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Generic Mevacor Lovastatin 10/20mg

Mevacor is generally well tolerated. Any side effects that have occurred have usually been mild and short-lived. If any side effects develop or change in intensity, inform your doctor as soon as possible. Check with your doctor before drinking alcohol while you are taking Lovastatin. Follow the diet and exercise program given to you by your health care provider. Tell your doctor or dentist that you take Lovastatin before you receive any medical or dental care, emergency care, or surgery. Women who may become pregnant should use effective birth control while taking Lovastatin. Check with your doctor if you have questions about using birth control.

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Mevacor Precautions

Lovastatin produced optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in clinically normal dogs in a dose-dependent fashion starting at 60 mg/kg/day, a dose that produced mean plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose (as measured by total enzyme inhibitory activity). No drug-related effects on fertility were found in studies with lovastatin in rats. In Phase III controlled clinical studies involving 613 patients treated with Mevacor, the adverse experience profile was similar to that shown below for the 8,245?patient

Phase Iii Clinical Studies

EXCEL study Study). Persistent increases of serum transaminases have been noted About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine was 9 percent. Mevacor was compared to placebo in 8,245 patients with hypercholesterolemia (total-C 240-300 mg//dL [6.2-7.8 mmol/L]) in the randomized, double-blind, parallel, 48 week EXCEL study. Clinical adverse experiences reported as possibly, probably or definitely drug-related in greater than 1% in any treatment group are shown in the table below.

Mevacor Overdosage

In AFCAPS/TexCAPS involving 6,605 participants treated with 20-40 mg/day of Mevacor (n=3,304) or placebo (n=3,301), the safety and tolerability profile of the group treated with Mevacor was comparable to that of the group treated with placebo during a median of 5.1 years of follow-up. The adversereactions that occurred were limited to those reported previously with lovastatin or cholestyramine. Other lipid-lowering agents were not administered concomitantly with lovastatin during controlled clinical studies.

In uncontrolled clinical studies, most of the patients who have developed myopathy were receiving concomitant therapy with cyclosporine, gemfibrozil or niacin (nicotinic acid). The combined use of lovastatin at doses exceeding 20 mg/day with cyclosporine, gemfibrozil, other fibrates or lipid-lowering doses (greater than 1 g/day) of niacin should be avoided The following effects have been reported with drugs in this class.