SITAGLIPTIN

Please see Precautions section.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although sitagliptin by itself usually does not cause low blood sugar (hypoglycemia),low blood sugar may occur if this drug is prescribed with other anti-diabetic medications. It is a good habit to carry glucose tablets or gel to treat low blood sugar .

Symptoms of low blood sugar include:

• sudden sweating,
• shaking,
• fast heartbeat,
• hunger,
• blurred vision,
• dizziness, or
• tingling hands/feet.

Symptoms of high blood sugar (hyperglycemia) include:

• thirst,
• increased urination,
• confusion,
• drowsiness,
• flushing,
• rapid breathing, and
• fruity breath odor

Tell your doctor right away of any serious side effects, including: change in the amount of urine.

Get medical help right away if you have any very serious side effects, including:

• signs of pancreatitis (such as persistent nausea/vomiting, loss of appetite, severestomach/abdominal/back pain).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions:

General:

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

• Allergy: Before taking sitagliptin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
• Medical History: Before using this medication, tell your doctor or pharmacist if you had: kidney disease, disease of the pancreas (pancreatitis), stones in yourgallbladder (gallstones).
• Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking sitagliptin.
• Renal impairment: Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.

Pregnancy Risk: Category B – No proven risk in humans. During pregnancy this medication should be used only when clearly needed.

Breastfeeding: It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions:

• Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia).

Overdose:

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Keep all medical appointments. Laboratory and/or medical tests (such as kidney function tests, blood glucose, hemoglobin A1c) should be performed before your start treatment, periodically to monitor your progress, or to check for side effects.

Attend a diabetes education program to learn more about diabetes and the important aspects of its treatment, including medications, diet, exercise, and getting regular eye/foot/medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar levels regularly as directed.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands:

Available Brands

• Januvia [ Merck Sharp & Dohme ]
• Xelevia [ Merck Sharp & Dohme ]