Drug class: HMG-CoA Reductase Inhibitors

Medically reviewed by Drugs.com on Oct 10, 2024. Written by ASHP.

Introduction

Antilipemic agent; hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitor (i.e., statin).

Uses for Simvastatin

Reduction in Risk of Cardiovascular Events

Adjunct to diet and other lifestyle modifications in adults with established coronary heart disease (CHD), cerebrovascular disease, peripheral vascular disease, and/or diabetes mellitus, who are at high risk of CHD; used to reduce risk of total mortality by reducing CHD death, risk of nonfatal MI and stroke, and need for revascularization procedures in such patients.

Also has been used for primary prevention^{† [off-label]} of atherosclerotic cardiovascular disease (ASCVD).

Extensive evidence demonstrates that statins can substantially reduce LDL-cholesterol concentrations and associated risk of ASCVD; may be used for secondary or primary prevention in high-risk patients.

AHA/ACC cholesterol management guideline states that lifestyle modification is the foundation of ASCVD risk reduction. Patients with established ASCVD or high risk of ASCVD should also be treated with a statin.

Because relative ASCVD risk reduction is correlated with degree of LDL-cholesterol lowering, use maximum tolerated intensity of a statin to achieve greatest benefit. High-intensity statin therapy (defined as reducing LDL-cholesterol concentrations by ≥50%) is recommended; if high-intensity statin therapy not possible (e.g., because of a contraindication or intolerable adverse effect), may consider moderate-intensity statin therapy (defined as reducing LDL-cholesterol concentrations by 30–49%). AHA/ACC considers simvastatin 20–40 mg daily to be a moderate-intensity statin. Although simvastatin 80 mg daily was evaluated in randomized controlled studies, this dosage is not recommended by FDA because of increased risk of myopathy.

When considering whether to initiate statin therapy for primary prevention, AHA/ACC recommends an individualized approach and shared decision making between patient and clinician. According to the guidelines, statin therapy may be considered in certain high-risk groups such as adults 20–75 years of age with LDL-cholesterol ≥190 mg/dL, adults 40–75 years of age with diabetes mellitus, adults 40–75 years of age without diabetes mellitus but with LDL-cholesterol levels ≥70 mg/dL and an estimated 10-year ASCVD risk ≥7.5%, and adults 40–75 years of age with chronic kidney disease (not treated with dialysis or transplantation) and LDL-cholesterol concentrations of 70–189 mg/dL who have a 10-year ASCVD risk ≥7.5%.

Has been shown to slow the progression and/or induce regression of atherosclerosis in coronary arteries by reducing intimal-medial wall thickness.

The addition of a nonstatin drug (e.g., ezetimibe, PCSK9 inhibitor) to statin therapy may be considered in certain high-risk patients who require further reduction in LDL-cholesterol concentrations, particularly if there is evidence from randomized controlled studies suggesting that the addition of the nonstatin drug further reduces ASCVD events.

Dyslipidemias

Adjunct to diet in adults to decrease elevated serum total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations, and to increase HDL-cholesterol concentrations in the management of primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb). May be used in combination with ezetimibe for additive antilipemic effects.

Adjunct to diet to decrease elevated serum total cholesterol, LDL-cholesterol, and apo B concentrations in the management of heterozygous familial hypercholesterolemia (HeFH) in boys and girls (≥1 year postmenarchal) 10–17 years of age who, despite an adequate trial of dietary management, have LDL-cholesterol concentration ≥190 mg/dL or LDL-cholesterol concentration ≥160 mg/dL and either a family history of premature cardiovascular disease or ≥2 other cardiovascular disease risk factors. May be used in combination with ezetimibe for additive antilipemic effects.

Used to reduce elevated serum total and LDL-cholesterol concentrations in adults with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering therapies (e.g., plasma LDL-apheresis) or when such therapies are not available. May be used in combination with ezetimibe for additive antilipemic effects.

