Medication info
Astroten 10 mg (Rosuvastatin Calcium)

Astroten 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
에스케이케미칼(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201001029 · Approved 2010.01.29 · Insurance code 644703330

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of the day, with or without food. The initial dosage is 5 mg once daily, which can be adjusted to a maintenance dose of up to 10 mg once daily if needed. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient’s response, with a maximum daily dose of 20 mg possible after 4 weeks or longer intervals.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the usual dosage range is once daily 5 mg to 20 mg. The dosage should be adjusted according to individual treatment goals.

Ingredients

Manufacturer
에스케이케미칼(주)

Efficacy & effects

Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary artery disease.
View approved original text

This medication is primarily used as an adjunct in patients with primary hypercholesterolemia, mixed hyperlipidemia, and specific familial hypercholesterolemia who are not adequately controlled by diet and exercise. In pediatric patients, it is also used as an adjunct to diet in cases of elevated LDL cholesterol levels and risk factors for early cardiovascular disease. Additionally, this drug helps lower total cholesterol and LDL cholesterol in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Moreover, it contributes to reducing the risk of stroke, myocardial infarction, and vascular revascularization in men aged 50 and older and women aged 60 and older who have certain cardiovascular risk factors. It is an effective medication for improving various dyslipidemias and cardiovascular disease risks.

How to take

Adult dose

This medication can be taken at any time of the day, with or without food. The initial dosage is 5 mg once daily, which can be adjusted to a maintenance dose of up to 10 mg once daily if needed. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient’s response, with a maximum daily dose of 20 mg possible after 4 weeks or longer intervals.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the usual dosage range is once daily 5 mg to 20 mg. The dosage should be adjusted according to individual treatment goals.

Precautions

This medication should not be used in certain patients. For example, it is contraindicated in patients who are allergic to any of the components of this medication, have severe hepatic impairment, or have muscle disorders. It should also be avoided in patients with significantly impaired renal function, pregnant or breastfeeding women, and women of childbearing age who do not use appropriate contraceptive methods. Because this medication can affect liver function and muscles, it is important for patients with a history of hepatic disease or high alcohol consumption to have multiple liver function tests before administration. If symptoms of muscle pain or weakness occur, it is crucial to consult a doctor immediately, and in severe cases, the medication should be discontinued. This medication contains lactose, so it is not suitable for patients with lactose intolerance or specific genetic diseases. Furthermore, due to numerous interactions with other medications, patients should inform their doctor or pharmacist of any other medications they are currently taking. Particularly, the risk of muscle-related side effects may increase when taken with certain antiviral agents, immunosuppressants, antifungals, and antibiotics. Pregnant or breastfeeding women should not use this medication, and women who may become pregnant should use appropriate contraceptive methods during treatment. In case of overdose, there is no specific antidote, so treatment should be based on symptoms, and liver function as well as muscle enzyme levels should be monitored regularly. Serious side effects, such as interstitial lung disease, severe liver damage, myopathy, kidney problems, etc. can occur rarely, so if any abnormal symptoms appear, immediate consultation with healthcare professionals is necessary. Caution is needed when driving or operating machinery as dizziness may occur. Finally, this medication may exhibit higher concentrations in Asian populations, potentially necessitating dosage adjustments.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions including urticaria
  • angioedema
  • pancreatitis
  • myopathy
  • rhabdomyolysis
  • severe muscle weakness
  • ocular muscle weakness
  • thrombocytopenia
  • jaundice
  • hepatitis
Show 8 more
  • Stevens-Johnson syndrome
  • immune-mediated necrotizing myopathy
  • edema
  • acute kidney injury
  • oliguria
  • cough
  • shortness of breath
  • severe chest discomfort.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
Show 13 more
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • 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 exposure to air and moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to preserve the drug's efficacy and safety over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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.

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.