Novicor 10 mg
Risk Factors:
Contraindications: Hypersensitivity to simvastatin. Active hepatic disease or unexplained persistent elevations of hepatic function test results pregnancy breastfeeding concurrent use of strong CYP3A4 inhibitors (e.g. clarithromycin cycloSPORINE gemfibrozil).Pregnancy/Lactation: Contraindicated in pregnancy (suppression of cholesterol biosynthesis may cause fetal toxicity) lactation. Risk of serious adverse reactions in breastfeeding infants. Children: Safety and efficacy not esTabletlished in children less than 10 yrs of age or in premenarchal girls. Elderly: No agerelated precautions noted.
Indications:
Secondary prevention of cardiovascular events in pts with hypercholesterolemia
and coronary heart disease (CHD) or at high risk for CHD. Treatment of
hyperlipidemias to reduce elevations in total serum cholesterol LDL-C
apolipoprotein B triglycerides VLDL-C and increase HDL-C. Treatment of
homozygous familial hypercholesterolemia. Treatment of heterozygous familial
hypercholesterolemia in adolescents (10?17 yrs females more than 1 yr
postmenarche).
Adverse Effects:
Generally well tolerated. Side effects are usually mild and transient. Occasional
(3%?2%): Headache abdominal pain/cramps constipation upper respiratory
tract infection. Rare (Less Than 2%): Diarrhea flatulence asthenia
nausea/vomiting depression.
Adverse effects/toxic reactions
Potential for ocular lens opacities. Hypersensitivity reaction hepatitis occur
rarely. Myopathy (muscle pain tenderness weakness with elevated serum
creatine kinase [CK] sometimes taking the form of rhabdomyolysis) has
occurred.
Don’t Use:
Cautions: History of hepatic disease diabetes
severe renal impairment substantial alcohol consumption. Withholding or
discontinuing simvastatin may be necessary when pt is at risk for renal failure
secondary to rhabdomyolysis. Concomitant use of other medications associated
with myopathy.