TRICOR Tablet (2021)

Βιβλιογραφική αναφορά

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AbbVie Inc.

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1. Indications and Usage

1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia TRICOR is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides ...

2. Dosage and Administration

2.1 General Considerations Patients should be placed on an appropriate lipid-lowering diet before receiving TRICOR, and should continue this diet during treatment with TRICOR. TRICOR tablets can be given ...

3. Dosage Forms and Strengths

48 mg yellow tablets, imprinted with the code identification letters FI. 48 mg yellow tablets, imprinted with the a logo and code identification letters FI. 145 mg white tablets, imprinted with the code ...

4. Contraindications

TRICOR is contraindicated in: patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)]. patients with active liver disease, including those ...

5. Warnings and Precautions

5.1 Mortality and Coronary Heart Disease Morbidity The effect of TRICOR on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. The Action to Control ...

6. Adverse Reactions

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 ...

6.1. Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Coumarin Anticoagulants Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR. Caution should be exercised when coumarin anticoagulants are given in ...

8.1. Pregnancy

Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. ...

8.2. Lactation

Risk Summary There is no available information on the presence of fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production. Fenofibrate is present in the ...

8.4. Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

8.5. Geriatric Use

Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Fenofibric acid exposure is ...

8.6. Renal Impairment

The use of TRICOR should be avoided in patients who have severe renal impairment [see Contraindications (4)]. Dose reduction is required in patients with mild to moderate renal impairment ...

8.7. Hepatic Impairment

The use of TRICOR has not been evaluated in subjects with hepatic impairment [see Contraindications (4) and Clinical Pharmacology (12.3)].

10. Overdosage

There is no specific treatment for overdose with TRICOR. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose ...

11. Description

TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) ...

12.1. Mechanism of Action

The active moiety of TRICOR is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate. The lipid-modifying ...

12.2. Pharmacodynamics

A variety of clinical studies have demonstrated that elevated levels of total-C, LDL-C, and apo B, an LDL membrane complex, are associated with human atherosclerosis. Similarly, decreased levels of HDL-C ...

12.3. Pharmacokinetics

Plasma concentrations of fenofibric acid after administration of three 48 mg or one 145 mg tablets are equivalent under fed conditions to one 200 mg micronized fenofibrate capsule. Fenofibrate is a pro-drug ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Two dietary carcinogenicity studies have been conducted in rats with fenofibrate. In the first 24-month study, Wistar rats were dosed with fenofibrate at 10, 45, and 200 mg/kg/day, approximately 0.3, 1, ...

14. Clinical Studies

14.1 Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia The effects of fenofibrate at a dose equivalent to 145 mg TRICOR (fenofibrate tablets) per day were assessed ...

16.1. How Supplied

TRICOR (fenofibrate tablets) is available in two strengths: 48 mg: Yellow tablets, imprinted with the code identification letters FI, available in bottles of 90 (NDC 0074-3173-90). Yellow tablets, ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°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 TRICOR. not to use TRICOR if there is a known hypersensitivity to fenofibrate or fenofibric acid. of medications that should not be taken ...