Medication info
Crestor 10mg (Rosuvastatin Calcium)

Crestor 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
알리코제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201505162 · Approved 2015.07.30 · Insurance code 656003930

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Take once daily at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is adjusted for greater LDL-cholesterol reduction as needed. The maintenance dose of 10 milligrams once daily is suitable for most patients. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.
Children's dosage
For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, administer 5 milligrams to 20 milligrams once daily. The dosage should be individually adjusted based on treatment goals, and at intervals of 4 weeks or more.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct when diet and exercise alone are not sufficient in managing primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct to dietary measures in patients with homozygous familial hypercholesterolemia. In patients with hypercholesterolemia, it effectively lowers total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis. Particularly, it is used as an adjunct dietary treatment in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. It is also beneficial for patients with primary dysbetalipoproteinemia and plays a role in reducing the risk of stroke, myocardial infarction, and vascular revascularization procedures in middle-aged and older adults with high cardiovascular risk. In summary, this medication is effectively used to lower the risk of various forms of hypercholesterolemia and cardiovascular diseases.

Dosage and Administration

Adult dosage

Take once daily at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is adjusted for greater LDL-cholesterol reduction as needed. The maintenance dose of 10 milligrams once daily is suitable for most patients. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Children's dosage

For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, administer 5 milligrams to 20 milligrams once daily. The dosage should be individually adjusted based on treatment goals, and at intervals of 4 weeks or more.

Precautions

This drug should not be administered to certain patients. For example, individuals who are allergic to this medication, those with active liver disease, muscle disorders, or severe renal impairment should not take this drug. Women who are pregnant, breastfeeding, or who may become pregnant should consult a specialist before use and employ appropriate contraception. Additionally, patients at high risk for myopathy or rhabdomyolysis should avoid high-dose therapy, and careful diagnosis and monitoring are needed before use for those with these risk factors. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic disorders. Patients who consume excessive alcohol or have a history of liver disease should have regular liver function tests, and those with hypothyroidism or nephrotic syndrome should prioritize treatment of the underlying condition. If symptoms such as muscle pain, weakness, fatigue, or fever occur, immediate medical consultation is necessary, and blood tests should be performed to check for muscle damage. This medication may interact with other drugs, especially with certain antivirals, immunosuppressants, and fibrates, so caution is required when used together. Clinical trials and post-market reports indicate that this drug can cause side effects such as liver function abnormalities, muscle-related adverse reactions, gastrointestinal disturbances, and skin rashes, so any abnormalities should be discussed with medical personnel. Avoid using this medication during pregnancy and breastfeeding, and women planning to become pregnant should ensure adequate contraception. There is no specific antidote for overdose, therefore treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Dizziness may occur while taking this medication, so caution is required when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, shortness of breath, jaundice, acute renal failure, oliguria, thrombocytopenia, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, severe skin reactions, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • ocular muscle weakness
  • cough
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • 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 at room temperature between 1 and 30 degrees Celsius. This helps to maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

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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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.