Xigduo XR extended release tablets contain 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 improve blood sugar control in adults with type 2 diabetes mellitus.

Xigduo XR is not for treating type 1 diabetes.

Xigduo XR is also used to lower the risk of needing to be in the hospital for heart failure in adults with type 2 diabetes who also have heart disease.

Xigduo XR is also used to reduce the risk of worsening kidney disease and death due to heart problems, and the need to be in the hospital for heart failure in adults with type 2 diabetes who also have chronic kidney disease.

You should not use Xigduo XR if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

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

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

In rare cases, this medicine can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.

Take Xigduo XR extended release tablets exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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

Take with food to prevent an upset stomach.

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

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

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.

If you need surgery or medical tests, tell any doctor who treats you that you are using Xigduo XR.

This medicine 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.

Your kidney function may need to be checked during treatment with Xigduo XR.

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.

Store at room temperature, away from moisture and heat.

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

Comments:
-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.

You should not use Xigduo XR if you are allergic to dapagliflozin (Farxiga) or metformin, or if you have:

• severe kidney disease (or if you are on dialysis); or

• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

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

• liver or kidney disease;

• low blood pressure;

• a bladder infection or urination problems;

• heart problems, low blood pressure;

• problems with your pancreas, including surgery; or

• if you are on a low salt diet.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Follow your doctor's instructions about using Xigduo XR if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.

Tell your doctor right away if you become pregnant. You should not use dapagliflozin and metformin during the second or third trimester of pregnancy.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using Xigduo XR.

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

Take the medicine (with food) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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

Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Call your doctor at once if you have:

• little or no urination;

• signs of a bladder infection - pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back;

• dehydration symptoms - dizziness, weakness, feeling light-headed (like you might pass out);

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

• lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired

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

Common Xigduo XR side effects may include:

• genital infections;

• headache;

• nausea, vomiting, diarrhea; or

• runny or stuffy nose, 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.

Tell your doctor about all your other medicines, especially:

• digoxin (digitalis, Lanoxin);

• rifampin;

• phenytoin;

• a diuretic or "water pill";

• insulin or other oral diabetes medications; or

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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 drug interactions are listed here.