Medication info
CMG Rosuvastatin Tablet 10mg (Rosuvastatin Calcium)

CMG Rosuvastatin Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets (15 tablets/PTP x 2 packs), 30 tablets/bottle
Approval status
Active

MFDS item code 201400918 · Approved 2014.02.28 · Insurance code 648602620

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of the day without regard to meals. The initial dose is 5 milligrams once daily, and a maintenance dose of 10 milligrams once daily is administered. The maintenance dose should be adjusted based on the patient's response at intervals of 4 weeks or more, with a maximum increase to 20 milligrams per day.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), a dosage of 5 to 20 milligrams is administered once daily. The dosage is adjusted at intervals of 4 weeks or more per individual patient.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

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

  • Hypercholesterolemia
  • hyperlipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunct to dietary management for patients with primary hypercholesterolemia and mixed hyperlipidemia when dietary changes and exercise alone are insufficient. It is also prescribed along with dietary measures for patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. This drug helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia and slows the progression of atherosclerosis. It is particularly effective in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia who have high LDL cholesterol levels. In populations at high risk of cardiovascular disease, it is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures. Overall, this medication effectively improves the risk of hyperlipidemia and cardiovascular diseases.

How to take

Adult dose

This medication can be taken at any time of the day without regard to meals. The initial dose is 5 milligrams once daily, and a maintenance dose of 10 milligrams once daily is administered. The maintenance dose should be adjusted based on the patient's response at intervals of 4 weeks or more, with a maximum increase to 20 milligrams per day.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), a dosage of 5 to 20 milligrams is administered once daily. The dosage is adjusted at intervals of 4 weeks or more per individual patient.

Precautions

This medication should not be administered to certain patients. First, it is contraindicated in patients with known allergy to this drug, severely impaired liver function, muscle disease, those taking certain immunosuppressants, severely impaired kidney function, pregnant or breastfeeding women, and patients with lactose intolerance. Second, while taking this medication, liver function and muscle condition should be regularly monitored, especially in patients who consume excessive alcohol or have a history of liver disease. Additionally, if symptoms such as myalgia, muscle weakness, or cramps occur, patients must promptly inform healthcare providers, and in severe cases, the medication should be discontinued. Third, when taken with certain other medications, the blood concentration of this drug may increase, raising the risk of muscle damage; therefore, patients should consult with a doctor or pharmacist about concomitant medications. Fourth, women of childbearing potential should use appropriate contraception while taking this medication and should immediately stop taking it if pregnancy is confirmed. Finally, during the use of this medication, there is a risk of serious side effects such as liver dysfunction, muscle-related abnormal symptoms, and skin rashes. Patients should visit a medical institution if abnormal symptoms occur. Regular check-ups and precautions are necessary for the safe use of this medication, and it should be taken according to a doctor's instructions.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, fatal and non-fatal liver failure, severe skin reactions, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, severe edema, severe allergic reactions, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal bloating
  • syncope
  • myalgia
  • gout
  • erectile dysfunction
  • thrombocytopenia
  • elevated transaminases
  • increased ALT
  • increased AST
  • increased CK
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive dysfunction

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, preferably at a temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP x 2 packs), 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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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.