Sitagliptin and metformin (oral route)

Brand Name

US Brand Name

Janumet

Janumet XR

Canadian Brand Name

Sandoz-Sitagliptin-Metformin

Sitagliptin-Metformin

Description

Metformin and sitagliptin combination is used to treat high blood sugar levels caused by type 2 diabetes. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. This medicine does not help patients who have insulin-dependent or type 1 diabetes.

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

This product is available in the following dosage forms:

Tablet, Extended Release
Tablet

Before Using

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 caution and an adjustment in the dose for patients receiving metformin and sitagliptin combination.

Breastfeeding

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.

Drug Interactions

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 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.

Abiraterone Acetate
Abiraterone Acetate, Micronized
Acarbose
Acetazolamide
Alogliptin
Aspirin
Bexagliflozin
Bictegravir
Brinzolamide
Bupropion
Capmatinib
Chloroquine
Chlorothiazide
Chlorpropamide
Chlorthalidone
Cimetidine
Ciprofloxacin
Dasabuvir
Delafloxacin
Diatrizoate
Dichlorphenamide
Dofetilide
Dolutegravir
Dorzolamide
Enoxacin
Ethiodized Oil
Fedratinib
Fexinidazole
Furosemide
Gatifloxacin
Gemifloxacin
Glimepiride
Glipizide
Glyburide
Grepafloxacin
Hydrochlorothiazide
Hydroflumethiazide
Hydroxychloroquine
Indapamide
Insulin

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
Atenolol
Betaxolol
Bisoprolol
Bitter Melon
Carteolol
Carvedilol
Celiprolol
Colesevelam
Esmolol
Fenugreek
Glecaprevir
Glucomannan
Goldenseal
Guar Gum
Hydrastis
Isocarboxazid
Labetalol
Levobunolol
Linezolid
Methylene Blue
Metipranolol
Metoprolol
Nadolol
Nebivolol
Oxprenolol
Ozanimod
Patiromer
Penbutolol
Phenelzine
Pibrentasvir
Pindolol
Practolol
Procarbazine
Propranolol
Psyllium
Rasagiline
Rifampin
Safinamide
Selegiline

Other Interactions

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.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

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 2 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, 2 times per day. Your doctor may gradually increase your dose until your blood sugar is controlled. If you are taking 850 mg of metformin 2 times per day, you may start with 50 mg of sitagliptin and 1000 mg of metformin 2 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

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 appear quickly. It usually occurs when other serious health problems are present, 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 you have more than one of these symptoms together, you should get emergency medical help right away.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

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.

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.

Check with your doctor right away if you have more than one of these symptoms: chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain. These may be signs of heart failure.

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.

This medicine may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

Let your doctor or dentist know that you are taking this medicine. Your doctor may advise you to temporarily stop taking this medicine before you have major surgery or diagnostic tests, including procedures that use contrast dye.

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.

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

Decreased appetite
diarrhea
fast, shallow breathing
general feeling of discomfort
muscle pain or cramping
sleepiness
stomach discomfort

Incidence not known

Blistering, peeling, or loosening of the skin
darkened urine
hives or welts, itching, or skin rash
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
pains in the stomach, side, or abdomen, possibly radiating to the back
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
severe joint pain
sores, ulcers, or white spots in the mouth or on the lips
vomiting
yellow eyes or skin

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 or feeling of fullness
excess air or gas in the stomach or intestines
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.

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