Medication info
Subast Tablets 10 mg (Rosuvastatin Calcium)

Subast Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/box [15 tablets/PTP/X2], 300 tablets/bottle
Approval status
Active

MFDS item code 201000984 · Approved 2010.01.28 · Insurance code 643505410

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg orally once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg orally once daily, which is adequate for most patients. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, every 4 weeks or longer interval, with a maximum daily dose of 20 mg.
Child dose
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 mg to 20 mg, taken once daily. The administered dose should be individually adjusted based on recommended treatment goals.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

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

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

This medication is primarily used to treat various types of hyperlipidemia, including primary hypercholesterolemia and familial hypercholesterolemia. It is utilized as an adjunct to diet and exercise when they are insufficient for control, particularly helping to lower total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. Additionally, it is used as an adjunct to diet for pediatric patients aged 10 to 17 years who are at high risk. It is also applicable to patients with primary dysbetalipoproteinemia. Most importantly, this drug contributes to reducing the risks of stroke, myocardial infarction, and arterial revascularization in middle-aged and older patients who are at high risk for cardiovascular disease. Therefore, this medication is effectively used for hypercholesterolemia and reducing cardiovascular disease risk.

How to take

Adult dose

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

Child dose

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 mg to 20 mg, taken once daily. The administered dose should be individually adjusted based on recommended treatment goals.

Precautions

This medication should not be administered to certain patients. For example, patients allergic to any ingredient of this medication, those with severe liver dysfunction, those with muscle diseases, and pregnant or breastfeeding women should not take this drug. Also, caution is necessary for patients with severely impaired kidney function or those taking specific medications together. This medication can affect liver function; therefore, patients with a history of liver disease or those who consume large amounts of alcohol should undergo liver function tests before use and regularly during treatment. If symptoms of muscle pain or weakness occur, consult a physician immediately and discontinue use if necessary. Special caution is needed for high-dose use, as the risk of muscle-related side effects increases. Since genetic factors or higher body volumes may increase concentration in Asians, dose adjustments may be necessary. Women who may become pregnant should use appropriate contraceptive methods, and this medication should not be taken during pregnancy. During the use of this medication, there is a risk of interactions with other drugs; therefore, inform healthcare professionals of all medications being taken. In case of overdose, there is no specific antidote, so immediately seek medical treatment according to symptoms. Be cautious as dizziness may occur while driving or operating machinery. This medication can rarely cause severe skin reactions, liver damage, and kidney problems; thus, if abnormal symptoms occur, consult healthcare professionals immediately.

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, polyneuropathy, severe muscle weakness, shortness of breath, ophthalmoplegia, acute renal failure, oliguria, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe skin reactions, severe swelling, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory abnormalities
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment.

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

Storage

This medication must be stored in a tightly closed container to avoid exposure to air or moisture, and should ideally be stored at room temperature between 1°C to 30°C. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [15 tablets/PTP/X2], 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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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.