JANUVIA (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with “221” on one side. They are supplied as follows:

NDC 0006-0221-31 unit-of-use bottles of 30

NDC 0006-0221-54 unit-of-use bottles of 90

NDC 0006-0221-28 unit dose blister packages of 100.

No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with “112” on one side. They are supplied as follows:

NDC 0006-0112-31 unit-of-use bottles of 30

NDC 0006-0112-54 unit-of-use bottles of 90

NDC 0006-0112-28 unit dose blister packages of 100.

No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with “277” on one side. They are supplied as follows:

NDC 0006-0277-31 unit-of-use bottles of 30

NDC 0006-0277-54 unit-of-use bottles of 90

NDC 0006-0277-33 unit-of-use blister calendar package of 30

NDC 0006-0277-28 unit dose blister packages of 100

NDC 0006-0277-82 bottles of 1000.

Storage

Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F), [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Medication Guide).

17.1 Instructions

Patients should be informed of the potential risks and benefits of JANUVIA and of alternative modes of therapy. Patients should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.

Patients should be informed that acute pancreatitis has been reported during postmarketing use of JANUVIA. Patients should be informed that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue JANUVIA and contact their physician if persistent severe abdominal pain occurs [see Warnings and Precautions (5.1)].

Patients should be informed that the incidence of hypoglycemia is increased when JANUVIA is added to a sulfonylurea or insulin and that a lower dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Patients should be informed that allergic reactions have been reported during postmarketing use of JANUVIA. If symptoms of allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking JANUVIA and seek medical advice promptly.

Physicians should instruct their patients to read the Medication Guide before starting JANUVIA therapy and to reread each time the prescription is renewed. Patients should be instructed to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

17.2 Laboratory Tests

Patients should be informed that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and A1C levels, with a goal of decreasing these levels towards the normal range. A1C is especially useful for evaluating long-term glycemic control. Patients should be informed of the potential need to adjust dose based on changes in renal function tests over time.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

US Patent Nos.: 6,699,871 and 7,326,708

Copyright © 2006, 2007, 2009, 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0431-t-1308r012


Medication Guide
JANUVIA® (jah-NEW-vee-ah)
(sitagliptin)
Tablets

Read this Medication Guide carefully before you start taking JANUVIA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about JANUVIA, ask your doctor or pharmacist.

What is the most important information I should know about JANUVIA?

Serious side effects can happen in people taking JANUVIA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death.

Certain medical problems make you more likely to get pancreatitis.

Before you start taking JANUVIA:

Tell your doctor if you have ever had

pancreatitis
stones in your gallbladder (gallstones)
a history of alcoholism
high blood triglyceride levels
kidney problems

Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

What is JANUVIA?

JANUVIA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JANUVIA is not for people with type 1 diabetes.
JANUVIA is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
If you have had pancreatitis (inflammation of the pancreas) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JANUVIA.
It is not known if JANUVIA is safe and effective when used in children under 18 years of age.

Who should not take JANUVIA?

Do not take JANUVIA if:

you are allergic to any of the ingredients in JANUVIA. See the end of this Medication Guide for a complete list of ingredients in JANUVIA.
Symptoms of a serious allergic reaction to JANUVIA may include:
rash
raised red patches on your skin (hives)
swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

What should I tell my doctor before taking JANUVIA?

Before you take JANUVIA, tell your doctor if you:

have or have had inflammation of your pancreas (pancreatitis).
have kidney problems.
have any other medical conditions.
are pregnant or plan to become pregnant. It is not known if JANUVIA will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.Pregnancy Registry: If you take JANUVIA at any time during your pregnancy, talk with your doctor about how you can join the JANUVIA pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. You can enroll in this registry by calling 1-800-986-8999.
are breast-feeding or plan to breast-feed. It is not known if JANUVIA will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUVIA.

Tell your doctor 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 your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take JANUVIA?

Take JANUVIA 1 time each day exactly as your doctor tells you.
You can take JANUVIA with or without food.
Your doctor may do blood tests from time to time to see how well your kidneys are working. Your doctor may change your dose of JANUVIA based on the results of your blood tests.
Your doctor may tell you to take JANUVIA along with other diabetes medicines. Low blood sugar can happen more often when JANUVIA is taken with certain other diabetes medicines. See “What are the possible side effects of JANUVIA? “.
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 two doses of JANUVIA at the same time.
If you take too much JANUVIA, call your doctor or local Poison Control Center right away.
When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions.
Check your blood sugar as your doctor tells you to.
Stay on your prescribed diet and exercise program while taking JANUVIA.
Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

What are the possible side effects of JANUVIA?

Serious side effects have happened in people taking JANUVIA.

See “What is the most important information I should know about JANUVIA?”.
Low blood sugar (hypoglycemia). If you take JANUVIA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include:
headache
drowsiness
weakness
dizziness
confusion
irritability
hunger
fast heart beat
sweating
feeling jittery

The most common side effects of JANUVIA include:

upper respiratory infection
stuffy or runny nose and sore throat
headache

JANUVIA may have other side effects, including:

stomach upset and diarrhea
swelling of the hands or legs, when JANUVIA is used with rosiglitazone (Avandia®). Rosiglitazone is another type of diabetes medicine.

These are not all the possible side effects of JANUVIA. For more information, ask your doctor or pharmacist.

Tell your doctor if you have any side effect that bothers you, is unusual or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store JANUVIA?

Store JANUVIA at 68°F to 77°F (20°C to 25°C).

Keep JANUVIA and all medicines out of the reach of children.

General information about the use of JANUVIA

Medicines are sometimes prescribed for purposes that are not listed in Medication Guides. Do not use JANUVIA for a condition for which it was not prescribed. Do not give JANUVIA to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about JANUVIA. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUVIA that is written for health professionals. For more information, go to www.JANUVIA.com or call 1-800-622-4477.

What are the ingredients in JANUVIA?

Active ingredient: sitagliptin

Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. The tablet film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.

High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

US Patent Nos.: 6,699,871 and 7,326,708

The trademarks depicted herein are owned by their respective companies.

Copyright © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

Revised: 08/2013

usmg-mk0431-t-1308r012

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