Xigduo XR

dapagliflozin-metformin
Chemical Name: metformin hydrochloride
Drug Type: antidiabetic combinations

You should not use this medicine if you have moderate to severe kidney disease, if you are on dialysis, or if you have metabolic acidosis. Dapagliflozin and metformin 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 dapagliflozin and metformin.

This medicine 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.

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.

Dapagliflozin and metformin is a combination medicine used together with diet and exercise to treat type 2 diabetes. This medicine is not for treating type 1 diabetes.

Dapagliflozin and metformin may also be used for purposes not listed in this medication guide.

You should not use this medicine 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 (or if you are on dialysis); or
  • metabolic acidosis 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 will need to temporarily stop taking dapagliflozin and metformin.

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, surgery, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.

To make sure dapagliflozin and metformin 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;
  • bladder cancer;
  • heart problems;
  • problems with your pancreas, including surgery; or
  • if you are on a low salt diet.

It is not known whether dapagliflozin and metformin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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 this medicine.

Dapagliflozin and metformin is not approved for use by anyone younger than 18 years old.

Your doctor may perform kidney function tests before you start taking dapagliflozin and metformin.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take with food to prevent an upset stomach.

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

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

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

Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine.

Dapagliflozin and metformin 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, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.

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.

Dapagliflozin and metformin 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 doctor may have you take extra vitamin B12 while you are taking dapagliflozin and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature, away from moisture and heat.

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.

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.

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Get emergency medical help if you have signs of an allergic reaction: 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:

  • little or no urination;
  • 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;
  • signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back; or
  • signs of a genital infection (penis or vagina)--pain, burning, itching, rash, redness, odor, or discharge.

Some people taking dapagliflozin have had bladder cancer, but it is not clear if this medicine was the actual cause.

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

Common 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 current medicines and any you start or stop using, especially:

  • digoxin (digitalis, Lanoxin);
  • a diuretic or "water pill";
  • insulin or other oral diabetes medications;
  • rifampin;
  • ritonavir;
  • NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; 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.

Your pharmacist can provide more information about dapagliflozin and metformin.