Medication info
Samsung Rosuvastatin Tablets 5mg (Rosuvastatin Calcium)

Samsung Rosuvastatin Tablets 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201900331 · Approved 2019.01.22 · Insurance code 642307290

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily as an initial dose, adjusting the maintenance dose to 10 mg once daily as needed. The maintenance dose should be adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg daily if needed. It can be taken at any time of day, with or without meals.
Children's dosage
For pediatric patients aged 10 to 17 years, the dosage is administered once daily in the range of 5 mg to 20 mg. The dosage should be individually adjusted based on therapeutic goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary heart disease
  • stroke risk
View approved original text

This medication helps when dietary control and exercise do not regulate lipid abnormalities such as primary hypercholesterolemia and mixed hyperlipidemia. It is also used to lower LDL-cholesterol and total cholesterol in patients with homozygous familial hypercholesterolemia or those with hypercholesterolemia to delay the progression of atherosclerosis. It is effective as an adjunct to diet in adolescents aged 10 years and older with familial hypercholesterolemia. Additionally, it assists patients with primary dysbetalipoproteinemia and contributes to reducing the risk of cardiovascular disease, thereby potentially lowering the risk of stroke, myocardial infarction, and arterial revascularization. It is used to improve various types of hyperlipidemia and cardiovascular risks.

Dosage and Administration

Adult dosage

Administer 5 mg once daily as an initial dose, adjusting the maintenance dose to 10 mg once daily as needed. The maintenance dose should be adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg daily if needed. It can be taken at any time of day, with or without meals.

Children's dosage

For pediatric patients aged 10 to 17 years, the dosage is administered once daily in the range of 5 mg to 20 mg. The dosage should be individually adjusted based on therapeutic goals at intervals of 4 weeks or more.

Precautions

It is very important not to use this medication in certain patients. For example, those who are allergic to any of the ingredients in this medication should not take it. Moreover, individuals with severely impaired liver function or persistently high liver enzymes of unknown origin should avoid using this medication. Patients with muscle diseases or issues with muscles due to certain autoimmune diseases should also avoid this medication. Patients with severely reduced kidney function, pregnant or nursing women, and women of childbearing potential who are not using adequate contraception should refrain from taking this medication. This medication should be used cautiously in individuals who consume large amounts of alcohol or have a history of liver diseases, and it is advisable to perform liver function tests before and during use. Additionally, if symptoms such as muscle pain or weakness occur, the physician should be informed immediately, and if severe, the medication should be discontinued. Special caution is required for individuals with diminished kidney function, those with thyroid dysfunction or a family history of such, elderly patients, and those who abuse alcohol. This medication may increase blood glucose levels in some patients, so individuals at risk for diabetes should manage their blood sugar meticulously. Furthermore, the effects of this medication can vary due to specific genetic differences; therefore, dose adjustment may be necessary according to the patient's condition. While taking this medication, serious skin rashes or allergic reactions may rarely occur, so if any abnormal skin symptoms arise, the medication should be stopped immediately and a hospital visit should be made. Caution is required when taking this medication with other drugs. In particular, combining it with certain antiviral drugs, immunosuppressants, antifungals, antibiotics, fibrate-class drugs, etc., may lead to increased blood levels of this medication, raising the risk of muscle-related side effects. Therefore, if other medications are being taken, it is essential to inform the doctor or pharmacist, and dose adjustments or monitoring may be necessary. Pregnant or nursing women should not take this medication, and women of childbearing potential should use adequate contraception. Taking this medication during pregnancy can pose risks to the fetus, so it should be discontinued immediately if pregnancy occurs. There is no specific antidote for overdose; therefore, treatment should be symptom-based, and liver function and muscle enzyme tests should be conducted to monitor the condition. Finally, this medication is not known to significantly impair driving or operating machinery, but caution is needed as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, severe rash accompanied by fever, blistering, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular muscle weakness, myopathy (including myositis), rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • appetite suppression
  • abdominal distention
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • 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 may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 and 30 degrees Celsius to effectively preserve the medication's efficacy.

Appearance and packaging

Appearance

Yellow 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.

Questions about this medicine

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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.