Rosuvastatin (Lexi-Drugs)

Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

Pronunciation

(roe soo va STAT in)

Brand Names: US

Crestor

Brand Names: Canada

ACT Rosuvastatin; AG-Rosuvastatin; APO-Rosuvastatin; Auro-Rosuvastatin; BIO-Rosuvastatin; Crestor; DOM-Rosuvastatin; JAMP-Rosuvastatin; Mar-Rosuvastatin; MED-Rosuvastatin; MINT-Rosuvastatin; MYLAN-Rosuvastatin [DSC]; PMS-Rosuvastatin; Priva-Rosuvastatin; RAN-Rosuvastatin; RIVA-Rosuvastatin; SANDOZ Rosuvastatin; TEVA-Rosuvastatin

Dosing: Adult

Note: Doses should be individualized according to the baseline LDL-cholesterol levels, the recommended goal of therapy, and patient response; adjustments should be made at intervals of 4 weeks or more.

Hyperlipidemia, mixed dyslipidemia, hypertriglyceridemia, primary dysbetalipoproteinemia: Oral:

Initial dose:

General dosing: 10 to 20 mg once daily; 20 mg once daily may be used in patients with severe hyperlipidemia (LDL >190 mg/dL) and aggressive lipid targets (McKenney 2009)

Conservative dosing: Patients requiring less aggressive treatment or predisposed to myopathy (including patients of Asian descent): 5 mg once daily

Titration: After initiation or upon titration, analyze lipid levels within 2 to 4 weeks (peak, steady-state lowering effects usually seen between 4 to 6 weeks [McKenney 2009]) and adjust dose accordingly; usual dosage range: 5 to 40 mg once daily (maximum dose: 40 mg/day)

Note: The 40 mg dose should be reserved for patients who have not achieved goal cholesterol levels on a dose of 20 mg daily, including patients switched from another HMG-CoA reductase inhibitor.

Homozygous familial hypercholesterolemia (HoFH): Oral: Initial: 20 mg once daily; after initiation or upon titration, analyze lipid levels within 2 to 4 weeks (peak, steady-state lowering effects usually seen between 4 to 6 weeks [McKenney 2009]) and adjust dose accordingly; usual dosage range: 5 to 40 mg once daily (maximum dose: 40 mg/day)

Prevention of cardiovascular disease/reduce the risk of atherosclerotic cardiovascular disease: Oral:

ACC/AHA Blood Cholesterol Guideline recommendations (ACC/AHA [Grundy 2018]; ACC/AHA [Stone 2013]):

Note: When choosing to initiate therapy and selecting dose-intensity, consider atherosclerotic cardiovascular disease (ASCVD) risk, risk enhancing factors, possibility for side effects, and drug interactions.

Primary prevention:

LDL-C ≥190 mg/dL and age 20 to 75 years: High-intensity therapy: 20 to 40 mg once daily

Diabetes, age 40 to 75 years and an estimated 10-year ASCVD risk <7.5%: Moderate-intensity therapy: 5 to 10 mg once daily

Diabetes, age 40 to 75 years and an estimated 10-year ASCVD risk ≥7.5%: High-intensity therapy: 20 to 40 mg once daily

LDL-C 70 to 189 mg/dL, age 40 to 75 years and an estimated 10-year ASCVD risk ≥7.5%: Moderate- to high-intensity therapy: 5 to 40 mg once daily

Secondary prevention:

Patient has clinical ASCVD (eg, coronary heart disease, stroke/TIA, or peripheral arterial disease presumed to be of atherosclerotic origin) or is post-CABG (AHA [Kulik 2015]) and:

Age ≤75 years: High-intensity therapy: 20 to 40 mg once daily

Age >75 years: Moderate- to high-intensity therapy: 5 to 40 mg once daily (ACC/AHA [Grundy 2018]); if a moderate-intensity dose (5 to 10 mg once daily) is started and tolerated, increase to a high-intensity dose (20 to 40 mg once daily) within 3 months (Rosenson 2019).

Not a candidate for high-intensity therapy: Moderate-intensity therapy: 5 to 10 mg once daily

US Preventive Services Task Force recommendations (USPSTF 2016): Age 40 to 75 years, no history of CVD, with ≥1 CVD risk factor (dyslipidemia, diabetes, hypertension, or smoking), and calculated 10-year CVD event risk of ≥10%:

Primary prevention: Moderate-intensity therapy: 5 to 10 mg once daily

Note: These recommendations do not pertain to patients with very high cholesterol levels (eg, LDL >190 mg/dL, familial hypercholesterolemia; were excluded from primary prevention trials); use clinical judgment in the treatment of these patients. In patients with a calculated 10-year CVD event risk of 7.5% to 10%, statin use may be considered based on patient characteristics.

Dosage adjustment for rosuvastatin with concomitant medications: Oral:

Cyclosporine: Rosuvastatin dose should not exceed 5 mg once daily

Gemfibrozil: Avoid concurrent use; if unable to avoid concurrent use, initiate rosuvastatin at 5 mg once daily (maximum: 10 mg/day)

Atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir: Initiate rosuvastatin at 5 mg once daily (maximum: 10 mg/day).

Dosage adjustment for hematuria and/or persistent, unexplained proteinuria while on 40 mg daily: Reduce dose and evaluate causes.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl <30 mL/minute/1.73 m2: Initial: 5 mg once daily (maximum: 10 mg/day).

Dosing: Hepatic Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer’s labeling; however, systemic exposure may be increased in patients with liver disease (increased AUC and Cmax); use is contraindicated in active liver disease or unexplained transaminase elevations.

