Tablets: JANUMET XR, 50 mg/500 mg, are light blue, bi-convex oval, film-coated tablets with “78″ debossed on one side. They are supplied as follows:
NDC 0006-0078-61 unit-of-use bottles of 60
NDC 0006-0078-62 unit-of-use bottles of 180
NDC 0006-0078-82 bulk bottles of 1000.
Tablets: JANUMET XR, 50 mg/1000 mg, are light green, bi-convex oval, film-coated tablets with “80″ debossed on one side. They are supplied as follows:
NDC 0006-0080-61 unit-of-use bottles of 60
NDC 0006-0080-62 unit-of-use bottles of 180
NDC 0006-0080-82 bulk bottles of 1000.
Tablets: JANUMET XR, 100 mg/1000 mg, are blue, bi-convex oval, film-coated tablets with “81″ debossed on one side. They are supplied as follows:
NDC 0006-0081-31 unit-of-use bottles of 30
NDC 0006-0081-54 unit-of-use bottles of 90
NDC 0006-0081-82 bulk bottles of 1000.
Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Store in a dry place with cap tightly closed. When container is subdivided, dispense into a USP tightly closed, moisture-resistant container.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients of the risks of lactic acidosis due to the metformin component, its symptoms, and conditions that predispose to its development, as noted in Warnings and Precautions (5.1). Advise patients to discontinue JANUMET XR immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, dizziness, slow or irregular heart beat, sensation of feeling cold (especially in the extremities) or other nonspecific symptoms occur. Gastrointestinal symptoms are common during initiation of metformin treatment and may occur during initiation of JANUMET XR therapy; however, inform patients to consult their physician if they develop unexplained symptoms. Although gastrointestinal symptoms that occur after stabilization are unlikely to be drug related, such an occurrence of symptoms should be evaluated to determine if it may be due to lactic acidosis or other serious disease. Instruct patients to inform their doctor that they are taking JANUMET XR prior to any surgical or radiological procedure, as temporary discontinuation of JANUMET XR may be required until renal function has been confirmed to have returned to its prior level [see Warnings and Precautions (5.1)].
Counsel patients against excessive alcohol intake, either acute or chronic, while receiving JANUMET XR.
Inform patients about the importance of regular testing of renal function and hematological parameters when receiving treatment with JANUMET XR.
Inform patients that acute pancreatitis has been reported during postmarketing use of JANUMET XR. Inform patients 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. Instruct patients to promptly discontinue JANUMET XR and contact their physician if persistent severe abdominal pain occurs [see Warnings and Precautions (5.2)].
Inform patients of the signs and symptoms of heart failure. Before initiating JANUMET XR, ask patients about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment. Instruct patients to contact their health care provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [see Warnings and Precautions (5.3)].
Inform patients that the incidence of hypoglycemia is increased when sitagliptin with or without metformin is added to an insulin secretagogue (e.g., sulfonylurea) or insulin therapy and that a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.
Inform patients that allergic reactions have been reported during postmarketing use of sitagliptin, one of the components of JANUMET XR. 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 JANUMET XR and seek medical advice promptly.
Severe and Disabling Arthralgia
Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [see Warnings and Precautions (5.10)].
Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if blisters or erosions occur [see Warnings and Precautions (5.11)].
Inform patients that the tablets must be swallowed whole and never split, crushed or chewed.
Incompletely Dissolved Tablets in Feces
Inform patients that incompletely dissolved JANUMET XR tablets may be eliminated in the feces. Tell patients that, if they repeatedly see tablets in feces, they should report this finding to their health care provider. Assess adequacy of glycemic control if a patient reports repeatedly observing tablets in feces.
Advise patients to notify their health practitioner or call the Poison Control Center immediately in case of JANUMET XR overdose.
Distributed by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright © 2012-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: 08/2017|
|Medication GuideJANUMET® XR (JAN-you-met XR)(sitagliptin and metformin hydrochloride extended-release)Tablets|
|Read this Medication Guide carefully before you start taking JANUMET XR 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 JANUMET XR, ask your doctor or pharmacist.|
|What is the most important information I should know about JANUMET XR?Serious side effects can happen in people taking JANUMET XR, including: |
Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:
Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with JANUMET XR if you:
The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your JANUMET XR for a while if you have any of these things.
JANUMET XR can have other serious side effects. See “What are the possible side effects of JANUMET XR?“
Before you start taking JANUMET XR: Tell your doctor if you have ever had
Stop taking JANUMET XR 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 JANUMET XR? |
| Who should not take JANUMET XR?Do not take JANUMET XR if: |
Symptoms of a serious allergic reaction to JANUMET XR may include rash, raised red patches on your skin (hives) or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
| What should I tell my doctor before taking JANUMET XR?Before you take JANUMET XR, tell your doctor if you: |
Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. JANUMET XR may affect how well other drugs work and some drugs can affect how well JANUMET XR works.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 JANUMET XR? |
| What are the possible side effects of JANUMET XR?Serious side effects have happened in people taking JANUMET XR or the individual medicines in JANUMET XR. |
| || || || || |
The most common side effects of JANUMET XR include:
| || || |
|Taking JANUMET XR with meals can help lessen the common stomach side effects of metformin that usually happen at the beginning of treatment. If you have unusual or sudden stomach problems, talk with your doctor. Stomach problems that start later during treatment may be a sign of something more serious. JANUMET XR may have other side effects, including swelling of the hands or legs. Swelling of the hands and legs can happen if you take JANUMET XR in combination with rosiglitazone (Avandia®). Rosiglitazone is another type of diabetes medicine. These are not all the possible side effects of JANUMET XR. 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 JANUMET XR? Store JANUMET XR at 68°F to 77°F (20°C to 25°C). Store in a dry place and keep cap tightly closed.Keep JANUMET XR and all medicines out of the reach of children.|
|General information about the use of JANUMET XR. Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use JANUMET XR for a condition for which it was not prescribed. Do not give JANUMET XR 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 JANUMET XR. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUMET XR that is written for health care professionals. For more information go to www.janumetxr.com or call 1-800-622-4477.|
|What are the ingredients in JANUMET XR? Active ingredients: sitagliptin and metformin hydrochloride extended-releaseInactive ingredients: |
|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.|
|Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC., Whitehouse Station, NJ 08889, USA For patent information: www.merck.com/product/patent/home.html. The trademarks depicted herein are owned by their respective companies. Copyright © 2012-2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. usmg-mk0431a-xrt-1708r008|
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