Sitagliptin/simvastatin

1-10%

Upper respiratory tract infection

Headache

Constipation

Nausea

Nasopharyngitis

Diarrhea

Angioedema

Hypersensitivity reactions

Stevens-Johnson syndrome

Hypoglycemia

Peripheral edema

Abdominal pain

Transaminases increased (>3x ULN)

CPK elevation (>3x ULN)

Bronchitis

<1%

Myalgia

Myopathy

Rhabdomyolysis

Postmarketing Reports

Acute pancreatitis including fatal and nonfatal hemorrhagic and necrotizing pancreatitis; pancreatitis suspected, promptly discontinue

Acute renal failure, sometimes requiring dialysis, in patients treated with sitagliptin; assess renal function prior to initiation and periodically thereafter

Serious allergic/hypersensitivity reactions (anaphylaxis, angioedema, and exfoliative skin conditions including SJS) in patients treated with sitagliptin; stop therapy and assess for other potential causes, institute monitoring and treatment; select alternative treatment

Constipation, headache, vomiting

Hepatic enzyme elevations

Arthralgia, myalgia, pain in extremity, and back pain

Cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use

Sitagliptin/simvastatin is a prescription medicine used to treat type 2 diabetes and high cholesterol in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before you take sitagliptin/simvastatin, tell your doctor if you:

• have or have had inflammation of your pancreas (pancreatitis).
• have kidney problems.
• drink substantial quantities of alcohol or ever had liver problems.
• have any other medical conditions.
• are taking drugs that prevent blood clots, such as warfarin.
• are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if the active ingredients in simvastatin and sitagliptin are excreted in human breast milk.

• Take one sitagliptin/simvastatin tablet each day, in the evening, exactly as your doctor tells you.
• Take sitagliptin/simvastatin tablets whole. Do not break, cut, crush, dissolve, or chew sitagliptin/simvastatin tablets before swallowing. If you cannot swallow tablets whole, tell your doctor.
• Your doctor may tell you to take sitagliptin/simvastatin along with other diabetes medicines. Low blood sugar can happen more often when sitagliptin/simvastatin is taken with certain other diabetes medicines. 
• If you take too much sitagliptin/simvastatin, call your doctor or go to the nearest hospital emergency room right away.
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
• Check your blood sugar as your doctor tells you to.
• Stay on your prescribed diet and exercise program while taking sitagliptin/simvastatin.
• Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
• Your doctor will monitor your condition with regular blood tests, including your blood sugar levels, hemoglobin A1C, and cholesterol levels, and to check for side effects.
• Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with sitagliptin/simvastatin.