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Xigduo XR is a medicine used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Xigduo XR is an extended-release medicine (a type of tablet that releases medicine into your body throughout the day).
How does this medication work?
Xigduo XR contains two medicines: dapagliflozin and metformin. Dapagliflozin works with your kidneys to help remove sugar through the urine. Metformin decreases the amount of sugar your liver makes and the amount of sugar your intestines absorb, and helps your body respond better to the insulin it makes naturally.
What are the beneficial effects of this medication and when should I begin to have results?
What: Lowering your blood sugar to a normal level may prevent or delay potential complications associated with diabetes, such as blindness, kidney failure, or heart problems.
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's instructions. It is important that you take Xigduo XR exactly as your healthcare provider prescribed.
How do I know it is working?
Check your blood sugar as instructed by your healthcare provider. Your healthcare provider may also do regular blood tests to measure your blood sugar levels and your hemoglobin A1C (measures your average blood sugar levels over a 2- to 3-month period). Stay on your prescribed diet and exercise program, as this may also affect the results of your blood tests.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
Metformin, one of the medicines in Xigduo XR, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can be life-threatening. This is a medical emergency and must be treated in the hospital. Call your healthcare provider right away if you feel cold in your hands or feet, dizzy or lightheaded, very weak or tired, or unusually sleepy or sleep longer than usual; or have a slow or irregular heartbeat, unusual muscle pain, trouble breathing, stomach pains, nausea, or vomiting, as these could be signs of lactic acidosis.
Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis. You have a higher chance of getting lactic acidosis with Xigduo XR if you have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye; have liver problems; drink alcohol very often or drink a lot of alcohol in a short period of time ("binge" drink); get dehydrated (lose a large amount of body fluids); have surgery; or have a heart attack, severe infection, or stroke.
More common side effects may include: vaginal yeast infections, stuffy or runny nose and sore throat (common cold), urinary tract infection, diarrhea, headache.
Symptoms of a vaginal yeast infection may include: vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching.
Less common side effects may include:
Dehydration, with symptoms such as dizziness, lightheadedness, or weakness, especially when you stand up. Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis.
Ketoacidosis (increased ketones in your blood or urine), with symptoms such as nausea, tiredness, vomiting, trouble breathing, or abdominal (stomach area) pain. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL.
Sudden kidney injury. Talk to your healthcare provider right away if you reduce the amount of food or liquid you drink (for example, if you are sick and cannot eat) or you start to lose liquid from your body (for example, from vomiting, diarrhea, or being in the sun too long).
Serious urinary tract infections, with symptoms such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in your urine. Sometimes people also may have a fever, back pain, nausea, or vomiting.
If you take Xigduo XR with another medicine that can cause low blood sugar, such as insulin or sulfonylureas (such as glimepiride, glipizide, or glyburide), your risk of getting low blood sugar is higher. Symptoms of low blood sugar may include headache, weakness, confusion, shaking, feeling jittery, drowsiness, dizziness, irritability, sweating, fast heartbeat, or hunger.
Yeast infection of the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms include redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around the penis.
Bladder cancer, with symptoms such as blood or a red color in your urine or pain while you urinate.
Xigduo XR may also cause low vitamin B12 levels or increase fats in your blood called LDL cholesterol (bad cholesterol).
Do not take Xigduo XR if you are allergic to it or any of its ingredients.
Do not take Xigduo XR if you have kidney problems or are on dialysis.
Do not take Xigduo XR if you have a condition called metabolic acidosis or diabetic ketoacidosis.
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Xigduo XR. Also, talk to your healthcare provider about your complete medical history, especially if you have type 1 diabetes or have had diabetic ketoacidosis; have kidney, liver, or heart problems; have a history of urinary tract infections or problems urinating; have or have had problems with your pancreas (including pancreatitis or surgery on your pancreas); have or have had bladder cancer; drink alcohol very often or "binge" drink; are going to get an injection of dye or contrast agents for an x-ray procedure; are going to have surgery; are eating less due to illness, surgery, or a change in your diet; or if you are pregnant, plan to become pregnant, or are breastfeeding.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults: Your healthcare provider will prescribe the appropriate dose for you, and may adjust the dose as needed, until the desired effects are achieved.
If you are also using insulin or taking another diabetes medicine called a sulfonylurea, your healthcare provider may adjust the dose of these medicines.
If your body is under some types of stress such as a fever, infection, trauma (such as a car accident), or surgery, your healthcare provider may need to adjust your diabetes medicine.
Take Xigduo XR exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Xigduo XR without first talking to your healthcare provider.
Take Xigduo XR once a day in the morning with food to lower your chance of an upset stomach.
Swallow Xigduo XR tablets whole. Do not crush, cut, or chew the tablets.
When you take Xigduo XR, you may see something in your stool that looks like a tablet. This is normal, and is the empty shell from the tablet after the medicine has been absorbed in your body.
Stay on your prescribed diet and exercise program while taking Xigduo XR.
Do not drink alcohol very often or "binge" drink while you are taking Xigduo XR.
If Xigduo XR is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Xigduo XR may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.
The effects of Xigduo XR during pregnancy and breastfeeding are unknown. Do not breastfeed while you are taking Xigduo XR. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
If you miss a dose of Xigduo XR, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once unless your healthcare provider tells you to do so.
Store at room temperature.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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