Sitagliptin

Sitagliptin is used for:

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Treating type 2 diabetes in patients who cannot control blood sugar levels by diet and exercise alone. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by increasing insulin release, which helps to lower blood sugar.

Do NOT use Sitagliptin if:

• you are allergic to any ingredient in Sitagliptin
• you have type 1 diabetes
• you have high blood ketone levels (diabetic ketoacidosis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sitagliptin:

Some medical conditions may interact with Sitagliptin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney problems

Some MEDICINES MAY INTERACT with Sitagliptin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin because the risk of its side effects may be increased by Sitagliptin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sitagliptin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sitagliptin:

Use Sitagliptin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Sitagliptin. Talk to your pharmacist if you have questions about this information.
• Take Sitagliptin by mouth with or without food.
• Continue to take Sitagliptin even if you feel well. Do not miss any doses.
• If you miss a dose of Sitagliptin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sitagliptin.

Important safety information:

• Carry an ID card at all times that says you have diabetes.
• Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Sitagliptin.
• Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Sitagliptin exactly as prescribed, tell your doctor.
• It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
• Lab tests, including fasting blood glucose, glycosylated hemoglobin, and kidney function, may be performed while you use Sitagliptin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sitagliptin with caution in the ELDERLY; they may be more sensitive to its effects.
• Sitagliptin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sitagliptin while you are pregnant. It is not known if Sitagliptin is found in breast milk. If you are or will be breast-feeding while you use Sitagliptin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sitagliptin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; nausea; runny or stuffy nose; sore throat; upper respiratory infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Sitagliptin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sitagliptin out of the reach of children and away from pets.

General information:

• If you have any questions about Sitagliptin, please talk with your doctor, pharmacist, or other health care provider.
• Sitagliptin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sitagliptin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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