Chronic liver disease: Some experts suggest starting at a low dose (eg, 5 mg once daily) and adjusting gradually based on monitoring of aminotransferase levels (Rosenson 2018)

Dosing: Adjustment for Toxicity: Adult

Severe muscle symptoms or fatigue: Promptly discontinue use; evaluate CPK, creatinine, and urinalysis for myoglobinuria (ACC/AHA [Stone 2013]).

Mild to moderate muscle symptoms: Discontinue use until symptoms can be evaluated; evaluate patient for conditions that may increase the risk for muscle symptoms (eg, hypothyroidism, reduced renal or hepatic function, rheumatologic disorders such as polymyalgia rheumatica, steroid myopathy, vitamin D deficiency, or primary muscle diseases). Upon resolution, resume the original or lower dose of rosuvastatin. If muscle symptoms recur, discontinue rosuvastatin use. After muscle symptom resolution, may then use a low dose of a different statin; gradually increase if tolerated. In the absence of continued statin use, if muscle symptoms or elevated CPK continues after 2 months, consider other causes of muscle symptoms. If determined to be due to another condition aside from statin use, may resume statin therapy at the original dose (ACC/AHA [Stone 2013]).

Dosing: Pediatric

Note: Doses should be individualized according to the baseline LDL-cholesterol levels, the recommended goal of therapy, and patient response; adjustments should be made at intervals of 4 weeks or more. A lower, conservative dosing regimen may be necessary in patient populations predisposed to myopathy, including patients of Asian descent or concurrently receiving other lipid-lowering agents (eg, gemfibrozil, niacin, fibric acid derivatives), amiodarone, atazanavir/ritonavir, cyclosporine, lopinavir/ritonavir, or indinavir (see conservative, maximum adult doses below).

Heterozygous familial hypercholesterolemia:

Children 8 to <10 years (females >1 year postmenarche): Oral: 5 to 10 mg once daily; maximum daily dose: 10 mg/day

Children ≥10 years and Adolescents (females >1 year postmenarche): Oral: 5 to 20 mg once daily; maximum daily dose: 20 mg/day

Homozygous familial hypercholesterolemia: Children ≥7 years and Adolescents: Oral: Initial dose: 20 mg once daily. Maximum daily dose in adults is 40 mg/day. Although higher doses have been used (ie, 80 mg/day), additional benefit has not been reported (Marais 2008). Note: Patients on a 40 mg daily dose who develop hematuria and/or persistent, unexplained proteinuria should have a dose reduction and diagnostic work-up for causes.

Dosing adjustment with concomitant medications: Children ≥7 years and Adolescents:

Atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir: Initiate rosuvastatin at 5 mg once daily; maximum daily dose: 10 mg/day

Cyclosporine: Do not exceed rosuvastatin maximum daily dose: 5 mg/day

Gemfibrozil: Avoid concurrent use; if unable to avoid concurrent use, initiate rosuvastatin at 5 mg once daily; maximum daily dose: 10 mg/day

Dosing adjustment for toxicity: Muscle symptoms (potential myopathy): Children ≥7 years and Adolescents: Discontinue use until symptoms can be evaluated; check creatine phosphokinase (CPK) level; based on experience in adult patients, also evaluate patient for conditions that may increase the risk for muscle symptoms (eg, hypothyroidism, reduced renal or hepatic function, rheumatologic disorders such as polymyalgia rheumatica, steroid myopathy, vitamin D deficiency, or primary muscle diseases). Upon resolution (symptoms and any associated CPK abnormalities), resume the original or consider a lower dose of rosuvastatin and retitrate. If muscle symptoms recur, discontinue rosuvastatin use. After muscle symptom resolution, may then reinitiate a different statin at an initial low dose; gradually increase if tolerated. Based on experience in adult patients, if muscle symptoms or elevated CPK persists for 2 months in the absence of continued statin use, consider other causes of muscle symptoms. If determined to be due to another condition aside from statin use, may resume statin therapy at the original dose (NHLBI 2011; Stone 2013).

Dosing: Renal Impairment: Pediatric

Children ≥7 years and Adolescents:

CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment required.

CrCl <30 mL/minute/1.73 m2 and not receiving hemodialysis: Initial: 5 mg once daily; maximum daily dose: 10 mg/day

Dosing: Hepatic Impairment: Pediatric

All patients: There are no dosage adjustments provided in the manufacturer’s labeling; systemic exposure (increased AUC and Cmax) may be increased in patients with liver disease; use is contraindicated in patients with active liver disease or unexplained transaminase elevations.

Use: Labeled Indications

Familial hypercholesterolemia:

Pediatric (excluding Ezallor): Adjunct to diet to reduce total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apo B) levels in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesteremia (HeFH) if after an adequate trial of diet therapy the following findings are present: LDL-C more than 190 mg/dL or more than 160 mg/dL and there is a positive family history of premature cardiovascular (CV) disease or 2 or more other CV disease risk factors; to reduce LDL-C, total-C, nonhigh-density lipoprotein cholesterol (non-HDL-C) and apo B in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH), either alone or with other lipid-lowering treatments (eg, LDL apheresis).

Adult: To reduce LDL-C, total cholesterol, and apo B in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are unavailable.

Hyperlipidemia and mixed dyslipidemia (Crestor only): Adjunctive therapy to diet to reduce elevated total cholesterol, LDL-C, apo B, non-HDL-C, and triglyceride levels, and to increase HDL-C in adults with primary hyperlipidemia or mixed dyslipidemia.

