Medication info
Samsung Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium)

Samsung Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium)

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

MFDS item code 201900332 · Approved 2019.01.22 · Insurance code 642307300

Summary

Main use
Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and inhibition of the progression of atherosclerosis
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, and most patients are adjusted to this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or more, with a maximum daily increase up to 20 mg.
Children's dosage
The usual dose range is 5 mg to 20 mg once daily. The dosage should be adjusted individually based on the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and inhibition of the progression of atherosclerosis

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

This medication is used for various types of dyslipidemia associated with hypercholesterolemia. In particular, it is used as an adjunctive therapy when diet and exercise do not improve primary hypercholesterolemia and mixed dyslipidemia patients. It also helps patients with homozygous familial hypercholesterolemia and dysbetalipoproteinemia in conjunction with a dietary regimen. It can also be used as an adjunctive therapy for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia who meet specific criteria. This medication lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis and helping to reduce the risk of cardiovascular diseases. It can be expected to reduce the risk of cardiovascular complications such as stroke, myocardial infarction, and arterial revascularization.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, and most patients are adjusted to this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or more, with a maximum daily increase up to 20 mg.

Children's dosage

The usual dose range is 5 mg to 20 mg once daily. The dosage should be adjusted individually based on the recommended treatment goals 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, individuals with allergies to its components, severely impaired liver function, muscle diseases, those taking specific immunosuppressants, severely impaired renal function, pregnant or breastfeeding women, and those with lactose intolerance should not take this medication. Moreover, it is important to periodically check liver function tests and muscle conditions before and during treatment with this drug. Patients with a history of liver disease or those who consume alcohol excessively should be especially cautious, and if high cholesterol is caused by conditions like hypothyroidism or nephrotic syndrome, these issues must be treated first. If symptoms such as muscle pain, muscle weakness, or myopathy occur, contact a physician immediately for testing. If severe muscle damage occurs, the usage of this medication should be stopped, and it may be restarted at a lower dose once symptoms improve. This medication can interact with other drugs, so there should be caution when taken in conjunction with certain antiviral medications, immunosuppressants, fibrates, and some antibiotics. Consultation with a physician is needed as the risk of muscle damage may increase when used in combination. Women who are pregnant or may become pregnant should not take this medication and should use appropriate contraception. Nursing mothers should also avoid taking this medication. In cases of overdose, there is no specific antidote, and symptomatic treatment as well as liver function and muscle enzyme testing are required. Be careful as dizziness may occur while driving or operating machinery. Finally, this medication may increase blood sugar levels in some patients, so individuals at high risk for diabetes should have their blood sugar levels checked regularly while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, chest tightness, breathing difficulties, liver abnormalities (jaundice), jaundice, Steven-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe allergic reactions, severe skin reactions, serious neurological symptoms, severe muscle weakness, oculomotor weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, thrombocytopenia, severe skin reactions, acute renal failure,

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • cough
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  • diarrhea
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • amnesia
  • peripheral neuropathy
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius at room temperature. This will help maintain the drug's efficacy and safety for a long period.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.

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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.