Medication info
Subatin Tablet 10mg (Rosuvastatin Calcium)

Subatin Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/PTP [15 tablets/PTP x 2]
Approval status
Active

MFDS item code 201508442 · Approved 2015.12.28 · Insurance code 684501310

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia, reducing the risk of cardiovascular diseases
Who uses it
Adults · Children
Adult dosage
Take 5 milligrams orally once daily at any time regardless of meals as an initial dose. If greater LDL cholesterol reduction is needed, adjust to the maintenance dose of 10 milligrams once daily. Adjust the dosage at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response. The maximum dose may be increased to 20 milligrams per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17), a dose of 5 to 20 milligrams once a day is administered. The dosage should be adjusted individually according to treatment goals, typically every 4 weeks or more.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia, reducing the risk of cardiovascular diseases

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medicine is used when diet and exercise alone are insufficient to control primary hypercholesterolemia and mixed dyslipidemia patients. It is also used as an adjunct to diet or other lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. It effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It can also be used as an adjunct to diet in pediatric patients with familial hypercholesterolemia, assisting in cholesterol level control. Additionally, it serves as an adjunct to dietary treatment in patients with primary dysbetalipoproteinemia and is effective in reducing the risk of cardiovascular diseases, thereby decreasing the risks of stroke, myocardial infarction, and vascular revascularization.

Dosage and Administration

Adult dosage

Take 5 milligrams orally once daily at any time regardless of meals as an initial dose. If greater LDL cholesterol reduction is needed, adjust to the maintenance dose of 10 milligrams once daily. Adjust the dosage at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response. The maximum dose may be increased to 20 milligrams per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17), a dose of 5 to 20 milligrams once a day is administered. The dosage should be adjusted individually according to treatment goals, typically every 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, patients with allergies to any component of this medication or those with severely impaired liver function, muscle diseases, severely decreased kidney function, and pregnant or breastfeeding women should not take this drug. Additionally, this medication should be used with caution in patients at risk of muscle-related side effects. If symptoms of muscle pain or weakness occur, medical personnel should be notified immediately, and the medication may need to be discontinued if necessary. Since it may affect liver function, patients with a history of liver disease or those who consume alcohol heavily should undergo regular liver function tests. This drug can interact with some medications, so if you are taking other medications, you must inform your healthcare provider. Women who could become pregnant should use appropriate contraception and should immediately discontinue this medication if pregnant. In cases of overdose, there is no specific antidote; treatment will depend on the symptoms, and liver and muscle enzyme tests will be necessary. This medication can cause symptoms such as dizziness, so caution is required when driving or operating machinery. Lastly, this medication may show higher blood levels in certain Asians; hence, dose adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe liver injury, liver failure, dyspnea, exacerbation of asthma and respiratory distress, severe myopathy, ocular myopathy, immune-mediated necrotizing myopathy, rhabdomyolysis, acute renal failure, and oliguria

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • chest pain
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  • cough
  • diarrhea
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thrombocytopenia
  • increased transaminases
  • increased ALT
  • increased AST
  • increased CK
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/PTP [15 tablets/PTP x 2]

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.