Medication info
Cretor Tablet 10 mg (Rosuvastatin Calcium)

Cretor Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 201005763 · Approved 2010.09.29 · Insurance code 649505880

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily, and can be adjusted to a maintenance dose for greater LDL cholesterol reduction if needed. The maintenance dose is 10 mg once daily for most patients at which they are controlled. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or longer, with a maximum daily dose of 20 mg.
Child dose
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 individually based on the recommended treatment goals for each patient.

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of premature coronary heart disease
View approved original text

This medicine is used primarily in cases where dietary changes and exercise do not sufficiently control primary hypercholesterolemia and combined hyperlipidemia. It also serves as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. In patients with hypercholesterolemia, it effectively lowers serum total cholesterol and LDL cholesterol levels, helping to delay the progression of atherosclerosis. It is also used as an adjunct to dietary modifications in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, particularly when there are risk factors for cardiovascular disease. It can also be used as an adjunct in patients with primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 and women over 60 with certain cardiovascular risk factors. Thus, this medicine is used for various forms of hyperlipidemia and risk reduction for cardiovascular diseases.

How to take

Adult dose

The initial dose is 5 mg once daily, and can be adjusted to a maintenance dose for greater LDL cholesterol reduction if needed. The maintenance dose is 10 mg once daily for most patients at which they are controlled. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or longer, with a maximum daily dose of 20 mg.

Child dose

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 individually based on the recommended treatment goals for each patient.

Precautions

This medicine should not be used in certain patients. For instance, patients allergic to any component of this medicine, those with liver function problems, muscle diseases, patients taking specific medications concurrently, patients with severely decreased kidney function, pregnant or nursing women, and patients with lactose intolerance should not take this medicine. Additionally, since this medicine can affect liver function or muscles, patients who consume alcohol heavily or have a history of liver disease should use it with caution. If muscle pain or weakness occurs, inform a healthcare professional immediately and receive muscle enzyme tests if needed. Special caution is required for elderly patients, those with reduced kidney function, and patients with hypothyroidism, as they are at higher risk for muscle-related side effects. It is advisable to monitor liver function tests and muscle-related tests regularly while taking this medicine, and to consult medical personnel immediately if any unusual symptoms occur. Furthermore, if taken in conjunction with certain medications, the concentration of this medicine in the blood may increase, raising the risk of side effects, so it is essential to report any other medications being taken. Women who are pregnant or may become pregnant should use appropriate contraceptive methods before taking this medicine and should stop taking it immediately if pregnancy is confirmed. Nursing mothers should also avoid using this medication for safety. In cases of overdose, there is no specific antidote, so treatment should be symptomatic, with monitoring of liver function and muscle enzyme levels. This medicine does not significantly affect the ability to drive or operate machinery, but caution is advised as dizziness may occur. Lastly, this medication may show higher blood concentrations in Asians, possibly requiring dosage adjustments.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, severe muscle weakness, ophthalmoplegia, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, fatal and non-fatal liver failure, severe skin reactions, dyspnea, interstitial lung disease, fever, chest tightness, difficulty breathing

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • chest discomfort
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  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • abnormal sensations
  • hematuria
  • cough

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

Storage

This medicine may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at a cool temperature below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 200 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.