Medication info
Subastin Tablet 5 mg (Rosuvastatin Calcium)

Subastin Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Yellow round film-coated tablet
Packaging
Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201508211 · Approved 2015.12.11 · Insurance code 665001980

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily. If greater LDL-cholesterol reduction is required, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20 mg per day.
Children's dosage
The usual dosing range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment goals for each individual patient.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atypical familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed hyperlipidemia who are unable to achieve lipid control through diet and exercise alone. It helps lower cholesterol levels particularly in patients with familial hypercholesterolemia when combined with diet or other therapies. This aids in delaying the progression of atherosclerosis and reducing the risk of cardiovascular disease. It is also prescribed to certain pediatric patients in high-risk groups to effectively reduce cholesterol and related protein levels. Overall, it is used to control cholesterol levels and improve cardiovascular health, contributing to the reduction of the risk of cardiovascular events like stroke and myocardial infarction.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily. If greater LDL-cholesterol reduction is required, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20 mg per day.

Children's dosage

The usual dosing range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment goals for each individual patient.

Precautions

This medication should not be used in certain patients. For example, those with an allergy to this drug, those with severely impaired liver function, patients with muscle disorders, and women who are pregnant or breastfeeding should not take this medication. Additionally, its use may be restricted in patients with severely reduced kidney function or those taking certain medications concomitantly. Women of childbearing potential should use appropriate contraception to lower the possibility of pregnancy and only take this drug after fully understanding the potential risks to the fetus. It is important to regularly monitor liver function and muscle status while taking this medication. If abnormal liver enzyme levels are detected or if symptoms such as muscle pain, muscle weakness, or cramps occur, medical personnel should be notified immediately. This medication can raise blood sugar levels in some patients, so those at risk for diabetes should periodically monitor their blood sugar control. Furthermore, the drug concentration may increase due to certain genetic factors, potentially requiring dosage adjustments depending on the patient's condition. There are drugs that can interact when taken with this medication, so if the patient is taking other medications, they must inform their healthcare provider. Careful observation should be taken when co-administering drugs that may increase the risk of muscle-related side effects. Pregnant or breastfeeding women should not use this drug, and women planning to conceive must consult with healthcare professionals before taking it. In case of overdose, there is no specific antidote, so patients must immediately visit the hospital for appropriate treatment and monitoring. Finally, dizziness may occur while taking this medication, so caution is necessary while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe swelling (edema), chest tightness, difficulty breathing, severe muscle weakness, oculomotor weakness, acute renal failure, oliguria, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, rhabdomyolysis, polyneuropathy, severe dermatological reactions, severe allergic reactions, serious neurological effects.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • arthralgia
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • sexual dysfunction
  • gynecomastia
  • depression
  • sleep disturbances
  • cognitive impairment

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow 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.

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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.