Medication info
Colostatin 5 mg (Rosuvastatin Calcium)

Colostatin 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201400123 · Approved 2014.01.13 · Insurance code 648507100

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This drug can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily and may be adjusted to a maintenance dose if a greater reduction in LDL cholesterol is needed. The maintenance dose is 10 mg once daily, and most patients are managed at this dosage. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more.
Child dose
The usual dosage range is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to the recommended therapeutic goals for each patient. The dosage may be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • 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 used as an adjunct to diet when primary hypercholesterolemia and mixed dyslipidemia are not adequately controlled with diet and exercise. It is also administered as an adjunct in patients with homozygous familial hypercholesterolemia alongside other lipid-lowering therapies, helping to lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. Additionally, it serves as an adjunct for patients with heterozygous familial hypercholesterolemia aged 10 to 17 years, aiding in the reduction of total cholesterol and LDL cholesterol levels. It is also used as an adjunct to diet for patients with primary dysbetalipoproteinemia. Furthermore, it is effective in reducing the risk of cardiovascular diseases such as stroke, myocardial infarction, and arterial revascularization in high-risk cardiovascular patients with elevated high-sensitivity C-reactive protein levels. Therefore, this drug is used for hypercholesterolemia and the reduction of cardiovascular disease risk.

How to take

Adult dose

This drug can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily and may be adjusted to a maintenance dose if a greater reduction in LDL cholesterol is needed. The maintenance dose is 10 mg once daily, and most patients are managed at this dosage. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to the recommended therapeutic goals for each patient. The dosage may be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, individuals allergic to the ingredients of this drug, those with severely impaired liver function, individuals with muscle disorders, and those taking certain medications may be at risk if they take this drug. Pregnant or breastfeeding women, as well as women who may become pregnant, must consult a doctor before taking this medication and should only take it when there is a high certainty that they will not become pregnant. Additionally, this medication contains lactose, and individuals with lactose intolerance should not take it. While taking this medication, liver function and muscle condition should be regularly monitored, especially in those who drink a lot of alcohol or have a history of liver disease. If symptoms like muscle pain, muscle weakness, fatigue, or fever occur, the patient should immediately inform their doctor, and in severe cases, discontinuation of the drug may be necessary. This drug may increase blood concentration when taken with certain medications, heightening the risk of side effects, so it is essential to inform the doctor or pharmacist if taking other medications. Pregnant or breastfeeding women should not take this drug, and women planning to become pregnant should use appropriate contraception. In cases of overdose, there is no specific antidote, so one must visit a medical institution immediately for appropriate treatment. Caution is needed when driving or operating machinery, as dizziness may occur. Finally, this drug may show higher blood concentrations in Asians, which may necessitate dosage adjustments.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, severe muscle weakness, ocular muscle weakness, jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, elevated serum creatinine levels, severe allergic reactions, severe skin reactions, shortness of breath, liver dysfunction (jaundice), severe swelling or urination abnormalities

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 distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • arthralgia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It should be kept at a temperature between 1 to 30 degrees Celsius, in a location that is not too hot or cold.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

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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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.