Xigduo XR

Generic name: Dapagliflozin And Metformin
Drug class: Antidiabetic combinations

Usage of Xigduo XR

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.

Xigduo XR 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.

Before taking Xigduo XR

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.

Relate drugs

How to use Xigduo XR

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.

Warnings

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.

What other drugs will affect Xigduo XR

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.

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