Medication info
Crebatin Tablet 5mg (Rosuvastatin Calcium)

Crebatin Tablet 5mg (Rosuvastatin Calcium)

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

MFDS item code 201501811 · Approved 2015.04.02 · Insurance code 649404760

Summary

Main use
Treatment for hypercholesterolemia and to reduce the risk of cardiovascular disease
Who uses it
Adults · Children
Adult dosage
Medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is usually 10 mg once daily for most patients. The maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response, with appropriate adjustments made every 4 weeks or longer, and may 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), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual treatment goals of each patient,

Ingredients

Manufacturer
영일제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and to reduce the risk of cardiovascular disease

  • 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
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as an adjunct when diet and exercise do not adequately control primary hypercholesterolemia and mixed dyslipidemia. It is also prescribed as an adjunct to diet or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This drug effectively lowers total cholesterol and LDL-cholesterol levels, thereby delaying the progression of atherosclerosis. It is particularly used in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia to reduce LDL-cholesterol and Apo-B protein levels. It is also applied as an adjunct to diet in patients with primary dysbetalipoproteinemia and is helpful in reducing the risk of cardiovascular diseases such as myocardial infarction and stroke in high-risk groups with elevated high-sensitivity C-reactive protein levels. Overall, this drug is used to improve blood lipid levels and reduce the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

Medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is usually 10 mg once daily for most patients. The maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response, with appropriate adjustments made every 4 weeks or longer, and may 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), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual treatment goals of each patient,

Precautions

This drug should not be used in certain patients. First, patients who are allergic to this medication or have severe liver dysfunction, those with muscle disorders, patients with severely impaired renal function, and women who are pregnant or breastfeeding should not take this drug. Additionally, patients at high risk for muscle issues should avoid high doses of this medication, and those with genetic problems such as lactose intolerance should not take it either. When using this medication, liver function and muscle condition should be regularly monitored, and especially if symptoms like muscle pain, muscle weakness, or muscle cramps occur, medical personnel should be notified immediately. Patients who consume alcohol heavily or have a history of liver disease, as well as those with hypothyroidism, should use this drug with caution and may need to repeat liver enzyme tests. This drug can interact with other medications, so if other medications are being taken, it is important to inform the physician or pharmacist. In particular, when taken with certain antiviral medications, immunosuppressants, or fibrate-based drugs, the risk of muscle disorders may increase. Women who may become pregnant should ensure proper contraception while taking this drug, and it should not be used during pregnancy. Breastfeeding women should also avoid this medication. There is no specific antidote in case of overdose, and treatment should be based on symptoms while monitoring liver function and muscle enzyme levels. This drug does not significantly affect the ability to drive or operate machinery, but caution is needed due to possible dizziness. Finally, if severe skin reactions like rash, swelling, or difficulty breathing occur while taking this medication, use should be stopped immediately and medical consultation should be sought.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, shortness of breath, cold sweat, pallor, severe rash with high fever, blisters, mucosal pain in the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, abnormalities in breathing accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • fatigue
  • numbness
  • dysesthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • dyspnea
  • ocular muscle weakness
  • thrombocytopenia
  • abnormal liver function tests
  • increased AST
  • increased ALT
  • increased CK
  • joint pain
  • depression
  • sleep disturbances

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.