Juvisync contains a combination of simvastatin and sitagliptin. Simvastatin is an HMG CoA reductase inhibitor, or "statin." Simvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Sitagliptin is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.

Juvisync is used in people with type 2 diabetes who also have high cholesterol or triglycerides (types of fat) in the blood. This medication is not for treating type 1 diabetes.

Juvisync is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors.

Juvisync may also be used for purposes not listed in this medication guide.

Juvisync is a combination medicine for people with type 2 diabetes who also have high cholesterol.

You should not use Juvisync if you have liver disease or severe kidney disease. Do not use if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Do not use Juvisync if you are pregnant, and stop taking the medicine if you become pregnant.

Do not use this medicine if you are breast-feeding.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Also call your doctor if you have severe pain in your upper stomach spreading to your back.

There are many other drugs that should not be used together with Juvisync. Tell your doctor about all other medicines you use. Do not consume grapefruit products while taking this medicine.

Take Juvisync exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Juvisync is usually taken once daily in the evening.

Do not crush, chew, or break the tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Juvisync is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly other medications. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

You should not use Juvisync if you are allergic to simvastatin or sitagliptin, or if you have:

• liver disease;

• severe kidney disease;

• if you are pregnant or breast-feeding; or

• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

There are many other drugs that should not be used together with this medicine. Some medicines can cause unwanted or dangerous effects when used with Juvisync. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cyclosporine;

• danazol;

• gemfibrozil;

• nefazodone;

• certain antibiotics--clarithromycin, erythromycin, or telithromycin;

• certain antifungal medications--itraconazole, ketoconazole, posaconazole, or voriconazole;

• the hepatitis C medications boceprevir or telaprevir; or

• certain HIV/AIDS medications--atazanavir, cobicistat (Stribild, Tybost), indinavir, nelfinavir, ritonavir, saquinavir, or tipranavir.

To make sure Juvisync is safe for you, tell your doctor if you have:

• a history of liver or kidney disease;

• a history of pancreatitis;

• a history of gallstones;

• high triglycerides (a type of fat in the blood);

• underactive thyroid;

• a history of alcoholism, or if you drink large amounts of alcohol; or

• if you use a blood thinner such as warfarin (Coumadin, Jantoven).

This medicine can harm an unborn baby or cause birth defects. Do not take Juvisync if you are pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy while you are taking Juvisync.

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not breast-feed while you are taking Juvisync.

Do not give this medication to anyone under 18 years old without medical advice.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit and grapefruit juice may interact with simvastatin and sitagliptin and lead to unwanted side effects. Avoid the use of grapefruit products while taking Juvisync.

Avoid eating foods that are high in fat or cholesterol. Simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can lower your blood sugar and may increase your risk of liver damage while taking this medicine.

Get emergency medical help if you have any signs of an allergic reaction to Juvisync: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Juvisync can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Stop using Juvisync and call your doctor at once if you have:

• confusion, memory problems;

• swelling, weight gain, urinating less than usual or not at all;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate;

• increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Juvisync side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• headache; or

• nausea, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Juvisync can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid), or if you use certain other drugs, such as:

• colchicine;

• fenofibric acid or fenofibrate;

• lomitapide;

• high doses of niacin (vitamin B3) or nicotinic acid;

• certain heart rhythm medicines--amiodarone or dronedarone; or

• heart or blood pressure medication--amlodipine, diltiazem, ranolazine, or verapamil.

This list is not complete and many other drugs can interact with simvastatin and sitagliptin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.