omyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness. The risk of myopathy, including rhabdomyolysis, occurring with use of JUVISYNC is increased when taking certain types of medication or consuming larger quantities of grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.
17.4 Pregnancy
Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using JUVISYNC. Discuss future pregnancy plans with your patients, and discuss when to stop taking JUVISYNC if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking JUVISYNC and call their healthcare professional.
17.5 Breastfeeding
Women who are breastfeeding should not use JUVISYNC. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.
Manufactured for:
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA
Manufactured by:
MSD International GmbH
Clonmel, Co. Tipperary,
Ireland
USPI-T-MK0431D1204R002
US Patent Nos.: 6,699,871 and 7,326,708
Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved
Medication Guide
JUVISYNC™ (JU-vih-sink)
(sitagliptin and simvastatin)
Tablets
Read this Medication Guide carefully before you start taking JUVISYNC and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about JUVISYNC, ask your doctor or pharmacist.
What is the most important information I should know about JUVISYNC?
Serious side effects can happen in people taking JUVISYNC, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking JUVISYNC:
Tell your doctor if you have ever had
pancreatitis
stones in your gallbladder (gallstones)
a history of alcoholism
high blood triglyceride levels
kidney problems
Stop taking JUVISYNC and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
What is JUVISYNC?
JUVISYNC is a prescription medicine that contains two medicines, sitagliptin and simvastatin, in one pill. JUVISYNC can be used in adults who need both sitagliptin and simvastatin.
Sitagliptin can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Simvastatin can be used with diet and exercise in adults at high risk for heart attack or stroke to lower your chance of:
death from heart problems
having a heart attack or stroke
needing certain blood vessel procedures
Simvastatin can be used in adults with certain cholesterol problems to lower levels of total cholesterol, LDL (bad) cholesterol, and fatty substances called triglycerides in the blood. In addition, simvastatin raises levels of HDL (good) cholesterol. Simvastatin is for people who cannot control their cholesterol levels by diet and ex |
