Janumet XR

Generic Name: sitagliptin and metformin (Oral route)

met-FOR-min hye-droe-KLOR-ide, sit-a-GLIP-tin FOS-fate

Oral route(Tablet)

Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk of lactic acidosis increases with conditions such as sepsis, dehydration, excessive alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Discontinue therapy and hospitalize the patient immediately for suspected lactic acidosis .

Commonly used brand name(s)

In the U.S.

  • Janumet
  • Janumet XR

Available Dosage Forms:

  • Tablet, Extended Release
  • Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Sitagliptin

Chemical Class: Metformin

Uses For Janumet XR

Metformin and sitagliptin combination is used to treat high blood sugar levels caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your blood. Chronic high blood sugar can lead to serious health problems in the future.

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Many people can control type 2 diabetes with diet alone or diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of metformin and sitagliptin combination you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.

Metformin and sitagliptin combination does not help patients who have insulin-dependent or type 1 diabetes, because they cannot produce insulin from their pancreas. Their blood glucose is best controlled by insulin injections.

This medicine is available only with your doctor's prescription.

Before Using Janumet XR

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of metformin and sitagliptin combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metformin and sitagliptin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving metformin and sitagliptin combination.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Acetrizoic Acid
  • Diatrizoate
  • Ethiodized Oil
  • Iobenzamic Acid
  • Iobitridol
  • Iocarmic Acid
  • Iocetamic Acid
  • Iodamide
  • Iodipamide
  • Iodixanol
  • Iodohippuric Acid
  • Iodopyracet
  • Iodoxamic Acid
  • Ioglicic Acid
  • Ioglycamic Acid
  • Iohexol
  • Iomeprol
  • Iopamidol
  • Iopanoic Acid
  • Iopentol
  • Iophendylate
  • Iopromide
  • Iopronic Acid
  • Ioseric Acid
  • Iosimide
  • Iotasul
  • Iothalamate
  • Iotrolan
  • Iotroxic Acid
  • Ioversol
  • Ioxaglate
  • Ioxitalamic Acid
  • Ipodate
  • Metrizamide
  • Metrizoic Acid
  • Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetazolamide
  • Alatrofloxacin
  • Balofloxacin
  • Cimetidine
  • Ciprofloxacin
  • Clinafloxacin
  • Dichlorphenamide
  • Dofetilide
  • Dolutegravir
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Levofloxacin
  • Lomefloxacin
  • Lomitapide
  • Moxifloxacin
  • Nilotinib
  • Norfloxacin
  • Ofloxacin
  • Pefloxacin
  • Prulifloxacin
  • Rufloxacin
  • Simeprevir
  • Sparfloxacin
  • Temafloxacin
  • Tocophersolan
  • Tosufloxacin
  • Trovafloxacin Mesylate
  • Vandetanib
  • Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Alprenolol
  • Atenolol
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bitter Melon
  • Bucindolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cephalexin
  • Clorgyline
  • Colesevelam
  • Dilevalol
  • Enalaprilat
  • Enalapril Maleate
  • Esmolol
  • Fenugreek
  • Glucomannan
  • Guar Gum
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Levobunolol
  • Linezolid
  • Mepindolol
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Oxprenolol
  • Pargyline
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Procarbazine
  • Propranolol
  • Psyllium
  • Ranolazine
  • Rifampin
  • Selegiline
  • Sotalol
  • Talinolol
  • Tertatolol
  • Timolol
  • Toloxatone
  • Tranylcypromine
  • Trospium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Acid in the blood (diabetic ketoacidosis or metabolic acidosis) or
  • Kidney disease, severe or
  • Type 1 diabetes—Should not be used in patients with these conditions.
  • Alcohol, excessive use or
  • Underactive adrenal glands or
  • Underactive pituitary gland or
  • Undernourished condition or
  • Weakened physical condition or
  • Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking metformin and sitagliptin combination.
  • Anemia or
  • Vitamin B12 deficiency—Use with caution. May make these conditions worse.
  • Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history with this medication or other dipeptidyl peptidase-4 (DPP-4) inhibitors—Use with caution. May increase the risk of this condition occurring again.
  • Congestive heart failure, acute or unstable or
  • Dehydration, severe or
  • Heart or blood vessel problems or
  • Hypoxemia (decreased oxygen in the blood) or
  • Liver disease or
  • Sepsis (severe infection) or
  • Shock (low blood pressure, blood circulation is poor)—These conditions can cause serious problems. If they happen, stop taking this medicine as soon as possible.
  • Fever or
  • Infection of any type or
  • Surgery (major) or
  • Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you with insulin.
  • Hypercholesterolemia (high cholesterol in the blood) or
  • Hypertriglyceridemia (high triglycerides and fats in the blood) or
  • Obesity or
  • Pancreas problems, history of—Use with caution. May increase risk for pancreatitis (swelling of the pancreas).
  • Radiologic procedures (eg, X-rays, CT scans, and MRIs) that require dyes to be injected in your vein—This medicine should be stopped before you have one of these procedures.

