Janumet (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with “575” debossed on one side. They are supplied as follows:

NDC 54868-5973-0 unit-of-use bottles of 60.

No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with “577” debossed on one side. They are supplied as follows:

NDC 54868-1097-0 unit-of-use bottles of 60

NDC 54868-1097-1 unit-of-use bottles of 180.

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

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

9984500

US Patent No.: 6,699,871

1,2 Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

3 GLUCOPHAGE® is a registered trademark of Merck Sante S.A.S, an associate of Merck KGaA of Darmstadt, Germany.
Licensed to Bristol-Myers Squibb Company.

Copyright © 2007, 2008, 2009, 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved

Relabeling of “Additional Barcode” by:
Physicians Total Care, Inc.
Tulsa, OK 74146

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide.

17.1 Instructions

Patients should be informed of the potential risks and benefits of JANUMET and of alternative modes of therapy. They 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.

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), should be explained to patients. Patients should be advised to discontinue JANUMET 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 therapy; however, patients should 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.

Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving JANUMET.

Patients should be informed about the importance of regular testing of renal function and hematological parameters when receiving treatment with JANUMET.

Patients should be informed that acute pancreatitis has been reported during postmarketing use of JANUMET. 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 JANUMET and contact their physician if persistent severe abdominal pain occurs [see Warnings and Precautions (5.2)].

Patients should be informed that the incidence of hypoglycemia is increased when JANUMET 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.

Patients should be informed that allergic reactions have been reported during postmarketing use of sitagliptin, one of the components of JANUMET. 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 and seek medical advice promptly.

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

17.2 Laboratory Tests

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.

Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin/hematocrit and red blood cell indices) and renal function (serum creatinine) should be performed, at least on an annual basis. While megaloblastic anemia has rarely been seen with metformin therapy, if this is suspected, Vitamin B12 deficiency should be excluded.


Medication Guide
JANUMET® (JAN-you-met)
(sitagliptin/metformin hydrochloride)
Tablets

Read this Medication Guide carefully before you start taking JANUMET 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, ask your doctor or pharmacist.

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

Serious side effects can happen in people taking JANUMET , including:

1. Lactic Acidosis. Metformin, one of the medicines in JANUMET, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Stop taking JANUMET and call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis.

You:

  • feel very weak or tired.
  • have unusual (not normal) muscle pain.
  • have trouble breathing.
  • have unusual sleepiness or sleep longer than usual.
  • have sudden stomach or intestinal problems with nausea and vomiting or diarrhea.
  • feel cold, especially in your arms and legs.
  • feel dizzy or lightheaded.
  • have a slow or irregular heart beat.

You have a higher chance of getting lactic acidosis if you:

  • have kidney problems. People whose kidneys are not working properly should not take JANUMET.
  • have liver problems.
  • have congestive heart failure that requires treatment with medicines.
  • drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking.
  • get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
  • have certain x-ray tests with dyes or contrast agents that are injected into your body.
  • have surgery.
  • have a heart attack, severe infection, or stroke.
  • are 80 years of age or older and have not had your kidneys tested.

2. Pancreatitis (inflammation of the pancreas) which may be severe and lead to death.

Certain medical problems make you more likely to get pancreatitis.

Before you start taking JANUMET:

Tell your doctor if you have ever had

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

Stop taking JANUMET 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?

  • JANUMET is a prescription medicine that contains two prescription diabetes medicines, sitagliptin (JANUVIA®) and metformin. JANUMET can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
  • JANUMET is not for people with type 1 diabetes.
  • JANUMET 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 JANUMET.
  • It is not known if JANUMET is safe and effective when used in children under 18 years of age.

Who should not take JANUMET?

Do not take JANUMET if:

  • you are allergic to any of the ingredients in JANUMET. See the end of this Medication Guide for a complete list of ingredients in JANUMET.
    Symptoms of a serious allergic reaction to JANUMET 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
  • you have kidneys which are not working properly.
  • you are going to get an injection of dye or contrast agents for an x-ray procedure, JANUMET will need to be stopped for a short time. Talk to your doctor about when you should stop JANUMET and when you should start JANUMET again. See “What is the most important information I should know about JANUMET?

What should I tell my doctor before taking JANUMET?