Hypertriglyceridemia: Adjunct to diet for the treatment of adults with hypertriglyceridemia.

Primary dysbetalipoproteinemia (type III hyperlipoproteinemia): Adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia (type III hyperlipoproteinemia).

Prevention of cardiovascular disease (Crestor only):

Primary prevention: To reduce the risk of stroke, myocardial infarction, or arterial revascularization procedures in patients without clinically evident coronary heart disease but with all of the following: 1) an increased risk of cardiovascular disease based on age ≥50 years old in men and ≥60 years old in women, 2) hsCRP ≥2 mg/L, and 3) the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.

Secondary prevention: Adjunctive therapy to diet to slow the progression of atherosclerosis in adults as part of a treatment strategy to lower total cholesterol and LDL-C to target levels.

Use: Off-Label: Adult

  Cardiac risk reduction for noncardiac surgery (perioperative therapy)Level of Evidence [G]

Based on the 2014 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery, perioperative initiation of statins is reasonable for patients undergoing vascular surgery and may be considered in patients with clinical indications according to guideline-directed medical therapy who are undergoing elevated risk procedures. In patients undergoing non-cardiac surgery who are currently receiving a statin, the statin should be continued.

  Noncardioembolic stroke/Transient ischemic attack (secondary prevention)Level of Evidence [G]

Based on the American Heart Association/American Stroke Association (AHA/ASA) guidelines for the prevention of stroke in patients with stroke and transient ischemic attack (TIA), statin therapy with intensive lipid-lowering effects is recommended to reduce the risk of recurrent stroke and future cardiovascular events in patients with ischemic stroke or TIA presumed to be of atherosclerotic origin who have an LDL-C concentration ≥100 mg/dL (with or without evidence for other clinical atherosclerotic cardiovascular disease [ASCVD]) or who have an LDL-C concentration <100 mg/dL (without evidence for other clinical ASCVD).

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Coronary Artery Bypass Graft Surgery:

“AHA Scientific Statement, Secondary Prevention After Coronary Artery Bypass Graft Surgery,” February 2015

AHA/ACC/HRS, “2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation,” March 2014

Diabetes Mellitus:

AACE/ACE, “Consensus Statement on the Comprehensive Type 2 Diabetes Management Algorithm- 2019 Executive Summary,” January 2019

American Diabetes Association, “Standards of Medical Care in Diabetes – 2019,” January 2019

Diabetes Canada, “Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada,” 2018

Dyslipidemia:

AACE/ACE, “Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease,” April 2017

ACC/AHA, “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults,” November 2013

AHA/ACC, “Guideline on the Management of Blood Cholesterol,” November 2018

Canadian Cardiovascular Society, “2012 Update of the Canadian Cardiovascular Society Guidelines for the Diagnosis and Treatment of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult,” 2012

NLA, “National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia” Part 1: April 2015; Part 2: December 2015

The Endocrine Society, “Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline,” September 2012

The Kidney Disease: Improving Global Outcomes (KDIGO), “Lipid Management in Chronic Kidney Disease: Synopsis of the Kidney Disease: Improving Global Outcomes 2013 Clinical Practice Guideline,” December 2013

Ischemic Heart Disease:

ACC/AHA/AATS/PCNA/SCAI/STS, “2014 Focused Update of the Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” July 2014

ACCF/AHA/ACP/AATS/PCNA/SCAI/STS, “2012 Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” November 2012

Non-ST-Elevation Acute Coronary Syndromes:

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes,” September 2014

Stroke:

AHA/ASA, “Guidelines for Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack,” May 2014.

“Guidelines for the Primary Prevention of Stroke,” December 2010

Surgery:

ACC/AHA, “2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery,” August 2014

Administration: Oral

Capsule:

Oral: Administer with or without food. May be taken at any time of the day. Swallow capsule whole; do not crush or chew. Capsule may be opened and contents emptied onto 1 teaspoonful of applesauce; swallow immediately without chewing.

Nasogastric tube: Capsule may be opened and contents emptied into a 60 mL catheter tipped syringe. Add 40 mL of water, then replace plunger and shake syringe vigorously for 15 seconds. Attach syringe to a ≥16-French NG tube and administer contents; flush NG tube with additional 20 mL of water. Mixture must be used immediately after preparation.

Tablet: Administer with or without food. May be taken at any time of the day; swallow tablet whole.

Administration: Pediatric

Oral: May be taken with or without food; may be taken at any time of the day; swallow tablet whole.

Dietary Considerations

Red yeast rice contains variable amounts of several compounds that are structurally similar to HMG-CoA reductase inhibitors, primarily monacolin K (or mevinolin) which is structurally identical to lovastatin; concurrent use of red yeast rice with HMG-CoA reductase inhibitors may increase the incidence of adverse and toxic effects (Lapi 2008; Smith 2003).

Storage/Stability

Capsule: Store between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.

Tablet: Store between 20°C and 25°C (68°F to 77°F). Protect from moisture.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, abdominal pain, nausea, joint pain, or weakness. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), hematuria, urinary retention, change in amount of urine passed, muscle pain, muscle tenderness, or muscle weakness (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to rosuvastatin or any component of the formulation; active liver disease; unexplained persistent elevations of serum transaminases; pregnancy; breastfeeding.