Adjunct to diet to decrease elevated serum triglyceride and VLDL-cholesterol concentrations in adults with primary dysbetalipoproteinemia (Fredrickson type III).

Adjunct to diet to decrease elevated serum triglyceride concentrations in adults with hypertriglyceridemia (Fredrickson type IV).

Efficacy of simvastatin remains to be established in patients with elevated chylomicrons as their primary lipid abnormality (Fredrickson types I and V).

Simvastatin Dosage and Administration

General

Pretreatment Screening

• Consider liver enzyme testing prior to initiating therapy.

• Obtain baseline hepatic panel in appropriate patients with chronic stable liver disease (including non-alcoholic fatty liver disease).

• Obtain baseline fasting lipid panel.

Patient Monitoring

• Perform fasting lipid panel periodically 4–12 weeks after statin initiation or dose adjustment; monitoring should continue every 3–12 months thereafter as clinically indicated.

• Periodically reinforce adherence to lifestyle modifications. Antilipemic therapy is an adjunct to, not a substitute for, lifestyle modification therapies that reduce the risk of ASCVD.

• Consider liver enzyme testing when clinically indicated; routine monitoring in the absence of symptoms is not recommended.

• Monitor hepatic panel in appropriate patients with chronic stable liver disease (including non-alcoholic fatty liver disease).

• Obtain creatine kinase (CK) levels in patients with severe statin-associated muscle weakness; routine monitoring in the absence of symptoms is not recommended.

Administration

Oral Administration

Administer orally (as tablets or oral suspension) in the evening.

Oral Suspension

Administer on an empty stomach. Shake bottle well for at least 20 seconds; measure dose with accurate measuring device, not a household teaspoon. Utilize 8 mg/mL (40 mg/5 mL) preparation for doses ≥ 40 mg.

Tablets

Administer without regard to meals. Administer a missed dose as soon as possible; do not double the next dose.

Simvastatin/ezetimibe Fixed-combination Preparation

Administer orally in the evening without regard to meals. Administer a missed dose as soon as possible; do not double the next dose.

Dosage

Pediatric Patients

Dyslipidemias

Oral

Children 10–17 years of age with heterozygous familial hypercholesterolemia (HeFH): Initially, 10 mg once daily.

Adjust dosage at intervals of ≥4 weeks. Recommended dosage range is 10–40 mg daily. Maximum 40 mg once daily.

Simvastatin/ezetimibe fixed combination (Vytorinand generic equivalents) in children 10–17 years of age with HeFH: Recommended dosage range is 10–40 mg of simvastatin and 10 mg ezetimibe daily.

Adults

Reduction in Risk of Cardiovascular Events

Oral

Use maximally tolerated statin intensity to achieve optimal ASCVD risk reduction benefit. High-intensity statin therapy (defined as reducing LDL-cholesterol concentrations by ≥50%) is preferred; if high-intensity statin therapy not possible (e.g., because of a contraindication or intolerable adverse effect), may consider moderate-intensity statin therapy (defined as reducing LDL-cholesterol concentrations by 30–49%).

The AHA/ACC guideline panel considers simvastatin 20–40 mg daily to be a moderate-intensity statin. Although simvastatin 80 mg daily was evaluated in randomized controlled studies, this dosage is not recommended by FDA because of increased risk of myopathy.

Manufacturers state usual dosage range is 5–40 mg daily. Some manufacturers suggest initial dosage of 10 or 20 mg once daily. Recommended initial dosage in patients with CHD or CHD risk equivalents is 40 mg once daily.

If response is inadequate with 40 mg daily, do not increase dosage; instead, switch to alternative LDL-lowering treatment.

Restrict use of the 80-mg daily dosage to patients who have been receiving long-term therapy (e.g., 12 months or longer) at this dosage without evidence of adverse muscular effects.

Dyslipidemias

Oral

Usual dosage range is 5 to 40 mg daily.

Some manufacturers suggest initial dosage of 10 or 20 mg once daily.

Recommended initial dosage in patients with CHD or CHD risk equivalents is 40 mg once daily.

