Medication info
Crebatin Tablet 10 mg (Rosuvastatin Calcium)

Crebatin Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
영일제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201501810 · Approved 2015.04.02 · Insurance code 649404750

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For the treatment of primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the initial dose is 5 mg once daily. The maintenance dose is 10 mg once daily, which can be adjusted to a maximum of 20 mg daily at intervals of 4 weeks or more as needed. The medication can be taken at any time of the day regardless of meals.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose once daily between 5 mg and 20 mg adjusted according to individual treatment goals. Dosing adjustments should occur every 4 weeks.

Ingredients

Manufacturer
영일제약(주)

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
  • primary 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 medicine is primarily used as an adjunct when dietary therapy and exercise alone do not control hypercholesterolemia and mixed dyslipidemia in patients. It is particularly effective in the treatment of heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, and dysbetalipoproteinemia. Additionally, it helps reduce cholesterol levels in pediatric patients meeting certain criteria for familial hypercholesterolemia. This drug lowers total cholesterol and LDL cholesterol levels, slows the progression of atherosclerosis, and contributes to the reduced risk of stroke, myocardial infarction, and other risks in patients at high risk for cardiovascular disease. Therefore, this medicine is used in the prevention and treatment of cardiovascular diseases associated with dyslipidemia.

Dosage and Administration

Adult dosage

For the treatment of primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the initial dose is 5 mg once daily. The maintenance dose is 10 mg once daily, which can be adjusted to a maximum of 20 mg daily at intervals of 4 weeks or more as needed. The medication can be taken at any time of the day regardless of meals.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose once daily between 5 mg and 20 mg adjusted according to individual treatment goals. Dosing adjustments should occur every 4 weeks.

Precautions

This medication may not be used in certain patients. For example, patients who are allergic to this drug, have severely impaired liver function, have muscle diseases, are taking certain medications with it, and women who are pregnant or breastfeeding should not take this medicine. Moreover, it is important to conduct repeated liver function tests and muscle-related tests before taking this medicine. Special caution should be exercised in individuals with a history of liver disease or high alcohol consumption, and any hypothyroidism should be treated prior to therapy. If symptoms of myalgia or muscle weakness occur, inform a physician immediately, and if necessary, discontinue the medicine. Severe muscle damage can lead to worsening renal failure, therefore, this drug should be discontinued in acute severe conditions. This drug may increase blood concentration when taken with certain medications, raising the risk of muscle damage; therefore, caution is required when used in combination with other drugs. Women who may become pregnant should use appropriate contraception and should not take this medication during pregnancy or while breastfeeding. In case of overdose, there is no specific antidote; therefore, symptomatic treatment and tests for liver function and muscle enzymes should be conducted. Dizziness may occur while taking this medicine, so caution should be exercised when driving or operating machinery. Finally, this medication may cause mild side effects such as headache, dizziness, myalgia, indigestion, etc., so if symptoms persist, consult a healthcare provider.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, Steven-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity, severe allergic reactions, severe skin reactions, severe muscle weakness, rhabdomyolysis, fatal and non-fatal liver failure, liver abnormalities (jaundice), severe swelling or urination abnormalities, dyspnea, difficulty breathing, asthma attacks, severe chest tightness, shortness of breath

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • thrombocytopenia
  • cough
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  • diarrhea
  • ocular muscle weakness
  • jaundice
  • hepatitis
  • increased transaminases
  • lupus-like syndrome
  • muscle rupture
  • arthralgia
  • immune-mediated necrotizing myopathy
  • hematuria
  • edema
  • depression
  • sleep disorder
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • AL

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

Storage

This medicine may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. This helps maintain the effectiveness of the drug over time.

Appearance and packaging

Appearance

Pink 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.