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SEPTA-SIMVASTATIN is a brand name for Simvastatin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .............................................................................................................. 3 CONTRAINDICATIONS ............................................................................................................................... 5 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
• Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. • Active liver disease or unexplained persistent elevations of serum transaminases.
• Pregnant and nursing women. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). SEPTA-SIMVASTATIN should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the possible harm.
If the patient becomes pregnant while taking SEPTA- SIMVASTATIN, the drug should be discontinued immediately and the patient appraised of the potential harm to the fetus. Atherosclerosis being a chronic process, discontinuation of lipid metabolism regulating drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia (see WARNINGS AND PRECAUTIONS, Pregnant Women and Nursing Women).
WARNINGS AND PRECAUTIONS Warnings and precautions are listed in alphabetical order. General Before instituting therapy with SEPTA-SIMVASTATIN, an attempt should be made to control hypercholesterolemia with appropriate diet and exercise, weight reduction in overweight and obese patients, and to treat other underlying medical problems (see INDICATIONS AND CLINICAL USE).
The patient should be advised to inform subsequent physicians of the prior use of simvastatin or any other lipid-lowering agent. In primary prevention intervention the effects of simvastatin-induced changes in lipoprotein levels, including reduction of serum cholesterol, on cardiovascular morbidity or mortality or total mortality have not been established.
Endocrine and Metabolism Effect on CoQ10 Levels (Ubiquinone):
Significant decreases in circulating CoQ10 levels in patients treated with simvastatin and other statins have been observed. The clinical significance of a potential long-term statin-induced deficiency of CoQ10 has not been established (see BIBLIOGRAPHY).
Effect on Lipoprotein(a):
In some patients, the beneficial effect of lowered total cholesterol and LDL-C levels may be partly blunted by a concomitant increase in the Lipoprotein(a) [Lp(a)] level. Further research is currently ongoing to elucidate the significance of Lp(a) plasma level variations.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Simvastatin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Therefore, until further experience is obtained, it is suggested, when feasible, that Lp(a) measurements be carried out in patients placed on therapy with simvastatin.
Page 6 of 50 Endocrine:
HMG-CoA reductase inhibitors interfere with cholesterol synthesis and as such might theoretically blunt adrenal and/or gonadal steroid production. Clinical studies with simvastatin and other HMG-CoA reductase inhibitors have suggested that these agents do not reduce plasma cortisol concentration or impair adrenal reserve and do not reduce basal plasma testosterone concentration.
However, the effects of HMG-CoA reductase inhibitors on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the pituitary-gonadal axis in premenopausal women are unknown. Patients treated with simvastatin who develop clinical evidence of endocrine dysfunction should be evaluated appropriately.
g. ketoconazole, spironolactone, or cimetidine) that may decrease the levels of endogenous steroid hormones (see DRUG INTERACTIONS, Overview). Hepatic/Biliary/Pancreatic In clinical studies, marked persistent increases (to more than 3 times the ULN) in serum transaminases have occurred in 1% of adult patients who received simvastatin (see ADVERSE REACTIONS, Laboratory Tests).
When the drug was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pretreatment levels. The increases were not associated with jaundice or other clinical signs or symptoms. There was no evidence of hypersensitivity.
Some of these patients had abnormal liver function tests prior to therapy with simvastatin and/or consumed substantial quantities of alcohol. 7%] vs. 6%]). The frequency of single elevations of SGPT (ALT) to 3 times the ULN was significantly higher in the simvastatin group in the first year of the study (20 vs.
023), but not thereafter. Elevated transaminases resulted in the discontinuation of 8 patients from therapy in the simvastatin group (n=2221) and 5 in the placebo group (n=2223). 4 years (median follow-up) of the study. All of the patients in this study received a starting dose of 20 mg of simvastatin; 37% were titrated to 40 mg.
8% at the 40 and 80 mg dose, respectively. 09% (n=9) for patients treated with placebo. It is recommended that liver function tests be performed at baseline and thereafter when clinically indicated. Patients titrated to the 80 mg dose […]