Medication info
Crestin Tablet 5 mg (Rosuvastatin Calcium)

Crestin Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
Yellow round film-coated tablet
Packaging
30 tablets (15 tablets/PTP x 2)
Approval status
Active

MFDS item code 202002683 · Approved 2020.04.16 · Insurance code 652904620

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose may be adjusted up to 10 mg once daily as needed. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response with an interval of 4 weeks or more, and may be increased to a maximum of 20 mg daily.
Children's dosage
For pediatric patients aged 10 to 17 years, the dose is 5 mg to 20 mg once daily. The dose should be adjusted based on the individual patient’s treatment goals, and dose adjustments should occur every 4 weeks or more.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk

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

This medication can be used as an adjunctive treatment in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are inadequate. It is also used in combination with dietary therapy or LDL apheresis in patients with homozygous familial hypercholesterolemia, lowering total cholesterol and LDL-cholesterol levels to delay the progression of atherosclerosis. In pediatric patients aged 10 to 17 years with familial hypercholesterolemia meeting specific criteria, it can also be used as an adjunct to dietary therapy. It is also used as an adjunct in patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in adult patients at high risk for cardiovascular disease. This medication is effectively used to improve cholesterol-related disorders and cardiovascular risk.

Dosage and Administration

Adult dosage

This can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose may be adjusted up to 10 mg once daily as needed. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response with an interval of 4 weeks or more, and may be increased to a maximum of 20 mg daily.

Children's dosage

For pediatric patients aged 10 to 17 years, the dose is 5 mg to 20 mg once daily. The dose should be adjusted based on the individual patient’s treatment goals, and dose adjustments should occur every 4 weeks or more.

Precautions

This medication should not be used in certain patients. For instance, patients who are allergic to this medication, those with severely impaired liver function, patients with muscle disorders, severely impaired kidney function, pregnant or breastfeeding women, and women of childbearing age who do not use effective birth control should not take this medication. Periodic monitoring of liver function and muscle status is necessary while using this medication. Patients with a history of liver disease or excessive alcohol consumption require extra caution. If symptoms such as myalgia or muscle weakness occur, consult a doctor immediately and discontinue use in severe cases. This medication can increase blood sugar levels in some patients, necessitating careful blood glucose management for those at high risk for diabetes. Moreover, patients with kidney or thyroid dysfunction, elderly patients, or those who abuse alcohol are at higher risk for muscle-related side effects, so a consultation with a physician prior to treatment is warranted. This medication may interact with several other drugs; therefore, if you are currently taking any medications, it is crucial to inform your healthcare professional. Specifically, combined use with certain antiviral agents, immunosuppressants, some antibiotics, and fibrate medications may increase the risk of muscle damage. This medication is to be avoided during pregnancy or breastfeeding as it could harm the fetus or infant; women planning to become pregnant should use appropriate contraception. In the case of overdose, there is no specific antidote, so it is essential to seek appropriate treatment and monitoring at a hospital immediately. This medication does not significantly affect driving or operating machinery, but caution is advised as dizziness may occur. Lastly, if skin rash, severe muscle pain, jaundice symptoms, etc., occur while taking this medication, consult a healthcare professional immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug rash (DRESS), rhabdomyolysis, severe muscle weakness, ocular myasthenia, jaundice, hepatitis, severe allergic reactions, severe skin reactions, severe edema, fatal and non-fatal liver failure, acute kidney failure, oliguria, dyspnea, respiratory issues accompanied by cough and fever

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • sensory abnormalities
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • myopathy (including myositis)
  • transaminase elevation
  • ALT increase
  • CK increase
  • AST increase
  • thrombocytopenia
  • 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 prevent exposure to air or moisture. The appropriate storage temperature is between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

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.