Medication info
Colostatin 20 mg (Rosuvastatin Calcium)

Colostatin 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201400124 · Approved 2014.01.13 · Insurance code 648507110

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication is taken once daily at any time, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to the maintenance dose if necessary. The maintenance dose of 10 mg once daily is adequate for most patients, and dosage adjustments should be made based on LDL cholesterol levels and treatment goals approximately every four weeks. The maximum dose is 20 mg once daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is administered once daily at 5 mg to 20 mg. The dosage should be adjusted according to each patient's treatment goals.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary management and exercise alone are insufficient. It is also prescribed as an adjunct to diet and other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. It lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also used in patients with primary dysbetalipoproteinemia and has a risk reduction effect for cardiovascular diseases, helping to reduce the risk of stroke, myocardial infarction, and percutaneous coronary intervention. Overall, this medication is effective for cholesterol management and reduction of cardiovascular disease risk.

How to take

Adult dose

This medication is taken once daily at any time, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to the maintenance dose if necessary. The maintenance dose of 10 mg once daily is adequate for most patients, and dosage adjustments should be made based on LDL cholesterol levels and treatment goals approximately every four weeks. The maximum dose is 20 mg once daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is administered once daily at 5 mg to 20 mg. The dosage should be adjusted according to each patient's treatment goals.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients who have an allergy to any component of this medication, those with active liver disease, patients with muscle disorders, patients with significantly impaired kidney function, and women who are pregnant or breastfeeding. Additionally, high doses are prohibited in patients at high risk of muscle disorders. Since this medication contains lactose, it should not be used in patients with lactose intolerance. When using this medication, liver function and muscle status should be monitored periodically. Patients who consume large amounts of alcohol or have a history of liver disease need to be particularly cautious. If symptoms like muscle pain, weakness, or cramps occur, consult a physician immediately. This medication may interact with other drugs, so inform your physician of any other medications you are taking. In particular, the risk of muscle damage may increase when combined with certain antiviral drugs, immunosuppressants, or fibrate derivatives. Women of childbearing potential should use adequate contraception while taking this medication, and should discontinue it immediately if they become pregnant. It is also safest for breastfeeding women not to take this medication. In cases of overdose, there is no specific antidote, so seek medical attention immediately for appropriate treatment. This medication can rarely cause serious side effects such as severe skin reactions, liver damage, kidney issues, and muscle damage, so report any unusual symptoms to medical personnel immediately. Dizziness may occur while driving or operating machinery, so caution is advised. The blood concentration of this medication may be higher in Asians, so dosage adjustments may be necessary. Monitoring growth and development is required when administering this medication to children and adolescents.

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)
  • Severe skin adverse reactions
  • Rhabdomyolysis, myopathy
  • Severe allergic reactions
  • Respiratory distress accompanied by coughing and fever
  • Liver abnormalities (jaundice), hepatitis
  • Severe muscle weakness, ophthalmoplegia
  • Thrombocytopenia
  • Acute renal failure, oliguria
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  • Severe edema
  • Serious neurological symptoms (e.g., seizures,

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • asthenia
  • hematuria
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  • diarrhea
  • chest discomfort
  • anorexia
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • cough
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is important to maintain the storage temperature between 1 degrees Celsius and 30 degrees Celsius. Proper storage will ensure the safety and efficacy of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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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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.