Sitagliptin Phosphate, Simvastatin Oral tablet
What is this medicine?
SIMVASTATIN; SITAGLIPTIN (SIM va stat in; sit a GLIP tin) is a combination of 2 medicines used in certain patients with type 2 diabetes. Sitagliptin lowers blood sugar. Simvastatin is known as a HMG-CoA reductase inhibitor or "statin". It lowers the level of cholesterol and triglycerides in the blood. This drug may also reduce the risk of heart attack, stroke, or other health problems in patients with risk factors for heart or blood vessel disease. Diet and lifestyle changes are often used with this drug.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
high levels of triglycerides in the blood
history of pancreatitis
if you often drink alcohol
muscle aches or weakness
an unusual or allergic reaction to simvastatin, sitagliptin, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a glass of water. It is usually taken once a day in the evening. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
antiviral medicines for HIV or AIDS
certain antibiotics like clarithromycin, erythromycin, and telithromycin
certain medicines for cholesterol like atorvastatin or rosuvastatin
certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, and voriconazole
red yeast rice
This medicine may also interact with the following medications:
calcium channel blockers like amlodipine, diltiazem and verapamil
certain medicines for cholesterol like fenofibrate
certain medicines for diabetes, like glipizide or glyburide
certain medicines that treat or prevent blood clots like warfarin
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
You may need blood work done while you are taking this medicine. You may need regular tests to make sure your liver is working properly.
A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.
Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.
Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.
Tell your doctor or health care professional right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness. Your doctor or health care professional may tell you to stop taking this medicine if you develop muscle problems. If your muscle problems do not go away after stopping this medicine, contact your health care professional.
This drug is only part of a total heart-health program. Your doctor or a dietician can suggest a low-cholesterol and low-fat diet to help. Avoid alcohol and smoking, and keep a proper exercise schedule.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Do not breast-feed an infant while taking this medicine. Serious side effects to an unborn child or to an infant are possible. Talk to your doctor or pharmacist for more information.
Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
loss of appetite
loss of memory
muscle cramps, pain
redness, blistering, peeling or loosening of the skin, including inside the mouth
right or left upper belly pain
signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness
trouble passing urine or change in the amount of urine
unusual stomach pain or discomfort
yellowing of the eyes or skin
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert