FIBRICOR Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Athena Bioscience, LLC

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

1.1 Severe Hypertriglyceridemia FIBRICOR is indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (≥500 mg/dL). Improving glycemic control in diabetic patients showing fasting ...

2. Dosage and Administration

2.1 General Considerations FIBRICOR can be given without regard to meals. Patients should be advised to swallow FIBRICOR tablets whole. Do not crush, dissolve or chew tablets. Patients should be placed ...

3. Dosage Forms and Strengths

35-mg: White, round tablets. Debossed AR 787. 105-mg: White, modified oval tablets. Debossed AR 788.

4. Contraindications

FIBRICOR 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 FIBRICOR on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. The Action to Control ...

6.1. Clinical Trials Experience

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

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval 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

FIBRICOR is 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 not influenced by age. ...

8.6. Renal Impairment

The use of FIBRICOR 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 FIBRICOR has not been evaluated in patients with hepatic impairment [see Contraindications (4)].

10. Overdosage

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

11. Description

FIBRICOR is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic ...

12.1. Mechanism of Action

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

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

Absorption The absolute bioavailability of FIBRICOR has not been determined as the compound is virtually insoluble in aqueous media suitable for injection. Following oral administration of FIBRICOR in ...

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 Severe Hypertriglyceridemia The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemic patients. ...

16.1. How Supplied

FIBRICOR (fenofibric acid) Tablets 35 mg, are white, round tablets, debossed AR 787 on one side and blank on the other side. Bottles of 30 NDC 71511-501-30 FIBRICOR (fenofibric acid) Tablets 105 mg, ...

16.2. Storage and Handling

Store at USP controlled room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF) DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

17. Patient Counseling Information

Patients should be advised: of the potential benefits and risks of FIBRICOR. not to use FIBRICOR if there is a known hypersensitivity to fenofibrate or fenofibric acid. that if they are taking coumarin ...