Proper Use of metformin and sitagliptin

This section provides information on the proper use of a number of products that contain metformin and sitagliptin. It may not be specific to Janumet XR. Please read with care.

Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Metformin and sitagliptin combination should be taken with meals to help reduce any stomach upset. Take the extended-release tablets as directed in the evening.

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

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Exercise regularly and test for sugar in your blood or urine as directed.

While taking Janumet® XR, you may see tablets in your stools. If you see tablets in your stool several times, tell your doctor right away. Do not stop taking this medicine without checking first with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For type 2 diabetes:
    • For oral dosage form (extended-release tablets):
      • For patients taking metformin alone:
        • Adults—At first, 100 milligrams (mg) of sitagliptin, plus the dose of metformin already being taken once a day. Your doctor may gradually increase your dose until your blood sugar is controlled. If you are taking 850 or 1000 mg of immediate-release metformin two times per day, you may start with two 50 mg sitagliptin tablets and 1000 mg of metformin taken together once a day.
        • Children—Use and dose must be determined by your doctor.
      • For patients taking sitagliptin alone:
        • Adults—At first, 100 milligrams (mg) of sitagliptin and 1000 mg of metformin once a day. Your doctor may gradually increase your dose until your blood sugar is controlled. However, the dose is usually not more than 100 mg of sitagliptin and 2000 mg of metformin once a day.
        • Children—Use and dose must be determined by your doctor.
      • For patients using Janumet® immediate-release tablets:
        • Adults—The dose is the same as the dose you are already taking. Your doctor may gradually increase your dose until your blood sugar is controlled. However, the dose is usually not more than 100 mg of sitagliptin and 2000 mg of metformin once a day.
        • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (immediate-release tablets):
      • For patients taking metformin alone:
        • Adults—At first, 50 milligrams (mg) of sitagliptin, plus the dose of metformin already being taken, two times per day. Your doctor may gradually increase your dose until your blood sugar is controlled. If you are taking 850 mg of metformin two times per day, you may start with 50 mg of sitagliptin and 1000 mg of metformin two times per day.
        • Children—Use and dose must be determined by your doctor.
      • For patients taking sitagliptin alone:
        • Adults—At first, 50 milligrams (mg) of sitagliptin and 500 mg of metformin two times per day. Your doctor may gradually increase your dose until your blood sugar is controlled. However, the dose is usually not more than 50 mg of sitagliptin and 1000 mg of metformin two times per day.
        • Children—Use and dose must be determined by your doctor.
      • For patients using metformin and sitagliptin together as separate tablets:
        • Adults—The dose is the same as the dose you are already taking. Your doctor may gradually increase your dose until your blood sugar is controlled.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Janumet XR

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear, and are usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness.

If symptoms of lactic acidosis occur, you should get immediate emergency medical help.

This medicine may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take this medicine with another type of diabetes medicine (eg, insulin, glimepiride, or pioglitazone). Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly.

Symptoms of low blood sugar include anxiety, behavior changes similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headaches that continue, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, sleepiness, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness (passed out), or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all your medicines.

It is important to tell the doctor in charge that you are taking this medicine if you are going to have any medical or surgical procedures.

Pancreatitis may occur while you are using this medicine. Check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Janumet XR Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • loss of consciousness
  • mental cloudiness
  • nausea
  • nightmares
  • not thinking clearly
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness
Rare
  • Abdominal or stomach discomfort
  • decreased appetite
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • muscle pain or cramping
  • shortness of breath
  • sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bloated
  • excess air or gas in the stomach or intestines
  • fever
  • full feeling
  • indigestion
  • lack or loss of strength
  • muscle aches
  • passing gas
  • sore throat
  • stuffy or runny nose
  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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