Simvastatin (sim-va-STAT-in), Sitagliptin Phosphate (sit-a-GLIP-tin FOS-fate)

Treats type 2 diabetes either alone or together with other medicines. Also treats high cholesterol and triglycerides in the blood. This medicine contains an HMG-CoA inhibitor, which is sometimes called a "statin."

Brand Name(s):

Juvisync

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Swallow the tablet whole. Do not break, crush, or chew it.
• Take the medicine in the evening, unless your doctor tells you otherwise.
• Your doctor will give you instructions about diet, exercise, testing your blood sugar, and adjusting your dose when you are sick. Carefully follow your doctor's instructions.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using amiodarone (Cordarone®), colchicine (Colcrys®), niacin, ranolazine (Ranexa®), voriconazole (Vfend®), certain blood pressure medicines (such as amlodipine, diltiazem, verapamil, Calan®, Cardizem®, Norvasc®, or Verelan®), other medicines for high cholesterol (such as bezafibrate, fenofibrate, Modalim®, or Tricor®), or a blood thinner (such as warfarin, Coumadin®).
• Make sure your doctor knows about all medicines you use to treat diabetes.
• Do not drink alcohol while you are using this medicine.
• Do not drink more than 1 quart of grapefruit juice each day.

Warnings While Using This Medicine:

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have low blood pressure, kidney disease, an infection, an underactive thyroid gland, or a muscle disorder. Tell your doctor if you have a history of liver disease, epilepsy (seizures), heart disease, or a stroke, or if you drink alcohol on a regular basis.
• Stop using this medicine and check with your doctor right away if you have severe stomach pain, especially if the pain spreads to your back. You might also have nausea, vomiting, fever, and lightheadedness. These may be symptoms of a rare condition called pancreatitis.
• Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin. You may need a different dose of this medicine. Chinese patients who are taking large amounts of niacin (more than 1 gram or 1000 milligrams per day) may have an increased risk for muscle injury.
• Stop using this medicine and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. You might also have a fever and unusual tiredness. These could be symptoms of a serious muscle problem called myopathy. Myopathy is more common when high doses of simvastatin are used, but some people get myopathy with lower doses.
• Stop using this medicine and check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
• Stop using this medicine and check with your doctor right away if you have dark-colored urine, a general feeling of tiredness or weakness, light-colored stools, loss of appetite, upper right stomach pain, vomiting, weight loss, or yellow eyes or skin. These could be symptoms of liver damage.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments. You will also need to check your blood sugar at home.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Change in how much or how often you urinate
• Dark-colored urine or pale stools
• Fever, chills, and body aches
• Increased hunger or thirst
• Muscle pain, tenderness, or weakness
• Nausea, vomiting, loss of appetite, pain in your upper stomach
• Sudden and severe stomach pain, nausea, fever, vomiting, and lightheadedness
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Headache
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088