Medication info
Crestor 20mg (Rosuvastatin Calcium)

Crestor 20mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
한국아스트라제네카(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 30 tablets (15 tablets/PTP x 2)
Approval status
Active

MFDS item code 200410326 · Approved 2004.08.31 · Insurance code 650700530

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
In primary hypercholesterolemia and other related conditions, the drug can be administered once daily at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, with adjustment to 10 milligrams once daily after an interval of 4 weeks or more if necessary. The maximum dose is 20 milligrams once daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer once daily in the range of 5 milligrams to 20 milligrams. Dosage should be adjusted every 4 weeks or more, as required.

Ingredients

Importer
한국아스트라제네카(주)

Efficacy & effects

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

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

This medication is used as an adjunct when dietary measures and exercise are insufficient for patients with primary hypercholesterolemia and mixed dyslipidemia. It also assists in patients with homozygous familial hypercholesterolemia as an adjunct to diet or other lipid-lowering therapies. It effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. In certain cases among pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, it is used as an adjunct to diet to lower cholesterol and apo-B protein levels. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in specific high-risk patients with cardiovascular disease risk factors. It is effectively used for a variety of hypercholesterolemia and cardiovascular disease risk reduction.

How to take

Adult dose

In primary hypercholesterolemia and other related conditions, the drug can be administered once daily at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, with adjustment to 10 milligrams once daily after an interval of 4 weeks or more if necessary. The maximum dose is 20 milligrams once daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer once daily in the range of 5 milligrams to 20 milligrams. Dosage should be adjusted every 4 weeks or more, as required.

Precautions

This drug should not be used in certain patients. For example, patients with allergies to this medication, severely impaired liver function, muscle disorders, specific renal dysfunction, pregnant or breastfeeding women, and fertile women not using adequate contraception should not take this medication. Additionally, patients at high risk for muscle disorders, such as those with moderate to severe renal impairment, hypothyroidism, a family history of muscle disorders, alcoholics, Asians, and patients taking fibrate drugs are prohibited from receiving high doses of this medication. This medication contains lactose; therefore, patients with lactose intolerance or related genetic diseases should not take it. Caution is needed for patients consuming excessive alcohol or with a history of liver disease while taking this medication, and repeating liver function tests before and during treatment is recommended. Moreover, if symptoms such as muscle pain, weakness, or cramps occur, they should immediately inform their healthcare provider. Patients at high risk for muscle-related side effects must carefully weigh the risks and benefits of treatment, and muscle enzyme levels should be checked before starting treatment; if abnormalities are found, administration should not begin. Severe muscle weakness or ocular myasthenia may occur; hence, discontinuation of the medication should be considered if symptoms appear. This medication, when used in combination with certain other drugs, may increase serum concentration and raise the risk of muscle side effects, so patients should consult their healthcare provider about concomitant medications. It should not be used during pregnancy or while breastfeeding, and women of childbearing potential should use suitable contraceptive methods. In case of overdose, there is no specific antidote, and treatment should be symptomatic; liver function and muscle enzyme levels should be regularly monitored. Dizziness may occur while driving or operating machinery, so caution is advised. Rarely, serious side effects such as severe skin reactions, liver damage, neurological abnormalities, and muscle rupture may occur, so if unusual symptoms arise, patients should immediately inform their healthcare provider. Lastly, the drug's plasma concentration may be higher in Asians; thus, dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, hyperbilirubinemia, liver failure, rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy, muscle rupture, severe muscle weakness, ocular myasthenia, respiratory distress, interstitial lung disease, acute renal failure, oliguria, increased serum creatinine, severe skin aberrations

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • appetite loss
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • amnesia
  • 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 is sensitive to air and humidity; therefore, it should be stored in a tightly sealed container. It is important to maintain storage temperatures between 1°C and 30°C. Proper storage will help preserve the medication’s effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 30 tablets (15 tablets/PTP x 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.