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xigduo xr

Xigduo XR contains a combination of dapagliflozin and metformin. Dapagliflozin and metformin are oral diabetes medicines that help control blood sugar levels. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin lowers glucose production in the liver and also causes your intestines to absorb less glucose.

Xigduo XR is used together with diet and exercise to treat type 2 diabetes. Dapagliflozin is not for treating type 1 diabetes.

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

Important information

You should not use Xigduo XR if you have moderate to severe kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Xigduo XR is not for treating type 1 diabetes.

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

Xigduo XR 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, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Before taking this medicine

You should not use Xigduo XR if you are allergic to dapagliflozin (Farxiga) or metformin (Glucophage, Actoplus Met, Avandamet, Fortamet, Glucovance, Janumet, Jentadueto, Kazano, Kombiglyze, Metaglip, PrandiMet, Riomet), or if you have:

  • moderate to severe kidney disease;

  • bladder cancer; or

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

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

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.

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

  • liver disease;

  • low blood pressure;

  • a history of bladder cancer;

  • high cholesterol levels;

  • a history of heart attack or stroke;

  • if you are on a low salt diet;

  • if you take blood pressure medicine; or

  • if you are 80 or older and your kidneys have not been tested.

It is not known whether Xigduo XR will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether dapagliflozin and metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Xigduo XR.

Xigduo XR is not approved for use by anyone younger than 18 years old.

How should I take Xigduo XR?

Take Xigduo XR exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may perform kidney function tests before you start taking Xigduo XR.

Take Xigduo XR with food to prevent an upset stomach.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor"s office.

Do not crush, chew, or break an extended-release Xigduo XR tablet. Swallow the tablet whole.

If you need to fast (stop eating) before a surgery, tell the surgeon ahead of time that you take Xigduo XR. You may need to stop using the medicine for a short time.

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

Xigduo XR can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using dapagliflozin.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. 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 dose of Xigduo XR or dosage schedule without your doctor"s advice.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine, which can lead to severely low blood pressure or a serious electrolyte imbalance.

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

Store at room temperature, away from moisture and heat.

Xigduo XR dosing information

Usual Adult Dose of Xigduo XR for Diabetes Type 2:

Individualize dose based on current treatment regimen:
Maintenance dose: Take orally once a day; titrate gradually based on effectiveness and tolerability
Maximum dose: Dapagliflozin 10 mg-metformin 2000 mg per day

-Patients taking an evening dose of metformin XR should skip their last dose before starting this drug; take this drug once daily in the morning with food.
-When used in combination with insulin or insulin secretagogue , a lower dose of with insulin or insulin secretagogue may be considered to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Xigduo XR is appropriate.

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.

An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: 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 Xigduo XR?

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

Xigduo XR side effects

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

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  • ketoacidosis (too much acid in the blood)- nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;

  • signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;

  • signs of a bladder infection - pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back; or

  • signs of a genital infection (penis or vagina) - pain, burning, itching, rash, redness, odor, or discharge.

Side effects may be more likely to occur in older adults.

Common Xigduo XR side effects may include:

  • bladder infection or genital infection;

  • headache;

  • nausea, vomiting, diarrhea; or

  • cold symptoms such as stuffy nose, sneezing, 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.

See also: Side effects (in more detail)

What other drugs will affect Xigduo XR?

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

  • digoxin (digitalis, Lanoxin);

  • a diuretic or "water pill";

  • insulin or other oral diabetes medications;

  • rifampin;

  • ritonavir; or

  • seizure medicine - phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with dapagliflozin and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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