Adjust dosage at intervals of ≥4 weeks.

Maximum recommended dosage is 40 mg once daily.

If response is inadequate with 40 mg daily, do not increase dosage; instead, switch to alternative LDL-lowering treatment. Restrict use of 80-mg daily dosage to patients who have been receiving long-term therapy (e.g., 12 months or longer) at this dosage without evidence of adverse muscular effects.

Homozygous familial hypercholesterolemia (HoFH): Recommended dosage is 40 mg once daily.

Simvastatin/ezetimibe fixed combination (Vytorinand generic equivalents): Usual dosage range is simvastatin 10–40 mg and ezetimibe 10 mg once daily. If LDL-cholesterol target goal cannot be achieved with simvastatin 40 mg/ezetimibe 10 mg once daily, do not increase dosage; instead, switch to alternative antilipemic agent(s) that provide greater LDL-cholesterol reduction. Restrict use of simvastatin 80 mg/ezetimibe 10 mg dosage.

Dosage Modification for Concomitant Therapy

Amiodarone, Amlodipine, or Ranolazine

Maximum dosage: Simvastatin 20 mg or simvastatin 20 mg in fixed combination with ezetimibe 10 mg once daily.

Lomitapide

Reduce simvastatin dosage by 50%.

Maximum dosage: Simvastatin 20 mg or simvastatin 20 mg in fixed combination with ezetimibe 10 mg once daily.

Restrict use of simvastatin 80 mg/ezetimibe 10 mg dosage.

Verapamil, Diltiazem, or Dronedarone

Maximum dosage: simvastatin 10 mg or simvastatin 10 mg in fixed combination with ezetimibe 10 mg once daily.

Special Populations

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease.

Contraindicated in patients with active liver disease, acute liver failure, decompensated cirrhosis, or unexplained, persistent increases in serum aminotransferase concentrations.

Renal Impairment

Simvastatin

Mild to moderate renal impairment: No dosage adjustment needed.

Severe renal impairment (Cl_Cr 15–29 mL/minute): Initially, 5 mg once daily. Use with caution; monitor closely.

Simvastatin/Ezetimibe Fixed Combination

Mild renal impairment: No dosage adjustment needed.

Moderate to severe renal impairment: Simvastatin 20 mg/ezetimibe 10 mg once daily; use higher dosages with caution and close monitoring.

Geriatric Patients

No specific dosage recommendations at this time. Select dosage with caution; monitor closely.

Pharmacogenomic Considerations in Dosing

Patients with solute carrier organic anion transporter (SLCO) 1B1 decreased or possible decreased function phenotypes: limit simvastatin dosage to <20 mg per day.

Patients with SLCO1B1 poor function phenotypes: alternative statin recommended.

Cautions for Simvastatin

Contraindications

• Concomitant use with potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, clarithromycin, erythromycin, nefazodone, cobicistat-containing preparations), gemfibrozil, cyclosporine, or danazol.

• Acute liver failure, active liver disease, including unexplained, persistent elevations of serum aminotransferases, or decompensated cirrhosis.

• Oral suspension: The manufacturer states that this formulation is contraindicated in women who are pregnant or may become pregnant, and in nursing mothers; however, because statins may prevent serious or potentially fatal cardiovascular events in certain high-risk patients who are pregnant, FDA has requested that the contraindication in pregnant women be removed from the prescribing information for all statins.

• Known hypersensitivity to simvastatin, ezetimibe, or any ingredient in the formulations.

Warnings/Precautions

Musculoskeletal Effects

Myopathy (manifested as muscle pain, tenderness, or weakness and serum CK [CPK] concentration increases >10 times the ULN) reported.

Rhabdomyolysis (defined as myopathy with a serum CK concentration >40 times the ULN) also reported; rare fatalities have occurred.

Incidence of myopathy, including rhabdomyolysis, appears highest during first year and then decreases during subsequent years of treatment.

