You are on page 1of 2

Name /bks_53161_deglins_md_disk/simvastatin 03/06/2014 09:07AM Plate # 0-Composite pg 1 # 1

1 mycin, nefazodone, boceprevir, telaprevir, or grapefruit juice), gemfibrozil, cyclo-
sporine or danazol (qrisk of myopathy/rhabdomyolysis); Active liver disease or
PDF Page #1
simvastatin (sim-va-sta-tin) unexplained persistant elevations in AST/ALT; OB, Lactation: Pregnancy or lacta-
Zocor tion.
Classification Use Cautiously in: History of liver disease; Alcoholism; Renal impairment ; Con-
Therapeutic: lipid-lowering agents current use of amiodarone, amlodipine, diltiazem, dronedarone, verapamil, lomitap-
Pharmacologic: HMG-CoA reductase inhibitors (statin) ide, or ranolazine (qrisk of myopathy/rhabdomyolysis); Chinese patients receiv-
ing ⱖ1 g/day of niacin (qrisk of myopathy; do not use simvastatin 80 mg/day in these
Pregnancy Category X
patients); OB: Women of childbearing age; Pedi: Children ⬍10 yr (safety not estab-
lished).
Indications
Adjunctive management of primary hypercholesterolemia and mixed dyslipidemias. Adverse Reactions/Side Effects
Secondary prevention of myocardial infarction, coronary revascularization, stroke, CNS: amnesia, confusion, dizziness, headache, insomnia, memory loss, weakness.
and cardiovascular mortality in patients with clinically evident coronary heart dis- GI: abdominal cramps, constipation, diarrhea, flatus, heartburn, altered taste, drug-
ease. induced hepatitis, dyspepsia,qliver enzymes, nausea, pancreatitis. GU: erectile dys-
function. Derm: rashes, pruritus. Endo: hyperglycemia. MS: RHABDOMYOLYSIS, ar-
Action thralgia, immune-mediated necrotizing myopathy, myopathy (q risk with 80 mg
Inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme
which is responsible for catalyzing an early step in the synthesis of cholesterol. Ther- dose). Misc: hypersensitivity reactions.
apeutic Effects: Lowering of total and LDL cholesterol and triglycerides. Slightly Interactions
increases HDL cholesterol. Slows the progression of coronary atherosclerosis with Drug-Drug: Risk of myopathy and rhabdomyolysis are significantlyqwith
resultant decrease in coronary heart disease-related events. concurrent use of cyclosporine, gemfibrozil, danazol , erythromycin, cla-
Pharmacokinetics rithromycin, telithromycin, protease inhibitors, nefazodone, boceprevir,
Absorption: 85% absorbed, but rapidly metabolized. telaprevir, ketoconazole, itraconazole, voriconazole, or posaconazole;
Distribution: Unknown. concurrent use contraindicated. Cholesterol-lowering effect may beqwith bile acid
Protein Binding: 95%. sequestrants ( cholestyramine, colestipol ). Bioavailability may bepby bile
Metabolism and Excretion: Extensively metabolized by the liver, most during acid sequestrants. Risk of myopathy isqby concurrent use of amiodarone, am-
first pass; excreted in bile and feces; 13% excreted unchanged by the kidneys. lodipine, diltiazem, dronedarone, verapamil, ranolazine, lomitapide, or
Half-life: Unknown. niacin. May slightlyqserum digoxin levels. Mayqrisk of bleeding with warfarin.
TIME/ACTION PROFILE (cholesterol-lowering effect) Drug-Food: Risk of myopathy and rhabdomyolysis are significantlyqwith
concurrent use of grapefruit juice.
ROUTE ONSET PEAK DURATION†
PO days 2–4 wk unknown Route/Dosage
†After discontinuation. The 80 mg dose should be restricted to patients who have been
Contraindications/Precautions taking this dose for ⱖ12 mo without evidence of muscle toxicity
Contraindicated in: Hypersensitivity; Concurrent use of strong CYP3A4 inhibi- PO (Adults): 5– 40 mg once daily in the evening; if LDL goal cannot be achieved with
tors (protease inhibitors, azole antifungals, erythromycin, clarithromycin, telithro- 40 mg/day dose, add another lipid-lowering therapy (do notqsimvastatin dose to 80
⫽ Canadian drug name. ⫽ Genetic Implication. CAPITALS indicate life-threatening, underlines indicate most frequent. Strikethrough ⫽ Discontinued.
Name /bks_53161_deglins_md_disk/simvastatin 03/06/2014 09:07AM Plate # 0-Composite pg 2 # 2

2 day during therapy. Medication helps control but does not cure elevated serum
cholesterol levels.
mg/day). Concurrent verapamil, diltiazem, or dronedarone therapy— Dose ● Advise patient that this medication should be used in conjunction with diet restric- PDF Page #2
should not exceed 10 mg/day. Concurrent amiodarone, amlodipine or ranolazine tions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smok-
therapy— Dose should not exceed 20 mg/day; Concurrent lomitapide therapy— ing.
pdose by 50% (dose should not exceed 20 mg/day or 40 mg/day for patients who ● Instruct patient to notify health care professional if unexplained muscle pain, ten-
previously received 80 mg/day chronically [for ⱖ12 mo] without evidence of myopa- derness, or weakness occurs, especially if accompanied by fever or malaise.
thy). ● Advise patient to wear sunscreen and protective clothing to prevent photosensitiv-
PO (Children 10– 17 yr): 10 mg/day initially, may beqat 4 wk intervals up to 40 ity reactions (rare).
mg/day. Concurrent amiodarone, amlodipine or ranolazine therapy— Dose ● Instruct patient to notify health care professional of all Rx or OTC medications, vi-
should not exceed 20 mg/day Concurrent verapamil or diltiazem therapy— Dose tamins, or herbal products being taken and consult health care professional be-
should not exceed 10 mg/day. fore taking any new medications.
Renal Impairment ● Advise patient to notify health care professional of medication regimen before
PO (Adults): CCr ⬍10 mL/min— 5 mg/day initially, titrate carefully. treatment or surgery.
● Instruct female patients to notify health care professional promptly if pregnancy is
NURSING IMPLICATIONS
planned or suspected, or if breast feeding.
Assessment ● Emphasize the importance of follow-up exams to determine effectiveness and to
● Obtain a diet history, especially with regard to fat consumption. monitor for side effects.
● Lab Test Considerations: Evaluate serum cholesterol and triglyceride levels
before initiating, after 4– 6 wk of therapy, and periodically thereafter. Evaluation/Desired Outcomes
● Monitor liver function tests prior to initiation of therapy and as clinically indicated. ● Decrease in LDL and total cholesterol levels.
If symptoms of serious liver injury, hyperbilirubinemia, or jaundice occur, dis- ● Increase in HDL cholesterol levels.
continue simvastatin and do not restart. May also causeqalkaline phosphatase ● Decrease in triglyceride levels.
and bilirubin levels. ● Slowing of the progression of coronary artery disease.
● If patient develops muscle tenderness during therapy, CPK levels should
be monitored. If CPK levels are markedlyqor myopathy occurs, therapy Why was this drug prescribed for your patient?
should be discontinued.
Potential Nursing Diagnoses
Noncompliance (Patient/Family Teaching)
Implementation
● PO: Administer once daily in the evening. May be administered without regard to
food.
● Avoid grapefruit and grapefruit juice during therapy; may increase risk of toxicity.
Patient/Family Teaching
● Instruct patient to take medication as directed, not to skip doses or double up on
missed doses. Advise patient to avoid drinking more than 1 qt of grapefruit juice/
䉷 2015 F.A. Davis Company