Classes
DEA Class; Rx
Common Brand Names; Lescol, Lescol XL
- Lipid-Lowering Agents, Statins;
- HMG-CoA Reductase Inhibitors
Description
Least potent, oral, HMG Co-A reductase inhibitor; used 1-2 times daily to treat hypercholesterolemia; indicated to reduce LDL and total cholesterol, plasma triglycerides, and apolipoprotein B; documented to slow the progression of coronary atherosclerosis in patients with CAD.
Indications
Indicated for the treatment of hypercholesterolemia, including hyperlipidemia, hyperlipoproteinemia, or hypertriglyceridemia, as an adjunct to dietary controll, for the purpose of reducing the risk of cardiovascular events (e.g., myocardial infarction prophylaxis, stroke prophylaxis).
Contraindications
Hypersensitivity to fluvastatin
Active liver disease, or unexplained elevated transminases
Adverse Effects
Headache (9%)
Dyspepsia (8%)
Abdominal pain (5%)
Diarrhea (5%)
Myalgia (5%)
Fatigue (3%)
Insomnia (3%)
Nausea (3%)
Sinusitis (3%)
Bronchitis (2%)
UTI (2%)
Transaminases increased (1.1%)
Rash
Back pain
Arthralgia
Myopathy
Rhabdomyolysis
Rupture of tendon
CPK increased
Pharyngitis
Rhinitis
Cough
Constipation
Pancreatitis
Dizziness
Warnings
Non-serious and reversible cognitive side effects may occur
Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with statin intake
Heavy alcohol use, history of liver disease, renal failure
Myopathy, risk of myopathy – incr by co-administration w/ fibrates, niacin, cyclosporine, macrolides, azole antifungals.
Withhold or discontinue treatment if myopathy develops, renal failure, or transaminase levels >3 times the upper limit of normal
Rare reports of immune-mediated necrotizing myopathy (IMNM), characterized by increased serum creatine kinase that persist despite discontinuing statin
Lipid-lowering effects additive with bile-acid binding resin or niacin
Take 2 hr after bile acid sequestrant
Pregnancy and Lactation
Owing to HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, fetal harm may occur when administered to pregnant females
There is no available information on effects of drug on breastfed infant or on milk production
Unknown whether is present in human milk; it has been shown that drugs in this class pass into human milk and atorvastatin is present in rat milk
Maximum Dosage
80 mg/day PO.
80 mg/day PO.
80 mg/day PO.
10 to 12 years: 80 mg/day PO.
1 to 9 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Fluvastatin sodium