Janumet XR

Generic Name: metformin and sitagliptin (met FOR min and SI ta glip tin)
Brand Name: Janumet, Janumet XR

What is Janumet XR (metformin and sitagliptin)?

Metformin and sitagliptin are oral diabetes medicines that help control blood sugar levels.

Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating.

Metformin and sitagliptin is a combination medicine used to treat type 2 diabetes. This medication is not for treating type 1 diabetes.

Metformin and sitagliptin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Janumet XR (metformin and sitagliptin)?

You should not use this medication if you have liver or kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Slideshow: Flashback: FDA Drug Approvals 2013

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

What should I discuss with my health care provider before taking Janumet XR (metformin and sitagliptin)?

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

You should not use this medicine if you are allergic to metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet) or sitagliptin (Januvia), or if you have:

  • kidney or liver disease; or

  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure metformin and sitagliptin is safe for you, tell your doctor if you have:

  • a history of pancreatitis or heart disease; or

  • if you are over 80 years old and have not recently had your kidney function checked.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and sitagliptin. Be sure your caregivers know ahead of time that you are using this medication.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether metformin and sitagliptin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Janumet XR (metformin and sitagliptin)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Take metformin and sitagliptin with meals.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Metformin and sitagliptin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, and eye care. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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).

What should I avoid while taking Janumet XR (metformin and sitagliptin)?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Janumet XR (metformin and sitagliptin) side effects

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • little or no urinating;

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • diarrhea, constipation, mild nausea, upset stomach;

  • headache, weakness, back pain, joint or muscle pain; or

  • cold symptoms such as runny or stuffy nose, sneezing, 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.

See also: Side effects (in more detail)

What other drugs will affect Janumet XR (metformin and sitagliptin)?

Other drugs may interact with metformin and sitagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. There are many other medicines that can increase or decrease the effects of metformin and sitagliptin on lowering your blood sugar. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about metformin and sitagliptin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.03. Revision Date: 2014-01-24, 4:08:43 PM.

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