ROSZET (ezetimibe/rosuvastatin calcium)
- excessive fat in the blood
- homozygous inherited high blood cholesterol
10 mg-10 mg tablet
- 1 tablet by oral route once daily
10 mg-20 mg tablet
- 1 tablet by oral route once daily
10 mg-40 mg tablet
- 1 tablet by oral route once daily
10 mg-5 mg tablet
- 1 tablet by oral route once daily
Default screening record
- 1 tablet by oral route once daily
- atazanavir
- cyclosporine
- cyclosporine modified
- Gengraf
- Kaletra
- lopinavir-ritonavir
- Neoral
- Olysio
- Reyataz
- Sandimmune
- simeprevir
Contraindicated
- Antara
- Cubicin
- daptomycin
- Endur-acin
- fenofibrate
- fenofibrate micronized
- fenofibrate nanocrystallized
- fenofibric acid
- fenofibric acid (choline)
- Fenoglide
- Fibricor
- Lipofen
- Lofibra
- niacin
- niacin (inositol niacinate)
- niacinamide
- Niacor
- Niaspan Extended-release
- Slo-niacin
- Tricor
- Triglide
- Trilipix
Severe
Moderate
- Acid Gone
- Acid Gone Antacid
- Advanced Antacid-antigas
- Al hyd-Mg tr-alg ac-sod bicarb
- Almacone
- Almacone-2
- alum-mag hydroxide-simeth
- aluminum hydrox-magnesium carb
- aluminum hydroxide gel
- aluminum-magnesium hydroxide
- Antacid
- Antacid Anti-gas
- Antacid Anti-gas Double Str
- Antacid Extra Strength
- Antacid Extra-strength
- Antacid Ii Plus Simethicone
- Antacid Liquid
- Antacid M
- Antacid Maximum Strength
- Antacid Multi-symptom
- Antacid Plus Anti-gas
- Antacid Plus Extra Strength
- Antacid Regular Strength
- Antacid Supreme
- Antacid Tablet
- Antacid With Simethicone
- Antacid-antigas
- Antacid-antigas Ii
- Antacid-simethicone
- Antacid-simethicone Ds
- Aptivus
- ASA-acetaminophen-caff-buffers
- aspirin, buffered
- Bayer Plus Extra Strength
- cal phos-mag hydrx-C & D3-phos
- calcium carb-mag hydrox-simeth
- calcium carbonate-mag hydroxid
- cholestyramine (with sugar)
- Cholestyramine Light
- cholestyramine-aspartame
- colchicine
- colchicine-probenecid
- Colcrys
- Colestid
- Colestid Flavored
- colestipol
- Comfort Gel
- Comfort Gel Extra Strength
- Coumadin
- Crixivan
- darunavir
- Digox
- digoxin
- diosmin complex no.1
- eltrombopag
- Flanax
- Foaming Antacid
- Foaming Antacid Extra Strength
- fosamprenavir
- Gaviscon
- Gaviscon Extra Strength
- Gelusil Antacid & Anti-gas
- gemfibrozil
- Geri-lanta
- Geri-mox Antacid-antigas
- Heartburn Antacid
- indinavir
- Invirase
- Jantoven
- Lanoxin
- Lanoxin Pediatric
- Lexiva
- Liquid Antacid
- Lopid
- Maalox Advanced
- Maalox Maximum Strength
- Mag-al
- Mag-al Plus
- Mag-al Plus Extra Strength
- Maglox
- magnesium hydroxide
- magnesium-aluminum-alginic ac
- Masanti Double Strength
- Mi-acid
- Mintox
- Mintox Maximum Strength
- Mintox Plus
- nelfinavir
- Norvir
- Norvir Soft Gelatin
- Phillips Milk Of Magnesia
- Prevalite
- Prezista
- Pro-cal
- Promacta
- Questran
- Questran Light
- Ri-gel
- Ri-gel Ii
- Ri-mox
- Ri-mox Plus
- Riginic
- ritonavir
- Rulox
- saquinavir mesylate
- Supreme Antacid
- tipranavir
- Vanquish
- Vasculera
- Viracept
- warfarin
- Child-pugh class B hepatic impairment
- Child-pugh class C hepatic impairment
- Hepatic failure
- Lactation
- Pregnancy
- Rhabdomyolysis
Contraindicated
- Abnormal hepatic function tests
- Acute pancreatitis
- Acute renal failure
- Alcoholism
- Child-pugh class A hepatic impairment
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Disease of liver
- Immune-mediated necrotizing myopathy
- Intracerebral hemorrhage
- Myopathy with CK elevation
