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EZETIMIBE-SIMVASTATIN (ezetimibe/simvastatin)
- Hyperlipidemia
- Heterozygous familial hypercholesterolemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed hyperlipidemia
- Vytorin 10-80 Tablet
- Vytorin 10-40 Tablet
- Vytorin 10-20 Tablet
- Vytorin 10-10 Tablet
- Ezetimibe-simvastatin Tablet
- By Indication
10 mg-80 mg tablet
- Dosage information is not available
Vytorin 10 mg-80 mg tablet
- Dosage information is not available
10 mg-40 mg tablet
- 1 tablet by oral route once daily
Vytorin 10 mg-40 mg tablet
- 1 tablet by oral route once daily
10 mg-20 mg tablet
- 1 tablet by oral route once daily
Vytorin 10 mg-20 mg tablet
- 1 tablet by oral route once daily
10 mg-10 mg tablet
- 1 tablet by oral route once daily
Vytorin 10 mg-10 mg tablet
- 1 tablet by oral route once daily
ezetimibe 10 mg-simvastatin 10 mg tablet
- 1 tablet by oral route once daily
ezetimibe 10 mg-simvastatin 20 mg tablet
- 1 tablet by oral route once daily
ezetimibe 10 mg-simvastatin 40 mg tablet
- 1 tablet by oral route once daily
ezetimibe 10 mg-simvastatin 80 mg tablet
- Dosage information is not available
Heterozygous familial hypercholesterolemia
- 1 tablet by oral route once daily
Homozygous familial hypercholesterolemia
- 1 tablet by oral route once daily
Hypercholesterolemia
- 1 tablet by oral route once daily
Hyperlipidemia
- 1 tablet by oral route once daily
Mixed hyperlipidemia
- 1 tablet by oral route once daily
- aliskiren-amlodipin-hcthiazide
- aliskiren-amlodipine
- amiodarone
- amiodarone in dextrose,iso-osm
- amlodipine
- amlodipine-atorvastatin
- amlodipine-benazepril
- amlodipine-olmesartan
- amlodipine-valsartan
- amlodipine-valsartan-hcthiazid
- amoxicil-clarithromy-lansopraz
- Amturnide
- Aptivus
- atazanavir
- Azor
- Biaxin
- Biaxin Xl
- Biaxin Xl Pak
- boceprevir
- Caduet
- Calan
- Calan Sr
- Cardizem
- Cardizem Cd
- Cardizem La
- Cartia Xt
- clarithromycin
- conivaptan in 5 % dextrose
- Cordarone
- Crixivan
- cyclosporine
- cyclosporine modified
- danazol
- darunavir
- delavirdine
- Dilacor Xr
- Dilt-xr
- diltiazem HCl
- dronedarone
- elvitegr-cobicist-emtric-tenof
- Erythrocin
- erythromycin
- erythromycin-sulfisoxazole
- Exforge
- Exforge Hct
- fosamprenavir
- gemfibrozil
- Gengraf
- Incivek
- indinavir
- Invirase
- itraconazole
- Juxtapid
- Kaletra
- Ketek
- ketoconazole
- Korlym
- Lexiva
- lomitapide
- Lopid
- lopinavir-ritonavir
- Lotrel
- Matzim La
- Mifeprex
- mifepristone
- Multaq
- nefazodone
- nelfinavir
- Neoral
- Nexterone
- Norvasc
- Norvir
- Norvir Soft Gelatin
- Noxafil
- olmesartan-amlodipin-hcthiazid
- Omeclamox-pak
- omeprazole-clarith-amoxicillin
- Onmel
- Pacerone
- posaconazole
- Prevpac
- Prezista
- Rescriptor
- Reyataz
- ritonavir
- Sandimmune
- saquinavir mesylate
- Sporanox
- Sporanox Pulsepak
- Stribild
- Tarka
- Taztia Xt
- Tekamlo
- telaprevir
- telithromycin
- telmisartan-amlodipine
- Tiazac
- tipranavir
- trandolapril-verapamil
- Tribenzor
- Twynsta
- Vaprisol
- verapamil
- Verelan
- Verelan Pm
- Vfend
- Vfend Iv
- Victrelis
- Viracept
- voriconazole
Contraindicated
- Antara
- Brilinta
- 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
- ticagrelor
- Tricor
- Triglide
- Trilipix
Severe
Moderate
- Aptiom
- Atripla
- azithromycin
- bosentan
- carbamazepine
- Carbatrol
- cholestyramine (with sugar)
- Cholestyramine Light
- cholestyramine-aspartame
- Cipro
- Cipro In D5W
- Cipro Xr
- ciprofloxacin
- ciprofloxacin (mixture)
- ciprofloxacin in D5W
- colchicine
- colchicine-probenecid
- Colcrys
- Colestid
- Colestid Flavored
- colestipol
- Coumadin
- Diflucan
