Janumet

Janumet Medication Information:

Janumet medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Janumet 50mg/500mg
Janumet 50mg/850mg
Janumet 50mg/1000mg
Janumet 850mg/ 50mg
Janumet XR 1000mg/50mg

About Janumet

What Janumet is used for

JANUMET is used in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes mellitus who are not controlled on metformin alone or who are currently on sitagliptin (JANUVIA) and metformin.

What Janumet does

JANUMET is a tablet that contains sitagliptin and metformin. These two medicines work together to help you achieve better blood sugar control.

Sitagliptin is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Sitagliptin helps to improve the levels of insulin when blood sugar level is high, especially after a meal. Sitagliptin also helps to decrease the amount of sugar made by the body. Sitagliptin is unlikely to cause low blood sugar (hypoglycemia).

Metformin is a member of the biguanide class of medicines, it helps to lower the amount of sugar made by the liver. Together, these medicines help you to achieve better blood sugar control.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and/or does not use the insulin that your body produces as well as it should. When this happens, sugar (glucose) builds up in the blood. This can lead to serious problems.

When Janumet should not be used

Do not take JANUMET if you

  • Have unstable and/or insulin-dependent (Type 1) diabetes mellitus

  • Have metabolic acidosis (including diabetic ketoacidosis, history or ketoacidosis or lacticacidosis—too much acid in the blood)

  • Have a liver or kidney problems

  • Drink a lot of alcohol

  • Have cardiovascular collapse (abrupt failure of blood circulation) or cardiorespiratory insufficiency

  • Are stressed, have severe infections, are experiencing trauma, prior to surgery or during the recovery phase

  • Suffer from severe dehydration (have lost a lot of water from your body)

  • Are allergic to sitagliptin, metformin, or any of the ingredients in JANUMET. See “What the important nonmedicinal ingredients are:”.

  • Are breastfeeding

  • Are pregnant or planning to become pregnant

  • Are going to get or receive an injection of dye or contrast agent for an x-ray procedure. Talk to your physician or pharmacist about when to stop JANUMET and when to start again.

What the medicinal ingredients for Janumet are

Sitagliptin phosphate monohydrate and metformin hydrochloride.

What the important nonmedicinal ingredients for Janumet are

Each film-coated tablet of JANUMET contains the following inactive ingredients: microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and black iron oxide.

What dosage forms Janumet comes in

Tablets. Each tablet contains sitagliptin/metformin hydrochloride 50 mg/500 mg, 50 mg/850 mg, or 50 mg/1000 mg.


Warnings and Precautions

Serious Warnings and Precautions

JANUMET contains metformin which can rarely cause lactic acidosis. Lactic acidosis can cause death and must be treated in the hospital (see section Lactic Acidosis: below). Since alcohol may increase the risk of lactic acidosis caused by metformin you should not drink a lot of alcohol if you take JANUMET (see section Lactic Acidosis: below).

Lactic Acidosis

Stop taking JANUMET if you get the following symptoms of lactic acidosis:

  • You feel very weak and tired.

  • You have unusual (not normal) muscle pain.

  • You have trouble breathing.

  • You have stomach pain with nausea and vomiting, or diarrhea.

  • You feel cold, especially in your arms and legs.

  • You feel dizzy or lightheaded.

  • You have a slow or irregular heart beat.

  • Your medical condition suddenly changes.

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

  • Have kidney problems.

  • Have congestive heart failure that requires treatment with medicines.

  • Drink a lot of alcohol (very often or 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 don’t drink enough fluids.

  • Have certain x-ray tests with injectable dyes or contrast agents used.

  • Have surgery.

  • Have a heart attack, severe infection, or stroke.

  • Are 80 years of age or older and have not had your kidney function tested.

BEFORE or while taking JANUMET talk to your physician or pharmacist if:

  • You have or have had an allergic reaction to sitagliptin, metformin or JANUMET.

  • You have heart problems.

  • You have or have had kidney problems.

  • You have liver problems.

  • Drink alcohol a lot (all the time or short-term “binge” drinking)

  • You are pregnant or plan to become pregnant. JANUMET is not recommended for use during pregnancy.

  • You are breast-feeding or plan to breast-feed, you should not use JANUMET. It is not known if JANUMET passes into breast milk.

  • Are older than 80 years. Patients over 80 years should not take JANUMET unless their kidney function is checked and it is normal.

JANUMET is not recommended for use in children under 18 years of age.


Interactions with Janumet

Some drugs may interact with JANUMET Careful monitoring is advised. Tell your doctor if you are taking:

  • other diabetes drugs such as glyburide

  • furosemide

  • nifedipine

  • cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin)

  • other drugs tend to produce hyperglycemia (high blood sugar) and may lead to a loss of blood sugar control. Some example of drugs that can increase the blood sugar include:

    • Thiazide and other diuretics (water pills)

    • Corticosteroids

    • Phenothiazines

    • Thyroid products

    • Estrogens or estrogens plus progestogen

    • Oral contraceptives

    • Phenytoin

    • Nicotinic Acid

    • Sympathomimetics

    • Calcium channel blocking drugs

    • Isoniazid

    • Beta-2-agonists

  • ACE inhibitors drugs may lower blood glucose and the combination with JANUMET should be carefully monitored.

Before using any drugs or herbal products, check with your physician or your pharmacist.


Proper Use of Janumet

Take JANUMET exactly as your physician has prescribed. Your physician will tell you how many JANUMET tablets to take and how often you should take them.

Your physician may need to increase your dose to control your blood sugar.

Usual dose

JANUMET should generally be given twice daily with meals to lower your chance of an upset stomach.

Continue to take JANUMET as long as your physician prescribes it so you can continue to help control your blood sugar.

You may need to stop JANUMET for a short time. Call your physician for instructions if you:

  • have a condition that may be associated with dehydration (large loss of body fluids) such as being sick with severe vomiting, diarrhea or fever, or if you drink fluids a lot less than normal.

  • plan to have surgery.

  • are going to get or receive an injection of dye or contrast agent for an x-ray procedure.

Overdose

If you take more than the prescribed dosage of JANUMET, contact your physician or poison control centre immediately.

Missed dose

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.


Side Effects for Janumet and What to Do About Them

Like all medicines, JANUMET may cause side effects.

The most common side effects in patients taking sitagliptin alone include: stuffy or runny nose and sore throat.

Common side effects of metformin include: diarrhea, nausea, upset stomach, abdominal bloating, gas, loss of appetite.

In rare cases, metformin, one of the medicines in JANUMET, can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This build-up can cause serious damage. You should also stop using JANUMET and call your physician right away if you have signs of lactic acidosis. Lactic acidosis is a medical emergency that must be treated in a hospital.

Tell your physician or pharmacist if you develop any unusual side effect, or any of the above side effects that do not go away or get worse.

The following additional side effects have been reported in general use with JANUMET or sitagliptin, one of the medicines in JANUMET:

  • Allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking JANUMET and call your physician right away. Your physician may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.

  • Inflammation of the pancreas.

Serious Side Effects, How Often They Happen and What to Do About Them
Symptom/Effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist
Only if severe In all cases
Rare Allergic reactions including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing    
Uncommon Feeling very weak, tired or uncomfortable; unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, suddenly developing a slow or irregular heartbeat    
Rare Lactic Acidosis: Symptoms include feeling very weak, tired or uncomfortable; unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, unusual fatigue and drowsiness, or suddenly developing a slow or irregular heartbeat    

This is not a complete list of side effects. For any unexpected effects while taking JANUMET, contact your physician or pharmacist.


 

Technical Information