Medication info
Krelorush Tablets 20mg (Rosuvastatin Calcium)

Krelorush Tablets 20mg (Rosuvastatin Calcium)

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

MFDS item code 201001009 · Notified 2010.01.28

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
It can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily, with maintenance doses adjusted according to treatment goals. The maintenance dose is typically 10 mg once daily, which is adequate for most patients. The maintenance dosage may be adjusted based on LDL cholesterol levels, treatment goals, and patients’ responses with an interval of 4 weeks or more, and the dose can be increased up to a maximum of 20 mg per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), a dose of 5mg to 20mg is administered once daily. The dosage can be adjusted based on treatment goals with an interval of 4 weeks or more.

Ingredients

Manufacturer
삼아제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • primary dyslipoproteinemia
  • 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 an adjunct to diet and exercise for patients with primary hypercholesterolemia and mixed hyperlipidemia when these methods are inadequate. It also complements dietary measures for patients with homozygous familial hypercholesterolemia or other lipid-lowering therapies. It is used in patients with hypercholesterolemia to lower total cholesterol and LDL cholesterol to slow the progression of atherosclerosis. In children or adolescents with heterozygous familial hypercholesterolemia, it can be prescribed as a dietary adjunct if their specific LDL cholesterol levels exceed certain values. It is effective in patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and revascularization procedures in middle-aged individuals at high risk for cardiovascular diseases. Overall, this medication is used to improve blood lipid levels and reduce cardiovascular disease risk.

Dosage and Administration

Adult dosage

It can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily, with maintenance doses adjusted according to treatment goals. The maintenance dose is typically 10 mg once daily, which is adequate for most patients. The maintenance dosage may be adjusted based on LDL cholesterol levels, treatment goals, and patients’ responses with an interval of 4 weeks or more, and the dose can be increased up to a maximum of 20 mg per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), a dose of 5mg to 20mg is administered once daily. The dosage can be adjusted based on treatment goals with an interval of 4 weeks or more.

Precautions

This medication should not be used in certain patients. Firstly, individuals allergic to any ingredients in this drug should not take it. Patients with active liver disease or abnormally elevated liver enzyme levels should avoid this drug. Patients with muscle disease or severely impaired kidney function, and women who are pregnant or breastfeeding should not use this drug. Moreover, patients at high risk of myopathy, especially those taking high doses, should avoid this drug, and caution is needed for those with a family history of genetic muscle disorders, alcohol dependence, or hypothyroidism. This drug contains lactose and is not suitable for patients with lactose intolerance or related hereditary conditions. When administered to patients with a history of excessive alcohol consumption or liver disease, liver function tests should be performed frequently, and patients with hypothyroidism or nephrotic syndrome should treat the underlying condition first. If symptoms of muscle pain or weakness occur, immediate consultation with healthcare professionals is necessary, and blood tests may be needed to assess muscle damage. In cases of acute severe disease or onset of severe muscle weakness, the medication should be discontinued. Also, this medication may increase the risk of muscle-related side effects when taken with certain other drugs, so it is important to consult healthcare professionals about concomitant medications. Patients on high doses should undergo kidney function tests, and Asian patients may require dosage adjustments due to higher drug concentrations. This medication can be used in children and adolescents but impacts on growth and maturation should be monitored. While taking this medication, rare occurrences of liver function abnormalities, skin rash, severe muscle damage, etc., can arise, so any abnormal symptoms should be consulted with healthcare professionals immediately. Women who are pregnant or planning to become pregnant must consult healthcare professionals and use appropriate contraceptive methods. In case of overdose, there is no specific antidote available, and treatment based on symptoms along with liver function and muscle enzyme tests is necessary. Care should be taken when driving or operating machinery as dizziness may occur. Lastly, this drug has been reported to have rare side effects such as interstitial lung disease, so if shortness of breath or persistent cough occurs, immediate consultation with healthcare professionals is necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), pancreatitis, jaundice, hepatitis, acute renal failure, oliguria, severe edema, severe muscle weakness, ocular myasthenia, immune-mediated necrotizing myopathy, rhabdomyolysis, severe allergic reactions, severe skin reactions, respiratory issues, liver abnormalities (jaundice

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • cough
  • diarrhea
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  • hematuria
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • fainting
  • general pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • arthralgia
  • 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 should be kept in a tightly closed container to protect it from air and moisture and stored in a cool place at or below 30 degrees Celsius. This will help to maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets (10 tablets/alu-alu x 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.