- Rhabdomyolysis
Severe
Moderate
- Dehydration
- Hematuria
- Hyperglycemia
- Kidney disease with likely reduction in GFR
- Memory impairment
- Metabolic syndrome x
- Proteinuria
- Severe renal impairment
- Untreated hypothyroidism
ROSZET (ezetimibe/rosuvastatin calcium)
- excessive fat in the blood
- homozygous inherited high blood cholesterol
- Myalgia
- Acute abdominal pain
- General weakness
- Headache disorder
- Nausea
More Frequent
Severe
Less Severe
- Biliary calculus
- Diabetes mellitus
- Increased alanine transaminase
- Increased aspartate transaminase
- Upper respiratory infection
- Abdominal pain with cramps
- Arthralgia
- Back pain
- Constipation
- Diarrhea
- Dizziness
- Fatigue
- Influenza
- Myalgia
- Pain in extremities
- Pharyngitis
- Sinusitis
- Skin rash
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Acute pancreatitis
- Anaphylaxis
- Angioedema
- Cholecystitis
- Depression
- Erythema multiforme
- Hepatic failure
- Hepatitis
- Hypersensitivity drug reaction
- Immune-mediated necrotizing myopathy
- Interstitial lung disease
- Jaundice
- Myopathy
- Myositis
- Pancreatitis
- Proteinuria
- Rhabdomyolysis
- Skin rash
- Thrombocytopenic disorder
- Urticaria
Less Severe
- Acute confusion
- Depression
- Dizziness
- Gynecomastia
- Hematuria
- Hyperglycemia
- Insomnia
- Memory impairment
- Muscle weakness
- Nausea
- Nightmares
- Paresthesia
- Peripheral neuropathy
- Pruritus of skin
- Sleep disorder
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Ezetimibe, rosuvastatin
No safety and efficacy established for combination product in pediatrics.
- 1 Day – 18 Years
- No safety and efficacy established for combination product in pediatrics.
Ezetimibe
- Severity Level:
C
- Additional Notes: Insuff human data avail; consider maternal benefit vs neonatal risk
Rosuvastatin
- Severity Level:
1
- Additional Notes: Insuff human data avail;theoretical risk based on mech of action
Contraindicated
Rosuvastatin
Contraindicated by mfr due to potential adverse effects in nursing infant
General | Excretion Potential | Effect on Infant | Notes |
Drug should not be given to breast feeding mothers | Excreted | Not known; no or inclusive data | Contraindicated by mfr due to potential adverse effects in nursing infant |
Precaution Exists
Ezetimibe
Insufficient data available; not recommended in combo with statins
General | Excretion Potential | Effect on Infant | Notes |
Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient data available; not recommended in combo with statins |
No Known Risk
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Contraindicated
None
Precaution Exists
Rosuvastatin
Musculoskeletal-Higher incidence of myopathy or rhabdomyolysis with age > 65 years and increased risk with severe renal disease. Hepatic-Monitor LFTs as liver dysfunction may increase drug exposure.
Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
Increased Risk / Adverse Effects | Y | Y | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
Homozygous familial hypercholesterolemia | |
E78.01 | Familial hypercholesterolemia |
Hyperlipidemia | |
E78.2 | Mixed hyperlipidemia |
E78.4 | Other hyperlipidemia |
E78.49 | Other hyperlipidemia |
E78.5 | Hyperlipidemia, unspecified |
0-9 | A-Z |
---|---|
E78.01 | Familial hypercholesterolemia |
E78.2 | Mixed hyperlipidemia |
E78.4 | Other hyperlipidemia |
E78.49 | Other hyperlipidemia |
E78.5 | Hyperlipidemia, unspecified |