Risk of myopathy is increased in patients receiving higher dosages of statins; risk also may be increased in geriatric patients (≥65 years of age), women, and patients with renal impairment or uncontrolled hypothyroidism.

Risk of myopathy increased in Chinese compared with non-Chinese patients taking simvastatin coadministered with lipid-modifying doses of a niacin (≥1 g/day); concomitant use not recommended.

Certain drug or food interactions also may increase risk of myopathy and/or rhabdomyolysis.

Risk of myopathy, including rhabdomyolysis, is greater with 80-mg daily dosage compared with lower daily dosages or compared with other statins with similar or greater LDL-cholesterol lowering efficacy. Restrict use of 80-mg daily dosage.

AHA/ACC recommends measuring CK levels in patients with severe statin-associated muscle symptoms; however, routine monitoring is not useful.

Discontinue if serum CK concentrations increase markedly or if myopathy is diagnosed or suspected.

Temporarily withhold therapy in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis; shock or hypotension; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures).

Immune-mediated Necrotizing Myopathy

Immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, reported rarely in patients receiving statins. Characterized by proximal muscle weakness and elevated CK concentrations that persist despite discontinuance of statin therapy, positive anti-HMG CoA reductase antibody, muscle biopsy showing necrotizing myopathy, and improvement following therapy with immunosuppressive agents.

Additional neuromuscular and serologic testing may be necessary; treatment with immunosuppressive agents may be required.

Discontinue if IMNM suspected. Consider risk of IMNM carefully prior to initiating therapy with another statin; monitor for signs and symptoms.

Hepatic Effects

Associated with increases in serum aminotransferase (AST, ALT) concentrations.

Rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including simvastatin.

Perform liver function tests before initiation of therapy and as clinically indicated (e.g., presence of manifestations suggestive of liver damage). Serious statin-related liver injury is rare and unpredictable, and routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury. AHA/ACC cholesterol management guideline states that it is reasonable to obtain liver function tests in patients with symptoms of hepatotoxicity (e.g., unusual fatigue or weakness, loss of appetite, abdominal pain, dark colored urine, yellowing of skin or sclera); however, routine monitoring not recommended.

ALT may emanate from muscle; therefore, concurrent increases in ALT and CK concentrations may indicate myopathy.

If serious liver injury with clinical manifestations and/or hyperbilirubinemia or jaundice occurs, promptly interrupt simvastatin therapy. If an alternate etiology is not found, do not restart simvastatin.

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease.

Contraindicated in patients with acute liver failure, active liver disease, including unexplained persistent elevations in hepatic transaminase levels, or decompensated cirrhosis.

Hyperglycemic Effects

Increases in HbA_1c and fasting serum glucose concentrations reported. Possible increased risk of developing diabetes.

AHA/ACC cholesterol management guideline states that in patients with increased risk of diabetes mellitus or new-onset diabetes mellitus, statin therapy and lifestyle modifications should be continued to reduce risk of ASCVD.

Use of Fixed Combinations

When used in fixed combination with ezetimibe, consider the cautions, precautions, and contraindications associated with ezetimibe.

Specific Populations

Pregnancy

All statins were previously contraindicated in pregnant women because fetal risk was thought to outweigh any possible benefit. However, the totality of evidence to date indicates limited potential for statins to cause malformations and other adverse embryofetal effects; FDA has therefore requested removal of the contraindication. Most pregnant patients should still discontinue statins because of the possibility of fetal harm; however, some patients (e.g., those with HoFH or established cardiovascular disease) may benefit from continued therapy. Consider patient's individual risks and benefits.

Patients who become pregnant or suspect that they are pregnant while receiving a statin should notify their clinician; clinician should advise patient on the appropriate course of action.

Increased risk of miscarriage reported in pregnant women exposed to statins; however, not clear whether drug-related or due to other confounding factors.

Lactation

Not known whether simvastatin is distributed into human milk; however, a small amount of another statin is distributed into human milk. Breastfeeding is not recommended during simvastatin therapy. Many patients can stop statin therapy temporarily until breast-feeding is complete; patients who require ongoing statin treatment should not breast-feed and should use alternatives such as infant formula.

