Description
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.
Directions
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.
Cautions
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.
Side Effects
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.
Xigduo XR side effects (more detail)
Product Code : 13782
Prescription Required
