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BAYCOL® (cerivastatin (removed from market 8/2001)) (cerivastatin sodium tablets) is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, apo B, and TG and to increase HDL-C levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb) when the response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone has been inadequate. Therapy with lipid-altering drugs should be a component of multiple risk factor intervention in those patients at significantly high risk for atherosclerotic vascular disease due to hypercholesterolemia.
Before considering therapy with lipid-altering agents, secondary causes of hypercholesterolemia, e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism, should be excluded and a lipid profile performed to measure Total-C, HDL-C, and triglycerides (TG). For patients with TG of 400 mg/dL or less, LDL-C can be estimated using the following equation:
LDL-C = [Total-C] minus [HDL-C + TG/5]
For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be directly measured by preparative ultracentrifugation. In many hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases, BAYCOL® (cerivastatin sodium tablets) is not indicated. Lipid determinations should be performed at intervals of no less than four weeks. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized in Table 4.
Table 4: National Cholesterol Education Program (NCEP) Treatment
Guidelines LDL-Cholesterol mg/dL (mmol/L)
|Definite Atherosclerotic Disease*||Two or More Other Risk Factors**||Initiation Level***||Goal|
|NO||NO||≥ 190 ( ≥ 4.9)||< 160 ( < 4.1)|
|NO||YES||≥ 160 ( ≥ 4.1)||< 130 ( < 3.4)|
|YES||YES or NO||≥ 130 ( ≥ 3.4)||≤ 100 ( ≤ 2.6)|
|* Coronary heart disease or peripheral vascular disease (including
symptomatic carotid artery disease).
** Other risk factors for coronary heart disease (CHD) include the following: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C < 35 mg/dL ( < 0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥ 60 mg/dL ( ≥ 1.6 mmol/L).
*** In CHD patients with LDL-C levels 100-129 mg/dL, the physician should exercise clinical judgment in deciding whether to initiate drug treatment.
At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C level is ≥ 130 mg/dL (NCEP-ATP II).
Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy.
Although BAYCOL® (cerivastatin (removed from market 8/2001)) may be useful to reduce elevated LDL-cholesterol levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it 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).1
DOSAGE AND ADMINISTRATION
The patient should be placed on a standard cholesterol-lowering diet before receiving cerivastatin sodium and should continue on this diet during treatment with cerivastatin sodium. (See NCEP Treatment Guidelines for details on dietary therapy.)
The starting-dose of BAYCOL® (cerivastatin (removed from market 8/2001)) is 0.4 mg once daily in the evening regardless of previous lipid therapy. Since the maximal effect of cerivastatin sodium is seen within 4 weeks lipid determinations should be performed at this time and the dose adjusted based upon patient response. Only patients requiring further lipid adjustment should be titrated to 0.8 mg. The dosage range is 0.2 mg to 0.8 mg. In patients with significant renal impairment (creatinine clearance ≤ 60 mL/min/1.73m2) lower doses are recommended. Cerivastatin sodium may be taken with or without food. `
Concomitant Therapy: The lipid-lowering effects on LDL-C and Total-C are additive when cerivastatin sodium is combined with a bile-acid-binding resin. When co-administering cerivastatin sodium and a bile-acid-exchange resin, e.g., cholestyramine, cerivastatin sodium should be given at least 2 hours after the resin (see also ADVERSE REACTIONS: Concomitant Therapy).
Dosage in Patients with Renal Insufficiency: No dose adjustment is necessary for patients with mild renal dysfunction (Clcr 61-90 mL/min/1.73m2). For patients with moderate or severe renal dysfunction, a starting dose of 0.2 mg or 0.3 mg is recommended (see CLINICAL PHARMACOLOGY - Special Populations - Renal).
BAYCOL® (cerivastatin sodium tablets) is supplied as 0.2-mg, 0.3-mg, 0.4-mg and 0.8-mg tablets. The different tablet strengths can be identified as follows:
|0.2 mg||light yellow||283||200 MCG|
|0.3 mg||yellow brown||284||300 MCG|
|0.4 mg||ocher||285||400 MCG|
|0.8 mg||brown orange||286||800 MCG|
BAYCOL® (cerivastatin sodium tablets) is supplied as follows:
Bottles of 30:
0.4 mg (NDC 0026-2885-69)
0.8 mg (NDC 0026-2886-69)
Bottles of 90:
0.2 mg (NDC 0026-2883-86)
0.3 mg (NDC 0026-2884-86)
0.4 mg (NDC 0026-2885-86)
0.8 mg (NDC 0026-2886-86)
Bottles of 1000:
0.4 mg (NDC 0026-2885-54)
Bottles of 5000:
0.4 mg (NDC 0026-2885-82)
The tablets should be protected from moisture and stored below 77°F (25°C). Dispense in tight containers.
1. Classification of Hyperlipoproteinemias
|Type||Lipoproteins Elevated||Lipid Elevations|
|I (rare)||chylomicrons||TG||↑ →C|
|V (rare)||chylomicrons, VLDL||TG||↑ →C|
|C=cholesterol, TG=triglycerides, LDL=low-density lipoprotein, VLDL= very-low-density lipoprotein, IDL=intermediate-density lipoprotein.|
Bayer Corporation, Pharmaceutical Division, 400 Morgan Lane, West Haven, CT 06516 USA. Made in Germany.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/17/2009
Additional Baycol Information
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