Medication info
Ezetimibe/Rosuvastatin 10/5 mg Tablets

Ezetimibe/Rosuvastatin 10/5 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
(주)보령
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/box (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201601210 · Approved 2016.02.29 · Insurance code 641906360

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and inhibition of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, a starting dose of 10/5 mg once daily is recommended. For patients requiring greater reduction of LDL cholesterol, the dosage may be adjusted. Lipid levels should be checked at intervals of at least 4 weeks after initiation of treatment or after dosage adjustment, and the dosage may be increased to a maximum of 10/20 mg daily.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and inhibition of the risk of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia.
View approved original text

This medication is used as an adjunct to diet for lowering total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels, and for raising HDL cholesterol levels in patients with primary hypercholesterolemia, particularly familial, non-familial, or mixed dyslipidemia. It can also be administered in combination with lipid-lowering medications in patients at high risk for atherosclerotic vascular disease due to hypercholesterolemia. This medication is used when there is an inadequate response to appropriate dietary measures and non-pharmacological interventions, and it is important to first confirm and treat any secondary causes. Lipid level monitoring includes total cholesterol, LDL, HDL cholesterol, and triglycerides, and lipid testing is required even during acute coronary events. This medication helps improve dyslipidemia and prevents cardiovascular disease.

How to take

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, a starting dose of 10/5 mg once daily is recommended. For patients requiring greater reduction of LDL cholesterol, the dosage may be adjusted. Lipid levels should be checked at intervals of at least 4 weeks after initiation of treatment or after dosage adjustment, and the dosage may be increased to a maximum of 10/20 mg daily.

Precautions

This medication contains both rosuvastatin and ezetimibe and is primarily used for the treatment of hypercholesterolemia. While taking this medication, muscle-related problems may occur, so if sudden muscle pain, weakness, or cramps occur, you should consult a physician immediately. In particular, in cases of severe acute infections, hypotension, major surgery or trauma, or serious metabolic and endocrine diseases, it may be necessary to temporarily discontinue this medication. This medication should not be used in patients with impaired liver function or active liver disease, severely impaired kidney function, or those with muscle disorders. Women who are pregnant or may become pregnant, as well as nursing mothers, should also avoid taking this medication. Additionally, individuals with allergies to any components of this medication should refrain from taking it, and patients with certain genetic disorders such as lactose intolerance should exercise caution. Regular monitoring of liver function tests and muscle-related tests should be conducted, and any unusual symptoms should be reported to a hospital immediately. When used in combination with other medications, be aware that the risk of side effects may increase due to interactions, so inform your physician or pharmacist if you are currently taking other medications. Particularly exercise caution when taken with fibrates, cyclosporine, or anticoagulants. During the course of taking this medication, avoid excessive alcohol consumption and regular check-ups are necessary to maintain liver health. Elderly individuals or those with impaired kidney function should also use this medication with caution, and dose adjustments may be necessary. Safety in children and adolescents has not been sufficiently established; thus, this medication is not recommended for pediatric use. There is a risk of dizziness while driving or operating machines, so caution is advised. Store in a place inaccessible to children, and it is best not to transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significant decrease in urine output.

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • elevated ALT
  • elevated AST
  • myalgia
  • edema
  • elevated blood bilirubin
  • acneiform dermatitis
  • pruritus
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  • dizziness
  • upper respiratory infection
  • cough
  • diarrhea
  • constipation
  • nausea
  • abdominal pain
  • itching
  • fatigue
  • numbness
  • sensory abnormalities
  • vomiting
  • gastritis
  • epigastric discomfort
  • belching
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • chest pain
  • discomfort in the chest
  • none

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is safe to store at room temperature between 1 degree and 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/box (10 tablets/PTP X 3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.