- Digox
- digoxin
- efavirenz
- efavirenz-emtricitabin-tenofov
- Epitol
- Equetro
- eslicarbazepine
- fluconazole
- fluconazole in dextrose(iso-o)
- fluconazole in NaCl (iso-osm)
- Gleevec
- imatinib
- isoniazid-rifamp-pyrazinamide
- Jantoven
- Lanoxin
- Lanoxin Pediatric
- oxcarbazepine
- Oxtellar Xr
- Prevalite
- Questran
- Questran Light
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- Sustiva
- Tegretol
- Tegretol Xr
- Tracleer
- Trileptal
- warfarin
- Zithromax
- Zithromax Tri-pak
- Zithromax Z-pak
- Zmax
- Lactating mother
- Myopathy related to drug and SLCo1b1 gene variant
- Myopathy with CK elevation
- Pregnancy
- Rhabdomyolysis
- SLCo1b1 intermediate function
- SLCo1b1 low function
Contraindicated
- Abnormal hepatic function tests
- Acute pancreatitis
- Alcoholism
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Disease of liver
- Immune-mediated necrotizing myopathy
- Intracerebral hemorrhage
- Invasive surgical procedure
- Myopathy related to drug and SLCo1b1 gene variant
- Myopathy with CK elevation
- SLCo1b1 intermediate function
- SLCo1b1 low function
Severe
Moderate
- Hyperglycemia
- Memory impairment
- Metabolic syndrome X
- Severe renal impairment
EZETIMIBE-SIMVASTATIN (ezetimibe/simvastatin)
- Hyperlipidemia
- Heterozygous familial hypercholesterolemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed hyperlipidemia
- Atrial fibrillation
- Bronchitis
- Myalgias
- Myopathy related to drug and SLCo1b1 gene variant
- Acute abdominal pain
- Constipation
- Diarrhea
- Dizziness
- Dyspepsia
- Flatulence
- Headache disorder
- Heartburn
- Infection
- Nausea
- Skin rash
- Upper respiratory infection
More Frequent
Severe
Less Severe
- Atrial fibrillation
- Biliary calculus
- Myalgias
- Sinusitis
- Upper respiratory infection
- Urinary tract infection
- Abdominal pain with cramps
- Arthralgias
- Arthritis
- Back pain
- Diarrhea
- Eczema
- Edema
- Fatigue
- Flatulence
- Flu-like symptoms
- Gastritis
- Influenza
- Insomnia
- Limb pain
- Myalgias
- Palpitations
- Pharyngitis
- Sinusitis
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Acute pancreatitis
- Anaphylaxis
- Anemia
- Angioedema
- Arthritis
- Bronchitis
- Bullous dermatitis
- Cataracts
- Chest pain
- Cholecystitis
- Dermatomyositis
- Diabetes mellitus
- Dyspnea
- Eosinophilia
- Erythema multiforme
- Hemolytic anemia
- Hepatic failure
- Hepatic necrosis
- Hepatitis
- Hypersensitivity drug reaction
- Immune-mediated necrotizing myopathy
- Interstitial lung disease
- Jaundice
- Leukopenia
- Lupus-like syndrome
- Myopathy
- Myositis
- Obstructive hyperbilirubinemia
- Ophthalmoplegia
- Pancreatitis
- Polymyalgia rheumatica
- Polymyositis
- Purpura
- Rhabdomyolysis
- Skin rash
- Stevens-johnson syndrome
- Thrombocytopenic disorder
- Toxic epidermal necrolysis
- Urinary tract infection
- Urticaria
- Vasculitis
Less Severe
- Acute confusion
- Alopecia
- Anorexia
- Arthralgias
- Blurred vision
- Cough
- Cramps
- Depression
- Dizziness
- Dry skin
- Dyschromia
- Dysesthesia
- Dysgeusia
- Dyspepsia
- Dysuria
- Edema
- Erectile dysfunction
- Facial palsy
- Fever
- Flushing
- General weakness
- Gynecomastia
- Hyperglycemia
- Hypesthesia
- Increased urinary frequency
- Insomnia
- Libido changes
- Malaise
- Memory impairment
- Muscle spasm
- Muscle weakness
- Nausea
- Nocturia
- Paresthesia
- Peripheral neuropathy
- Pruritus of skin
- Rhinitis
- Skin nodules
- Skin photosensitivity
- Symptoms of anxiety
- Tremor
- Vertigo
- Vomiting
- Xerostomia
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Ezetimibe
Safety and efficacy not established in pediatrics <10 years.
