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Ezallor Sprinkle Generic Name & Formulations
Legal Class
Rx
General Description
Rosuvastatin (as calcium) 5mg, 10mg, 20mg, 40mg; caps.
Pharmacological Class
HMG-CoA reductase inhibitor.
How Supplied
Caps 5mg, 10mg, 20mg, 40mg—30, 90
Manufacturer
Generic Availability
NO
Ezallor Sprinkle Indications
Indications
Adjunct to diet in hypertriglyceridemia. Adjunct to diet in primary dysbetalipoproteinemia (Type III hyperlipoproteinemia). Adjunct to other lipid-lowering treatments (or if these treatments are unavailable), in homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB.
Limitations of Use
Not studied in Fredrickson Type I and V dyslipidemias.
Ezallor Sprinkle Dosage and Administration
Adult
Swallow whole. If unable to swallow caps, can open and sprinkle contents onto applesauce; consume immediately. May be given via NG tube. Take once daily. Dose range 5–40mg. HoFH: initially 20mg. All others: usual starting dose 10–20mg. Use max 40mg dose only if 20mg is insufficient. Asian patients: consider 5mg initially (see full labeling). Concomitant cyclosporine, darolutamide: max 5mg. Concomitant regorafenib: max 10mg. Concomitant atazanavir/ritonavir, lopinavir/ritonavir, simeprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir: initially 5mg; max 10mg. Concomitant gemfibrozil (if unavoidable): initially 5mg; max 10mg. Severe renal impairment (CrCl <30mL/min) not on hemodialysis: initially 5mg; max 10mg.
Children
<18yrs: not established.
Ezallor Sprinkle Contraindications
Contraindications
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy. Nursing mothers.
Ezallor Sprinkle Boxed Warnings
Not Applicable
Ezallor Sprinkle Warnings/Precautions
Warnings/Precautions
Discontinue if myopathy or elevated CK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Immune-mediated necrotizing myopathy; monitor. Monitor liver function before starting therapy and as clinically indicated. Interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs; do not restart if alternate etiology not found. History of liver disease or heavy alcohol ingestion. Severe renal impairment. Hypothyroidism (if inadequately treated). Asian patients. Elderly (≥65yrs). Advise females of reproductive potential to use effective contraception during treatment.
Ezallor Sprinkle Pharmacokinetics
See Literature
Ezallor Sprinkle Interactions
Interactions
See Adults. Avoid gemfibrozil. Increased risk of myopathy with niacin (≥1g/day), fenofibrates, cyclosporine, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, colchicine; use caution. Concomitant with sofosbuvir/velpatasvir/voxilaprevir, ledipasvir/sofosbuvir: not recommended. Monitor INR with anticoagulants. Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine). Separate dosing of antacids (give ≥2hrs after rosuvastatin).
Ezallor Sprinkle Adverse Reactions
Adverse Reactions
Headache, myalgia, abdominal pain, asthenia, nausea; myopathy, rhabdomyolysis with renal dysfunction, elevated liver enzymes, proteinuria and hematuria (consider dose reduction if persistent), increased HbA1c and fasting serum glucose, rare: cognitive impairment, hepatic failure.
Ezallor Sprinkle Clinical Trials
See Literature
Ezallor Sprinkle Note
Not Applicable
Ezallor Sprinkle Patient Counseling
See Literature
