What is JANUVIA used for?
JANUVIA is used in addition to diet and exercise to improve blood sugar levels in adult patients with type 2 diabetes mellitus:
- 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)
How does JANUVIA work?
JANUVIA contains the medicinal ingredient sitagliptin which belongs to 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 are the ingredients in JANUVIA?
Medicinal ingredients: sitagliptin phosphate monohydrate
Non-medicinal ingredients: Anhydrous dibasic calcium phosphate (calcium hydrogen phosphate, anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol (macrogol), polyvinyl alcohol, red iron oxide, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide.
What strengths are JANUVIA tablets available in?
Tablets: 25 mg, 50 mg, 100 mg
Who should not use JANUVIA?
- If you are allergic (hypersensitive) to sitagliptin or any of the other ingredients in JANUVIA.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JANUVIA. Talk about any health conditions or problems you may have, including if you:
- have or have had pancreatitis (inflammation of the pancreas);
- have risk factors for pancreatitis such as:
- gallstones (solid particles that form in the gall bladder),
- a history of alcoholism,
- high triglyceride levels;
- have type 1 diabetes;
- have or have had diabetic ketoacidosis (increased ketones in the blood or urine);
- have or have had kidney problems;
- have liver problems;
- had an organ transplant;
- have human immunodeficiency syndrome (HIV);
- are pregnant or plan to become pregnant; JANUVIA is not recommended for use during pregnancy;
- are breastfeeding or plan to breastfeed. It is not known if JANUVIA passes into breast milk.
Other warnings you should know about JANUVIA
Serious Skin Reactions and Pancreatitis:
- JANUVIA can cause serious side effects, including:
- Pancreatitis (inflammation of the pancreas) which can be life-threatening and cause death.
- Serious Skin Reactions called Stevens-Johnson syndrome and bullous pemphigoid. These reactions can happen after your first dose or up to 3 months after you start JANUVIA.
Hypoglycemia (low blood sugar):
- When JANUVIA is used with metformin and a sulfonylurea medicine or with insulin (with or without metformin), hypoglycemia (low blood sugar) can occur. Lower doses of the sulfonylurea medicine or insulin may be required while you take JANUVIA. You should use caution when driving or using machines if you are taking JANUVIA with a sulfonylurea medicine or with insulin.
JANUVIA may cause abnormal blood tests. Your healthcare professional will do blood tests before you start JANUVIA and while you are taking it. They may check your blood sugar, liver function and how well your kidneys are working. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
How to take JANUVIA?
- Take JANUVIA exactly as your healthcare professional tells you to.
- JANUVIA can be taken with or without food.
What is the usual dose of JANUVIA?
100 mg once daily. Your healthcare professionals may adjust your dose if you have kidney problems.
What to do if you overdose on JANUVIA?
If you think you have taken too much JANUVIA, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
What to do if you miss a dose of JANUVIA?
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 to make up for a missed dose.
What are the side effects of JANUVIA?
These are not all the possible side effects you may feel when taking JANUVIA. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Stuffy or runny nose
- Sore throat
- Joint pain
- Muscle aches
- Arm or leg pain
- Back pain
Serious side effects and what to do about them
Talk to your healthcare professional
Stop taking drug and get immediate medical help
Only if severe
In all cases
Hypoglycemia (low blood sugar – when used with metformin and a sulfonylurea, or when used with insulin with or without metformin): shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood.
Pancreatitis (inflammation of the pancreas): prolonged severe stomach pain and possible vomiting.
Allergic reactions: rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Serious skin reactions including Stevens-Johnson syndrome, bullous pemphigoid: blisters or breakdown of your skin.
Acute kidney failure (sometimes requiring dialysis): nausea, loss of appetite and weakness, pass little or no urine, breathlessness.
Rhabdomyolysis (breakdown of damaged muscle): muscle spasms, weakness, red-brown (tea-coloured) urine.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.