Medication info
Topstatin 20mg (Rosuvastatin Calcium)

Topstatin 20mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Pink round film-coated tablet
Packaging
Blister - 28 tablets/box [(14 tablets/blister) X 2], Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201000979 · Approved 2010.01.28 · Insurance code 645603800

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be administered at any time of the day, regardless of meals. The initial dose is 5mg taken once daily and can be adjusted to a maintenance dose as needed. The maintenance dose is generally 10mg once daily, adjusted according to LDL cholesterol levels and patient response at intervals of at least 4 weeks. The maximum dose is 20mg per day.
Child dose
The general dosage range for pediatric patients aged 10 to 17 years is 5mg to 20mg once daily. The dosage should be adjusted individually according to the treatment goal, with adjustments made at intervals of at least 4 weeks.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased 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 therapy in patients with primary hypercholesterolemia and mixed dyslipidemia whose conditions are not controlled by diet and exercise alone. It may also be used as an adjunct to other therapies in patients with homozygous familial hypercholesterolemia. Additionally, it helps lower total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis and assisting in cholesterol control in high-risk pediatric patients. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia and contributes to reducing the risk of cardiovascular diseases. Ultimately, it is effective for improving blood lipid levels and lowering the risk of cardiovascular complications.

How to take

Adult dose

This medication can be administered at any time of the day, regardless of meals. The initial dose is 5mg taken once daily and can be adjusted to a maintenance dose as needed. The maintenance dose is generally 10mg once daily, adjusted according to LDL cholesterol levels and patient response at intervals of at least 4 weeks. The maximum dose is 20mg per day.

Child dose

The general dosage range for pediatric patients aged 10 to 17 years is 5mg to 20mg once daily. The dosage should be adjusted individually according to the treatment goal, with adjustments made at intervals of at least 4 weeks.

Precautions

This medication should not be administered to certain patients. For instance, individuals with allergies to any of its components, patients with severe liver dysfunction, those with muscle disorders, patients with severe kidney impairment, and women who are pregnant or breastfeeding should not use this medication. This medication can affect liver health, therefore, patients with a history of liver disease or those who consume alcohol excessively should undergo regular liver function tests before and during treatment. If there are conditions such as hypothyroidism, treatment for that condition should be completed before starting this medication. Muscle-related adverse reactions may occur, so if symptoms such as muscle pain or weakness develop, they should immediately inform healthcare professionals. Particularly, if muscle enzyme levels are elevated, discontinuation of this medication may be required. This medication may raise blood sugar levels in some patients, so those at high risk for diabetes should consistently monitor their blood sugar. Interactions may occur when taken with other medications, therefore, patients taking other drugs should inform their healthcare provider and consult them. This is particularly important when taken with certain antiviral agents, immunosuppressants, antibiotics, or fibrate medications. Women who may become pregnant should use appropriate contraception while taking this medication and should not use it during pregnancy. Breastfeeding women should also avoid using this medication. In case of overdose, there is no specific antidote; therefore, treatment should be symptomatic, and liver and muscle function tests may be necessary. Patients may experience dizziness or headaches when taking this medication, so caution should be observed while driving or operating machinery. Finally, if skin rash or severe allergic reactions occur while taking this medication, they should immediately stop taking the drug and contact healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe allergic reactions, severe skin reactions, difficulty breathing, respiratory distress, severe muscle weakness, ophthalmoplegia, myopathy, rhabdomyolysis, acute kidney failure, oliguria, thrombocytopenia, increased serum creatinine, severe edema, severe liver damage, and hyperbilirubinemia.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • 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 sealed container to protect it from air and moisture, and it is best kept at a temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the effect of the medicine for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Blister - 28 tablets/box [(14 tablets/blister) X 2], 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.

Questions about this medicine

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

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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.