Medication info
Crestor 5 mg (Rosuvastatin Calcium)

Crestor 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
알리코제약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201601698 · Approved 2016.03.30 · Insurance code 656004140

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dosage is 5 mg once daily, and if more reduction of LDL cholesterol levels is needed, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, and most patients can be managed on this dosage. The maintenance dose should be appropriately adjusted every 4 weeks or longer intervals based on LDL cholesterol levels, treatment goals, and patient response, and can be increased to a maximum of 20 mg per day.
Children's dosage
The usual dosage range for pediatric patients with homozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment goals for individual patients.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia who are difficult to control with diet and exercise. It helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is also used to reduce cholesterol levels in pediatric patients with homozygous familial hypercholesterolemia, and is effective as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization in men over 50 years old and women over 60 years old who have elevated high-sensitivity C-reactive protein and additional cardiovascular risk factors. Thus, this medication is used to regulate blood lipid levels and reduce cardiovascular risk.

Dosage and Administration

Adult dosage

The initial dosage is 5 mg once daily, and if more reduction of LDL cholesterol levels is needed, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, and most patients can be managed on this dosage. The maintenance dose should be appropriately adjusted every 4 weeks or longer intervals based on LDL cholesterol levels, treatment goals, and patient response, and can be increased to a maximum of 20 mg per day.

Children's dosage

The usual dosage range for pediatric patients with homozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment goals for individual patients.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication or have severe liver dysfunction, those with muscle diseases, and women who are pregnant or breastfeeding should not take it. Additionally, caution should be exercised in patients with abnormal liver function or those who consume alcohol in excess, and liver function tests should be repeatedly performed before and during treatment. Patients with hypothyroidism or nephrotic syndrome should prioritize treatment of the underlying conditions. This medication can cause muscle pain or related conditions; therefore, if symptoms such as muscle pain or weakness occur, the physician should be notified immediately. Especially if muscle enzyme levels significantly increase, the medication should be discontinued, and dosing can be adjusted based on improvement of symptoms. This medication can also affect kidney function in some patients; thus, regular kidney function tests are recommended. Asian patients may show higher drug concentrations, necessitating dose adjustment. While this medication is not known to have a significant impact on driving or machine operation ability, dizziness may occur, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including hives and angioedema, severe myalgia, myopathy, rhabdomyolysis, chest discomfort, difficulty breathing, respiratory distress, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe liver damage, severe muscle weakness, ocular muscle weakness, immune-mediated necrotizing myopathy, acute renal failure, oligoanuria, elevated serum creatinine

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • arthralgia
  • fatigue
  • numbness
  • sensory disturbances
  • nausea
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1°C to 30°C at room temperature to preserve the medication's effectiveness.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 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.