Complete SPL Sections
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 white to off-white, oval-shaped, biconvex, film-coated tablets debossed with ‘ RH37 ’ on one side and other side plain. 145 mg white to off-white, oval-shaped, biconvex, film-coated tablets debossed with ‘ RH38 ’ on one side and other side plain.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Fenofibrate is 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)] • Hepatotoxicity [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, USP is a lipid regulating agent 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 molecular formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients Each film-coated tablet contains colloidal silicon dioxide, crospovidone, hypromellose (3 cps), microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sucrose, sodium lauryl sulfate, sodium stearyl fumarate, soybean lecithin, talc, titanium dioxide, and xanthan gum. Meets USP Dissolution Test 1.
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
Fenofibrate tablets, USP are available in two strengths: 48 mg white to off-white, oval-shaped, biconvex, film-coated tablets debossed with ‘ RH37 ’ on one side and other side plain and are available as follows: NDC 63304-448-30 Bottles of 30 NDC 63304-448-90 Bottles of 90 NDC 63304-448-05 Bottles of 500 145 mg white to off-white, oval-shaped, biconvex, film-coated tablets debossed with ‘ RH38 ’ on one side and other side plain and are available as follows: NDC 63304-449-30 Bottles of 30 NDC 63304-449-90 Bottles of 90 NDC 63304-449-05 Bottles of 500 Storage Store at 20º - 25º C (68º - 77º F) [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SUN PHARMA NDC 63304-448-30 FENOFIBRATE TABLETS, USP 48 mg Rx only 30 Tablets
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SUN PHARMA NDC 63304-448-90 FENOFIBRATE TABLETS, USP 48 mg Rx only 90 Tablets
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SUN PHARMA NDC 63304-448-05 FENOFIBRATE TABLETS, USP 48 mg Rx only 500 Tablets
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SUN PHARMA NDC 63304-449-30 FENOFIBRATE TABLETS, USP 145 mg Rx only 30 Tablets
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SUN PHARMA NDC 63304-449-90 FENOFIBRATE TABLETS, USP 145 mg Rx only 90 Tablets
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SUN PHARMA NDC 63304-449-05 FENOFIBRATE TABLETS, USP 145 mg Rx only 500 Tablets