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Empagliflozin and linagliptin

Generic Name: empagliflozin and linagliptin (EM-pa-gli-FLOE-zin & LIN-a-GLIP-tin)
Brand Name: Glyxambi

Empagliflozin and linagliptin is used for:

Treating type 2 diabetes in certain patients. It is used along with diet and exercise.

Empagliflozin and linagliptin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor 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 DPP-4 inhibitor works by increasing the amount of insulin released by your body and decreasing the amount of sugar made by your body.

Do NOT use empagliflozin and linagliptin if:

  • you are allergic to any ingredient in empagliflozin and linagliptin
  • you have type 1 diabetes
  • you have high blood or urine ketone levels (diabetic ketoacidosis)
  • you have severe kidney problems or are on dialysis

Contact your doctor or health care provider right away if any of these apply to you.

Before using empagliflozin and linagliptin:

Some medical conditions may interact with empagliflozin and linagliptin. 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 a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, saxagliptin)
  • if you have kidney problems, low or high blood pressure, or high cholesterol
  • if you have a history of inflammation of the pancreas (pancreatitis), stones in your gallbladder (gallstones), alcoholism, high blood triglyceride levels, urinary tract infections, problems with urinating, yeast infections of the penis or vagina, or if you are a man who has not been circumcised
  • if you are dehydrated or have low blood volume, or if you are on a low salt (sodium) diet

Some MEDICINES MAY INTERACT with empagliflozin and linagliptin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Insulin or other oral diabetes medicine (eg, repaglinide, glipizide) because the risk of low blood sugar may be increased
  • Medicines to lower your blood pressure (eg, diuretics, such as furosemide, hydrochlorothiazide, or spironolactone) because the risk of low blood pressure may be increased
  • Rifamycins (eg, rifampin) because they may decrease empagliflozin and linagliptin's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if empagliflozin and linagliptin 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 empagliflozin and linagliptin:

Use empagliflozin and linagliptin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Empagliflozin and linagliptin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get empagliflozin and linagliptin refilled.
  • Take empagliflozin and linagliptin by mouth in the morning with or without food.
  • Check with your doctor to see if you should drink extra fluids while taking empagliflozin and linagliptin.
  • Take empagliflozin and linagliptin on a regular schedule to get the most benefit from it. Taking empagliflozin and linagliptin at the same time each day will help you remember to take it.
  • Continue to take empagliflozin and linagliptin even if you feel well. Do not miss any doses.
  • If you miss a dose of empagliflozin and linagliptin, 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.

Ask your health care provider any questions you may have about how to use empagliflozin and linagliptin.

Important safety information:

  • Tell your doctor or dentist that you take empagliflozin and linagliptin before you receive any medical or dental care, emergency care, or surgery.
  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • Empagliflozin and linagliptin 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.
  • Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take empagliflozin and linagliptin exactly as prescribed, tell your doctor.
  • 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 empagliflozin and linagliptin.
  • 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 empagliflozin and linagliptin's side effects.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Empagliflozin and linagliptin 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.
  • Severe and sometimes fatal inflammation of the pancreas (pancreatitis) has been reported in patients taking linagliptin. Discuss any questions or concerns with your doctor. Contact your doctor immediately if you develop severe or persistent stomach or back pain with or without nausea or vomiting.
  • Empagliflozin and linagliptin will cause your urine to test positive for glucose. Be sure your doctor and lab personnel know you are taking empagliflozin and linagliptin.
  • Lab tests may be performed while you use empagliflozin and linagliptin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use empagliflozin and linagliptin with caution in the ELDERLY; they may be more sensitive to its effects, including dehydration, dizziness, low blood pressure, and kidney problems.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using empagliflozin and linagliptin while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while you are taking empagliflozin and linagliptin.

Possible side effects of empagliflozin and linagliptin:

All medicines may cause side effects, but many people have no, or minor, side effects. If any of the following COMMON side effects continue or become bothersome, check with your doctor: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nose or throat irritation; runny or stuffy nose; sore throat.

Seek medical attention right away if any of these SEVERE side effects occur:

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; fast or irregular heartbeat; flaking, peeling, or swelling of the skin; increased or painful urination; muscle pain or weakness; penis discharge, redness, rash, itching, pain, or swelling; severe or persistent headache, dizziness, or light-headedness; sluggishness; symptoms of low blood sugar (eg, confusion, increased sweating, weakness, tremors, dizziness, fainting, drowsiness, headache, irritability, chills, fast heartbeat, vision changes, increased hunger); 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); unusual tiredness or weakness; vaginal discharge, itching, or odor; very dry mouth or eyes.

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 empagliflozin and linagliptin:

Store empagliflozin and linagliptin 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 empagliflozin and linagliptin out of the reach of children and away from pets.

General information:

  • If you have any questions about empagliflozin and linagliptin, please talk with your doctor, pharmacist, or other health care provider.
  • Empagliflozin and linagliptin 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 empagliflozin and linagliptin 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 empagliflozin and linagliptin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to empagliflozin and linagliptin. 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 empagliflozin and linagliptin.

Review Date: November 3, 2016

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.

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