Medication info
Rosuvastatin Calcium (Unmodified) / Ezetimibe 10/5 mg

Rosuvastatin Calcium (Unmodified) / Ezetimibe 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets/box [(10 tablets/blister × 3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201601219 · Approved 2016.02.29 · Insurance code 657805800

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. A starting dose of 10/5 mg daily is recommended. The dosage can be adjusted within the range of 10/5 mg to 10/20 mg daily, and the blood lipid levels should be checked at intervals of at least 4 weeks before making adjustments. The dose can be increased up to 10/20 mg daily.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)

  • 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 helps to lower the blood levels of total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol in patients with primary hypercholesterolemia, particularly in those with familial and non-familial hypercholesterolemia and mixed dyslipidemia, and increases good cholesterol HDL-cholesterol. It is used in conjunction with dietary restrictions on saturated fats and cholesterol and is administered when non-pharmacological treatments show insufficient efficacy. It is primarily used in patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, and it is important to identify and treat secondary causes of dyslipidemia, such as diabetes and hypothyroidism, before administering medication. Blood lipid tests include total cholesterol, LDL, HDL, and triglycerides; if triglycerides are very high, special tests may be required to accurately measure LDL levels. This medication is used as an effective lipid-modulating agent for the prevention and treatment of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily regardless of meals. A starting dose of 10/5 mg daily is recommended. The dosage can be adjusted within the range of 10/5 mg to 10/20 mg daily, and the blood lipid levels should be checked at intervals of at least 4 weeks before making adjustments. The dose can be increased up to 10/20 mg daily.

Precautions

This medication carries a risk of muscle abnormalities, so if severe muscle pain or weakness occurs, consult a doctor immediately. Particularly patients with severe infections, hypotension, major surgery or trauma, endocrine disorders may temporarily pause or discontinue this medication. Those with hypersensitivity to this medication or have liver disease, muscle disease, severe renal impairment should not take it. Pregnant women or women who could become pregnant and nursing mothers should also avoid this medication. Patients with poor liver function or alcohol dependence should use this medication with caution and undergo regular liver function tests and muscle-related tests. This medication contains lactose and should not be administered to patients with lactose intolerance. There may be interactions with other medications, so inform your doctor or pharmacist if you are taking other drugs. Caution is especially needed when taken with anticoagulants, certain antibiotics, antifungals, or immunosuppressants. During the use of this medication, liver function and muscle status should be monitored regularly, and notify medical personnel immediately if any abnormal symptoms arise. Dizziness or headache may occur, so caution is advised when driving or operating machinery. It should be avoided during pregnancy as it may harm the fetus, and women of childbearing age should use appropriate contraception while taking this medication. The safety of this medication has not been established in children and is therefore not recommended. There is no specific antidote for overdose, so adhere to the recommended dosage and seek medical attention immediately if abnormal symptoms occur. Keep this medication out of the reach of children and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema and facial swelling), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), general malaise, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urination

Mild side effects

  • Pharyngitis
  • arthralgia
  • headache
  • dizziness
  • upper respiratory infection
  • myalgia
  • fatigue
  • constipation
  • nausea
  • abdominal pain
Show 26 more
  • diarrhea
  • itching
  • rash
  • weakness
  • pruritus
  • elevated bilirubin levels
  • increased serum creatinine
  • chest discomfort
  • vomiting
  • abdominal bloating
  • sensory disturbances
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • tremor
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets/box [(10 tablets/blister × 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.