Medication info
Crestba Tablet 20mg (Rosuvastatin Calcium)

Crestba Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201400840 · Approved 2014.02.24 · Insurance code 649102280

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For adult patients with primary hypercholesterolemia and others, this medication can be taken once daily at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is often adjusted to 10 milligrams once daily for most patients. After an interval of 4 weeks or more, the maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response, potentially escalating to a maximum of 20 milligrams daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dose is administered once daily at a range of 5 milligrams to 20 milligrams. The dosing should be adjusted based on the treatment goals for each individual patient.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Treatment of 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 medication is used as an adjunctive treatment when diet and exercise alone are insufficient for patients with primary hypercholesterolemia and mixed dyslipidemia. It is particularly beneficial when used in conjunction with other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. This drug effectively lowers total cholesterol and LDL-cholesterol levels, thereby slowing the progression of atherosclerosis. It is also appropriate for pediatric patients with heterozygous familial hypercholesterolemia aged between 10 and 17 years, to be used as an adjunct to diet when specific criteria are met. Additionally, it is used as an adjunct to diet for patients with primary dysbetalipoproteinemia. Finally, this drug helps reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in men over 50 years of age and women over 60 years of age with elevated high-sensitivity C-reactive protein levels. Overall, it is used to improve cardiovascular health.

How to take

Adult dose

For adult patients with primary hypercholesterolemia and others, this medication can be taken once daily at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is often adjusted to 10 milligrams once daily for most patients. After an interval of 4 weeks or more, the maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response, potentially escalating to a maximum of 20 milligrams daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dose is administered once daily at a range of 5 milligrams to 20 milligrams. The dosing should be adjusted based on the treatment goals for each individual patient.

Precautions

This medication should not be administered to certain patients, such as those with an allergy to this drug, severe liver disease, or muscle disorders, as well as those taking certain medications, severely impaired renal function patients, and women who are pregnant or breastfeeding. It is important to regularly monitor liver function and muscle condition before and during treatment, especially for patients with a history of liver disease or who consume alcohol heavily. If symptoms like muscle pain or weakness occur, patients should notify healthcare professionals immediately, and treatment may need to be discontinued in severe cases. This medication contains lactose, so patients with lactose intolerance should avoid taking it. Additionally, this drug may interact with other medications, so patients should inform their healthcare provider about any other medications they are taking, especially with certain antiviral drugs, immunosuppressants, and fibrate medications. Women with childbearing potential should use appropriate contraceptive methods, and those who are pregnant or breastfeeding should avoid taking it. In cases of overdose, there is no specific antidote, and symptomatic treatment should be initiated while monitoring liver function and muscle enzyme levels. This drug may cause side effects such as dizziness, so caution is advised when driving or operating machinery. Finally, rare but serious side effects such as interstitial lung disease or severe skin reactions may occur with long-term use, so patients should consult healthcare professionals immediately if any unusual symptoms appear.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, myopathy, severe muscle weakness, ocular myasthenia, jaundice, hepatitis, severe liver damage, fatal and non-fatal liver failure, severe edema, acute kidney failure, oliguria, severe allergic reactions, severe skin reactions, dyspnea, respiratory issues, severe neurological effects

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • cough
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  • diarrhea
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • memory loss
  • 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 may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is recommended to maintain the storage temperature between 1 degree to 30 degrees Celsius. This will help preserve the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 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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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.