Medication info
Subastin Tablet (Rosuvastatin Calcium)

Subastin Tablet (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Pink round film-coated tablet
Packaging
Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201000966 · Approved 2010.01.28 · Insurance code 665001300

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
It can be administered at any time of day regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose can be adjusted as needed. The maintenance dose of 10 mg once daily is suitable for most patients. The maintenance dose should be adjusted at intervals of 4 weeks or more according to LDL cholesterol levels and patient response, with a maximum daily dose of 20 mg possible.
Child dose
The usual dosage range for pediatric patients aged 10 to 17 years is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to the recommended therapeutic target, with adjustments made at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • coronary heart disease risk factors
  • stroke risk
  • myocardial infarction risk
  • risk of arterial vascular intervention
View approved original text

This medication is used when primary hypercholesterolemia, familial hypercholesterolemia, or mixed hyperlipidemia cannot be controlled by diet and exercise alone. It effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, helping to slow the progression of atherosclerosis. Additionally, it assists in regulating cholesterol levels in some pediatric patients aged 10 to 17 years with familial hypercholesterolemia. It is also suitable as an adjunct to dietary therapy for patients with primary dysbetalipoproteinemia and contributes to reducing the risk of stroke, myocardial infarction, and vascular intervention in middle-aged men and women at high risk for cardiovascular diseases. Overall, this medication is used to effectively improve blood cholesterol levels and reduce the risk of cardiovascular complications.

How to take

Adult dose

It can be administered at any time of day regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose can be adjusted as needed. The maintenance dose of 10 mg once daily is suitable for most patients. The maintenance dose should be adjusted at intervals of 4 weeks or more according to LDL cholesterol levels and patient response, with a maximum daily dose of 20 mg possible.

Child dose

The usual dosage range for pediatric patients aged 10 to 17 years is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to the recommended therapeutic target, with adjustments made at intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, patients who have allergies to any ingredient of this drug, those with severely impaired liver function, those with muscle diseases, those with severely reduced kidney function, and women who are pregnant or breastfeeding should not take this medication. Additionally, high-dose administration is prohibited for patients at high risk of muscle-related side effects. This drug contains lactose, so patients with lactose intolerance should avoid it. It is important to periodically monitor liver function and muscle condition while taking this medication. Special caution is necessary for patients with a history of liver disease, those who consume large amounts of alcohol, and patients with hypothyroidism. If symptoms such as muscle pain, weakness, or cramps occur, inform a doctor immediately and undergo checks. This drug can rarely cause serious side effects such as severe skin reactions, liver damage, and myopathy, so if any unusual symptoms occur, discontinue use immediately and consult healthcare professionals. This medication may interact with other drugs, so inform healthcare providers of any medications being taken. In particular, taking it with certain antiviral drugs, immunosuppressants, or fibrates may increase the risk of muscle side effects. Women who may become pregnant must use appropriate contraceptive methods before taking this medication and should not take it while pregnant. It is also advisable to avoid this medication while breastfeeding. In the case of overdose, there are no specific antidotes, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Caution is advised while driving or operating machinery as dizziness may occur. Finally, the drug concentration may be higher in Asians, so dosage adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated drug reaction syndrome (DRESS), severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, rhabdomyolysis, severe swelling or urination abnormalities (acute kidney failure, oliguria), liver abnormalities (jaundice), sudden and severe headache, and others

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • chest discomfort
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  • cold sweat
  • pallor
  • muscle cramps
  • fatigue
  • numbness
  • sensory abnormalities
  • nausea
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • and various other minor side effects

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius, avoiding extremes of hot or cold.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Bottle - 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.