This medicine is a dipeptidyl peptidase-4 (DPP-4) enzyme 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. An additional patient information leaflet is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. TAKE THIS MEDICINE by mouth with meals as directed by your doctor. STORE THIS MEDICINE 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 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. DO NOT TAKE MORE THAN THE RECOMMENDED DOSE without checking with your doctor. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, 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.
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 liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are 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 80 YEARS OF AGE 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 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; sudden stomach or bowel problems with nausea and vomiting; 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; digoxin; morphine; procainamide; quinidine; quinine; ranitidine; triamterene; trimethoprim; vancomycin; 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; phenothiazines (eg, chlorpromazine); phenytoin; sulfonylureas (eg, glipizide); sympathomimetics (eg, albuterol, pseudoephedrine); thyroid hormones (eg, levothyroxine); carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); topiramate; rifamycins (eg, rifampin); or medicines that may harm the kidney (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; tacrolimus; NSAIDs; cyclosporine). 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. Tell your doctor if you drink alcohol or have a history of heart problems, inflammation of the pancreas (pancreatitis), stones in your gallbladder (gallstones), high blood triglyceride levels, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, lactic acidosis, or alcohol abuse. TELL YOUR DOCTOR of any other medical conditions including vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12 levels, anemia, infection, fever, recent injury, moderate to severe burns, upcoming surgery or lab procedures, allergies, pregnancy, or breast-feeding. TELL YOUR DOCTOR if you have heart failure, especially heart failure that is treated by medicine. TELL YOUR DOCTOR if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) caused by a similar medicine (eg, sitagliptin). USE OF THIS MEDICINE IS NOT RECOMMENDED if you have type 1 diabetes, a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (eg, diabetic ketoacidosis), severe dehydration, previous stroke, a recent heart attack, if you are in shock, or if you will be having certain surgery or lab procedures. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are 80 years of age 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 cough, decreased appetite, diarrhea, gas, headache, indigestion, nausea, sore throat, stomach upset, stuffy or runny nose, vomiting, or weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain or discomfort; dizziness or lightheadedness; 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; unusual or persistent stomach pain or discomfort; slow or irregular heartbeat; symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); unusual drowsiness; or unusual tiredness or weakness. 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; tightness in the chest; or swelling of the mouth, face, lips, throat, or tongue; 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.
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 this medicine exactly as prescribed, tell your doctor. Proper diet, regular exercise, and regular blood sugar testing are important for best results with this medicine. FOLLOW THE DIET AND EXERCISE PROGRAM given to you by your health care provider. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.