hieve serum lipoprotein goals. A pharmacokinetic study with simvastatin showed the mean plasma level of HMG-CoA reductase inhibitory activity to be approximately 45% higher in patients aged 70—78 compared with patients aged 18—30 years. However, long-term therapy with 20—80 mg/day PO has been used safely in elderly patients in clinical trials, with no differences in safety compared to younger patients. In the 4S trial and the Heart Protection Study, 23% and 52% of the patients, respectively, were elderly. The were no differences in the cardiovascular or stroke protection benefits of simvastatin between older and younger patients in these clinical outcome trials.
Pregnancy
Ezetimibe; simvastatin is classified as FDA pregnancy category X and is contraindicated for use during pregnancy, because of the potential effects of HMG-CoA reductase inhibitors on cholesterol pathways and the potential for fetal harm. Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Treatment should be immediately discontinued as soon as pregnancy is recognized. In a prospective review of about 100 pregnancies in women exposed to simvastatin or another structurally related HMG-CoA reductase inhibitor, the incidence of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. However, 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. If the patient becomes pregnant while taking this drug, Ezetimibe; Simvastatin should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus. Ezetimibe; Simvastatin should only be administered to females of child-bearing potential, including adolescents at least 1 year post-menarche, when such patients are highly unlikely to conceive and have been informed of the potential hazards. Females should be counseled regarding appropriate methods of contraception while on therapy.
Breast-feeding
Ezetimibe; simvastatin should be avoided during breast-feeding. Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for infant growth and development, including synthesis of steroids and cell membranes. HMG-CoA reductase inhibitors decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway; therefore, ezetimibe; simvastatin is contraindicated for use during breast-feeding. If pharmacotherapy is necessary in the nursing mother, a nonabsorbable resin such as cholestyramine, colesevelam, or colestipol should be considered. These agents do not enter the bloodstream and thus will not be excreted during lactation. However, resins bind fat-soluble vitamins and prolonged use may result in deficiencies of these vitamins in the mother and her nursing infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Children, infants, neonates
The safety and efficacy of ezetimibe; sim |
