This may make it more likely that you will have yeast infections of the vagina or penis while taking Xigduo XR. Your healthcare provider may choose a different medicine for you.

History of kidney or bladder infections or difficulty peeing. Tell your healthcare provider about any kidney or bladder infections or if you have trouble peeing. Your healthcare provider may choose a different medicine for you.

Have surgery scheduled. Talk to your healthcare provider if you are having surgery so you know when to stop and restart your Xigduo XR.

Other Medicines and Supplements. Xigduo XR may interact with other medicines and supplements. Before taking Xigduo 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.

Pregnancy. Xigduo XR may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant, contact your healthcare provider right away. 

Breastfeeding. It is not known if Xigduo 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 stop breastfeeding or stop Xigduo XR.

How can I get more information about Xigduo XR?

For more information about Xigduo XR, you can visit the manufacturer’s website at https://www.astrazeneca-us.com/medicines.html or call them at 800-236-9933.

Interactions

Does Xigduo XR interact with foods or drinks?

There are no known interactions between Xigduo XR and foods or drinks.

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

Being on a ketogenic diet while taking Xigduo XR may increase your risk of ketoacidosis. See the Side Effects section for more details. 

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

Does Xigduo 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 Xigduo XR.

  • 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
  • A carbonic anhydrase inhibitor, such as zonisamide (Zonegran), acetazolamide (Diamox), topiramate (Topamax), or methimazole
  • Other medicines for diabetes

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

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

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

Does Xigduo XR (dapagliflozin/metformin) 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 Xigduo XR?

If you or someone else has used too much Xigduo 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 Xigduo 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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