Safety and efficacy not established age under 10 years and in pre-menarche girls.
Manufacturer recommends post-menarche females be counseled on appropriate contraception.
- 1 Day – 10 Years
- Safety and efficacy not established in pediatrics <10 years.
- 10 Years – 18 Years
- Safety and efficacy not established in pediatrics <10 years.
Simvastatin
Safety and efficacy not established in pediatrics <10 years.
Safety and efficacy not established age under 10 years and in pre-menarche girls.
Manufacturer recommends post-menarche females be counseled on appropriate contraception.
- 1 Day – 10 Years
- Safety and efficacy not established age under 10 years and in pre-menarche girls.
- Manufacturer recommends post-menarche females be counseled on appropriate contraception.
- 10 Years – 18 Years
- Safety and efficacy not established age under 10 years and in pre-menarche girls.
- Manufacturer recommends post-menarche females be counseled on appropriate contraception.
Ezetimibe
- Severity Level:
C
- Additional Notes:
Hmg Coa Reductase Inhibitors
- Severity Level:
X
- Additional Notes:
Contraindicated
Simvastatin
Contraindicated per manufacturer; other hmg reductase inhib excreted in milk
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Contraindicated per manufacturer; other hmg reductase inhib excreted in milk |
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
Simvastatin
Musculoskeletal-Higher incidence of myopathy or rhabdomyolysis with age over 65 particularly with renal disease. Plasma levels in the elderly are 45% higher. FDA MedWatch(06/09/2011) recommends against the use of the 80mg dose for new drug starts regardless of age, and only allows for use in those patients stabilized on 80mg with no evidence for myopathy. Do not titrate beyond 40mg/day to achieve LDL-C goal. Alternative agents should be considered. Hepatic-Monitor LFTs; liver dysfunction.
| 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
| Heterozygous familial hypercholesterolemia | |
| E78.01 | Familial hypercholesterolemia |
| Homozygous familial hypercholesterolemia | |
| E78.01 | Familial hypercholesterolemia |
| Hypercholesterolemia | |
| E78.0 | Pure hypercholesterolemia |
| E78.00 | Pure hypercholesterolemia, unspecified |
| E78.01 | Familial hypercholesterolemia |
| Hyperlipidemia | |
| E78.2 | Mixed hyperlipidemia |
| E78.4 | Other hyperlipidemia |
| E78.49 | Other hyperlipidemia |
| E78.5 | Hyperlipidemia, unspecified |
| Mixed hyperlipidemia | |
| E78.2 | Mixed hyperlipidemia |
| 0-9 | A-Z |
|---|---|
| E78.0 | Pure hypercholesterolemia |
| E78.00 | Pure hypercholesterolemia, unspecified |
| E78.01 | Familial hypercholesterolemia |
| E78.01 | Familial hypercholesterolemia |
| E78.01 | Familial hypercholesterolemia |
| E78.2 | Mixed hyperlipidemia |
| E78.2 | Mixed hyperlipidemia |
| E78.4 | Other hyperlipidemia |
| E78.49 | Other hyperlipidemia |
| E78.5 | Hyperlipidemia, unspecified |
Formulary Reference Tool