NDC 66582-321-54 unit of use packages of 90 (nine foil pouches each containing one 10-count blister card)

Tablets LIPTRUZET 10 mg/40 mg are white to off-white oval, biconvex film-coated tablets with code "322" on one side.

They are supplied as follows:

NDC 66582-322-30 unit of use packages of 30 (three foil pouches each containing one 10-count blister card)

NDC 66582-322-54 unit of use packages of 90 (nine foil pouches each containing one 10-count blister card)

Tablets LIPTRUZET 10 mg/80 mg are white to off-white capsule-shaped, biconvex film-coated tablets with code "323" on one side.

They are supplied as follows:

NDC 66582-323-30 unit of use packages of 30 (three foil pouches each containing one 10-count blister card)

NDC 66582-323-54 unit of use packages of 90 (nine foil pouches each containing one 10-count blister card)

Storage of Unit of Use Packages of 30 and 90

Store LIPTRUZET at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in the foil pouch until use. After the foil pouch is opened, protect LIPTRUZET from moisture and light. Once a tablet is removed, slide blister card back into case. Store the case in a dry place, and discard any unused tablets 30 days after the pouch is opened.

17 PATIENT COUNSELING INFORMATIONSee 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 Instructions
Patients 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 read