Januvia - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||Diabetes, Type 2|
|Class:||Dipeptidyl peptidase 4 inhibitors|
|Ingredients:||sitagliptin phosphate monohydrate, microcrystalline cellulose, anhydrous dibasic calcium phosphate (calcium hydrogen phosphate, anhydrous), croscarmellose sodium, magnesium stearate, 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 yellow iron oxide|
(as sitagliptin phosphate monohydrate)
About this Medication
What the Medication is Used For
- JANUVIA can be used to improve blood sugar levels in adult patients with type 2 diabetes mellitus in addition to diet and exercise:
- alone in patients who cannot take metformin
- in combination with metformin
- in combination with metformin and a sulfonylurea (e.g. glyburide, gliclazide or glimepiride)
- in combination with premixed or long/intermediate acting insulin (with or without metformin)
- in combination with pioglitazone (with or without metformin)
What it Does
JANUVIA is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). JANUVIA helps to improve the levels of insulin when blood sugar level is high, especially after a meal. JANUVIA also helps to decrease the amount of sugar made by the body. JANUVIA is unlikely to cause low blood sugar (hypoglycemia).
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 it should not be Used
Do not take JANUVIA if you are allergic to any of the ingredients in JANUVIA.
What the Medicinal Ingredient Is
sitagliptin phosphate monohydrate
What the Important Non-Medicinal Ingredients Are
Each film-coated tablet of JANUVIA contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate (calcium hydrogen phosphate, anhydrous), croscarmellose sodium, magnesium stearate, 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 yellow iron oxide.
What Dosage Forms it Comes In
Tablets: Each tablet contains 25, 50 or 100 mg sitagliptin.
Warnings and Precautions
Cases of inflammation of the pancreas (pancreatitis) which may be severe and lead to death have been reported in patients taking JANUVIA.
BEFORE you use JANUVIA talk to your physician or pharmacist if:
- you have or have had pancreatitis (inflammation of the pancreas) or any risk factors for pancreatitis such as gallstones (solid particles that form in the gall bladder), a history of alcoholism, high triglyceride levels.
- you have type 1 diabetes.
- you have or have had diabetic ketoacidosis (increased ketones in the blood or urine).
- you are taking a sulfonylurea. When JANUVIA is used in combination with a sulfonylurea and metformin, or in combination with insulin (with or without metformin), low blood sugar can occur. Your physician may consider lowering the dose of the sulfonylurea or insulin. Take precautions to avoid low blood sugar while driving or using machinery.
- you have or have had an allergic reaction to JANUVIA.
- you have congestive heart failure.
- you have or have had kidney problems.
- you have liver problems.
- you are pregnant or plan to become pregnant. JANUVIA is not recommended for use during pregnancy.
- you are breast-feeding or plan to breast-feed. It is not known if JANUVIA passes into breast milk.
JANUVIA is not recommended for use in children under 18 years of age.
Interactions with this Medication
Tell your physician or pharmacist about all the medicines you take. This includes prescription and non-prescription medicines, and herbal supplements.
Proper Use of this Medication
Take JANUVIA exactly as your physician has prescribed.
100 mg once daily by mouth with or without food. The daily dose may be adjusted in patients with kidney problems.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you miss a dose, take it 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 a double dose of JANUVIA on the same day.
Side Effects and What to do About Them
Like all medicines, JANUVIA may cause side effects.
The most common side effects of JANUVIA include: stuffy or runny nose and sore throat.
Tell your physician or pharmacist if you develop any unusual side effects, or any of the above side effects that do not go away or gets worse.
When JANUVIA is used with metformin and a sulfonylurea medicine, or with insulin (with or without metformin), low blood sugar (hypoglycemia) can occur. Lower doses of the sulfonylurea medicine or insulin may be required while you use JANUVIA. The signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery. Discuss with your physician or pharmacist how to treat low blood sugar.
Additional side effects have been reported in general use with JANUVIA:
- 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 JANUVIA 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
- Kidney problems (sometimes requiring dialysis)
- Joint pain
- Muscle aches
- Arm or leg pain
- Back pain
Serious Side Effects, how often they Happen and what to do about them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking|
|Hypoglycemia (when used with metformin and a sulfonylurea, or when used with insulin with or without metformin)||✓|
|Pancreatitis: symptoms of pancreatitis (prolonged severe abdominal pain which may be accompanied by vomiting)||✓||✓|
|Allergic reactions including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.||✓|
|Acute kidney failure: symptoms may include nausea, loss of appetite and weakness, pass little or no urine, breathlessness.||✓|
This is not a complete list of side effects. For any unexpected effects while taking JANUVIA, contact your physician or pharmacist.
How to Store It
Store at room temperature (15°C to 30°C).
Keep JANUVIA and all medicines safely away from children.
Reporting Suspected Side Effects
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator
Postage paid labels and the Consumer Side Effect Reporting Form are available at
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. »
Also, you can report any suspected adverse reactions associated with the use of health products to Merck Canada Inc. by one of the following 3 ways:
- Call toll-free at 1-800-567-2594
- Fax toll-free to 877-428-8675 or
- Mail to: Merck Canada Inc.
Medical Information Center
16750 route Transcanadienne
Kirkland, QC H9H 4M7
If you want more information about JANUVIA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or merck.ca.
- Contact the Medical Information Centre by
- Telephone: 1-800-567-2594
- Email: firstname.lastname@example.org