Sitagliptin/metformin (By mouth)

Introduction

Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide), Sitagliptin Phosphate (sit-a-GLIP-tin FOS-fate)

Treats type 2 diabetes. Used together with proper diet and exercise to help control blood sugar.

Brand Name(s)

Janumet

When This Medicine Should Not Be Used

How to Use This Medicine

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.
• It is best to take this medicine with food or milk.
• Carefully follow your doctor's instructions about any special diet or exercise program.
• 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• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.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 are using insulin or other medicines to treat your diabetes (such as glipizide, glimepiride, glyburide, tolbutamide, Amaryl®, Glucotrol®, or Orinase®), cimetidine (Tagamet®), digoxin (Digitek®, Lanoxin®), isoniazid (Nydrazid®), morphine, nicotinic acid (niacin), procainamide (Procanbid®), quinidine, quinine, ranitidine (Zantac®), trimethoprim (Proloprim®, Trimpex®), or vancomycin (Vancocin®).
• Tell your doctor if you are also using birth control pills, certain blood pressure medicines (such as atenolol, metoprolol, nifedipine, diltiazem, Cardizem®, or Procardia®), a diuretic or "water pill" (such as amiloride, furosemide, triamterene, Dyrenium®, or Lasix®), a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®), phenytoin (Dilantin®), a steroid medicine (such as prednisone, Medrol®), or a thyroid medicine.
• Do not drink alcohol while you are using this medicine.

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.
• Change in how much or how often you urinate.
• Dizziness, shakiness, or increased hunger.
• Extreme weakness, tiredness, or confusion.
• Fast heartbeat, cold sweats, or shakiness.
• Fever, chills, runny or stuffy nose, cough, sore throat, and body aches.
• Lightheadedness or fainting.
• Rapid breathing, trouble breathing, or nausea and vomiting.
• Sudden and severe stomach pain, fever, or loss of appetite.

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

• Diarrhea, mild stomach pain, or upset stomach.
• Headache.
• Lack or loss of strength.

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

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, kidney problems, heart disease, adrenal or pituitary problems, vitamin B12 deficiency, or a history of pancreas problems. Make sure your doctor knows if you get hurt or sick, especially if you have severe vomiting, diarrhea, or fever.
• Tell your doctor if you are overweight, or if you have high cholesterol or fats in the blood. These conditions may increase your risk for pancreatitis (swelling of the pancreas).
• Pancreatitis may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.
• You may need to stop using this medicine several days before having surgery or medical tests. This medicine may interact with the dye used for an X-ray or CT scan.
• 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, trouble breathing, fever, or nausea.
• You may develop low blood sugar while you are taking this medicine. You may feel weak, drowsy, confused, anxious, or very hungry. You may have trouble seeing or have a headache that won't go away. Ask your doctor what you should do if this happens. Some things that can lead to low blood sugar are exercising more than normal or waiting too long to eat.
• 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. You will also need to check your blood sugar regularly at home.
• 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.