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Precautions and Warnings With Alogliptin and Metformin

Specific Alogliptin and Metformin 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 alogliptin and metformin, 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.
  • Alogliptin and metformin contains the medication metformin, which can cause a rare but life-threatening condition known as lactic acidosis (a buildup of lactic acid in the bloodstream). People with certain health conditions have a higher risk for this complication, including those who have kidney disease, liver disease, or heart failure. Lactic acidosis is a medical emergency that requires hospital treatment. Let your healthcare provider know immediately if you develop signs of this, such as:
    • Fatigue or tiredness
    • Muscle pain
    • Difficulty breathing
    • Unexplained abdominal (stomach) problems with nausea, vomiting, and diarrhea.
(Click Metformin and Lactic Acidosis to learn more.)
  • Other things can increase your risk for lactic acidosis, such as:
    • Drinking a lot of alcohol regularly or large amounts in a short period ("binge drinking"). Do not drink large amounts of alcohol during alogliptin and metformin treatment (see Metformin and Alcohol).
    • Getting dehydrated, which can happen if you don't drink enough fluids; get sick with fever, diarrhea, or vomiting; or sweat a lot. Let your healthcare provider know if you may be dehydrated.
    • Having certain medical procedures, including surgery or x-ray tests with contrast media or injectable dyes. Let your healthcare provider know if you will be having a medical procedure. You may need to temporarily stop taking alogliptin and metformin.
  • This medication has been reported to cause inflammation of the pancreas (known medically as pancreatitis), which can be severe enough to be life-threatening. Contact your healthcare provider right away if you have signs of pancreatitis, such as nausea, vomiting, and severe abdominal (stomach) pain that may radiate to your back.

    People who have kidney or liver problems or those with a history of pancreatitis, gallstones, or alcoholism are at a higher risk for pancreatitis. Let your healthcare provider know if any of these conditions apply to you.  
  • Although generally rare, some people may have a severe allergic reaction to this medication. Stop taking alogliptin and metformin 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.
  • There have been reports of liver problems occurring in people treated with alogliptin and metformin. Your healthcare provider may want to test your liver function before starting treatment. Let him or her know if you develop any signs of liver problems, such as:
    • Upper-right abdominal (stomach) pain
    • Loss of appetite
    • Fatigue or unusual tiredness
    • Dark urine
    • Yellowing of the skin or whites of the eyes (jaundice).
  • People who have kidney disease have a higher risk for potentially serious alogliptin and metformin side effects and should not be treated with this medication. Your healthcare provider will check your kidney function (renal function) before you start this drug and then at least once a year during treatment.

    Because certain medical procedures may temporarily affect how well your kidneys function, you may need to temporarily stop taking alogliptin and metformin before a surgical procedure or a procedure where you will be given contrast dye.
  • This medication may decrease the amount of B12 in your body. Your healthcare provider will check your B12 levels with a simple blood test during treatment.
  • Alogliptin and metformin is not likely to cause dangerously low blood sugar (hypoglycemia). However, if you take it in combination with other diabetes medicines that lower blood sugar, such as insulin or a sulfonylurea medicine, your risk for hypoglycemia may be higher. You may also be at a higher risk for hypoglycemia if you are older, do not eat enough, exercise strenuously without eating enough, have pituitary or adrenal problems, or drink large amounts of alcohol.
  • Although this medication is quite effective at controlling blood glucose levels, it is not known whether treatment actually lowers the risk for coronary artery disease, strokes, or other heart and blood vessel problems associated with diabetes.
  • Your healthcare provider may need to change the dose of your diabetes medications if your body is under stress, such as from an infection, fever, accident, or surgery. Let your healthcare provider know right away if any of these things happen to you.
  • Alogliptin and metformin is a pregnancy Category B medication, which means it is probably safe for use during pregnancy, although the full risks are currently unknown. Talk to your healthcare provider before using this medication when pregnant (see Kazano and Pregnancy).
  • It is unknown whether alogliptin and metformin passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Kazano and Breastfeeding).
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Alogliptin and Metformin Information

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