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Ezallor Sprinkle
rosuvastatin
Adult Dosing .
Dosage forms: CAP: 5 mg, 10 mg, 20 mg, 40 mg
primary hyperlipidemia
- [5-40 mg PO qd]
- Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents; search 'cholesterol' for epocrates Adult Cholesterol Tx Selector decision tool
heterozygous familial hypercholesterolemia
- [5-40 mg PO qd]
- Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents; search 'cholesterol' for epocrates Adult Cholesterol Tx Selector decision tool
homozygous familial hypercholesterolemia
- [5-40 mg PO qd]
- Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents; search 'cholesterol' for epocrates Adult Cholesterol Tx Selector decision tool
hypertriglyceridemia
- [5-40 mg PO qd]
- Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents; search 'cholesterol' for epocrates Adult Cholesterol Tx Selector decision tool
primary dysbetalipoproteinemia
- [5-40 mg PO qd]
- Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents; search 'cholesterol' for epocrates Adult Cholesterol Tx Selector decision tool
cardiovascular event risk reduction
- [5-40 mg PO qd]
- Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents; search 'cholesterol' for epocrates Adult Cholesterol Tx Selector decision tool
atherosclerotic cardiovascular dz
- [5-40 mg PO qd]
- Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents; search 'cholesterol' for epocrates Adult Cholesterol Tx Selector decision tool
renal dosing
- [adjust dose amount]
- CrCl <30: start 5 mg qd, max 10 mg qd
- HD: consider decr. usual dose, max 10 mg qd; no supplement after dialysis; PD: not defined
hepatic dosing
- [see below]
- acute hepatic failure or decompensated cirrhosis: contraindicated
Peds Dosing .
- Dosage forms: CAP: 5 mg, 10 mg, 20 mg, 40 mg
heterozygous familial hypercholesterolemia
- [8-9 yo]
- Dose: 5-10 mg PO qd; Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents
- [10 yo and older]
- Dose: 5-20 mg PO qd; Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents
homozygous familial hypercholesterolemia
- [7 yo and older]
- Dose: 20 mg PO qd; Info: may adjust dose q4wk; start 5 mg PO qd in Asian pts (risk of incr. drug levels); may open cap, but do not crush/chew contents
renal dosing
- [adjust dose amount]
- CrCl <30: start 5 mg qd, max 10 mg qd
- HD: consider decr. usual dose, max 10 mg qd; no supplement after dialysis; PD: not defined
hepatic dosing
- [see below]
- acute hepatic failure or decompensated cirrhosis: contraindicated
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy (except high-risk pts)
- myopathy
- hepatic failure, acute
- cirrhosis, decompensated
- avoid: breastfeeding (high-risk pts)
- caution: hypersensitivity to tartrazine (generic form)
- caution: alcohol abuse
- caution: pts 65 yo and older
- caution: Asian pts (risk of incr. drug levels)
- caution: female pts of reproductive potential
- caution: renal impairment
- caution: hepatic dz hx
- caution: diabetes mellitus
- caution: hypothyroidism
- caution: immune-mediated necrotizing myopathy hx
Drug Interactions .
Overview
rosuvastatin
statin
- BCRP substrate
- NTCP substrate
- OATP1B1 substrate
- OATP1B3 substrate
- OATP2B1 substrate
- binds to polyvalent cations
- rhabdomyolysis
Avoid/Use Alternative
- atorvastatin
- colchicine
- cyclosporine
- fenofibrate
- fenofibric acid
- fluvastatin
- gemfibrozil
- ledipasvir
- lovastatin
- niacin (vitamin B3)
- pitavastatin
- pravastatin
- red yeast rice
- rosuvastatin
- simvastatin
- tafamidis
- tedizolid phosphate
- voxilaprevir
Monitor/Modify Tx
- abiraterone acetate
- acalabrutinib
- aluminum hydroxide
- asciminib
- atazanavir
- belumosudil
- bempedoic acid
- brigatinib
- capmatinib
- ceftobiprole
- cholestyramine
- clarithromycin
- clopidogrel
- cobicistat
- colestipol
- danicopan
- daptomycin
- darolutamide
- darunavir
- elacestrant
- elafibranor
- elagolix
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eltrombopag
- eluxadoline
- enasidenib
- encorafenib
- febuxostat
- fostamatinib
- fostemsavir
- futibatinib
- gilteritinib
- glecaprevir
- grazoprevir
- ibrutinib
- imatinib
- irbesartan
- itraconazole
- lanthanum
- lazertinib
- leflunomide
- lenacapavir
- leniolisib
- letermovir
- lopinavir/ritonavir
- magnesium carbonate
- magnesium citrate
- magnesium hydroxide
- magnesium oxide
- magnesium supplement
- maribavir
- midostaurin
- momelotinib
- osimertinib
- oteseconazole
- pacritinib
- pibrentasvir
- pirtobrutinib
- pretomanid
- quinapril
- raltegravir
- regorafenib
- resmetirom
- ritonavir
- rolapitant
- rucaparib
- selpercatinib
- selumetinib
- sotorasib
- sparsentan
- stiripentol
- sulfate bowel prep
- telmisartan
- teriflunomide
- ticagrelor
- tipranavir
- tolvaptan
- trofinetide
- turmeric
- vadadustat
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vimseltinib
- voclosporin
- warfarin
Caution Advised
- apalutamide
- carbamazepine
- eslicarbazepine acetate
- maralixibat
- omaveloxolone
- rifampin
- St. John's wort
Adverse Reactions .
Serious Reactions
- myopathy
- immune-mediated necrotizing myopathy
- tendon rupture
- rhabdomyolysis
- acute renal failure
- hepatotoxicity
- pancreatitis
- hypersensitivity rxn
- angioedema
- thrombocytopenia
- diabetes mellitus
- interstitial lung dz
- myasthenia gravis
Common Reactions
- headache
- myalgia
- abdominal pain
- asthenia
- nausea
- arthralgia
- dizziness
- constipation
- diabetes mellitus
- CK elevated
- ALT or AST elevated
- proteinuria
- hematuria
- cognitive impairment
- insomnia
- gynecomastia
Safety/Monitoring .
Monitoring Parameters
Cr at baseline; LFTs at baseline, then as clinically indicated; CK at baseline if myopathy risk, then as clinically indicated; glucose if diabetes risk
Look/Sound-Alike Drug Names
rosuvastatin confused with: atorvastatin
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy in non-high risk pts, otherwise weigh risk/benefit in high risk pts; risk of teratogenicity not expected based on limited human data, though possible risk of teratogenicity based on limited or conflicting human data w/ other statins; no known risk of teratogenicity based on animal data at MRHD, though risk of decr. fetal wt and delayed ossification based on animal data at 10-12x MRHD; possible risk of delayed fetal development based on drug's mechanism of action
Lactation
Clinical Summary
avoid breastfeeding in high risk pts, otherwise weigh risk/benefit in non-high risk pts; no human data available to assess risk of infant harm, though possible risk of drug excretion into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver minimally; CYP450: 2C9 substrate; Info: active metabolite
Excretion: feces 90%; Half-life: 19h
Subclass: Dyslipidemia: HMG-CoA Reductase Inhibitors (Statins)
Mechanism of Action
inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, inhibiting cholesterol synthesis
Formulary .
No Formulary Selected
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