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Precautions and Warnings With Sitagliptin and Metformin Extended-Release

Specific Sitagliptin and Metformin Extended-Release Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Very preliminary data suggests incretin mimetics, such as sitagliptin and metformin extended-release, may increase the risk of precancerous cellular changes (called pancreatic duct metaplasia) in people with type 2 diabetes. Researchers are continuing to study the possibility that incretin mimetics might increase the risk of pancreatic cancer, although at this time there is not enough information to know for sure if there is any increased risk.
  • Sitagliptin and metformin extended-release contains metformin (Glucophage®, Glucophage XR®, Glutametz®, and Fortamet®), which can cause a rare but life-threatening condition known as lactic acidosis (a buildup of lactic acid in the bloodstream). You may have a higher chance of developing this condition if you:
    • Have kidney problems
    • Have liver problems
    • Have congestive heart failure that is treated with medications
    • Have certain x-rays or procedures in which you are injected with a dye or contrast agent
    • Have surgery that requires you to restrict your food or fluid intake
    • Have had a heart attack or stroke
    • Have a serious infection
    • Get dehydrated, which can happen if you don't drink enough fluids or get sick with fever, diarrhea, or vomiting
    • Are an older adult
    • Drink large amounts of alcohol (see Metformin and Alcohol).
  • Lactic acidosis is a medical emergency that must be treated in a hospital. Let your healthcare provider know immediately if you develop any signs of lactic acidosis during treatment with sitagliptin and metformin extended-release, which may include:
    • Feeling very weak, tired, or sleepy
    • Unusual muscle pain
    • Difficulty breathing
    • Unexplained abdominal (stomach) problems with nausea, vomiting, and diarrhea
    • Feeling cold in your arms or legs
    • Feeling dizzy or lightheaded
    • Having a slow or irregular heartbeat (see Metformin and Lactic Acidosis).
  • Because liver problems can increase the risk for lactic acidosis, this medicine should generally not be used in people with liver disease.
  • Drinking large amounts of alcohol on a regular basis or "binge" drinking increases the risk for lactic acidosis. Do not consume excessive amounts of alcohol during sitagliptin and metformin extended-release treatment.
  • There have been reports of pancreatitis (inflammation of the pancreas) occurring in people taking sitagliptin (Januvia®), one of the active components of sitagliptin and metformin extended-release. This can be severe enough to cause death. People who have a history of alcoholism or have had pancreatitis in the past, gallstones, or high blood triglyceride levels may have a higher risk for this complication. Contact your healthcare provider right away if you have signs of pancreatitis, such as:
    • Nausea
    • Vomiting
    • Severe abdominal (stomach) pain that may radiate toward your back.
  • You will need to temporarily stop taking sitagliptin and metformin extended-release if you are going to have a surgical or medical procedure that requires you to limit your food and fluid intake. Your healthcare provider will restart you on the medicine when you are eating and drinking normally again.
  • Sitagliptin (one of the medicines in sitagliptin and metformin extended-release) has been reported to cause kidney problems, which can increase your risk for lactic acidosis. Your healthcare provider will check how well your kidneys are functioning using a blood test before you start sitagliptin and metformin extended-release and at least once a year during treatment. If these tests show your kidneys are not functioning normally, you will need to stop taking this medication.
  • Medical procedures in which you will be given a dye or contrast agent, such as x-rays or computed tomography (CT) scans, can temporarily affect your kidney function, increasing your risk for lactic acidosis. You will need to stop taking sitagliptin and metformin extended-release before such procedures, and should not restart it for at least 48 hours or until your kidney function returns to normal. Your healthcare provider will check your kidney function with a blood test. 
  • This medication may decrease the amount of B12 in your body. Your healthcare provider may choose to check your B12 levels using a simple blood test during treatment.
  • This medicine may cause dangerously low blood sugar (hypoglycemia) when taken in combination with other diabetes medicines that lower blood sugar, such as insulin or a sulfonylurea medicine. Low blood sugar is also more common in older adults, people who are not eating enough, people who drink large amounts of alcohol, and in those with adrenal and pituitary problems.
  • Although this medication is quite effective at controlling blood glucose levels, it is not known whether treatment with it (or any other diabetes medicine) will decrease your risk for coronary artery disease, strokes, or other heart and blood vessel problems associated with diabetes.
  • Your blood sugar may temporarily increase when your body is under stress. Let your healthcare provider know if you have an infection, fever, accident, or surgery, as these things can cause stress on your body. At these times, you may need insulin to control your blood sugar levels, even if your blood sugar was previously well controlled.
  • There have been reports of people having a severe allergic reaction to sitagliptin, one of the active medications in sitagliptin and metformin extended-release. Stop taking this drug and contact your healthcare provider right away if you have signs of an allergic reaction, such as:
    • An unexplained skin rash, itching, flaking, or peeling
    • Hives
    • Difficulty breathing or swallowing
    • Swelling of the face, lips, or throat.
  • Sitagliptin and metformin extended-release is a pregnancy Category B medication. This means it is probably safe for use during pregnancy, although the full risks are currently unknown (see Janumet XR and Pregnancy).
  • It is unknown whether sitagliptin and metformin extended-release passes through human breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Janumet XR and Breastfeeding).
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Sitagliptin and Metformin Extended-Release Information

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