Source: FDA, National Drug Code (US) Revision Year: 2020
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. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
LESCOL XL is indicated
The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below.
| Category | Total-C (mg/dL) | LDL-C (mg/dL) |
|---|---|---|
| Acceptable | <170 | <110 |
| Borderline | 170-199 | 110-129 |
| High | ≥200 | ≥130 |
Children treated with fluvastatin in adolescence should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals.
In patients with clinically evident Coronary Heart Disease (CHD), LESCOL XL is indicated to:
LESCOL XL has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V).
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.
Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.
For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 80 mg as one LESCOL XL tablet administered as a single dose at any time of the day. For patients requiring LDL-C reduction to a goal of <25%, a starting dose of 20 mg may be used.
The recommended starting dose for LESCOL XL is one 80 mg tablet administered as a single dose at any time of the day.
The recommended starting dose is one 20 mg fluvastatin capsule. Dose adjustments, up to a maximum daily dose administered one LESCOL XL 80 mg tablet once daily should be made at 6-week intervals. Doses should be individualized according to the goal of therapy [see NCEP Pediatric Panel Guidelines and Clinical Studies (14)]1.
1National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics.89(3):495-501. 1992.
Do not exceed a dose of 20 mg twice-daily fluvastatin capsules in patients taking cyclosporine [see Drug Interactions (7.1)].
Do not exceed a dose of 20 mg twice-daily fluvastatin capsules in patients taking fluconazole [see Drug Interactions (7.2)].
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 as required. The dialyzability of fluvastatin sodium and of its metabolites in humans is not known at present [see Warnings and Precautions (5)].
In the pediatric population, there have been reports of overdosage with fluvastatin sodium in children, including a 2 year-old and the other 3 years of age, either of whom may have possibly ingested fluvastatin sodium. The maximum amount of fluvastatin sodium that could have been ingested was 80 mg (4 × 20 mg capsules). Vomiting was induced by ipecac in both children and no capsules were noted in their emesis. Neither child experienced any adverse symptoms and both recovered from the incident without problems.
In the postmarketing experience there have been reports of accidental ingestion of fluvastatin capsules in infants up to 3 years of age. In one case, increased serum CPK values were noted. There have been reports of intentional overdose in adolescents with the development of hepatic enzyme elevations, convulsions and gastroenteritis/vomiting/diarrhea. One case of intentional overdose as suicide attempt in a 15 year-old female reported ingestion of 2,800 mg LESCOL XL with hepatic enzyme elevation.
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.
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