Sitagliptin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Sitagliptin is not for treating type 1 diabetes.

Sitagliptin may also be used for purposes not listed in this medication guide.

Call your doctor if you have symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Stop taking sitagliptin and call your doctor if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without vomiting.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take this medicine with or without food. Follow your doctor's instructions.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Sitagliptin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Diabetes Type 2:

100 mg orally once a day

Comments:
-When used in combination with an insulin secretagogue (e.g. sulfonylurea) or insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

You should not use sitagliptin if you are allergic to it, or if you have diabetic ketoacidosis (call your doctor for treatment with insulin).

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• heart problems;

• pancreatitis;

• high triglycerides (a type of fat in the blood);

• gallstones; or

• alcoholism.

Follow your doctor's instructions about using sitagliptin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Your name may need to be listed on a sitagliptin pregnancy registry when you start using this medicine.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Sitagliptin is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Be sure to follow all diet and exercise recommendations made by your doctor or dietician.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop taking sitagliptin and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without vomiting.

Sitagliptin may cause serious side effects. Call your doctor at once if you have:

• severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin;

• severe or ongoing pain in your joints;

• little or no urination; or

• symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects of sitagliptin may include:

• low blood sugar;

• headache; or

• runny or stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sitagliptin may not work as well when you use other medicines at the same time. Many other drugs can also affect blood sugar control.

You may be more likely to have low blood sugar if you also use insulin.

Other drugs may affect sitagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before and during your treatment with sitagliptin. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to sitagliptin. Your doctor will also tell you how to check your response to sitagliptin by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Janumet® (containing Metformin, Sitagliptin)
• Juvisync® (containing Simvastatin, Sitagliptin)
• Steglujan® (containing Ertugliflozin, Sitagliptin)