Medication info
Crestor 10 mg (Rosuvastatin Calcium)

Crestor 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
한국아스트라제네카(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 30 tablets (15 tablets/PTP×2)
Approval status
Active

MFDS item code 200210097 · Approved 2002.01.15 · Insurance code 650700520

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer 5 mg once daily at any time of day, regardless of meals. If further reduction in LDL cholesterol is necessary, the maintenance dose can be adjusted, with 10 mg once daily being the typical adjustment for most patients. The maintenance dose should be adjusted periodically over 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.
Child dose
In pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), administer 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals over intervals of 4 weeks or more.

Ingredients

Importer
한국아스트라제네카(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is primarily used for the treatment of hypercholesterolemia and hyperlipidemia. It is particularly used as an adjunct when nutrition and exercise are insufficient to control primary hypercholesterolemia, including familial hypercholesterolemia and mixed dyslipidemia. It is also utilized as an adjunct to diet therapy in pediatric patients with specific criteria for heterozygous familial hypercholesterolemia. Additionally, it is beneficial for patients with dysbetalipoproteinemia. This drug lowers total cholesterol and LDL cholesterol, delaying the progression of atherosclerosis and effectively reducing the risk of stroke, myocardial infarction, and arterial revascularization procedures in middle-aged and older patients with elevated high-sensitivity C-reactive protein and cardiovascular risk factors. Therefore, this medication is used for hyperlipidemia and to decrease cardiovascular disease risk.

How to take

Adult dose

Administer 5 mg once daily at any time of day, regardless of meals. If further reduction in LDL cholesterol is necessary, the maintenance dose can be adjusted, with 10 mg once daily being the typical adjustment for most patients. The maintenance dose should be adjusted periodically over 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Child dose

In pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), administer 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals over intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, it should not be administered to individuals with an allergy to this drug, patients with liver disease, myopathy, severe kidney impairment, or women who are pregnant or breastfeeding. Before taking this medication, it is essential to periodically examine liver function and muscle condition, particularly for patients with a history of liver disease or significant alcohol intake. If symptoms such as muscle pain or weakness occur, inform a physician immediately. Furthermore, this drug may interact with other medications, so it is crucial to inform healthcare providers of any medications being taken. Certain medications may elevate the blood concentration of this drug, increasing the risk of muscle damage. Women who may become pregnant should use appropriate contraception while taking this medication and must discontinue usage immediately if they become pregnant. It is also advised that breastfeeding women avoid taking this medication. In case of an overdose, there is no specific antidote, and treatment should be symptomatic, with monitoring of liver function and muscle enzyme levels. This drug may cause side effects such as dizziness, so caution is advised when driving or operating machinery. Lastly, this drug may show higher concentrations in Asians, and dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe edema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, rhabdomyolysis, severe muscle weakness, ocular myasthenia, fatal and non-fatal liver failure, severe allergic reactions, severe skin reactions, respiratory problems

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • cough
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  • diarrhea
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • sleep disturbances
  • depression
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • amnesia
  • forgetfulness
  • confusion

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. Storing it this way helps ensure the drug's effectiveness is preserved.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 30 tablets (15 tablets/PTP×2)

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.