This medicine is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide antidiabetic combination used along with a diet and exercise program to control high blood sugar in certain patients with type 2 diabetes.
Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE by mouth with the evening meal unless your doctor tells you otherwise. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same times each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.
WARNING: THIS MEDICINE 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 a severe bloodstream infection (sepsis), liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are dehydrated, elderly, or who drink alcohol. Lab tests, including kidney function, may be performed while you take this medicine. DO NOT BEGIN TO TAKE THIS MEDICINE IF YOU ARE MORE THAN 80 YEARS OLD 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 this medicine 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 lightheadedness; slow or irregular heartbeat; fast or difficult breathing; unusual stomach discomfort; unusual weakness or tiredness; feeling of being unusually cold; or general feeling of being unwell. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking amiloride; beta-blockers (eg, propranolol); cimetidine; clarithromycin; digoxin; itraconazole; ketoconazole; morphine; nefazodone; procainamide; protease inhibitors (eg, atazanavir, boceprevir, ritonavir); quinidine; quinine; ranitidine; telithromycin; triamterene; trimethoprim; vancomycin; calcium channel blockers (eg, nifedipine); corticosteroids (eg, prednisone); diuretics (eg, furosemide, hydrochlorothiazide); estrogen; hormonal contraceptives (eg, birth control pills); insulin, sulfonylureas (eg, glipizide, or other medicine for diabetes); isoniazid; nicotinic acid; phenothiazines (eg, chlorpromazine); phenytoin; sympathomimetics (eg, albuterol, pseudoephedrine); thyroid hormones (eg, levothyroxine); or medicines that may harm the kidney (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; cyclosporine; nonsteroidal anti-inflammatory drugs / NSAIDs, such as ibuprofen; tacrolimus). Ask your doctor if you are unsure if any of your medicines might harm the kidney. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor if you drink alcohol or have a history of heart problems, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), high blood or urine ketone or acid levels associated with diabetes (eg, diabetic ketoacidosis), adrenal or pituitary problems, lactic acidosis, pancreatitis, gallstones, high blood triglyceride levels, or alcohol abuse. Inform your doctor of any other medical conditions, including heart failure (especially heart failure that is treated by medicine), vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12 levels, anemia, infection, fever, recent injury, moderate to severe burns, allergies, pregnancy, or breast-feeding. Tell your doctor if you will be having surgery or certain lab procedures. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have type 1 diabetes, a severe infection, low blood oxygen levels, kidney or liver problems, diabetic ketoacidosis, dehydration, previous stroke, a recent heart attack, if you are in shock, or if you will be having surgery or certain lab procedures. IT IS NOT RECOMMENDED that you begin to take this medicine if you are 80 years old or older, unless lab tests show that you do not have decreased kidney function. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include diarrhea, gas, headache, indigestion, mild stomach pain or upset, nausea, symptoms of respiratory tract infection (eg, cough, mild sore throat, runny or stuffy nose, sneezing), temporary metallic taste, or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain or discomfort; dizziness or lightheadedness; fainting; fast or difficult breathing; fever, chills, or persistent sore throat; feeling of being unusually cold; flaking, peeling, or swelling of the skin; frequent or painful urination; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; symptoms of pancreatitis (eg, severe stomach pain with or without nausea or vomiting); unusual drowsiness; unusual or persistent stomach pain or discomfort; or unusual tiredness or weakness. THIS MEDICINE DOES NOT USUALLY CAUSE LOW BLOOD SUGAR (hypoglycemia). However, hypoglycemia may be more likely to occur if you take this medicine along with certain other medicines for diabetes (eg, sulfonylureas, insulin). It may also be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. Signs of hypoglycemia include increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, or fainting. It is a good habit to carry glucose tablets or gel to treat hypoglycemia. If you do not have a reliable source of glucose available, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. To prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. DO NOT DRIVE OR PERFORM OTHER POSSIBLY UNSAFE TASKS IF YOU HAVE SYMPTOMS OF LOW BLOOD SUGAR. If you experience low blood sugar, tell your doctor. AN ALLERGIC REACTION TO THIS MEDICINE is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include dizziness or lightheadedness, feeling of being unusually cold, general feeling of being unwell, muscle pain or tenderness, rapid or difficult breathing, unusual drowsiness, slow or irregular heartbeat, unusual stomach discomfort, and unusual weakness or tiredness.
This medicine is not a substitute for proper diet and regular exercise. It is recommended you attend a diabetes education program to better understand diabetes, prevention of complications, and all the important aspects of its treatment. These include meals/diet, exercise, weight loss, personal hygiene, medicine and blood glucose monitoring, and the need for regular eye, foot, and medical exams. Follow your doctor's instructions carefully. FOLLOW THE DIET AND EXERCISE PLAN provided by your doctor. Carry an identification card at all times that says you are diabetic. Monitor your blood sugar levels regularly according to your doctor's directions. If your blood sugar level is often higher or lower than it should be and you are taking this medicine according to directions, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medication.