card any unused tablets 30 days after the pouch is opened.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information).
Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.
17.1 Muscle PainAll patients starting therapy with LIPTRUZET should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing LIPTRUZET. The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (>1 liter) of grapefruit juice. Patients should discuss all medication, both prescription and over-the-counter, with their physician.
17.2 Liver EnzymesIt is recommended that liver enzyme tests be performed before the initiation of LIPTRUZET and if signs or symptoms of liver injury occur. All patients treated with LIPTRUZET should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
17.3 PregnancyWomen of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using LIPTRUZET. Discuss future pregnancy plans with your patients, and discuss when to stop taking LIPTRUZET if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking LIPTRUZET and call their healthcare professional.
17.4 Breast-FeedingWomen who are breast-feeding should be advised to not use LIPTRUZET. Patients who have a lipid disorder and are breast-feeding should be advised to discuss the options with their healthcare professionals.
17.5 Important Storage and Administration InstructionsPatients should be advised to store LIPTRUZET at room temperature, 20-25°C (68-77°F). They should also be advised:
not to open a pouch until they are ready to use LIPTRUZET
that after the foil pouch is opened, LIPTRUZET should be protected from moisture and light, and stored in a dry place
that for packages containing a plastic case (unit of use packages of 30 and 90), once they remove a tablet from the blister card, they should slide the blister card back into the plastic case
to discard any unused tablets 30 days after the pouch is opened
Tablets should be swallowed whole. Do not crush, dissolve, or chew tablets.
If a dose is missed, the patient should not take an extra dose. Just resume the usual schedule.
SPL UNCLASSIFIED SECTION
Manufactured by:
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
U.S. Patent Nos. 5,846,966 and RE37,721.
USPI-T-0653C1305R000
PATIENT PACKAGE INSERT
Patient Information
LIPTRUZET™ (LIP-true-zett)
(ezetimibe and atorvastatin)
Tablets
Generic name: ezetimibe and atorvastatin tablets
Read this information carefully before you start taking LIPTRUZET™ and each time you get more LIPTRUZET. 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 LIPTRUZET, ask your doctor. Only your doctor can determine if LIPTRUZET is right for you.
What is LIPTRUZET?
LIPTRUZET contains 2 cholesterol-l |