Canadian labeling: Additional contraindications (not in US labeling): Concomitant administration of cyclosporine; use of 40 mg dose in Asian patients, patients with predisposing risk factors for myopathy/rhabdomyolysis (eg, hereditary muscle disorders, history of myotoxicity with other HMG-CoA reductase inhibitors, concomitant use with fibrates or niacin, severe hepatic impairment, severe renal impairment [CrCl <30 mL/minute/1.73 m2], hypothyroidism, alcohol abuse, situations where an increase in rosuvastatin plasma levels may occur)

Warnings/Precautions

Concerns related to adverse effects:

• Diabetes mellitus: Small increases in HbA1c (mean: ~0.1%) and fasting blood glucose have been reported with rosuvastatin; however, the benefits of statin therapy far outweigh the risk of dysglycemia.

• Hematuria/proteinuria: Hematuria (microscopic) and proteinuria have been observed; more commonly reported in adults receiving rosuvastatin 40 mg daily. Typically, transient and not associated with a decrease in renal function. Consider dosage reduction if unexplained hematuria and proteinuria persists.

• Hepatotoxicity: Postmarketing reports of fatal and nonfatal hepatic failure are rare. If serious hepatotoxicity with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, interrupt therapy. If an alternate etiology is not identified, do not restart rosuvastatin. Liver enzyme tests should be obtained at baseline and as clinically indicated; routine periodic monitoring of liver enzymes is not necessary.

• Hypersensitivity: Hypersensitivity reactions, including rash, pruritus, urticaria, and angioedema, have been reported.

• Myopathy/rhabdomyolysis: Rhabdomyolysis with acute renal failure secondary to myoglobinuria and/or myopathy have been reported; patients should be monitored closely. This risk is dose-related and is increased with concurrent use of strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, protease inhibitors), cyclosporine, fibric acid derivatives (eg, gemfibrozil), or niacin (doses ≥1 g/day); if concurrent use is warranted, consider lower starting and maintenance doses of rosuvastatin. Use caution in patients with inadequately treated hypothyroidism, patients taking other drugs associated with myopathy (eg, colchicine), ≥65 years of age, and women; these patients are predisposed to myopathy. Immune-mediated necrotizing myopathy (IMNM) associated with HMG-CoA reductase inhibitors use has also been reported. Patients should be instructed to report unexplained muscle pain, tenderness, weakness, or brown urine, particularly if accompanied by malaise or fever. Discontinue therapy if markedly elevated CPK levels occur or myopathy is diagnosed/suspected.

Disease-related concerns:

• Hepatic impairment and/or ethanol use: Use with caution in patients who consume large amounts of ethanol or have a history of liver disease. Use is contraindicated with active liver disease or unexplained transaminase elevations.

• Renal impairment: Dosage adjustment required in patients with a CrCl <30 mL/minute/1.73 m2 and not receiving hemodialysis.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Asian population: Increased risk of rosuvastatin-associated myopathy in certain subgroups; dosage adjustment should be considered for patients of Asian descent.

• Elderly: Use with caution in patients with advanced age; these patients are more predisposed to myopathy.

• Surgical patients: The manufacturer recommends temporary discontinuation for elective major surgery, acute medical or surgical conditions, or in any patient experiencing an acute or serious condition predisposing to renal failure (eg, sepsis, hypotension, trauma, uncontrolled seizures). Based on current research and clinical guidelines, HMG-CoA reductase inhibitors should be continued in the perioperative period for noncardiac and cardiac surgery (ACC/AHA [Fleisher 2014]; ACC/AHA [Hillis 2011]). Perioperative discontinuation of statin therapy is associated with an increased risk of cardiac morbidity and mortality.

Other warnings/precautions:

• Appropriate use: Secondary causes of hyperlipidemia should be ruled out prior to therapy. Rosuvastatin has not been studied when the primary lipid abnormality is chylomicron elevation (Fredrickson types I and V).

Geriatric Considerations

Effective and well tolerated in the elderly, although age ≥65 years is a risk factor for myopathy. The definition of and, therefore, when to treat hyperlipidemia in the elderly is a controversial issue. According to the ACC/AHA, high-intensity statin doses are indicated for patients <75 years of age with existing clinical atherosclerotic cardiovascular disease (ASCVD); patients without clinical ASCVD if LDL-C is >190 mg/dL; patients without clinical ASCVD who are 40-75 years with type 1 or type 2 diabetes and with an estimated 10-year ASCVD risk ≥7.5%. Patients 40-75 years with a 10-year ASCVD risk >7.5% are candidates for moderate- to high-intensity statin therapy. Patients >75 years with existing clinical ASCVD are candidates for moderate-intensity statin doses. There are no data or recommendations on managing patients >75 years without clinical ASCVD who have type 1 or 2 diabetes or with a 10-year risk of ASCVD >7.5% (with or without diabetes) (Stone 2013). It is the authors’ belief that pharmacologic treatment be reserved for those whom the benefits of treatment are believed to outweigh the potential adverse effects, drug interactions, and cost of treatment.

Pregnancy Considerations

Rosuvastatin is contraindicated in pregnant females or those who may become pregnant.

Adverse events have been observed in some animal reproduction studies. There are reports of congenital anomalies following maternal use of HMG-CoA reductase inhibitors in pregnancy; however, maternal disease, differences in specific agents used, and the low rates of exposure limit the interpretation of the available data (Godfrey 2012; Lecarpentier 2012). Cholesterol biosynthesis may be important in fetal development; serum cholesterol and triglycerides increase normally during pregnancy. The discontinuation of lipid lowering medications temporarily during pregnancy is not expected to have significant impact on the long term outcomes of primary hypercholesterolemia treatment.

Rosuvastatin should be discontinued immediately if an unplanned pregnancy occurs during treatment.

