Medication info
Subast Tablet 5mg (Rosuvastatin Calcium)

Subast Tablet 5mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/box [15 tablets/PTPX2], 300 tablets/bottle
Approval status
Active

MFDS item code 201310819 · Approved 2013.12.23 · Insurance code 643506750

Summary

Main use
Inhibition of atherosclerosis progression by reducing high cholesterol levels and cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of day, with or without food. The initial dose is 5mg once daily, and if more reduction of LDL-cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10mg once daily, and most patients are titrated to this dose. Dosage adjustments should be made every 4 weeks or longer based on LDL-cholesterol levels, treatment goals, and patient response.
Child dose
The usual dose range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5mg to 20mg once daily. The dosage should be adjusted according to the recommended treatment goals for individual patients.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Inhibition of atherosclerosis progression by reducing high cholesterol levels and cardiovascular disease risk

  • Hyperlipidemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased total cholesterol
  • increased LDL-cholesterol
  • increased Apo-B protein levels
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication helps patients with hyperlipidemia and dyslipidemia. It is especially used as an adjunct when dietary and exercise measures are insufficient for managing primary hyperlipidemia and mixed dyslipidemia. It is also used as an adjunct to dietary therapy in patients with homozygous familial hypercholesterolemia or primary dysbetalipoproteinemia. This medication may also be used in young patients with high LDL-cholesterol levels and cardiovascular risk factors. Additionally, it is effective in reducing the risk of cardiovascular diseases, such as stroke and myocardial infarction, in males over 50 and females over 60 with elevated high-sensitivity C-reactive protein levels and other cardiovascular risk factors. In summary, this medication is used to correct hyperlipidemia and related lipid abnormalities and to reduce cardiovascular disease risk.

How to take

Adult dose

This medication can be taken at any time of day, with or without food. The initial dose is 5mg once daily, and if more reduction of LDL-cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10mg once daily, and most patients are titrated to this dose. Dosage adjustments should be made every 4 weeks or longer based on LDL-cholesterol levels, treatment goals, and patient response.

Child dose

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

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication or who have severely impaired liver function should not take it. Additionally, patients with muscular diseases or severe renal impairment, as well as pregnant or breastfeeding women, should not take this medication. Women of reproductive potential should only be administered after counseling on appropriate contraception to reduce the possibility of pregnancy. Particular caution must be exercised when using this medication in patients at high risk of muscle-related side effects. For instance, patients with moderate to severe renal impairment, hypothyroidism, a family history of muscle disorders, alcohol dependence, and certain ethnicities (such as Asians) should be extra careful. Also, the risk of muscle side effects may increase when taken with certain other medications, so it is important to consult a physician. This medication contains lactose, so it should not be administered to patients with lactose intolerance or related genetic disorders. It is important to regularly monitor liver function and muscle status during treatment. If abnormal elevations in liver enzyme levels, muscle pain, or muscle weakness occur, the patient must notify their physician immediately. This medication may cause rare side effects such as interstitial lung disease, severe liver injury, and severe skin reactions, so if symptoms such as shortness of breath, rash, or jaundice occur, treatment should be discontinued and medical advice sought immediately. This medication can interact with other drugs, so if the patient is taking any other medications, they must inform their physician or pharmacist. Extra caution is needed when taken with medications that could raise the risk of muscle damage. Pregnant or nursing women should not use this medication, and women planning pregnancy should use appropriate birth control methods. In cases of overdose, there is no specific antidote, so treatment should be based on symptoms, and liver function and muscle enzyme levels must be monitored. This medication is known not to have a significant effect on driving or machinery operation, but dizziness may be a concern, so caution is needed.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe myopathy, ophthalmoplegia, rhabdomyolysis, immune-mediated necrotizing myopathy, thrombocytopenia, acute kidney injury, oliguria, severe rash with fever, blistering, skin desquamation, mucosal pain in mouth/eyes, severe swelling

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • thrombocytopenia
  • diarrhea
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  • hematuria
  • fatigue
  • numbness
  • parathesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion

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, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/box [15 tablets/PTPX2], 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.