Medication info
Subast Tablet 20 Milligrams (Rosuvastatin Calcium)

Subast Tablet 20 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/box [15 tablets/PTP/X2], 300 tablets/bottle
Approval status
Active

MFDS item code 201000983 · Approved 2010.01.28 · Insurance code 643505440

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This can be taken at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is 10 milligrams once daily. The maintenance dose can be adjusted every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and the patient’s response, and can be increased to a maximum of 20 milligrams daily.
Child dose
For pediatric patients aged 10 to 17 years, the dosage can be 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually according to the treatment goals, with adjustments made at intervals of 4 weeks or longer.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dyslipidemia
  • 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 primarily used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary control and exercise are insufficient. It is also used together with dietary methods or other treatments in patients with homozygous familial hypercholesterolemia to assist in cholesterol management. It lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, effectively delaying the progression of atherosclerosis. It is used as an adjunct to diet in children with heterozygous familial hypercholesterolemia who meet specific criteria. It also assists patients with primary dysbetalipoproteinemia and is effective in reducing the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged patients at high risk for cardiovascular diseases. This medication is used for hyperlipidemia and reducing the risk of cardiovascular diseases.

How to take

Adult dose

This can be taken at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is 10 milligrams once daily. The maintenance dose can be adjusted every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and the patient’s response, and can be increased to a maximum of 20 milligrams daily.

Child dose

For pediatric patients aged 10 to 17 years, the dosage can be 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually according to the treatment goals, with adjustments made at intervals of 4 weeks or longer.

Precautions

This medication should not be administered to certain patients. For example, it must not be used in patients who have allergies to any of its components, those with severely impaired liver function, patients with muscle diseases, and those with severely impaired kidney function. Women who are pregnant or nursing, as well as women of childbearing age who are not using appropriate contraception, must consult a physician before using this medication, and potential risks to the fetus must be adequately considered. Patients at high risk for muscle-related side effects, such as those with moderate or severe kidney impairment, hypothyroidism, a family history of muscle diseases, or those taking certain medications, should avoid high doses of this medication. Additionally, this medication contains lactose, so patients with lactose intolerance should not use it. Patients with poor liver function or those consuming excessive alcohol should undergo regular liver function tests while using this medication, and patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome should start this medication after treating the underlying condition. If symptoms like muscle pain, weakness, or cramps occur, they should inform a doctor immediately, and blood tests should be conducted to check for muscle damage. If symptoms are severe or blood test results are unfavorable, discontinuation of the medication may be necessary. Rarely, severe skin reactions, liver damage, neurological abnormalities, or muscle rupture may occur with this medication, so patients should consult medical personnel immediately if any unusual symptoms arise. This medication may interact with other drugs, so patients taking other medications should inform their doctor or pharmacist, especially if taking certain antivirals, immunosuppressants, or fibrate medications. Pregnant or nursing women should not use this medication, and women of childbearing age should use appropriate contraceptive methods. In cases of overdose, there is no specific antidote, and treatment should be symptomatic, with regular monitoring of liver function and muscle enzyme levels. Dizziness may occur while taking this medication, so patients should exercise caution when driving or operating machinery.

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, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, polyneuropathy, Stevens-Johnson syndrome, acute kidney failure, oliguria, severe edema, increased blood pressure, thrombocytopenia

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
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  • hematuria
  • thrombocytopenia
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • appetite loss
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive decline
  • forgetfulness
  • memory impairment
  • confusion

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. Doing so will help ensure the medication's effectiveness is safely maintained for a long period of time.

Appearance and packaging

Appearance

Pink round film-coated tablets

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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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.