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LESCOL XL Extended-release tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Novartis Pharmaceuticals Corporation

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1. Indications and Usage

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. ...

2. Dosage and Administration

2.1 General Dosing Information Dose range: 20 mg to 80 mg/day. LESCOL XL can be administered orally as a single dose, with or without food. Do not break, crush or chew LESCOL XL tablets prior to administration. ...

3. Dosage Forms and Strengths

LESCOL XL 80 mg tablets are yellow, round, slightly biconvex film-coated tablets with beveled edges debossed with LESCOL XL on one side and 80 on the other.

4. Contraindications

4.1 Hypersensitivity to Any Component of This Medication LESCOL XL is contraindicated in patients with hypersensitivity to any component of this medication. 4.2 Active Liver Disease LESCOL XL is contraindicated ...

5. Warnings and Precautions

5.1 Skeletal Muscle <b>Rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LESCOL XL and other drugs in this class.</b> LESCOL XL should be prescribed with caution ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) <em> ...

6.3. Postmarketing Experience

Because adverse reactions from spontaneous reports are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal ...

7. Drug Interactions

7.1 Cyclosporine Cyclosporine coadministration increases fluvastatin exposure. Therefore, in patients taking cyclosporine, therapy should be limited to fluvastatin 20 mg twice daily <em>[see Warnings and ...

8.1. Pregnancy

Pregnancy Category X LESCOL XL is contraindicated in women who are or may become pregnant <em>[see Contraindications (4.3)]</em>. Lipid lowering drugs are contraindicated during pregnancy, because cholesterol ...

8.3. Nursing Mothers

Based on animal data, fluvastatin is present in breast milk in a 2:1 ratio (milk:plasma). Because of the potential for serious adverse reactions in nursing infants, nursing women should not take LESCOL ...

8.4. Pediatric Use

The safety and efficacy of LESCOL XL in children and adolescent patients 9 to 16 years of age with heterozygous familial hypercholesterolemia have been evaluated in open-label, uncontrolled clinical trials ...

8.5. Geriatric Use

Fluvastatin exposures were not significantly different between the nonelderly and elderly populations (age ≥65 years) <em>[see Clinical Pharmacology (12.3)]</em>. Since advanced age (>65 years) is a predisposing ...

8.6. Hepatic Impairment

LESCOL XL are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases <em>[see Clinical Pharmacology (12.3)]</em>.

8.7. Renal Impairment

Dose adjustments for mild to moderate renal impairment are not necessary. Fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore, caution should ...

10. Overdosage

To date, there has been limited experience with overdosage of fluvastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted ...

11. Description

Fluvastatin sodium is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [<em>R</em>,<em>S ...

12.1. Mechanism of Action

Fluvastatin is a competitive inhibitor of HMG-CoA reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols, including cholesterol. ...

12.3. Pharmacokinetics

Absorption Following oral administration of the capsule, fluvastatin reaches peak concentrations in less than 1 hour. The absolute bioavailability is 24% (range 9% to 50%) after administration of a 10 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

A 2-year study was performed in rats at dose levels of 6, 9, and 18-24 (escalated after 1 year) mg/kg/day. These treatment levels represented plasma drug levels of approximately 9, 13, and 26-35 times ...

14. Clinical Studies

14.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia LESCOL XL has been studied in five controlled studies of patients with primary hypercholesterolemia and mixed dyslipidemia. ...

15. References

1. National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. <em>Pediatrics</em>. 89(3):495-501.1992. 2. Manson, ...

16.1. How Supplied

LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mg: Yellow, round, slightly biconvex film-coated tablet with beveled edges debossed with LESCOL XL on one side and 80 on the other. Bottles of ...

16.2. Storage and Handling

Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (59ºF and 86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking LESCOL XL should be advised that high cholesterol is a chronic condition and they should adhere to their ...
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