Adequate contraception is recommended if an HMG-CoA reductase inhibitor is required in females of reproductive potential. Females planning a pregnancy should discontinue the HMG-CoA reductase inhibitor 1 to 2 months prior to attempting to conceive (AHA/ACC [Grundy 2018]).

Breast-Feeding Considerations

Rosuvastatin is present in breast milk (limited data). Due to the potential for serious adverse reactions in a breastfed infant, use while breastfeeding is contraindicated by the manufacturer.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%: Neuromuscular & skeletal: Myalgia (2% to 13%)

1% to 10%:

Central nervous system: Headache (6% to 9%), dizziness (4%)

Endocrine & metabolic: Diabetes mellitus (new onset: 3%)

Gastrointestinal: Nausea (4% to 6%), constipation (3% to 5%)

Genitourinary: Cystitis (interstitial; Huang 2015)

Hepatic: Increased serum ALT (2%; >3 times ULN)

Neuromuscular & skeletal: Arthralgia (4% to 10%), increased creatine phosphokinase (3%; >10 x ULN: Children 3%), weakness (5%)

<1%, postmarketing, and/or case reports: Abnormal thyroid function test, cognitive dysfunction (reversible; includes amnesia, confusion, memory impairment), depression, elevated glycosylated hemoglobin (HbA1c), gynecomastia, hematuria (microscopic), hepatic failure, hepatitis, hypersensitivity reaction (including angioedema, pruritus, skin rash, urticaria), immune-mediated necrotizing myopathy, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased serum bilirubin, increased serum glucose, increased serum transaminases, interstitial pulmonary disease, jaundice, myoglobinuria, myopathy, myositis, pancreatitis, peripheral neuropathy, proteinuria (dose related), renal failure, rhabdomyolysis, sleep disorder (including insomnia and nightmares), thrombocytopenia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of BCRP/ABCG2, CYP2C9 (minor), CYP3A4 (minor), OATP1B1/1B3 (SLCO1B1/1B3); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Acipimox: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Antacids: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Apalutamide: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Asunaprevir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Bezafibrate: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Bezafibrate may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). More specifically, bezafibrate may increase the serum concentration of fluvastatin Management: Monitor patients closely for myopathy with concomitant use of bezafibrate and HMG-CoA reductase inhibitors. Concomitant use is contraindicated in patients predisposed to myopathy and alternative therapy should be considered. Risk D: Consider therapy modification

CarBAMazepine: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Ciprofibrate: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Management: Avoid the use of HMG-CoA reductase inhibitors and ciprofibrate if possible. If concomitant therapy is considered, benefits should be carefully weighed against the risks, and patients should be monitored closely for signs/symptoms of muscle toxicity. Risk D: Consider therapy modification

Clopidogrel: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Cobicistat: May increase the serum concentration of Rosuvastatin. Management: Rosuvastatin dose should not exceed 10 mg/day with concurrent use of atazanavir and cobicistat or 20 mg/day with concurrent use of darunavir and cobicistat. Risk D: Consider therapy modification

Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Colchicine may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk D: Consider therapy modification

CycloSPORINE (Systemic): May increase the serum concentration of Rosuvastatin. Management: Limit rosuvastatin to 5 mg/day in patients who are also receiving cyclosporine. Canadian labeling contraindicates concomitant use of rosuvastatin with cyclosporine. Risk D: Consider therapy modification

Daclatasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

DAPTOmycin: HMG-CoA Reductase Inhibitors (Statins) may enhance the adverse/toxic effect of DAPTOmycin. Specifically, the risk of skeletal muscle toxicity may be increased. Management: Consider temporarily stopping HMG-CoA reductase inhibitor therapy prior to daptomycin. If used together, regular (i.e., at least weekly) monitoring of CPK concentrations is recommended. Risk D: Consider therapy modification

Dasabuvir: May increase the serum concentration of Rosuvastatin. Management: Limit the rosuvastatin dose to a maximum of 10 mg per day when used with the ombitasvir/paritaprevir/ritonavir/dasabuvir combination product. Labeling outside of the US recommends limiting the rosuvastatin dose to 5 mg per day. Risk D: Consider therapy modification

Dronedarone: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Elagolix: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Elbasvir: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to a maximum of 10 mg/day when used together with elbasvir and grazoprevir. Monitor closely for evidence of statin-related toxicities such as myalgia or myopathy. Risk D: Consider therapy modification

Eltrombopag: May increase the serum concentration of Rosuvastatin. Management: Consideration a preventive 50% reduction in rosuvastatin adult dose when starting this combination; Canadian labeling recommends limiting rosuvastatin to a maximum of 20 mg/day. Risk D: Consider therapy modification

Eluxadoline: May increase the serum concentration of Rosuvastatin. Management: Use the lowest effective dose of rosuvastatin if combined with eluxadoline. Risk D: Consider therapy modification

Eslicarbazepine: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Fostamatinib: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Fusidic Acid (Systemic): May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for muscle toxicities, including rhabdomyolysis may be significantly increased. Management: Avoid concurrent use whenever possible. Use is listed as contraindicated in product characteristic summaries in several countries, although UK labeling suggests that use could be considered under exceptional circumstances and with close supervision. Risk X: Avoid combination

Gemfibrozil: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Gemfibrozil may increase the serum concentration of Rosuvastatin. Management: If possible, avoid concomitant use of rosuvastatin with gemfibrozil. If concomitant can not be avoided, limit rosuvastatin to 10 mg/day (US recommendation) or 20 mg/day (Canadian recommendation). Monitor for signs/symptoms of rhabdomyolysis. Risk X: Avoid combination

