Medication info
Colostatin 10 mg (Rosuvastatin Calcium)

Colostatin 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle [for domestic use], 30 tablets/box [for export (10T/PTP x 3)], 300 tablets/bottle [for domestic use]
Approval status
Active

MFDS item code 201000973 · Approved 2010.01.28 · Insurance code 648506270

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and risk reduction of cardiovascular diseases
Who takes it
Adults · Children
Adult dose
For adult patients with primary hypercholesterolemia and others, the treatment begins at 5 mg once daily, regardless of meals. The maintenance dose is 10 mg once daily, adjusted according to LDL-cholesterol levels and patient response with intervals of 4 weeks or more. The maximum dose is 20 mg once daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is between 5 mg and 20 mg once daily. The dosage should be individually adjusted according to treatment goals with intervals of 4 weeks or more.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • increased total cholesterol
  • increased LDL-cholesterol
  • increased Apo-B protein levels
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
View approved original text

This medication is used as an adjunct when diet and exercise alone do not adequately control patients with primary hypercholesterolemia and mixed dyslipidemia. It is also prescribed in conjunction with other lipid-lowering treatments for patients with homozygous familial hypercholesterolemia. This medication helps lower total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It is also used as a dietary supplement for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, provided they meet specific LDL-cholesterol criteria. It additionally aids dietary management for patients with primary dysbetalipoproteinemia. Most importantly, this medication reduces the risk of cardiovascular diseases and lowers the risks associated with stroke, myocardial infarction, and arterial revascularization procedures. Therefore, it is utilized to improve overall lipid management.

How to take

Adult dose

For adult patients with primary hypercholesterolemia and others, the treatment begins at 5 mg once daily, regardless of meals. The maintenance dose is 10 mg once daily, adjusted according to LDL-cholesterol levels and patient response with intervals of 4 weeks or more. The maximum dose is 20 mg once daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is between 5 mg and 20 mg once daily. The dosage should be individually adjusted according to treatment goals with intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this medication's components, have liver dysfunction, muscle diseases, are taking certain immunosuppressants, have severe kidney dysfunction, are pregnant or breastfeeding, or have lactose intolerance should not take this medication. Additionally, as this medication may affect liver function or muscle conditions, individuals who consume large amounts of alcohol or have a history of liver disease should use it with caution. If symptoms such as muscle pain or weakness occur, notify a healthcare professional immediately, and blood tests may be required to check for muscle damage. This medication may interact with other drugs, so it is crucial to inform the healthcare team of any medications being taken. Particularly, there may be an increased risk of muscle adverse reactions when used in conjunction with certain antiviral drugs, immunosuppressants, antibiotics, and fibrate-class medications. Women who are pregnant or planning to become pregnant should not take this medication and should practice appropriate contraception. For breastfeeding women, it is also advisable to avoid this medication. In case of overdose, there is no specific antidote, so symptomatic treatment is necessary, and liver function and muscle enzyme levels should be monitored periodically. During the use of this medication, caution is advised with driving or operating machinery due to possible dizziness. Lastly, this medication can be used in children and adolescents, but since it may affect growth and development, it should be used under the direction of a specialist.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions, including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular myasthenia, rhabdomyolysis, acute kidney failure, oliguria, thrombocytopenia, increased serum creatinine, severe skin reactions, severe allergic reactions, respiratory distress, breathing problems, severe swelling or urinary disorders, or severe neurological symptoms.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, hematuria, diarrhea, chest discomfort, loss of appetite, abdominal bloating, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, fatigue, numbness, paresthesia, joint pain, fatal and non-fatal liver failure, neuropsychiatric symptoms (such as depression, sleep disturbances), sexual dysfunction, gynecomastia, post-marketing cognitive disorders (such as memory decline, decreased concentration)

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. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle [for domestic use], 30 tablets/box [for export (10T/PTP x 3)], 300 tablets/bottle [for domestic use]

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.