Dapagliflozin Propanediol (dap-a-gli-FLOE-zin proe-pane-DYE-ol), Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide)

Treats type 2 diabetes. Used to lower the risk of hospitalization for heart failure in patients with type 2 diabetes and heart or blood vessel disease (including heart failure). Also used to lower the risk of worsening of kidney disease, end stage kidney disease, cardiovascular death, and hospitalization in patients with chronic kidney disease or heart failure when the heart is weak and cannot pump enough blood.

Brand Name(s):

Xigduo XR

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine in the morning with food.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dapagliflozin/metformin works. Tell your doctor if you are using any of the following:
  • Acetazolamide, cimetidine, dichlorphenamide, digoxin, dolutegravir, isoniazid, lithium, morphine, nicotinic acid, quinine, ranitidine, ranolazine, rifampin, ritonavir, trimethoprim, vancomycin, vandetanib, zonisamide
  • Birth control pills (including estrogen)
  • Blood pressure medicine
  • Diuretic (water pill, including amiloride, triamterene)
  • Insulin or other diabetes medicine
  • Medicine for heart rhythm changes (including procainamide, quinidine)
  • Medicine to treat seizures (including phenobarbital, phenytoin, topiramate, zonisamide)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Phenothiazine medicine
  • Steroid medicine
  • Thyroid medicine
• Several other medicines may affect your blood sugar levels. Closely monitor your blood sugar levels when you start or stop another medicine while you are using dapagliflozin/metformin.
• Limit the amount of alcohol you drink. Heavy alcohol use increases your risk for lactic acidosis.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the second and third part of your pregnancy, unless your doctor tells you to. If you had problems ovulating or have irregular periods, this medicine may cause you to ovulate, which could lead to pregnancy if you are sexually active.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, liver disease, adrenal or pituitary disease, heart failure, vitamin B12 deficiency, or a history of pancreas problems, urinary tract or genital yeast infections. Tell your doctor if you are on a low-salt diet, if you drink alcohol, or if you are having a surgery or other procedures that require fasting.
• This medicine may cause the following problems:
  • Lactic acidosis (rare but serious build-up of acid in the blood)
  • Low blood pressure
  • Diabetic ketoacidosis (high ketones and acid in the blood), which can be life-threatening
  • Kidney problems
  • Low blood sugar, when used with other diabetes medicines
  • Increased risk of genital yeast or urinary tract infections
  • Fournier's gangrene (skin or tissue damage of the area between the anus and genitals)
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may interact with the dye used for an x-ray or a CT scan.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, bloody urine, difficult or painful urination, lower back or side pain, chills
• Fast or trouble breathing, stomach pain, nausea, vomiting, severe weakness
• Increased hunger, headache, confusion, shaking, trembling, sweating
• Lightheadedness, dizziness, fainting
• Pain, tenderness, redness, or swelling of the area between the anus and genitals, fever
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache
• Redness, itching, pain, or swelling of the penis, bad-smelling discharge from the penis
• Stuffy or runny nose, sore throat
• White or yellow vaginal discharge, vaginal itching or odor

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088