Medication info
Cretor 5 mg (Rosuvastatin Calcium)

Cretor 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
Light yellow round film-coated tablet
Packaging
30 tablets (10 tablets/PTP packaging x 3), 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201604209 · Approved 2016.07.07 · Insurance code 649507260

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For adult patients with primary hypercholesterolemia, mixed dyslipidemia, etc., this 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 can be adjusted to 10 mg once daily if necessary. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and patient response at intervals of at least 4 weeks, with a maximum dose of 20 mg per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended dose is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to treatment goals and dose adjustments.

Ingredients

Manufacturer
유니메드제약(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 for patients with primary hypercholesterolemia and mixed dyslipidemia that are difficult to control solely with diet and exercise. It is particularly helpful as an adjunct to diet in patients with familial hypercholesterolemia or primary dysbetalipoproteinemia. Additionally, it lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. It is also used in pediatric patients aged 10 to 17 years with hypercholesterolemia and in adults at high risk for cardiovascular diseases to help reduce the risk of complications after stroke, myocardial infarction, or vascular revascularization. Thus, this medication is utilized to improve various hypercholesterolemia and cardiovascular disease-related risks.

Dosage and Administration

Adult dosage

For adult patients with primary hypercholesterolemia, mixed dyslipidemia, etc., this 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 can be adjusted to 10 mg once daily if necessary. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and patient response at intervals of at least 4 weeks, with a maximum dose of 20 mg per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended dose is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to treatment goals and dose adjustments.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication, have severely impaired liver function, have myopathy, have severe renal impairment, or are pregnant or breastfeeding should not take this medication. This medication may affect liver function or muscle health, so patients with a history of liver disease or symptoms of myalgia or myopathy should consult their doctor before taking it and be monitored closely. If symptoms such as muscle pain, muscle weakness, fatigue, or fever occur during treatment, it is essential to inform healthcare providers immediately, and blood tests may be needed to check for muscle damage. Also, when taken with specific medications, blood concentration may increase, raising the risk of muscle damage, so patients should inform their doctor or pharmacist if they are taking other medications. Women of childbearing potential should use appropriate contraception when taking this medication and should discontinue it immediately if they become pregnant. In case of overdose, there is no specific antidote, so symptomatic treatment should be provided, and liver function and muscle enzyme levels should be monitored. Caution is required when driving or operating machinery, as dizziness may occur. This medication generally has many mild side effects, but in rare cases, serious skin reactions, liver damage, or muscle damage can occur, so any unusual symptoms should be discussed with a healthcare professional immediately.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe myopathy, ocular myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, thrombocytopenia, severe edema associated with hypertension, dyspnea, chest tightness

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • increased serum creatinine
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best stored in a cool place below 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Light yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3), 30 tablets/bottle, 300 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.