Before you take JANUMET, tell your doctor if you:

  • have or have had inflammation of your pancreas (pancreatitis).
  • have kidney problems.
  • have liver problems.
  • have heart problems, including congestive heart failure.
  • are older than 80 years. If you are over 80 years old you should not take JANUMET unless your kidneys have been checked and they are normal.
  • drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if JANUMET 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 JANUMET at any time during your pregnancy, talk with your doctor about how you can join the JANUMET 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 JANUMET will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUMET.

Tell your doctor about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal supplements. JANUMET may affect how well other drugs work and some drugs can affect how well JANUMET 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?

  • Take JANUMET exactly as your doctor tells you.
  • Your doctor may change your dose of JANUMET if needed.
  • Your doctor may tell you to take JANUMET along with certain other diabetes medicines. Low blood sugar can happen more often when JANUMET is taken with certain other diabetes medicines. See “What are the possible side effects of JANUMET?
  • Take JANUMET with meals to lower your chance of having an upset stomach.
  • Continue to take JANUMET as long as your doctor tells you.
  • If you take too much JANUMET, call your doctor or local Poison Control Center right away.
  • If you miss a dose, take it with food 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 JANUMET at the same time.
  • You may need to stop taking JANUMET for a short time. Call your doctor for instructions if you:
    • are dehydrated (have lost too much body fluid). Dehydration can occur if you are sick with severe vomiting, diarrhea or fever, or if you drink a lot less fluid than normal.
    • plan to have surgery.
    • are going to get an injection of dye or contrast agent for an x-ray procedure. See “What is the most important information I should know about JANUMET? ” and “Who should not take JANUMET?
  • 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 problems 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 JANUMET.
  • 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.
  • Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with JANUMET.

What are the possible side effects of JANUMET?

Serious side effects have occurred in people taking JANUMET.

  • See “What is the most important information I should know about JANUMET?”.
  • Low blood sugar (hypoglycemia). If you take JANUMET 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 JANUMET. Signs and symptoms of low blood sugar may include:
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heart beat
  • sweating
  • feeling jittery
  • Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUMET and call your doctor right away. See “Who should not take JANUMET? “. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

The most common side effects of JANUMET include:

  • stuffy or runny nose and sore throat
  • upper respiratory infection
  • diarrhea
  • nausea and vomiting
  • gas, upset stomach, indigestion
  • weakness
  • headache

Taking JANUMET 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 may have other side effects, including:

  • swelling of the hands or legs. Swelling of the hands and legs can happen if you take JANUMET in combination with rosiglitazone (Avandia®). Rosiglitazone is another type of diabetes medicine.

These are not all the possible side effects of JANUMET. 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?

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

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

General information about the use of JANUMET

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use JANUMET for a condition for which it was not prescribed. Do not give JANUMET 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. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUMET that is written for health care professionals. For more information go to www.JANUMET.com or call 1-800-622-4477.

What are the ingredients in JANUMET?

Active ingredients: sitagliptin and metformin hydrochloride.

Inactive ingredients: microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, and sodium stearyl fumarate. The tablet film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and black 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.

JANUMET® and JANUVIA® are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Avandia® is a registered trademark of GlaxoSmithKline.

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

Revised February 2010

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

9984500

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

Janumet®
(sitagliptin/metformin HCl) tablets

50 mg/500 mg

Rx only

Each tablet contains 64.25 mg sitagliptin phosphate (equivalent to 50 mg sitagliptin) and 500 mg metformin hydrochloride.

Dispense the accompanying Medication Guide to each patient.

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

See accompanying circular for dosage information.

image of 50/500 mg package label
(click image for full-size original)

Janumet® (sitagliptin/metformin HCl) tablets

50 mg/1000 mg

Rx only

Dispense the accompanying Medication Guide to each patient.

Each tablet contains 64.25 mg sitagliptin phosphate (equivalent to 50 mg sitagliptin) and 1000 mg metformin hydrochloride.

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

See accompanying circular for dosage information.

image of 50/1000 mg package label
(click image for full-size original)

JANUMET sitagliptin and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5973(NDC:0006-0575)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 50 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN 500 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE K29/32
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink (light pink) Score no score
Shape OVAL (capsule-shaped) Size 17mm
Flavor Imprint Code 575
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5973-0 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022044 12/17/2008
JANUMET sitagliptin and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1097(NDC:0006-0577)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 50 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN 1000 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE K29/32
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color red (red) Score no score
Shape OVAL (capsule-shaped) Size 21mm
Flavor Imprint Code 577
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-1097-0 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-1097-1 180 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022044 06/17/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 05/2010 Physicians Total Care, Inc.

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