Sitagliptin (By mouth)

When This Medicine Should Not Be Used

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease or a history of pancreas problems.
• 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 and inflammation 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.
• Tell your doctor if you have a fever, an infection, or an injury, or if you are planning to have surgery. Your doctor may need to change your dose of sitagliptin.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing or swallowing; or chest pain after using this medicine.
• 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 at home.
• This medicine is only one 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.

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.
• You may take this medicine with or without food.
• Carefully follow your doctor's instructions about any special diet.
• 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®). Tell your doctor if you are also using digoxin (Digitek®, Lanoxin®).

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.
• Fast heartbeat, cold sweats, or shakiness.
• Fever, chills, runny or stuffy nose, cough, sore throat, and body aches.
• Headache or blurred vision.
• Lightheadedness, dizziness, or hunger.
• Severe drowsiness, confusion, or mental changes.
• Sudden and severe stomach pain, nausea, vomiting, or loss of appetite.
• Unusual tiredness or weakness.

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

• Mild nausea, diarrhea, or stomach pain.

Introduction

Sitagliptin (sit-a-GLIP-tin)

Treats type 2 diabetes either alone or together with other medicines.

Brand Name(s)

Januvia

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