Females and Males of Reproductive Potential

AHA/ACC cholesterol management guideline states women (including adolescents) of childbearing age who are sexually active should be counseled to use a reliable form of contraception.

Pediatric Use

Safety and efficacy of simvastatin not established in children <10 years of age or in premenarchal girls for the treatment of heterozygous familial hypercholesterolemia (HeFH). Advise adolescent girls to use effective and appropriate contraceptive methods during therapy to reduce the likelihood of unintended pregnancy.

Safety and efficacy of simvastatin in fixed combination with ezetimibe not established in children <10 years of age for the treatment of HeFH or in pediatric patients with other types of hyperlipidemia.

Geriatric Use

No overall differences in safety or efficacy relative to younger adults. However, increased sensitivity cannot be ruled out; higher dosages (i.e., 80 mg daily) associated with increased risk of myopathy, including rhabdomyolysis, in patients ≥65 years of age. Use with caution, since age ≥65 years is a predisposing factor for myopathy.

Patients >75 years of age may have higher risk of adverse effects and lower adherence to statin therapy; consider expected benefits versus adverse effects prior to initiating statin therapy in this population.

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease.

Contraindicated in patients with acute liver failure, active liver disease, unexplained persistent increases in serum aminotransferase concentrations, or decompensated cirrhosis.

Renal Impairment

History of renal impairment may be a risk factor for development of rhabdomyolysis; monitor closely for adverse musculoskeletal effects.

Use with caution in patients with severe renal impairment; dosage adjustments necessary in such patients.

In patients with moderate to severe renal impairment receiving simvastatin 20 mg/ezetimibe 10 mg in fixed combination, incidence of certain adverse effects (serious effects; those resulting in drug discontinuance; musculoskeletal effects, liver enzyme abnormalities, or incident cancer) was similar to that with placebo. Use higher dosages with caution and close monitoring in such patients, since renal impairment increases risk for myopathy.

Pharmacogenomic Considerations

Genetic variation in the solute carrier organic anion transporter (SLCO) family member (SLCO1B1), ABCG2 (also known as breast cancer resistance protein [BCRP]), and CYP2C9 genes alter systemic exposure to statins, which can increase the risk for statin-associated musculoskeletal symptoms.

In patients with phenotypes that result in increased statin exposure, consider potential for other patient-specific issues that may increase statin exposure (e.g., renal and hepatic function, drug-drug interactions).

Experts state statin therapy should neither be discontinued nor avoided based on SLCO1B1, ABCG2, or CYP2C9 genotype results for patients with an indication for statin therapy.

SLCO1B1 decreased or possible decreased function phenotype or poor function phenotype: Increased exposure.

CYP2C9 intermediate metabolizer or poor metabolizer phenotypes: Increased exposure.

Combined SLCO1B1 (decreased or possible decreased or poor function) and CYP2C9 intermediate or poor metabolizer phenotypes: Increased exposure.

Patients with such phenotypes may require lower doses or an alternative.

Common Adverse Effects

Simvastatin (≥5%): Upper respiratory tract infections, headache, abdominal pain, constipation, nausea.

Simvastatin/ezetimibe (≥2%): Headache, increased alanine aminotransferase, myalgia, upper respiratory tract infection, diarrhea.

Drug Interactions

Metabolized by CYP3A4; does not inhibit CYP3A4.

Substrate of organic anion transport protein (OATP) 1B1 and P-gp.

When used in fixed combination with ezetimibe, consider interactions associated with ezetimibe.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, cobicistat-containing drugs): May increase plasma simvastatin concentrations and increase risk of myopathy or rhabdomyolysis. Concomitant use contraindicated.

CYP3A4 substrates: Simvastatin not expected to affect plasma concentrations of CYP3A4 substrates.

Drugs Affecting or Affected by Transport Systems

OATP1B1 inhibitors: May increase plasma simvastatin acid concentrations and increase risk of myopathy.