Glecaprevir and Pibrentasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest statin dose possible if combined with glecaprevir/pibrentasvir and monitor for increased statin effects/toxicities. Avoid concomitant use with atorva-, simva-, or lovastatin. Limit rosuvastatin to 10 mg daily and reduce pravastatin dose 50% Risk D: Consider therapy modification

Grazoprevir: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to a maximum of 10 mg/day when used together with elbasvir and grazoprevir. Monitor closely for evidence of statin-related toxicities such as myalgia or myopathy. Risk D: Consider therapy modification

Itraconazole: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Lanthanum: HMG-CoA Reductase Inhibitors (Statins) may decrease the serum concentration of Lanthanum. Management: Administer HMG-CoA reductase inhibitors at least two hours before or after lanthanum. Risk D: Consider therapy modification

Ledipasvir: May increase the serum concentration of Rosuvastatin. Risk X: Avoid combination

Letermovir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Niacin: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Risk C: Monitor therapy

Niacinamide: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May increase the serum concentration of Rosuvastatin. Management: Limit the rosuvastatin dose to a maximum of 10 mg per day when used with the ombitasvir/paritaprevir/ritonavir/dasabuvir combination product. Canadian labeling recommends limiting the rosuvastatin dose to 5 mg per day. Risk D: Consider therapy modification

Osimertinib: May increase the serum concentration of BCRP/ABCG2 Substrates. Risk C: Monitor therapy

PAZOPanib: HMG-CoA Reductase Inhibitors (Statins) may enhance the hepatotoxic effect of PAZOPanib. Specifically, the risk for increased serum transaminase concentrations may be increased. Management: Simvastatin is specifically implicated in the interaction. There is a lack of data regarding risk with other statins, but caution appears warranted with any statins. Atorvastatin should be avoided due to P-gp inhibition. Risk C: Monitor therapy

Protease Inhibitors: May increase the serum concentration of Rosuvastatin. Management: Start at the lowest rosuvastatin dose and monitor for toxicity. See full drug interaction monograph for details. Risk D: Consider therapy modification

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Red Yeast Rice: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk X: Avoid combination

Regorafenib: May increase the serum concentration of BCRP/ABCG2 Substrates. Risk C: Monitor therapy

Repaglinide: HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Repaglinide. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Rolapitant: May increase the serum concentration of BCRP/ABCG2 Substrates. Management: Monitor patients receiving rolapitant for increased exposure to and/or effects of BCRP/ABCG2 substrates. Use the lowest effective rosuvastatin dose when used in combination with rolapitant. Risk C: Monitor therapy

Rupatadine: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for increased CPK and/or other muscle toxicities may be increased.Risk C: Monitor therapy

Simeprevir: May increase the serum concentration of Rosuvastatin. Management: Limit initial rosuvastatin dose to 5 mg/day when being started in a patient who is also being treated with simeprevir. The maximum rosuvastatin dose should not exceed 10 mg/day with concurrent use of simeprevir. Risk D: Consider therapy modification

Tedizolid: May increase the serum concentration of BCRP/ABCG2 Substrates. Risk C: Monitor therapy

Teriflunomide: May increase the serum concentration of Rosuvastatin. Management: Limit the maximum adult rosuvastatin dose to 10 mg/day in patients receiving teriflunomide, and monitor for evidence of rosuvastatin toxicity (eg, muscle toxicity, elevated transaminase concentrations). Risk D: Consider therapy modification

Tolvaptan: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. Risk D: Consider therapy modification

Tolvaptan: May increase the serum concentration of BCRP/ABCG2 Substrates. Risk D: Consider therapy modification

Trabectedin: HMG-CoA Reductase Inhibitors (Statins) may enhance the myopathic (rhabdomyolysis) effect of Trabectedin. Risk C: Monitor therapy

Velpatasvir: May increase the serum concentration of Rosuvastatin. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): HMG-CoA Reductase Inhibitors (Statins) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Voxilaprevir: May increase the serum concentration of Rosuvastatin. Risk X: Avoid combination

Monitoring Parameters

ACC/AHA Blood Cholesterol Guideline recommendations (ACC/AHA [Grundy 2018]; ACC/AHA [Stone 2013]):

Lipid panel (total cholesterol, HDL, LDL, triglycerides): Lipid profile (fasting or nonfasting) before initiating treatment. Fasting lipid profile should be rechecked 4 to 12 weeks after starting therapy and every 3 to 12 months thereafter. If 2 consecutive LDL levels are <40 mg/dL, consider decreasing the dose.

Hepatic transaminase levels: Baseline measurement of hepatic transaminase levels (ie, AST and ALT); measure AST, ALT, total bilirubin, and alkaline phosphatase if symptoms suggest hepatotoxicity (eg, unusual fatigue or weakness, loss of appetite, abdominal pain, dark-colored urine or yellowing of skin or sclera) during therapy.

CPK: CPK should not be routinely measured. Baseline CPK measurement is reasonable for some individuals (eg, family history of statin intolerance or muscle disease, clinical presentation, concomitant drug therapy that may increase risk of myopathy). May measure CPK in any patient with symptoms suggestive of myopathy (pain, tenderness, stiffness, cramping, weakness, or generalized fatigue).

Evaluate for new-onset diabetes mellitus during therapy; if diabetes develops, continue statin therapy and encourage adherence to a heart-healthy diet, physical activity, a healthy body weight, and tobacco cessation.

