Sitagliptin

Sitagliptin is used along with diet and exercise to help control blood sugar levels in adults with type 2 diabetes mellitus (it is not for type 1 diabetes).

Sitagliptin may also be used for other reasons that are not mentioned in this medication guide.

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.

Sitagliptin is usually taken once per day with or without food. Follow your doctor's instructions.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests including checking your kidney function.

You may be given other medications to help with your condition. Keep taking these medicines for as long as your doctor has prescribed.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store the tablets at room temperature away from moisture and heat.

Store the oral solution in the refrigerator. Protect from light, heat and do not freeze.

Sitagliptin may be used for only a certain number of months after opening. Throw away any medicine not used within that time. Talk to your pharmacist if you have any questions.

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.

You should not use sitagliptin if you are allergic to it or any of its ingredients.

Tell your doctor if you have or have ever had:

• heart problems such as heart failure;
• pancreatitis;
• high triglycerides (a type of fat in the blood);
• gallstones;
• alcoholism; or
• kidney disease (or if you are on dialysis).

It is not known if sitagliptin will harm an unborn baby. Follow your doctor's instructions about using sitagliptin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

Ask a doctor if it is safe to breastfeed while using this medicine.

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

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

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

• severe or ongoing pain in your joints;
• a severe skin reaction-- itching, blisters, breakdown of the outer layer of skin;
• severely low blood sugar--extreme weakness, confusion, tremors, sweating, fast heartbeats, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions); or
• kidney problems or symptoms of heart failure--swelling, urinating less, rapid weight gain, feeling tired or short of breath.

Common side effects of sitagliptin may include:

• low blood sugar (if you also use insulin or another oral diabetes medication);
• cold symptoms such as stuffy or runny nose, sneezing, sore throat; or
• headache.

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.

Usual Adult Dose for Diabetes Type 2:

100 mg orally once a dayComments: -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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any limits on food, drinks, or activities.

When you begin or stop taking sitagliptin, your doctor might need to change the doses of other medicines that you take regularly. Inform your doctor about all your other medicines, especially:

• insulin or oral diabetes medicine.

Many medications can influence your blood sugar and may also impact sitagliptin. This includes both prescription and over-the-counter medicines, as well as vitamins and herbal products. Let your doctor know about all other medicines you are using. Not all possible interactions are mentioned here.