Medication info
Crezin 5 mg (Rosuvastatin Calcium)

Crezin 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
아이큐어(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201603368 · Approved 2016.06.10 · Insurance code 674401250

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Adults with primary hypercholesterolemia, mixed dyslipidemia, and primary dysbetalipoproteinemia should take this medication at an initial dose of 5 mg once daily, at any time of day, regardless of meals. If needed, the dosage may be adjusted to 10 mg once daily based on LDL cholesterol levels and patient response, and can be increased up to a maximum of 20 mg.
Children's dosage
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) are administered once daily at a dose ranging between 5 mg and 20 mg. The dosage should be adjusted according to individual treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
아이큐어(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct to diet and exercise for patients with primary hypercholesterolemia and mixed dyslipidemia when these lifestyle changes are not sufficient. It also plays an auxiliary role in the treatment of patients with homozygous familial hypercholesterolemia, lowering total cholesterol and LDL cholesterol levels and delaying the progression of atherosclerosis. It is additionally used as an adjunct to diet in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. This medication is also beneficial for patients with primary dysbetalipoproteinemia, and it helps reduce the risks of stroke, myocardial infarction, and arterial revascularization in middle-aged and older patients at high risk for cardiovascular disease. Overall, it is used to manage cholesterol levels and improve cardiovascular health.

Dosage and Administration

Adult dosage

Adults with primary hypercholesterolemia, mixed dyslipidemia, and primary dysbetalipoproteinemia should take this medication at an initial dose of 5 mg once daily, at any time of day, regardless of meals. If needed, the dosage may be adjusted to 10 mg once daily based on LDL cholesterol levels and patient response, and can be increased up to a maximum of 20 mg.

Children's dosage

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) are administered once daily at a dose ranging between 5 mg and 20 mg. The dosage should be adjusted according to individual treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication or those with severely impaired liver function, muscle disorders, and those taking certain immunosuppressants should not take this medication. Additionally, patients with significantly impaired kidney function, pregnant or nursing women, and fertile women who do not use appropriate contraception should also avoid this medication. High-dose administration of this medication is contraindicated in patients at high risk for muscle-related side effects, such as those with moderately impaired kidney function, thyroid disorders or family history thereof, alcohol abuse, individuals of Asian descent, and those taking specific lipid-lowering medications. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic disorders. When administering this medication, it is important to regularly monitor liver function and muscle status. Patients with a history of significant alcohol intake or liver disease should have their liver enzyme levels checked frequently, and if symptoms of muscle pain or weakness occur, they should immediately inform their healthcare provider. This medication can affect muscles and may lead to muscle pain, myopathy, and rarely severe muscle breakdown known as rhabdomyolysis, so caution is necessary. Additionally, this medication should be discontinued in cases of acute kidney failure or severe physical stress. Be cautious of interactions with other medications, as the plasma concentration of this medication may increase when taken with certain drugs, leading to a higher risk of side effects. Particular attention should be paid when coadministered with certain antivirals, immunosuppressants, and fibrate-class drugs; coadministration is sometimes not recommended. Pregnant or nursing women should not take this medication, and women of childbearing potential should use appropriate contraception. In the case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme testing are required. This medication does not significantly affect driving or operating machinery; however, caution is advised as dizziness may occur. If severe rash or allergic reactions occur while taking this medication, discontinue use immediately and consult a healthcare provider.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including rash and angioedema, rhabdomyolysis, Stevens-Johnson syndrome, eosinophilia and systemic symptoms Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), immune-mediated necrotizing myopathy, jaundice, hepatitis, acute kidney failure, oliguria, tightness in the chest, difficulty breathing, respiratory distress, severe muscle weakness, ocular muscle weakness, thrombocytopenia, serious adverse drug reactions (myalgia, joint pain)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • joint pain
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • increased transaminases
  • abnormal liver function tests
  • elevated ALT
  • elevated AST
  • elevated CK
  • headache
  • dizziness
  • chest pain
  • cough

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness.

Appearance and packaging

Appearance

Yellow 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.

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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.