Important Safety Information
WARNING: RISK OF LACTIC ACIDOSISMetformin, one of the medicines in KAZANO , can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking KAZANO and call your doctor right away if you feel very weak or tired, have unusual (not normal) muscle pain, have trouble breathing, have unusual sleepiness or sleep longer than usual, have unexplained stomach or intestinal problems with nausea and vomiting or diarrhea, feel cold, especially in the arms or legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat, as these could be symptoms of lactic acidosis. You have a higher chance of getting lactic acidosis if you have kidney problems (if your kidneys are not working properly you should not take KAZANO), have liver problems, have congestive heart failure that requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a large amount of body fluids, which can happen if you are sick with a fever, vomiting, or diarrhea, or when you sweat a lot with activity or exercise and do not drink enough fluids), have certain x-ray tests with injectable dyes or contrast agents that are injected into your body, have surgery, have a heart attack, severe infection, or stroke.
KAZANO may not be right for everyone. KAZANO can cause serious side effects.
Do not take KAZANO if you have kidney problems, have a condition called metabolic acidosis or have had diabetic ketoacidosis (increased ketones in the blood or urine), or are going to get an injection of dye or contrast agents for an x-ray procedure. If you are older than 80 years, you should not take KAZANO unless your kidneys have been checked and they are normal.
Do not take KAZANO if you are allergic to any of its ingredients.
Stop taking KAZANO and contact your doctor or go to the nearest hospital emergency room right away if you experience swelling of your face, lips, throat, or other areas on your skin, difficulty swallowing or breathing, raised red areas on your skin (hives), skin rash, itching, flaking, or peeling, as these may be symptoms of a serious allergic reaction.
Inflammation of the pancreas (pancreatitis), which may be severe, can happen to people taking KAZANO. Tell your doctor if you have ever had pancreatitis, kidney problems, or liver problems. Stop taking KAZANO and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Before taking KAZANO, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing especially when lying down, an unusually fast increase in weight, or swelling of feet, ankles, or legs. These may be symptoms of heart failure.
KAZANO may cause liver problems. Call your doctor right away if you experience nausea, vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of your skin or eyes.
If you take KAZANO with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take KAZANO. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, and then call your doctor. Signs and symptoms of low blood sugar include shaking or feeling jittery, sweating, fast heartbeat, change in vision, hunger, headache, change in mood, confusion, or dizziness.
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Before taking KAZANO, you should tell your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if KAZANO can harm an unborn baby, or if it passes into breast milk.
The most common side effects of KAZANO were cold-like symptoms (upper respiratory tract infection; 8.0%), stuffy or runny nose and sore throat (6.8%), diarrhea (5.5%), increase in blood pressure (5.5%), headache (5.3%), back pain (4.3%), and urinary tract infection (4.2%).
Tell your doctor about all the medicines, vitamins, and supplements you take. Medicines can affect each other. You should contact your doctor before you start or stop other medicines. You may need to have your dose of KAZANO, or certain other medicines, changed.
Indication for KAZANO
KAZANO is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. KAZANO is not for people with type 1 diabetes or diabetic ketoacidosis (increased ketones in blood or urine).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
Indication for KAZANO (alogliptin and metformin HCl) 12.5 mg/500 mg and 12.5 mg/1000 mg Tablets
KAZANO is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. KAZANO is not for patients with type 1 diabetes or diabetic ketoacidosis (increased ketones in blood or urine).