Baycol
Baycol Information
Baycol (cerivastatin sodium) is indicated as an adjunct to diet for the reduction of elevated total and LDL cholesterol 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.
How Does Baycol Work?
Cholesterol and triglycerides circulate as proof of lipoprotein complexes throughout the bloodstream. These complexes can be separated via ultracentrifugation into high- density lipoprotein (HDL), intermediate-density lipoprotein (IDL), low-density lipoprotein (LDL) and very-low-density lipoprotein VLDL fractions. In the liver, cholesterol and triglycerides (T) are synthesized, incorporated into VLDL, and released into the plasma for delivery to peripheral tissues.
A variety of clinical studies have demonstrated that elevated levels of total cholesterol (total- C), LDL- C. and apolipoprotein B (apo- B, a membrane complex for LDLC) promote human atherosclerosis. Similarly, decreased levels of HDL- C (and its transport complex, apolipoprotein A) are associated with the development of atherosclerosis. Epidemiologic Investigations have established that cardiovascular morbidity and mortality vary directly with the level of total- C and LDL- C and inversely with the level of HDL- C.
In patients with hypercholesterolemia, Baycol (cerivastatin sodium tablets) has been shown to reduce plasma total cholesterol, LDL-C, and apolipoprotein B. In addition, it also reduces plasma triglycerides and increases plasma HDL-C. The agent has no consistent effect on plasma Lp( a). The effect of BAYCOL on cardiovascular morbidity and mortality has not been determined.
Mechanism of Action
The active ingredient in Baycol, Cerivastatin, is a competitive inhibitor of HMG-CoA reductase, which is responsible for the conversion of 3- hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols, including cholesterol. The inhibition of cholesterol biosynthesis by cerivastatin reduces the level of cholesterol in hepatic cells, which stimulates the synthesis of LDL receptors, thereby increasing the uptake of cellular LDL particles. The end result of these biochemical processes is a reduction of the plasma cholesterol concentration.
Baycol Ingredients and Composition
How To Take Baycol and Baycol Dosage and Administration
The patient should be placed on a standard cholesterol-lowering diet before receiving Baycol (cerivastatin sodium) and should continue on this diet during treatment with cerivastatin sodium.
The recommended dose is 0.3 mg once daily in the evening. Baycol (cerivastatin sodium) may be taken with or without food. The recommended Baycol starting dose in patients with significant renal impairment (creatinine clearance 160 mL/min/1.73m2) is 0.2 mg once daily in the evening.
Since the maximal effect of Baycol (cerivastatin sodium) is seen within 4 weeks, lipid determinations should be performed at this time.
Concomitant Therapy
The lipid-lowering effects on LDL-C and Total-C are additive when Baycol (cerivastatin sodium) is combined with a bile acid-binding resin. When coadministering cerivastatin sodium and a bile- acidexchange resin, e.g., cholestyramine, cerivastatin sodium should be given at least 2 hours after the resin.
Dosage in Patients with Renal Insufficiency
No Baycol dose adjustment is necessary for patients with mild renal dysfunction (Clcr 61-90 mL/min/l.73m2). For patients with moderate or severe renal dysfunction, a starting dose of 0.2 mg is recommended.
If you suspect a Baycol Overdose
The maximum single oral dose of Baycol cerivastatin sodium received by healthy volunteers and patients is 0.4 mg.
No specific recommendations concerning the treatment of a Baycol overdose can be made. Should an overdose occur, it should be treated symptomatically and supportive measures should be undertaken as required.
Dialysis of cerivastatin sodium is not expected to significantly enhance clearance since the drug is extensively (99%) bound to plasma proteins.
Baycol Side Effects
Baycol Precautions and Contraindications
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).
You should report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, to your doctor, as this might be associated with Baycol.
Contraindications to Baycol
Active liver disease or unexplained persistent elevations of serum transaminases.
Taking Baycol during Pregnancy or Breast-feeding
Pregnancy and lactation: Atherosclerosis is a chronic process, and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long- term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologicalty active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursin mothers. Baycol (Cerivastatin sodium) should be administered to women of child-bearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, ceriva statin sodium should be discontinued and the patient should be apprised of the potential hazard to the fetus.
Hypersensitivity to any component of this medication.
Baycol Clinical Trials and Studies
Storing Baycol
The tablets should be protected from moisture and stored below 77° F (25° C).
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