Medication info
Krelova Tablets 10 mg (Rosuvastatin Calcium)

Krelova Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (10 tablets/PTP*3)
Approval status
Active

MFDS item code 201001014 · Approved 2010.01.28 · Insurance code 643703260

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer 5 mg once daily starting at any time of the day regardless of meals. If a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted to 10 mg once daily, and the dosage can be increased up to 20 mg per day, based on patient response, with intervals of at least 4 weeks between adjustments.
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, a dose of 5 mg to 20 mg is administered once daily. The dose should be individually adjusted according to treatment goals, with intervals of at least 4 weeks between adjustments.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

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

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

This medication is used for patients with hypercholesterolemia and dyslipidemia. It is particularly used as an adjunct for patients with primary hypercholesterolemia or mixed dyslipidemia that are difficult to control with diet and exercise. Additionally, it is administered to patients with homozygous familial hypercholesterolemia combined with diet or other lipid-lowering therapies to enhance effectiveness. This drug lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. It is also used in children aged 10 years or older meeting specific criteria for familial hypercholesterolemia, helping reduce the risk of cardiovascular disease, such as stroke, myocardial infarction, and arterial revascularization. Thus, this drug is used to improve blood lipid levels in various conditions associated with dyslipidemia and to prevent cardiovascular diseases.

How to take

Adult dose

Administer 5 mg once daily starting at any time of the day regardless of meals. If a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted to 10 mg once daily, and the dosage can be increased up to 20 mg per day, based on patient response, with intervals of at least 4 weeks between adjustments.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, a dose of 5 mg to 20 mg is administered once daily. The dose should be individually adjusted according to treatment goals, with intervals of at least 4 weeks between adjustments.

Precautions

This medication should not be administered to certain patients. For example, individuals who are allergic to any component of this drug, those with severely impaired liver function, muscle disorders, or those with severely reduced kidney function, should not take this medication. Additionally, pregnant or nursing women, as well as women who could become pregnant, must consult a physician before taking this medication. This drug can affect liver function, and caution is needed for those with a history of liver disease or those who consume alcohol in excess. It is advisable to regularly check liver enzyme levels and muscle health during treatment. If symptoms such as muscle pain or weakness occur, inform your physician immediately, and treatment may be discontinued in severe cases. This drug may interact with certain medications, so it is essential to inform healthcare professionals if other medications are being taken. Particularly caution is required when taken with drugs that could increase the risk of muscle-related side effects. Pregnant or nursing women should refrain from using this medication, and women planning to become pregnant should use appropriate contraception. In cases of overdose, there is no specific antidote available; immediate medical treatment is required, with monitoring of liver function and muscle enzyme levels. Caution should also be exercised when driving or operating machinery, as dizziness may occur. Lastly, this drug contains lactose, so individuals with lactose intolerance should not use it, and dosage adjustment may be necessary for individuals of Asian descent.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions including urticaria and angioedema
  • Severe swelling (edema)
  • Chest tightness, difficulty breathing, dyspnea
  • Stevens-Johnson syndrome
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Jaundice, hepatitis
  • Severe liver failure
  • Severe muscle weakness, ocular muscle weakness
  • Immune-mediated necrotizing myopathy
  • Acute renal failure
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  • Sudden and severe headache, seizures, confusion, visual disturbances, paralysis
  • Accompanied by increased blood pressure

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • fatigue
  • cough
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  • diarrhea
  • hematuria
  • chest pain
  • loss of appetite
  • abdominal distension
  • fatigue
  • numbness
  • paresthesia
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • arthralgia
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

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

Appearance and packaging

Appearance

Pink round film-coated tablets

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.