Medication info
Roston 20 mg (Rosuvastatin Calcium)

Roston 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu x 2)
Approval status
Active

MFDS item code 201400387 · Approved 2014.01.28 · Insurance code 670606770

Summary

Main use
Treatment for hypercholesterolemia and reduced risk of cardiovascular diseases
Who takes it
Adults · Children
Adult dose
The initial dosage is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, it can be adjusted to the maintenance dosage. The maintenance dosage is usually adjusted to 10 mg once daily for most patients. The maintenance dosage should be adjusted appropriately at intervals of 4 weeks or more depending on LDL-cholesterol levels, treatment goals, and patient response, with a maximum of 20 mg per day.
Child dose
The usual dosage range is 5 mg to 20 mg once daily. The dosing should be individually adjusted according to the treatment goals recommended for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Treatment for hypercholesterolemia and reduced risk of cardiovascular diseases

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

This medication is primarily used as an adjunct to diet and exercise in patients with primary hypercholesterolemia and mixed dyslipidemia that cannot be controlled by diet and exercise alone. It is also beneficial for patients with familial hypercholesterolemia, particularly for some pediatric patients aged 10 to 17 years, as it helps lower total cholesterol and LDL-cholesterol levels, thereby reducing the risk of cardiovascular disease. Additionally, it is used as an adjunct to diet in patients with primary dysbetalipoproteinemia. This drug is effective in lowering total cholesterol and LDL-cholesterol levels to target levels, slowing the progression of atherosclerosis, and reducing the risk of cardiovascular events, especially stroke, myocardial infarction, and vascular revascularization. Therefore, it is very useful in the treatment and prevention of various diseases associated with hyperlipidemia.

How to take

Adult dose

The initial dosage is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, it can be adjusted to the maintenance dosage. The maintenance dosage is usually adjusted to 10 mg once daily for most patients. The maintenance dosage should be adjusted appropriately at intervals of 4 weeks or more depending on LDL-cholesterol levels, treatment goals, and patient response, with a maximum of 20 mg per day.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The dosing should be individually adjusted according to the treatment goals recommended for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication, those with severe liver dysfunction, patients with muscle disorders, patients with significantly impaired kidney function, and pregnant or breastfeeding women should not take this medication. Additionally, the use of high doses of this medication is prohibited in patients at high risk for muscle disorders. Risk factors include moderate renal impairment, hypothyroidism, family history of muscle disorders, and alcohol dependence. This medication contains lactose, so patients who are lactose intolerant should not take it. It is important to check liver function tests and muscle status before taking this medication, especially for patients who consume alcohol excessively or have a history of liver disease. During treatment, if symptoms such as muscle pain, muscle weakness, fatigue, or fever develop, notify your doctor immediately, and in severe cases, treatment may need to be discontinued. This medication can affect liver function; therefore, if symptoms of liver damage or jaundice appear, discontinue use immediately. Patients at risk for diabetes should regularly monitor blood sugar levels, as this medication may increase blood sugar levels and caution is required. This medication may interact with other drugs; therefore, if you are taking any other medications, you must inform your doctor or pharmacist, as the risk of abnormal muscle reactions may increase when used with certain medications. Women who may become pregnant should use appropriate contraception methods and should not take this medication during pregnancy. In the event of overdose, there is no specific antidote, so treatment should be administered based on symptoms, and liver function and muscle enzyme levels need to be monitored. Lastly, this medication may cause dizziness, so caution is needed when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms drug reaction (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, oculobulbar myasthenia, jaundice, hepatitis, acute kidney failure, oliguria, chest tightness, dyspnea with cough and fever, severe rash with high fever, blistering, skin peeling, mucosal involvement of mouth/eyes

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
Show 19 more
  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • decreased appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • increased transaminases
  • elevated ALT
  • elevated AST
  • elevated CK

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

Storage

This medication can be sensitive to air or moisture, so it must be stored in a sealed container. The storage temperature should be kept at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.