Saxagliptin/metformin (By mouth)

Introduction

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

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

Brand Name(s)

Kombiglyze XR

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to saxagliptin (Onglyza®) or metformin (Avandamet®, Glucophage®, Glucovance®, Metaglip®). You should not use this medicine if you have severe kidney disease, severe liver disease, type 1 diabetes, or metabolic acidosis (diabetic ketoacidosis). This medicine is not recommended in patients 80 years of age or older who have kidney problems.

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.
• 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 should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

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• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• 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 also use insulin or 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 also use 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®.

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. Tell your doctor if you have gallstones, high triglycerides in the blood, or a history of angioedema (swelling of the face, lips, tongue, or throat) to similar medicines, such as linagliptin, sitagliptin, or Januvia®. Tell your doctor if you drink alcohol.
• Do not let yourself get dehydrated. Be sure to drink extra fluids when you exercise or increase your activity or if you have vomiting or diarrhea.
• This medicine may cause a rare but serious condition called lactic acidosis. Call your doctor right away if you have unusual tiredness or weakness, muscle pain, stomach pain, trouble breathing, fever, or nausea.
• Stop using this medicine and check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness. These may be signs of pancreatitis (inflammation of the pancreas).
• 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.
• Talk with your doctor before you have any surgery or an x-ray that uses an injection of dyes (contrast agents) into your veins.
• 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 to help control 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
• Blistering, peeling, or red skin rash
• Decrease in how much or how often you urinate, painful or difficult urination
• Fast, slow, or uneven heartbeat
• Increased hunger, shakiness, sweating, or thirst
• Muscle pain or cramping
• Sudden and severe stomach pain, nausea, vomiting, fever, and lightheadedness
• Swelling in your hands, ankles, or feet
• Trouble breathing
• Unusual weakness or tiredness

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

• Cough, sore throat, stuffy or runny nose, and body aches
• Diarrhea, loss of appetite, or mild stomach pain
• General feeling of discomfort
• Headache
• Mild skin rash

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