Medication info
Crelor Tablet 5 mg (Rosuvastatin Calcium)

Crelor Tablet 5 mg (Rosuvastatin Calcium)

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

MFDS item code 201903850 · Approved 2019.06.13 · Insurance code 678601370

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dosage is 5 mg once daily, and in cases where greater reductions in LDL cholesterol levels are needed, it can be adjusted to a maintenance dosage. The maintenance dosage is usually 10 mg once daily, which is sufficient for most patients. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum of 20 mg per day.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment target for individual patients.

Ingredients

Manufacturer
(주)다산제약

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 artery disease
View approved original text

This medication is primarily used to treat patients with primary hypercholesterolemia or mixed dyslipidemia that are not controlled by diet and exercise. It also serves as an adjunct to diet or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. This drug is effective in lowering total cholesterol and LDL cholesterol levels to slow the progression of atherosclerosis. Additionally, it is used to reduce cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also useful as an adjunct to diet for patients with primary dysbetalipoproteinemia. Furthermore, it helps in reducing the risks of stroke, myocardial infarction, and vascular revascularization in patients at high risk for cardiovascular disease. Therefore, this medication is used to improve various diseases and risk factors associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

The initial dosage is 5 mg once daily, and in cases where greater reductions in LDL cholesterol levels are needed, it can be adjusted to a maintenance dosage. The maintenance dosage is usually 10 mg once daily, which is sufficient for most patients. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum of 20 mg per day.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment target for individual patients.

Precautions

This medication should not be used in patients with certain diseases or conditions. For example, it is contraindicated in patients who have had allergic reactions to this drug, those with severe liver dysfunction, or those with muscle disorders. Additionally, it should not be used in patients with severely impaired renal function, pregnant or breastfeeding women, or fertile women who are not practicing appropriate contraception. This medication contains lactose, and it should not be administered to patients with lactose intolerance or related genetic disorders. When using this medication, regular checks of liver function and muscle condition should be conducted, especially in patients who consume significant amounts of alcohol or have a history of liver disease. If symptoms such as muscle pain, weakness, fatigue, or fever occur, the doctor should be informed immediately, and the medication may need to be discontinued. Patients at high risk of serious muscle disorders, such as those with moderate to severe renal impairment, hypothyroidism, or a family history of muscle disease, should be particularly cautious when using this medication and should have muscle enzyme levels monitored before and after treatment. This medication may increase the concentration of other specific drugs in the bloodstream when used concomitantly, raising the risk of side effects. Therefore, it is essential to consult a physician or pharmacist if other medications are being taken. Pregnant or breastfeeding individuals should avoid this medication due to potential risks to the fetus or infant, and women planning to become pregnant should use appropriate contraception. In case of overdose, there is no specific antidote, and treatment should be symptomatic, with monitoring of liver function and muscle enzymes. Rarely, this medication may cause severe skin reactions, liver damage, neurological abnormalities, or myopathy. Therefore, if any unusual symptoms occur, immediate medical attention should be sought. Caution is necessary as dizziness may occur during driving or operating machinery. Patients are advised to undergo regular blood tests and clinical examinations while taking this medication and to use it safely according to their doctor's instructions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, jaundice, severe lethargy, sudden and severe headache, lightning headache, seizures, confusion, vision abnormalities, paralysis, urine

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • 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 protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius room temperature. This helps to preserve the medication's effectiveness and safety for an extended period.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

For domestic use - 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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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.