Names and pronunciation
(roe-soo′va-sta-tin) Crestor, Ezallor Sprinkle
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Individual generic drug information
Extracted information for rosuvastatin only.
(roe-soo′va-sta-tin) Crestor, Ezallor Sprinkle
Source page 1183
Func. class.: Antilipemic
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Chem. class.: HMG-CoA reductase inhibitor R
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ACTION: Inhibits HMG-CoA reductase enzyme, which reduces cholesterol synthesis
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USES: As an adjunct for primary hypercholesterolemia (types IIa, IIb) and mixed dyslipidemia, elevated serum triglycerides, homozygous/heterozygous familial hypercholesterolemia (FH), slowing of atherosclerosis, CV disease prophylaxis, MI, stroke prophylaxis (normal LDL)
Source page 1183
Extracted information for rosuvastatin only.
CONTRAINDICATIONS: Preg- nancy, breastfeeding, hypersensitivity, active hepatic disease Precautions: Children <10 yr, geriatric patients, past hepatic disease, alcoholism, severe acute infections, trauma, hypoten- sion, uncontrolled seizure disorders, severe metabolic disorders, electrolyte imbalances, severe renal impairment, hypothyroidism, Asian patients
Source pages 1183, 1184
SIDE EFFECTS CNS: Headache, dizziness, insomnia, paresthesia, confusion GI: Nausea, constipation, abdominal pain, flatus, diarrhea, dyspepsia, heartburn, kidney failure, liver dysfunc- tion, vomiting HEMA: Thrombocytopenia, hemolytic anemia, leukopenia INTEG: Rash, pruritus MS: Asthenia, muscle cramps, arthri- tis, arthralgia, myalgia, myositis, rhab- domyolysis; leg, shoulder, or localized pain
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INTERACTIONS Increase: Toxicity—cyclosporine, do not use together • Do not exceed 20 mg/day when used with clopidogrel, eltrombopag, dronedar- one, itraconazole Increase: hepatotoxicity—alcohol Increase: myalgia, myositis, rhabdomy- olysis—cycloSPORINE, gemfibrozil, nia- cin, clofibrate, azole antifungals, antiret- roviral protease inhibitors, fibric acid derivatives Increase: bleeding risk—warfarin Drug/Lab Test Increase: LFTs
Source page 1184
Extracted information for rosuvastatin only.
DOSAGE AND ROUTES Hypercholesterolemia, hyperlipo- proteinemia, and/or hypertriglyceri- demia • Adult: PO 10 mg/day as usual start- ing dose; 5 mg/day in those requiring less aggressive LDL cholesterol reduc- tions, in patients with CrCl <30 mL/min, or in patients at higher risk for myopa- thy; range 5-40 mg/day For slowing the progression of ath- erosclerosis • Adult: PO 10 mg/day as usual starting dose; initially 5 mg/day in those requir- ing less aggressive LDL cholesterol re- ductions, in patients with CCr <30 mL/ min, or in patients at higher risk for my- opathy; range 5-40 mg/day Primary prevention of cardiovascu- lar disease • Adult: PO 10-20 mg/day as usual start- ing dose; range 5-40 mg/day Renal dose • Adult: PO CCr <30 mL/min, initially, 5 mg/day in those not receiving dialysis; max 10 mg/day Available forms Sprinkle capsule 5, 10, 20, 40 mg; tablet 40 mg Administer • May be taken at any time of day, with/ without food • Store in cool environment in airtight, light-resistant container
Source page 1184
Extracted information for rosuvastatin only.
Assess: • Diet; obtain diet history including fat, cholesterol in diet • Fasting cholesterol, LDL, HDL, triglyc- erides at baseline and q4-6wk, then peri- odically • Liver function: LFTs at baseline, then if clinically indicated; AST, ALT, LFTs may increase • Renal function in patients with com- promised renal system: BUN, creatinine, I&O ratio • Rhabdomyolysis: muscle pain, ten- derness, obtain CPK; if these occur, product may need to be discontinued; for patients with Asian ancestry: increased blood levels, rhabdomyolysis • Pregnancy/breastfeeding: do not use in pregnancy, breastfeeding
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Evaluate: • Therapeutic response: decreased LDL, cholesterol, triglycerides, increased HDL, slowing CAD
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report suspected pregnancy; to use contraception while taking product; not to breastfeed • To report weakness, muscle tender- ness, pain, fever, liver injury (jaundice, anorexia, abdominal pain) • That blood work and follow-up exams will be necessary during treatment • To report severe GI symptoms, dizzi- ness, headache, muscle pain, weak- ness • That previously prescribed regimen will continue: low-cholesterol diet, exer- cise program, smoking cessation HIGH ALERT
Source page 1185
Extracted information for rosuvastatin only.
PHARMACOKINETICS Peak 3-5 hr, minimal live metabolism (about 10%), 88% protein bound, excreted primarily in feces (90%), crosses placenta, half-life 19 hr, not dialyzable
Source page 1184
Filter the extracted dose blocks for this individual drug.
hyperlipo- proteinemia, and/or hypertriglyceri- demia
• Adult: PO 10 mg/day as usual start- ing dose; 5 mg/day in those requiring less aggressive LDL cholesterol reduc- tions, in patients with CrCl <30 mL/min, or in patients at higher risk for myopa- thy; range 5-40 mg/day For slowing the progression of ath- erosclerosis
Candidate age grouping · source page 1184
hyperlipo- proteinemia, and/or hypertriglyceri- demia
• Adult: PO 10 mg/day as usual starting dose; initially 5 mg/day in those requir- ing less aggressive LDL cholesterol re- ductions, in patients with CCr <30 mL/ min, or in patients at higher risk for my- opathy; range 5-40 mg/day Primary prevention of cardiovascu- lar disease
Candidate age grouping · source page 1184
hyperlipo- proteinemia, and/or hypertriglyceri- demia
• Adult: PO 10-20 mg/day as usual start- ing dose; range 5-40 mg/day Renal dose
Candidate age grouping · source page 1184
hyperlipo- proteinemia, and/or hypertriglyceri- demia
• Adult: PO CCr <30 mL/min, initially, 5 mg/day in those not receiving dialysis; max 10 mg/day Available forms Sprinkle capsule 5, 10, 20, 40 mg; tablet 40 mg Administer
Candidate age grouping · source page 1184
hyperlipo- proteinemia, and/or hypertriglyceri- demia
• May be taken at any time of day, with/ without food
Candidate age grouping · source page 1184
hyperlipo- proteinemia, and/or hypertriglyceri- demia
• Store in cool environment in airtight, light-resistant container
Candidate age grouping · source page 1184