If patient develops a confusional state or memory impairment, may evaluate patient for nonstatin causes (eg, exposure to other drugs), systemic and neuropsychiatric causes, and the possibility of adverse effects associated with statin therapy.

Reference Range

Treatment goals: May vary depending on clinical condition, different clinical practice guidelines and expert opinion. Refer to clinical practice guidelines for specific treatment goals.

Advanced Practitioners Physical Assessment/Monitoring

Rule out secondary causes of hyperlipidemia prior to initiation. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. Obtain liver enzyme tests prior to therapy and as needed. Obtain CPK when myopathy is considered or in high-risk patients. Follow-up with lipid panel within 2 to 4 weeks of initiation or titration.

Nursing Physical Assessment/Monitoring

Check ordered labs and report and abnormalities. Monitor for and educate patient to report signs and symptoms of myopathy (muscle pain, weakness, fatigue). Consider dietary assessment and plan for teaching.

Product Availability

Ezallor (rosuvastatin capsules): FDA approved December 2018; anticipated availability is currently unknown. Consult the prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Crestor: 5 mg, 10 mg, 20 mg, 40 mg

Generic: 5 mg, 10 mg, 20 mg, 40 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Crestor: 5 mg, 10 mg, 20 mg, 40 mg

Generic: 5 mg, 10 mg, 20 mg, 40 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C10AA07
Generic Available (US)

Yes

Pricing: US

Tablets (Crestor Oral)

5 mg (per each): $10.44

10 mg (per each): $10.44

20 mg (per each): $10.44

40 mg (per each): $10.44

Tablets (Rosuvastatin Calcium Oral)

5 mg (per each): $0.04 – $8.95

10 mg (per each): $0.07 – $8.95

20 mg (per each): $0.09 – $8.95

40 mg (per each): $0.12 – $8.95

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme in cholesterol synthesis (reduces the production of mevalonic acid from HMG-CoA); this then results in a compensatory increase in the expression of LDL receptors on hepatocyte membranes and a stimulation of LDL catabolism. In addition to the ability of HMG-CoA reductase inhibitors to decrease levels of high-sensitivity C-reactive protein (hsCRP), they also possess pleiotropic properties including improved endothelial function, reduced inflammation at the site of the coronary plaque, inhibition of platelet aggregation, and anticoagulant effects (de Denus 2002; Ray 2005).

Pharmacodynamics/Kinetics

Note: In pediatric patients (10 to 17 years of age), maximum serum concentration and AUC have been shown to be similar to adult values

Onset of action: Within 1 week; maximal at 4 weeks

Distribution: Vd: 134 L

Protein binding: 88%

Metabolism: Hepatic (10%), via CYP2C9 (1 active metabolite identified: N-desmethyl rosuvastatin, one-sixth to one-half the HMG-CoA reductase activity of the parent compound)

Bioavailability: 20% (high first-pass extraction by liver)

Half-life elimination: 19 hours

Time to peak, plasma: 3 to 5 hours

Excretion: Feces (90%), primarily as unchanged drug

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Plasma concentrations increase about 3-fold in patients with severe renal impairment (CrCl <30 mL/minute/1.73 m2) not requiring hemodialysis. Steady-state plasma concentrations in patients on chronic hemodialysis are ~50% higher compared with patients with normal renal function.

Hepatic function impairment: Cmax and AUC are increased in patients with Child-Pugh class A or Child-Pugh class B hepatic impairment.

Race: Asian patients have ~2-fold elevation in exposure (AUC and Cmax).

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Assess unusual presentations of muscle weakness or myopathy resulting from lipid therapy such as patient having a difficult time brushing teeth or weakness with chewing. Refer patient back to their physician for evaluation and adjustment of lipid therapy.

Effects on Bleeding

No information available to require special precautions

Index Terms

Ezallor; Rosuvastatin Calcium

FDA Approval Date
August 12, 2003
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Brand Names: International

Advochol (EG); Alvostat (SG); Astende (EC); Cemicresto (EG); Clivas (UA); Creazin (KR); Cresadex (EC); Crestat (LK); Crestor (AE, AR, AT, AU, BB, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CN, CO, CR, CY, CZ, DK, DO, EC, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GT, GY, HK, HN, HR, ID, IE, IL, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LR, LT, LU, LV, MA, ML, MR, MT, MU, MW, MX, NE, NG, NI, NL, NO, NZ, PA, PE, PH, PL, PR, PT, PY, QA, RO, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, SR, SV, TH, TN, TR, TT, TW, TZ, UA, UG, UY, VE, VN, ZA, ZM, ZW); Creva (BD); Delorin (VN); Devastin (VN); Fortius (IN); Justechol (EG); K-Zuva (TH); Lipichek (PH); Merovast (VN); Neustatin-R (KR); Recansa (ID); Robestar (ET, ID); Rolip (PK); Romazic (LV); Rosart (UA); Rosca (LK); Rosetor (BD); Rossuwell (VN); Rostab (BD); Rostatin (TH); Rostin (ID, KR); Rosu (LK); Rosucard (MT, SG); Rosucol (EC, PH); Rosucor (ET); Rosucrest (ZW); Rosufer (ID); Rosugrix (TH); Rosunor (BD); Rosuterol (KR); Rosuva (IE); Rosuvas (LB); Rosuvaz (PH); Rosuxl (HK); Roswin (PH); Roswiss (LK); Rotip (TW); Rotorlip (VN); Rovartal (CR, DO, GT, HN, NI, PA, PY, SV); Rovas (ZW); Rovasto (KR); Rovastor (TH); Rovasyn (LV); Rovatitan (KR); Rovetin (KR); Rovista (PH, PK); Rovitan (KR); Rozavas (BD); Rozinin (TW); Rupilip (MX); Rustor (PH); Ruxicol (CR, DO, GT, HN, NI, PA, SV); RVS (LK); Sinlip (PY); Softan (CN); Statinor (ZW); Stator (IL); Surotin (TH); Tintaros (MT); Toreza (CR, DO, GT, HN, NI, PA, SV); Vaptor (VN); Vastrol (ID); Visacor (NZ); Vivacor (BR, KR, SG); Zyrova (PH)

