Prescription Drug Information: Fenofibrate (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
Fenofibrate tablets USP are available in two strengths:
48 mg, white to white-off oval shaped tablets debossed with “LU” on one side and “B21” on the other side.
They are supplied as follows:
NDC 50268-338-12 (10 tablets per card, 2 cards per carton).
145 mg, white to off-white oval shaped tablets debossed with “LU” on one side and “B22” on the other side.
For Institutional Use Only. Dispensed in Unit Dose Package.
Storage
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
17 PATIENT COUNSELING INFORMATION
Patients should be advised:
- of the potential benefits and risks of fenofibrate.
- not to use fenofibrate if there is a known hypersensitivity to fenofibrate or fenofibric acid.
- of medications that should not be taken in combination with fenofibrate.
- that if they are taking coumarin anticoagulants, fenofibrate may increase their anti-coagulant effect, and increased monitoring may be necessary.
- to continue to follow an appropriate lipid-modifying diet while taking fenofibrate.
- to take fenofibrate once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
- to return to their physician’s office for routine monitoring.
- to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking fenofibrate.
- to inform their physician of symptoms of liver injury (e.g., jaundice, abdominal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; or any other new symptoms.
- not to breastfeed during treatment with fenofibrate and for 5 days after the final dose.
Manufactured for:
AvKARE
Pulaski, TN 38478
Mfg. Rev. 08/20
AV Rev. 08/21(P)
AvPAK
FENOFIBRATE fenofibrate tablet | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
|
Labeler — AvPAK (832926666) |
Revised: 01/2024 AvPAK
RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.
https://rxdruglabels.com/lib/rx/rx-meds/fenofibrate-25/page/5/