Medication info
Crelorba Tablet 5 mg (Rosuvastatin Calcium)

Crelorba Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Yellow, round, film-coated tablet
Packaging
30 tablets (10 tablets / PTP X 3)
Approval status
Active

MFDS item code 201405753 · Approved 2014.12.04 · Insurance code 643703950

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Take 5 mg once daily as an initial dose, regardless of meals. If more LDL cholesterol reduction is needed, the maintenance dose can be adjusted, with most patients being maintained at 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient's response, with adjustments made at intervals of 4 weeks or longer.
Child dose
For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, the typical dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to each patient's treatment goals.

Ingredients

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

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary changes and exercise alone are not sufficient. It is also used in patients with homozygous familial hypercholesterolemia along with dietary changes or other lipid-lowering therapies. It effectively lowers total cholesterol and LDL cholesterol levels to target levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It may also be used as an adjunct in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia who have LDL cholesterol levels exceeding certain criteria. It is beneficial for patients with primary dysbetalipoproteinemia and contributes to reducing the risk of myocardial infarction, stroke, and arterial revascularization in men over 50 years and women over 60 years with certain cardiovascular risk factors. Overall, it is used to improve cardiovascular health.

How to take

Adult dose

Take 5 mg once daily as an initial dose, regardless of meals. If more LDL cholesterol reduction is needed, the maintenance dose can be adjusted, with most patients being maintained at 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient's response, with adjustments made at intervals of 4 weeks or longer.

Child dose

For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, the typical dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to each patient's treatment goals.

Precautions

This medication should not be administered to certain patients. For example, it should be avoided in patients with allergies to its components, severe liver problems, muscle disorders, and those with significantly impaired kidney function. Additionally, women who are pregnant or breastfeeding, or those of childbearing potential without adequate contraception should not take this medication. This medication requires special caution in patients at high risk of muscle-related side effects, such as those with moderate or severe renal impairment, hypothyroidism, a history of genetic muscle diseases, alcohol dependence, or those using certain concomitant medications. This medication contains lactose and should not be administered to patients with lactose intolerance or associated genetic disorders. It is important to periodically monitor liver function and muscle status during treatment. Patients who consume substantial amounts of alcohol or have a history of liver disease should be observed more closely, and treatment may be discontinued if liver enzyme levels are abnormally high. If symptoms such as muscle pain, weakness, or cramps occur, immediate notification to medical personnel and further evaluation are necessary. In cases of suspected severe muscle damage, treatment should be halted, and reevaluation of re-administration should be done after recovery. This medication may interact with certain drugs, so patients should inform their healthcare providers if they are taking other medications. Particularly, the risk of muscle side effects may be increased when used in combination with certain antiviral agents, immunosuppressants, antifungals, antibiotics, and fibrate agents. It should not be used during pregnancy or breastfeeding, and women planning to conceive should use appropriate contraception. In cases of overdose, there are no specific antidotes, and treatment should be symptomatic along with monitoring liver function and muscle enzyme levels. This medication does not significantly affect the ability to drive or operate machinery; however, caution is advised due to possible dizziness. Finally, this medication may result in higher systemic levels in Asian individuals, and dosage adjustments may be necessary. It is critical to consult healthcare personnel and follow their instructions before taking the medication.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, severe muscle weakness, ocular myasthenia, respiratory distress, jaundice, hepatic failure, severe edema, thrombocytopenia, acute renal failure, oliguria, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), severe central nervous system symptoms, severe edema.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • asthenia
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • lichenoid drug rash
  • lupus-like syndrome
  • muscle rupture
  • arthralgia
  • depression
  • sleep disturbances
  • sexual dysfunction.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. In addition, it is best to keep the medication at room temperature, between 1°C and 30°C, avoiding extreme cold or heat.

Appearance and packaging

Appearance

Yellow, round, film-coated tablet

Package unit

30 tablets (10 tablets / PTP X 3)

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.