Rosuvastatin (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(roe soo va STAT in)

Brand Names: US

Crestor

Brand Names: Canada

ACT-Rosuvastatin; Apo-Rosuvastatin; Crestor; Dom-Rosuvastatin; Jamp-Rosuvastatin; Mar-Rosuvastatin; Med-Rosuvastatin; Mint-Rosuvastatin; Mylan-Rosuvastatin; PMS-Rosuvastatin; RAN-Rosuvastatin; Riva-Rosuvastatin; Sandoz-Rosuvastatin; Teva-Rosuvastatin

What is this drug used for?
  • It is used to lower bad cholesterol and raise good cholesterol (HDL).
  • It is used to lower triglycerides.
  • It is used to slow the progress of heart disease.
  • It is used in some people to lower the chance of heart attack, stroke, and certain heart procedures.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to rosuvastatin or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Active liver disease or a rise in liver enzymes.
  • If you are taking gemfibrozil.
  • If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
  • If you are breast-feeding. Do not breast-feed while you take this drug.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • High blood sugar has happened with this drug. This includes diabetes that is new or worse. Talk with the doctor.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Follow the diet and workout plan that your doctor told you about.
  • Avoid or limit drinking alcohol to less than 3 drinks a day. Drinking too much alcohol may raise your chance of liver disease.
  • Take antacids that have aluminum or magnesium in them at least 2 hours after taking this drug.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • If you are of Asian descent, use this drug with care. You could have more side effects.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Use birth control that you can trust to prevent pregnancy while taking this drug.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Blood in the urine.
  • Not able to pass urine or change in how much urine is passed.
  • This drug may cause muscle pain, tenderness, or weakness. Sometimes, a very bad muscle problem may happen that may lead to kidney problems. Rarely, deaths have happened in people who get these problems when taking drugs like this one. Call your doctor right away if you have muscle pain, tenderness, or weakness that is not normal (with or without fever or feeling out of sorts). Call your doctor right away if you have muscle signs that last after your doctor has told you to stop taking this drug.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Belly pain.
  • Upset stomach.
  • Joint pain.
  • Weakness.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take this drug at the same time of day.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • Take with or without food.
  • Tablets:
  • Swallow whole with some water or other drink.
  • Capsules:
  • Swallow whole. Do not chew or crush.
  • If you cannot swallow this drug whole, you may sprinkle the contents on applesauce. If you do this, swallow the mixture right away without chewing.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or within 12 hours of each other.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Rosuvastatin (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(roe soo va STAT in)

Brand Names: US

Crestor

Brand Names: Canada

ACT-Rosuvastatin; Apo-Rosuvastatin; Crestor; Dom-Rosuvastatin; Jamp-Rosuvastatin; Mar-Rosuvastatin; Med-Rosuvastatin; Mint-Rosuvastatin; Mylan-Rosuvastatin; PMS-Rosuvastatin; RAN-Rosuvastatin; Riva-Rosuvastatin; Sandoz-Rosuvastatin; Teva-Rosuvastatin

What is this drug used for?
  • It is used to lower bad cholesterol and raise good cholesterol (HDL).
  • It is used to lower triglycerides.
  • It may be given to your child for other reasons. Talk with the doctor.
  • Capsules:
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: Active liver disease or a rise in liver enzymes.
  • If your child is taking gemfibrozil.
  • If your child is pregnant:
  • Do not give this drug to your child if she is pregnant.
  • If your child is breast-feeding a baby:
  • Be sure your child does not breast-feed a baby while taking this drug.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • High blood sugar has happened with this drug. This includes diabetes that is new or worse. Talk with the doctor.
  • Have your child’s blood sugar checked as you have been told by your child’s doctor.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
  • Have your child follow the diet and workout plan your child’s doctor told you about.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Give antacids that have aluminum or magnesium in them at least 2 hours after giving this drug.
  • If your child is taking warfarin, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
  • If your child is of Asian descent, use this drug with care. Your child could have more side effects.
  • If your child is or may be sexually active:
  • Have your child use birth control to prevent pregnancy while taking this drug.
  • If your child is pregnant:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Blood in the urine.
  • Not able to pass urine or change in how much urine is passed.
  • This drug may cause muscle pain, tenderness, or weakness. Sometimes, a very bad muscle problem may happen that may lead to kidney problems. Rarely, deaths have happened in people who get these problems when taking drugs like this one. Call the doctor right away if your child has muscle pain, tenderness, or weakness that is not normal (with or without fever or feeling out of sorts). Call the doctor right away if your child has muscle signs that last after the doctor has told you to stop giving this drug.
  • Liver problems have rarely happened with this drug. Sometimes, this has been deadly. Call your child’s doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Belly pain.
  • Upset stomach.
  • Joint pain.
  • Weakness.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug at the same time of day.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • To gain the most benefit, do not miss giving your child doses.
  • Give this drug with or without food.
  • Have your child swallow whole with some water or other drink.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or within 12 hours of each other.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.