P-gp inhibitors: May increase plasma simvastatin exposure and increase risk of myopathy

Specific Drugs and Foods

Simvastatin Pharmacokinetics

Absorption

Bioavailability

Undergoes extensive first-pass metabolism in the liver. Absolute bioavailability is <5%. Peak plasma concentrations (including metabolites) attained in 4 hours.

Onset

Maximal to near-maximal therapeutic response occurs within 4–6 weeks.

Simvastatin/ezetimibe fixed-combination preparation (Vytorinand generic equivalents) is bioequivalent to corresponding dosages of the individual components.

Food

Total (HMG-CoA reductase) inhibitor concentration not affected by a low fat meal.

Simvastatin oral suspension: Simvastatin AUC decreased 18% and simvastatin β-hydroxyacid AUC increased 44% when administered with a high-fat meal.

Special Populations

Patients with severe renal insufficiency may have higher systemic exposure.

Distribution

Extent

Crosses the blood-brain barrier in animals.

Not known whether distributed into human milk.

Plasma Protein Binding

About 95% bound to plasma proteins.

Elimination

Metabolism

Metabolized by CYP3A4 to active metabolites.

Substrate of P-gp and organic anion transporter protein (OATP) 1B1.

Elimination Route

Excreted in urine (13%) and feces (60%).

Half-life

2–3 hours.

Special Populations

Dialyzability, including metabolites, unknown.

HMG-CoA reductase inhibitory activity levels higher in geriatric patients.

Stability

Storage

Oral

Oral Suspension

20–25°C. Do not freeze or refrigerate. Protect from heat.

Use within 30 days of opening.

Tablets

Simvastatin: 5–30°C.

Simvastatin/ezetimibe fixed combination: Well-closed containers at 20–25°C.

Actions

• Prodrug requiring hydrolysis in vivo for activity.

• Inhibits HMG-CoA reductase, causing subsequent reduction in hepatic cholesterol synthesis. Reduces serum concentrations of total cholesterol, LDL-cholesterol, VLDL-cholesterol, apo B, and triglycerides.

• Other favorable (pleiotropic) effects include an antiproliferative influence on smooth muscle cells, reconstruction of endothelial activity, antioxidant, antithrombotic, anticancer, and anti-inflammatory effects.

Advice to Patients

• Advise patients of the importance of adhering to nondrug therapies and measures, including adherence to a heart-healthy diet, regular exercise, avoidance of tobacco products, and maintenance of a healthy weight.

• Advise patients of the risk of myopathy and/or rhabdomyolysis and that risk is increased with higher dosages (i.e., 80 mg daily) or when used concomitantly with certain other drugs or grapefruit juice. Advise patients to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, or if such manifestations persist after discontinuance of therapy.

• Advise patients of the risk of adverse hepatic effects and the importance of promptly reporting any symptoms suggestive of liver injury (e.g., fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice).

• Advise patients of the risk of increased glucose concentrations and development of type 2 diabetes.

• Advise patients that simvastatin tablets may be administered with or without food.

• Advise patients that simvastatin oral suspension should be administered on an empty stomach. Advise patients to shake the bottle of simvastatin oral suspension well for at least 20 seconds before measuring the dose with an accurate measuring device, not a household teaspoon.

• Advise patients that the fixed-combination preparation containing simvastatin and ezetimibe (Vytorin and generic equivalents) is administered with or without food.

• If a dose of simvastatin tablets or the fixed-combination preparation containing simvastatin and ezetimibe is missed, advise patients to take the missed dose as soon as possible; do not double the next dose.

• Advise females of reproductive potential (including adolescents) of the risk to a fetus and to use effective contraception during treatment. Advise women to contact their clinician if they become pregnant or suspect pregnancy during therapy.

• Advise women not to breastfeed during therapy. If the patient has a lipid disorder and is breast-feeding, stress the importance of contacting a clinician to discuss other antilipemic treatment options.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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Frequently asked questions

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