Medication info
Rosuvastatin Calcium/Ezetimibe 10/10 mg

Rosuvastatin Calcium/Ezetimibe 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Yellow, rectangular film-coated tablet
Packaging
30 tablets/PTP [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201506789 · Approved 2015.09.24 · Insurance code 665002050

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication should be administered once daily, irrespective of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended, with a dosage range of 10/5 mg to 10/20 mg per day. Patients requiring more reduction in LDL cholesterol may have their dosage adjusted, with lipid levels being monitored at intervals of more than four weeks to adjust the dosage accordingly. The maximum daily dosage can be increased up to 10/20 mg.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • raised total cholesterol
  • raised LDL cholesterol
  • raised Apo B protein
  • raised triglycerides
  • raised 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 to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to raise HDL cholesterol levels. It is especially prescribed when dietary modification and non-pharmacological treatments are insufficient for patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia. Prior to treatment, other causes that may induce dyslipidemia, such as diabetes and hypothyroidism, should be identified and treated if necessary. This medication should be taken in conjunction with appropriate dietary measures to enhance efficacy, and lipid levels should be monitored to track treatment progress. Lipid tests should be performed within 24 hours after hospitalization in cases of acute coronary events and should also be referenced when planning treatment upon discharge. Overall, this medication helps to improve lipid levels in the blood, thereby promoting cardiovascular health.

How to take

Adult dose

This medication should be administered once daily, irrespective of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended, with a dosage range of 10/5 mg to 10/20 mg per day. Patients requiring more reduction in LDL cholesterol may have their dosage adjusted, with lipid levels being monitored at intervals of more than four weeks to adjust the dosage accordingly. The maximum daily dosage can be increased up to 10/20 mg.

Precautions

This medication may cause muscle problems, and if severe muscle pain or weakness occurs, the physician should be notified immediately. There is a risk of impaired kidney function due to muscle damage; therefore, it may be necessary to temporarily discontinue this medication in cases of serious infections, surgeries, or trauma. Patients with allergies to any of this medication's components, severe liver or kidney dysfunction, muscle diseases, or those who are pregnant or breastfeeding should not take this medication. Patients with severe kidney dysfunction or abnormal liver function should use this medication with caution and undergo regular liver function tests and muscle-related examinations. This medication may elevate liver enzyme levels, so patients with a history of liver disease or those who consume alcohol heavily should exercise caution. Blood glucose levels may increase; therefore, diabetic patients should manage their blood glucose levels diligently. This medication may interact with other drugs, so individuals taking other medications should inform their physician or pharmacist, especially when co-administered with anticoagulants, fibrates, certain antibiotics, or antifungal agents. The safety of this medication has not been thoroughly established for children and adolescents; thus, it is not recommended for pediatric patients. Elderly patients face a higher risk of muscle issues and should use this medication with extra caution. Women who are pregnant or may become pregnant should consult a healthcare provider before starting this medication and should use appropriate birth control methods. If severe skin rashes, fever, or swelling occur while taking this medication, it should be discontinued immediately, and medical advice should be sought. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. This medication should be stored out of reach of children, and transferring to other containers should be avoided.

Side effects and when to seek care immediately

Serious side effects

Urticaria, edema, chest tightness, cold sweat, severe allergic reaction, severe skin adverse reaction, difficulty breathing, dyspnea, jaundice, liver abnormalities, sudden and severe headache, confusion, paralysis, severe neurological symptoms, significant decrease in urine output, increased blood pressure, severe edema or urination abnormalities, rhabdomyolysis, acute renal failure, immune-mediated necrotizing myopathy, Stevens-Johnson syndrome, systemic symptoms accompanying medication

Mild side effects

  • Pharyngitis
  • dyspepsia
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • dry mouth
  • pruritus
  • itching
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  • increased blood glucose
  • increased blood lactate dehydrogenase
  • thrombocytopenia
  • myalgia
  • muscle cramps
  • fatigue
  • weakness
  • abnormal sensations
  • loss of appetite
  • abdominal distension
  • diarrhea
  • vomiting
  • discomfort in the epigastrium
  • belching
  • gastrointestinal disorders
  • tongue disorders
  • cough
  • nasal congestion
  • bronchitis
  • rhinitis
  • cystitis
  • soft tissue inflammation
  • dermatitis
  • skin burning sensation
  • alopecia
  • urticaria

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. It is also safest to store it at room temperature, between 1 to 30 degrees Celsius, without extreme heat or cold.

Appearance and packaging

Appearance

Yellow, rectangular film-coated tablet

Package unit

30 tablets/PTP [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle

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.