Medication info
Rosuro Tablet 10mg (Rosuvastatin Calcium)

Rosuro Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Pink circular film-coated tablet
Packaging
30 tablets per box [10 tablets/PTP x 3], 30 tablets per bottle
Approval status
Active

MFDS item code 200810870 · Approved 2008.11.07 · Insurance code 643305080

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5mg once daily, and it can be adjusted for maintenance if greater LDL-cholesterol reductions are needed. The maintenance dose is usually 10mg once daily, and most patients are controlled at this dosage. The maintenance dose should be appropriately adjusted after intervals of 4 weeks or longer based on LDL-cholesterol levels, therapeutic goals, and patient response, up to a maximum of 20mg per day.
Child dose
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17) is 5mg to 20mg once daily. The dosages should be individually adjusted according to the recommended therapeutic goals for each patient.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are inadequate. It is particularly useful for patients with familial hypercholesterolemia, as it lowers total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis. It can also be administered as a dietary adjunct in pediatric patients aged 10 to 17 who meet specific criteria. Moreover, it is used for reducing the risk of stroke, myocardial infarction, and revascularization in adults at high risk for cardiovascular diseases. It effectively helps in managing blood lipids and preventing cardiovascular diseases.

How to take

Adult dose

The initial dose is 5mg once daily, and it can be adjusted for maintenance if greater LDL-cholesterol reductions are needed. The maintenance dose is usually 10mg once daily, and most patients are controlled at this dosage. The maintenance dose should be appropriately adjusted after intervals of 4 weeks or longer based on LDL-cholesterol levels, therapeutic goals, and patient response, up to a maximum of 20mg per day.

Child dose

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17) is 5mg to 20mg once daily. The dosages should be individually adjusted according to the recommended therapeutic goals for each patient.

Precautions

This drug should not be used in certain patients. For example, patients with allergies to any component of this drug, severe liver dysfunction, muscle disorders, severe renal impairment, pregnant or lactating women, and those taking specific medications should not be administered this drug. Before taking this drug, regular liver function tests and muscle-related tests are required, and patients with a history of liver disease or heavy alcohol consumption should exercise extra caution. Symptoms such as muscle pain, weakness, or cramps should be reported to medical personnel immediately. This drug can interact with other medications, so if patients are taking other medications, they must inform their doctor or pharmacist. Particularly, the risk of muscle damage may increase when taken with certain antiviral agents, immunosuppressants, antibiotics, and fibrate derivatives. Women of childbearing potential should use appropriate contraceptive methods, and this drug should not be taken during pregnancy. Additionally, breastfeeding women should avoid taking this medication. In cases of overdose, there is no specific antidote, so treatment should be symptomatic, and monitoring of liver function and muscle enzyme levels is necessary. Patients may experience dizziness while taking this drug, so caution should be exercised when driving or operating machinery. Lastly, this drug may rarely cause serious skin reactions or damage to the liver, kidneys, and muscles, so any unusual symptoms should prompt immediate consultation with healthcare providers.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, tightness in the chest, difficulty breathing, severe swelling (edema), severe rash with fever, blisters, skin peeling, pain of oral/ocular mucosa, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, acute renal failure, oliguria, severe edema, sudden and severe headaches, lightning headaches, seizures, confusion, visual disturbances

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • increased serum creatinine
  • increased ALT
  • increased AST
  • increased CK
  • arthralgia
  • amnesia
  • peripheral neuropathy
  • polyneuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction

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. Additionally, it is important to maintain the storage temperature between 1 degree and 30 degrees Celsius to ensure the medication's effectiveness.

Appearance and packaging

Appearance

Pink circular film-coated tablet

Package unit

30 tablets per box [10 tablets/PTP x 3], 30 tablets per 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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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.