Medication info
Topstatin 10mg Tablets (Rosuvastatin Calcium)

Topstatin 10mg Tablets (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Pink, round, film-coated tablets
Packaging
Blister - 28 tablets/box [(14 tablets/blister) x 2], Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201000978 · Approved 2010.01.28 · Insurance code 645603790

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Start with 5 mg once daily at any time during the day, regardless of meals. If necessary, maintain at 10 mg once daily and adjust according to LDL cholesterol levels and therapeutic goals at intervals of four weeks or more. The maximum dose is 20 mg once daily.
Child dose
Pediatric patients aged 10 to 17 years are administered between 5 mg and 20 mg once daily, adjusted individually based on therapeutic goals. Dose adjustments should be made at intervals of four weeks or more.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This drug is used primarily as an adjunct therapy in patients with primary hypercholesterolemia and mixed dyslipidemia who are not adequately controlled by diet and exercise. It is also prescribed as an adjunct to diet in patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. In patients with hypercholesterolemia, it effectively reduces total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. It can also be used to lower cholesterol levels in pediatric patients aged 10 to 17 years with familial hypercholesterolemia. In adult patients at high risk for cardiovascular disease, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures. In summary, this medication is used for various types of dyslipidemia related to hypercholesterolemia and for reducing cardiovascular disease risk.

How to take

Adult dose

Start with 5 mg once daily at any time during the day, regardless of meals. If necessary, maintain at 10 mg once daily and adjust according to LDL cholesterol levels and therapeutic goals at intervals of four weeks or more. The maximum dose is 20 mg once daily.

Child dose

Pediatric patients aged 10 to 17 years are administered between 5 mg and 20 mg once daily, adjusted individually based on therapeutic goals. Dose adjustments should be made at intervals of four weeks or more.

Precautions

This drug should not be used in certain patients. For example, it should not be administered to patients with allergies to any components of this drug, patients with severely impaired liver function, or those with muscle diseases. Moreover, it is advisable for pregnant or nursing women, as well as fertile women not using adequate contraception, to avoid this medication. This drug may affect liver function, so patients with a history of liver disease or those consuming excessive alcohol should undergo multiple liver function tests before administration. Patients with hypothyroidism or kidney disease should also use this drug with caution, and if they experience muscle-related side effects like myalgia or myopathy, they must promptly inform their doctor. Additionally, this drug may interact with other medications, so be sure to inform your physician or pharmacist of any other medications you are taking. Particularly, the risk of muscle damage may increase when used with some antibiotics, antifungals, immunosuppressants, and fibrate medications. If symptoms such as myalgia, weakness, or fever occur during the treatment with this drug, immediately notify medical personnel, and also carefully observe for rare but severe skin reactions or liver damage. Women planning to become pregnant or who are pregnant should not use this drug, and if pregnancy occurs while taking this medication, they should stop taking it immediately and consult a doctor. In cases of overdose, there is no specific antidote, so symptomatic treatment and liver and muscle function testing are necessary. This drug does not appear to significantly affect the ability to drive or operate machinery, but caution is advised due to the potential for dizziness. Finally, as this drug may have higher blood concentrations in Asians, dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, severe muscle weakness, ocular myasthenia, rhabdomyolysis, acute renal failure, oliguria, thrombocytopenia, elevated serum creatinine, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms, serious

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • myalgia
  • weakness
  • hematuria
Show 24 more
  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • lupus-like syndrome
  • muscle rupture
  • depression

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

Pink, round, film-coated tablets

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

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.