Medication info

Krelor 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)휴온스메디텍
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Active

MFDS item code 201604101 · Approved 2016.06.30

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
It can be administered at any time during the day regardless of meals. The initial dosage is 5 milligrams once daily, while the maintenance dose is 10 milligrams once daily, which is adjusted in most patients. The maintenance dose should be appropriately adjusted according to LDL cholesterol levels, treatment goals, and patient response, with a maximum increase to 20 milligrams per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted at intervals of 4 weeks or more as recommended.

Ingredients

Manufacturer
(주)휴온스메디텍

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
  • 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 in patients with primary hypercholesterolemia or mixed dyslipidemia that are not controlled by diet and exercise. It lowers LDL cholesterol and total cholesterol levels, delaying the progression of atherosclerosis, and is also used with diet or other treatments in patients with homozygous familial hypercholesterolemia. Additionally, it helps improve cholesterol levels in pediatric patients aged 10 to 17 years with a family history or risk factors. It can also serve as an adjunct to diet in patients with primary dysbetalipoproteinemia. In middle-aged patients with elevated high-sensitivity C-reactive protein levels and cardiovascular disease risk factors, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures. Overall, it is used to improve cardiovascular health.

Dosage and Administration

Adult dosage

It can be administered at any time during the day regardless of meals. The initial dosage is 5 milligrams once daily, while the maintenance dose is 10 milligrams once daily, which is adjusted in most patients. The maintenance dose should be appropriately adjusted according to LDL cholesterol levels, treatment goals, and patient response, with a maximum increase to 20 milligrams per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted at intervals of 4 weeks or more as recommended.

Precautions

This medication should not be used in certain patients. For instance, patients with allergies to this drug's components, those with severe liver impairment, patients with muscle disorders, and those with significantly reduced kidney function should not take this drug. Women who are pregnant or nursing, or those of childbearing age who are not using appropriate contraceptive methods should avoid this drug. Additionally, patients vulnerable to muscle-related disorders should avoid high doses. This drug contains lactose, so patients with certain genetic conditions like lactose intolerance should not take it. Patients with a history of liver disease or excessive alcohol consumption should have regular liver function tests while taking this medication. Those with conditions such as hypothyroidism or nephrotic syndrome should have these conditions treated first. If symptoms of myalgia or muscle weakness occur, patients should immediately inform their doctor, and if necessary, blood tests should be conducted to check for muscle damage. Caution is advised when taking other medications as some may increase the risk of muscle problems. High doses may cause temporary changes in kidney function, thus kidney function tests should also be considered. Asian patients may have higher systemic exposure to this drug, requiring potential dosage adjustments. This drug may rarely cause serious skin reactions or liver damage; if symptoms such as rash or jaundice occur, the medication should be discontinued immediately, and medical consultation should be sought. During pregnancy or nursing, this drug can be harmful to the fetus or infant; thus, its use should be avoided, and women who could become pregnant should ensure they are utilizing appropriate contraceptive methods. There is no specific antidote for overdose; treatment is symptomatic, and liver function and muscle-related tests should be continuously monitored. Lastly, this drug is unlikely to affect driving or operating machinery but caution should be taken as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, severe muscle weakness, ophthalmoplegia, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, polyneuropathy, severe dermatological reactions, severe allergic reactions, difficulty breathing, asthma attacks, liver abnormalities (jaundice), severe neurological symptoms, severe injuries

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • abnormal sensation
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3)

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.