Januvia is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.

Januvia is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Januvia is not for treating type 1 diabetes.

You should not use Januvia if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

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

Before taking this medicine

You should not use Januvia if you are allergic to sitagliptin, 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 Januvia if you are pregnant or you become pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester. Having high blood sugar may cause complications in both the mother and the baby.

Your name may need to be listed on a Januvia 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.

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

Take Januvia exactly as it was prescribed for you. 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 Januvia with or without food. Follow your doctor's instructions.

Your blood sugar may 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, blurred vision, headache, and tiredness.

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.

Januvia 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:

Usual dose: 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 Januvia if you are allergic to sitagliptin, 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 Januvia if you are pregnant or you become pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester. Having high blood sugar may cause complications in both the mother and the baby.

Your name may need to be listed on a Januvia 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.

Januvia 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).

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 to Januvia (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 Januvia 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.

Call your doctor at once if you have:

• severe autoimmune reactionitching, blisters, breakdown of the outer layer of skin;

• severe or ongoing pain in your joints;

• little or no urination; or

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

Common Januvia side effects 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.

Januvia 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.

This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.