Generic Name: linagliptin/metformin (LIN-a-GLIP-tin/met-FOR-min)
Brand Name: Jentadueto
Linagliptin/metformin 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 linagliptin/metformin.
Do not begin to take linagliptin/metformin 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 linagliptin/metformin 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; sudden stomach or bowel problems with nausea and vomiting; or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold, especially in your arms or legs, or if you have a general feeling of being unwell.
Linagliptin/metformin is used for:
Treating type 2 diabetes in certain patients. It is used along with diet and exercise.
Linagliptin/metformin is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination. It works by increasing the amount of insulin released by your body. It decreases the amount of sugar made by your body. It also helps make your body more sensitive to the insulin that you naturally produce.
Do NOT use linagliptin/metformin if:
- you are allergic to any ingredient in linagliptin/metformin
- you have type 1 diabetes
- you have a severe infection, low blood oxygen levels, kidney or liver problems, or high blood ketone or acid levels (eg, diabetic ketoacidosis), or you are severely dehydrated
- you have had a stroke or a recent heart attack, or you are in shock
- you are 80 years old or older, unless lab tests show that you do not have decreased kidney function
- you will be having certain surgery or lab procedures
Contact your doctor or health care provider right away if any of these apply to you.
Before using linagliptin/metformin:
Some medical conditions may interact with linagliptin/metformin. 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, sitagliptin)
- if you have heart failure, especially heart failure that is treated by medicine
- if you have a history of heart problems, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, blockage, paralysis), adrenal or pituitary problems, or lactic acidosis
- if you have a history of inflammation of the pancreas (pancreatitis), stones in your gallbladder (gallstones), or high blood triglyceride levels
- if you have vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12 levels, or anemia
- if you have an infection, fever, recent injury, or moderate to severe burns
- if you drink alcohol or have a history of alcohol abuse
- if you will be having surgery or lab procedures
- if you take a beta-blocker (eg, propranolol) or you are using insulin
Some MEDICINES MAY INTERACT with linagliptin/metformin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide) or topiramate because the risk of lactic acidosis may be increased
- Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), insulin, isoniazid, meglitinides (eg, repaglinide), nicotinic acid, phenothiazine (eg, chlorpromazine), phenytoin, sulfonylureas (eg, glipizide), sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased
- Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin because they may increase the risk of linagliptin/metformin's side effects
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus) because they may increase the risk of linagliptin/metformin's side effects. Ask your doctor if you are unsure if any of your medicines might harm the kidney
- Rifamycins (eg, rifampin) because they may decrease linagliptin/metformin's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if linagliptin/metformin 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 linagliptin/metformin:
Use linagliptin/metformin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with linagliptin/metformin. Talk to your pharmacist if you have questions about this information.
- Take linagliptin/metformin by mouth with meals as directed by your doctor.
- Take linagliptin/metformin on a regular schedule to get the most benefit from it.
- Continue to take linagliptin/metformin even if you feel well. Do not miss any doses.
- If you miss a dose of linagliptin/metformin, 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 linagliptin/metformin.
Important safety information:
- 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 linagliptin/metformin.
- Do not drink large amounts of alcohol while you use linagliptin/metformin. Talk to your doctor or health care provider before you drink alcohol while you use linagliptin/metformin.
- Do NOT take more than the recommended dose without checking with your doctor.
- Tell your doctor or dentist that you take linagliptin/metformin before you receive any medical or dental care, emergency care, or surgery.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- 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 linagliptin/metformin exactly as prescribed, tell 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.
- Linagliptin/metformin 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, 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, 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 non-diet 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.
- Metformin 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 right away. This may be a sign of lactic acidosis.
- Lab tests, including kidney function, fasting blood glucose, hemoglobin A1c, and complete blood cell counts, may be performed while you use linagliptin/metformin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use linagliptin/metformin with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in elderly patients.
- Linagliptin/metformin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking linagliptin/metformin while you are pregnant. Linagliptin/metformin is found in breast milk. If you are or will be breast-feeding while you take linagliptin/metformin, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of linagliptin/metformin:
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:
Cough; decreased appetite; diarrhea; gas; headache; indigestion; nausea; runny or stuffy nose; sore throat; stomach upset; vomiting; weakness.
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); chest pain or discomfort; dizziness or light-headedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain, tenderness, or weakness; red, blistered, swollen, or peeling skin; slow or irregular heartbeat; symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.
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 linagliptin/metformin:
Store linagliptin/metformin at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep linagliptin/metformin out of the reach of children and away from pets.
- If you have any questions about linagliptin/metformin, please talk with your doctor, pharmacist, or other health care provider.
- Linagliptin/metformin 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 linagliptin/metformin 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 linagliptin/metformin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to linagliptin/metformin. 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 linagliptin/metformin.
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.