Complete SPL Sections#
RECENT MAJOR CHANGES
RECENT MAJOR CHANGES SECTION
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
48 mg tablets are yellow, oval shaped, biconvex, film coated tablets debossed with "158" on one side and plain on other side. 145 mg tablets are white, oval shaped, biconvex, film coated tablets debossed with "159" on one side and plain on other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Fenofibrate tablets are contraindicated in: patients with severe renal impairment, including those receiving dialysis [ see Clinical Pharmacology ( 12.3 ) ]. patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [ see Warnings and Precautions ( 5.2 ) ]. patients with preexisting gallbladder disease [ see Warnings and Precautions ( 5.5 ) ]. nursing mothers [ see Use in Specific Populations ( 8.2 ) ]. patients with known hypersensitivity to fenofibrate or fenofibric acid [ see Warnings and Precautions ( 5.9 ) ].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions ( 5.1 )] Hepatoxicity [see Warnings and Precautions ( 5.2 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.9 )] Venothromboembolic disease [see Warnings and Precautions ( 5.10 )]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.
11 DESCRIPTION
DESCRIPTION SECTION
Fenofibrate tablets, USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sucrose. In addition, individual tablets contain: 48 mg tablets lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, D&C yellow #10 aluminum lake, FD & C blue #2/indigo carmine aluminum lake and FD & C yellow #6/sunset yellow FCF aluminium lake. 145 mg tablets lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
145 mg tablets are white, oval shaped, biconvex, film coated tablets debossed with "159" on one side and plain on other side. Available as following. Bottles of 90 tablets with child-resistant closure, NDC 68071-1712-9 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Patients should be advised: of the potential benefits and risks of fenofibrate tablets. not to use fenofibrate tablets if there is a known hypersensitivity to fenofibrate or fenofibric acid. of medications that should not be taken in combination with fenofibrate tablets. that if they are taking coumarin anticoagulants, fenofibrate tablets may increase their anti-coagulant effect, and increased monitoring may be necessary. to continue to follow an appropriate lipid-modifying diet while taking fenofibrate tablets. to take fenofibrate tablets 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 tablets. 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 tablets and for 5 days after the final dose. Call you doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information call Leading Pharma, LLC at 1-844-740-7500 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana-502307, INDIA. Manufactured for: Leading Pharma, LLC Fairfield, NJ 07004 USA. Issued: 05/2022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
