Medication info

Subatin Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/PTP [(15 tablets/PTP x 2), 28 tablets/PTP [(14 tablets/PTP x 2)]
Approval status
Expired

MFDS item code 201907349 · Approved 2019.10.18

This product's status changed to Expired on 2024.10.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in the treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk.
Who uses it
Adults · Children
Adult dosage
The initial dosage is 5mg once daily, and for patients requiring further reduction in LDL cholesterol, it can be adjusted to an appropriate maintenance dose. The maintenance dose is usually 10mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, with a maximum increase up to 20mg per day.
Children's dosage
The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5mg to 20mg once daily. The dosages should be adjusted based on the treatment goals recommended for individual patients.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Effectiveness in the treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk.

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary 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 used to manage various types of dyslipidemia associated with hypercholesterolemia. It is particularly used as an adjunct when dietary changes and exercise alone cannot manage primary hypercholesterolemia and mixed hyperlipidemia. It is also used as an adjunct to diet for patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. For pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years meeting certain criteria, it helps lower total cholesterol and LDL cholesterol levels. Furthermore, it has been shown to reduce the risk of cardiovascular diseases such as coronary heart disease, stroke, and myocardial infarction. Thus, this drug is used to improve dyslipidemia and lower the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

The initial dosage is 5mg once daily, and for patients requiring further reduction in LDL cholesterol, it can be adjusted to an appropriate maintenance dose. The maintenance dose is usually 10mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, with a maximum increase up to 20mg per day.

Children's dosage

The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5mg to 20mg once daily. The dosages should be adjusted based on the treatment goals recommended for individual patients.

Precautions

This medication should not be used in certain patients. For instance, patients who are allergic to this medication, have severely impaired liver function, have muscle disorders, or are pregnant or breastfeeding should not take this drug. It is important to check liver function tests and muscle status before taking this medication. Patients with liver disease or hypothyroidism should treat those diseases prior to treatment. If symptoms like muscle pain or weakness occur, inform your doctor immediately, and consider discontinuing this medication if necessary. Particular caution should be exercised for elderly patients, those with impaired kidney function, and those who consume alcohol frequently due to the risk of muscle abnormalities. This medication contains lactose, so patients with lactose intolerance should avoid taking it. Additionally, this medication may interact with other drugs, particularly specific antivirals, antifungals, immunosuppressants, and fibrate class medications, so it's essential to inform your doctor or pharmacist of any medications you are currently taking. Women with the potential for pregnancy should use appropriate contraception while taking this medication, and if pregnancy is confirmed, they should stop taking it immediately. In case of overdose, there is no specific antidote, so one should seek appropriate treatment immediately at a medical institution. It is advisable to monitor liver function and muscle status periodically while taking this medication, and be cautious as dizziness can occur during exercise or while operating machinery. Lastly, this medication can rarely cause serious skin reactions or liver damage, so if symptoms of rash or jaundice appear, discontinue use immediately and consult medical personnel.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain of oral/ocular mucosa, severe skin adverse reactions, respiratory distress, asthma attacks, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • arthralgia
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough.

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 air or moisture from entering, and it is best kept at room temperature, between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/PTP [(15 tablets/PTP x 2), 28 tablets/PTP [(14 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.