Generic Name: dapagliflozin and metformin (dap-a-gli-FLOE-zin & met-FOR-min)
Brand Name: Xigduo XR
Xigduo XR may rarely cause a serious and sometimes fatal condition called lactic acidosis. Most of these cases have occurred in diabetic patients who also have certain kidney problems. The risk of lactic acidosis may be greater if you have liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are elderly or drink alcohol. Lab tests, including kidney function, may be performed while you take Xigduo XR.
Do not begin to take Xigduo XR if you are 80 years old or older unless lab tests show that you do not have decreased kidney function. Do not take it if you have a severe infection, have low blood oxygen levels, or are dehydrated. Tell your doctor you take Xigduo XR before you have any surgery or lab procedures.
Contact your doctor right away if you notice symptoms such as muscle pain or tenderness; unusual drowsiness, dizziness, or light-headedness; slow or irregular heartbeat; fast or difficult breathing; unusual stomach discomfort; or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold or if you have a general feeling of being unwell.
Xigduo XR is used for:
Treating type 2 diabetes in certain patients. It is used along with diet and exercise.
Xigduo XR is a sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanide antidiabetic combination. The SGLT2 inhibitor works by decreasing the amount of sugar the body absorbs and increasing the amount of sugar that leaves the body in the urine. The biguanide antidiabetic works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.
Do NOT use Xigduo XR if:
- you are allergic to any ingredient in Xigduo XR
- you have type 1 diabetes
- you have a severe infection, low blood oxygen levels, moderate to severe kidney problems, liver problems, high blood or urine ketone levels (diabetic ketoacidosis), dehydration, or bladder cancer
- you have had a stroke or a recent heart attack, or you are in shock
- you are 80 years old or older and have not had a kidney function test
- you will be having surgery or certain lab procedures
Contact your doctor or health care provider right away if any of these apply to you.
Before using Xigduo XR:
Some medical conditions may interact with Xigduo XR. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have heart failure, especially heart failure that is treated by medicine
- if you have low or high blood pressure, high cholesterol, high potassium blood levels, vomiting, diarrhea, poor health or nutrition, low blood volume, low blood calcium or vitamin B12 levels, anemia, an infection, fever, recent injury, or moderate to severe burns
- if you have a history of bladder cancer or yeast infections of the penis or vagina, or if you are a man who has not been circumcised
- if you have history of heart problems, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, kidney or liver problems, or lactic acidosis
- if you drink alcohol or have a history of alcohol abuse
- if you will be having surgery or certain lab procedures
- if you take a beta-blocker (eg, propranolol) or if you are on a low salt (sodium) diet
Some MEDICINES MAY INTERACT with Xigduo XR. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin, or medicines that may harm the kidneys (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; tacrolimus) because they may increase the risk of Xigduo XR's side effects. Ask your doctor if you are unsure if any of your medicines might harm the kidneys
- Topiramate or other carbonic anhydrase inhibitors (eg, acetazolamide, dichlorphenamide, zonisamide) because they may increase the risk of lactic acidosis
- Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), estrogen, hormonal contraceptives (eg, birth control pills), insulin or other oral diabetes medicine (eg, repaglinide, glipizide), isoniazid, nicotinic acid, phenothiazines (eg, chlorpromazine), sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide, spironolactone) because the risk of low blood pressure or high potassium levels may be increased
- Phenytoin, phenobarbital, rifampin, or ritonavir because they may decrease Xigduo XR's effectiveness
- Digoxin because the risk of its side effects may be increased by Xigduo XR
This may not be a complete list of all interactions that may occur. Ask your health care provider if Xigduo XR may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Xigduo XR:
Use Xigduo XR as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Xigduo XR comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Xigduo XR refilled.
- Take Xigduo XR in the morning with food.
- Swallow Xigduo XR whole. Do not break, crush, or chew before swallowing.
- Check with your doctor to see if you should drink extra fluids while taking Xigduo XR.
- Take Xigduo XR on a regular schedule to get the most benefit from it. Taking Xigduo XR at the same time each day will help you remember to take it.
- Continue to take Xigduo XR even if you feel well. Do not miss any doses.
- If you miss a dose of Xigduo XR, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once unless your doctor has told you otherwise.
Ask your health care provider any questions you may have about how to use Xigduo XR.
Important safety information:
- Dizziness may occur while you take Xigduo XR. This effect may be worse if you take it with alcohol or certain medicines. Use Xigduo XR with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Xigduo XR may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not drink large amounts of alcohol while you take Xigduo XR. Talk to your doctor or health care provider before you drink alcohol while you take Xigduo XR.
- You may notice undissolved parts of Xigduo XR in your stool. This is normal and not a cause for concern.
- Carry an ID card at all times that says you have diabetes.
- Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Xigduo XR.
- Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Xigduo XR exactly as prescribed, tell your doctor.
- Do NOT take more than the recommended dose without checking with your doctor.
- It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
- Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of Xigduo XR's side effects.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Tell your doctor or dentist that you take Xigduo XR before you receive any medical or dental care, emergency care, or surgery.
- People who take Xigduo XR may have an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.
- Xigduo XR usually does not cause low blood sugar. However, low blood sugar may occur when it is used along with certain other medicines for diabetes (eg, insulin, sulfonylureas). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Xigduo XR may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
- Xigduo XR will cause your urine to test positive for glucose. Be sure your doctor and lab personnel know you are taking Xigduo XR.
- Lab tests may be performed while you use Xigduo XR. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Xigduo XR with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xigduo XR while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while you are taking Xigduo XR.
Possible side effects of Xigduo XR:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; headache; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); fainting; penis discharge, redness, rash, itching, pain, or swelling; severe or persistent headache or dizziness; symptoms of kidney problems or urinary tract infection (eg, blood in the urine, change in the amount of urine produced, difficult or painful urination, unusual or persistent pain in the mid- to lower back, unexplained swelling); vaginal discharge, itching, or odor.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Xigduo XR:
Store Xigduo XR at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xigduo XR out of the reach of children and away from pets.
- If you have any questions about Xigduo XR, please talk with your doctor, pharmacist, or other health care provider.
- Xigduo XR is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Xigduo XR or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xigduo XR. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xigduo XR. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Xigduo XR.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
More about Xigduo XR (dapagliflozin / metformin)
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- Drug class: antidiabetic combinations