Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide), Saxagliptin (sax-a-GLIP-tin)

Used together with proper diet and exercise to control blood sugar levels in patients with type 2 diabetes.

Brand Name(s):

Kombiglyze XR

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should be taken with the evening meal to help reduce stomach or bowel side effects that may occur during the first few weeks of treatment.
• To best manage your diabetes, carefully follow your doctor's instructions about any special diet, exercise, or weight loss. Test your blood sugar regularly.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• While taking the extended-release form of this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using diabetes medicine that you take by mouth such as glyburide, glipizide, Actos®, Amaryl®, Avandia®, Glucophage®, Glucotrol®, or Glucovance®.
• Make sure your doctor knows if you are also using medicine to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, telithromycin, Biaxin®, Ketek®, Nizoral®, or Sporanox®), or medicine to treat depression (such as nefazodone, Serzone®).
• Your doctor should know if you also use cimetidine (Tagamet®), digoxin (Lanoxin®), isoniazid (Nydrazid®), morphine, nicotinic acid (Vitamin B3), phenytoin (Dilantin®), procainamide (Procanbid®, Pronestyl®), quinidine (Quinidex®), quinine (Qualaquin®), ranitidine (Zantac®), trimethoprim (Bactrim®, Primsol®, Proloprim®, Septra®), or vancomycin (Vancocin®, Vancoled®).
• Tell your doctor if you use diuretics or "water pills" (such as amiloride, furosemide, hydrochlorothiazide [HCTZ], triamterene, Dyrenium®, or Lasix®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®), thyroid replacement (such as levothyroxine, liothyronine, Cytomel®, or Synthroid®), estrogen hormones (Premarin®), or birth control pills. Make sure your doctor knows if you use heart or blood pressure medicine such as amlodipine, atenolol, metoprolol, nifedipine, propranolol, timolol, verapamil, Adalat®, Cardizem®, Inderal®, Lotrel®, Norvasc®, Procardia®, Tiazac®, or Toprol®.
• Do not drink alcohol while you are using this medicine.
• Make sure your doctor knows about all other treatments you are using for diabetes, including insulin.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, anemia, vitamin B12 deficiency, breathing problems, congestive heart failure, heart attack, problems with your adrenal or pituitary gland, severe infection (sepsis), or a history of alcoholism.
• If your blood sugar gets too low, you may feel weak, drowsy, confused, anxious, or very hungry. You may also sweat, shake, or have blurred vision, a fast heartbeat, or a headache that will not go away. If you have symptoms of low blood sugar (hypoglycemia), check your blood sugar. If your blood sugar is 70 mg/dL (milligrams per deciliter) or below, do one of the following: Drink 4 ounces (one-half cup) of fruit juice, or eat 5 to 6 pieces of hard candy, or take 2 to 3 glucose tablets. Recheck your blood sugar 15 minutes later. If your blood sugar goes above 70 mg/dL, eat a snack or a meal. If your blood sugar is still below 70 mg/dL, drink one-half cup juice, or eat 5 to 6 pieces of candy, or take 2 to 3 glucose tablets. Carry candy or some type of sugar with you at all times, especially if you are away from home. You can take this if you feel that your blood sugar is too low, even if you do not have a blood glucose meter. Always carefully follow your doctor's instructions about how to treat your low blood sugar. Learn what to do if your blood sugar gets too low. Teach friends, coworkers, and family members what they can do to help if you have low blood sugar. Some things that can lead to low blood sugar are exercising more than normal or waiting too long to eat. Tell your doctor about any sudden change in your medical condition.
• This medicine may not work as well if you have surgery, get hurt, or get sick. Also, avoid getting dehydrated while you are using this medicine, especially if you have a fever, vomiting, or diarrhea. Be sure to drink extra fluids whenever you exercise or increase your activity, or if you sweat more than usual.
• This medicine may cause a rare, but serious condition called lactic acidosis in some people. Call your doctor right away if you get sick, or if you have unusual tiredness, weakness, muscle pain, stomach pain, trouble breathing, fever, or nausea.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine is only part of a complete program for controlling diabetes. It is important that you always eat a healthy diet, watch your weight, and get regular exercise.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decrease in how much or how often you urinate, painful or difficult urination.
• Extreme weakness, tiredness, or confusion.
• Fast heartbeat, cold sweats, or shakiness.
• Fever, chills, cough, sore throat, stuffy or runny nose, and body aches.
• Increased hunger, sweating, or thirst.
• Lightheadedness or fainting.
• Rapid breathing, trouble breathing, or nausea and vomiting.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, loss of appetite, or stomach pain.
• Headache.
• Rash or itching skin.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088