Patient Information Sheet: Sitagliptin Phosphate (marketed as Januvia)

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Patient Information Sheet
Sitagliptin Phosphate (marketed as Januvia)

This is a summary of the most important information about Januvia. For details, talk to your healthcare professional.

What Is Januvia?

Januvia is a prescription medicine used along with diet and exercise to lower blood sugar in patients with type 2 diabetes mellitus (type 2 diabetes). Januvia may be taken alone or along with certain other medicines to control blood sugar.

Januvia lowers blood sugar when blood sugar is high, especially after a meal.
Januvia also lowers blood sugar between meals.
Januvia helps to improve the levels of insulin produced by your own body after a meal.
Januvia decreases the amount of sugar made by the body.
Januvia is unlikely to cause your blood sugar to be lowered to a dangerous level (hypoglycemia) because it does not work when your blood sugar is low.

Januvia has not been studied in children under 18 years of age.

Januvia has not been studied with medicines known to cause low blood sugar, such as sulfonylureas or insulin. Ask your healthcare professional if you are taking a sulfonylurea or other medicine that can cause low blood sugar.

Who Should Not Take Januvia?

You should not take Januvia if you have any of the following conditions:

type 1 diabetes mellitus
diabetic ketoacidosis (increased ketones in the blood or urine)

What Are The Risks?

The most common side effects that may occur with Januvia include:

upper respiratory infection
stuffy or runny nose and sore throat
headache

Januvia may occasionally cause stomach discomfort and diarrhea.

Tell your healthcare professional if you have any side effects that bothers you or that does not go away. Other side effects may occur when using Januvia. For more information, ask your healthcare professional.

What Should I Tell My Healthcare Professional?

Before you start taking Januvia, tell your healthcare professional if you:

have any allergies
have kidney problems
are pregnant or plan to become pregnant, because Januvia may not be right for you. It is not known if Januvia will harm your unborn baby. If you are pregnant, talk with your healthcare professional about the best way to control your blood sugar while you are pregnant. If you use Januvia during pregnancy, talk with your healthcare professional about how you can be on the Januvia registry. The toll-free telephone number for the pregnancy registry is: 1-800-986-8999.
are breast-feeding or plan to breast-feed. Januvia may be passed in your milk to your baby. Talk with your healthcare professional about the best way to feed your baby if you are taking Januvia.

During periods of stress on the body, such as fever, trauma, infection or surgery, your medication needs may change; contact your doctor right away.

Can Other Medicines Or Food Affect Januvia?

Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

How Should I Take Januvia?

Take Januvia exactly as your healthcare professional tells you to take it.
Take Januvia by mouth once a day.
Take Januvia with or without food.
If you have kidney problems, your doctor may prescribe lower doses of Januvia. Your healthcare professional may perform blood tests on you from time to time to measure how well your kidneys are working.
Your healthcare professional may prescribe Januvia along with certain other medicines that lower blood sugar.

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of Januvia.

If you take too much Januvia, call your healthcare professional or local Poison Control Center right away.

Link to Januvia's Approved Labeling

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Date created: November 7, 2006, updated December 4, 2006