Medication info
Rosumin 5 mg (Rosuvastatin Calcium)

Rosumin 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Yellow round film-coated tablet
Packaging
28 tablets/Alu-Alu, 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201707673 · Approved 2017.10.31 · Insurance code 662503740

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) with a cardiovascular disease risk reduction effect
Who uses it
Adults · Children
Adult dosage
The starting dosage is 5 mg once daily, which can be adjusted to a maintenance dose for more significant LDL cholesterol lowering if needed. The maintenance dose is 10 mg once daily, and most patients can be managed with this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20 mg once daily.
Children's dosage
The usual dose range is 5 mg to 20 mg once daily. The dosing should be individually adjusted based on the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • risk of stroke
  • risk of myocardial infarction
View approved original text

This medication is used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone do not suffice. It is also prescribed together with dietary therapy or other lipid-lowering therapies to patients with homozygous familial hypercholesterolemia to lower total cholesterol and LDL cholesterol levels, thus delaying the progression of atherosclerosis. It is especially effective in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, helping to control cholesterol levels that do not improve with diet alone. It also serves as an adjunct to diet in patients with primary dysbetalipoproteinemia. Moreover, this drug is used to reduce the risk of stroke, myocardial infarction, and vascular revascularization in patients with elevated high-sensitivity C-reactive protein levels who are at high cardiovascular risk. Thus, it is effectively used for reducing the risk of various dyslipidemias and cardiovascular diseases.

Dosage and Administration

Adult dosage

The starting dosage is 5 mg once daily, which can be adjusted to a maintenance dose for more significant LDL cholesterol lowering if needed. The maintenance dose is 10 mg once daily, and most patients can be managed with this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20 mg once daily.

Children's dosage

The usual dose range is 5 mg to 20 mg once daily. The dosing should be individually adjusted 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, patients allergic to this medication, those with severely impaired liver function, patients with muscle disorders, and pregnant or nursing women should avoid taking it. Additionally, patients with very poor kidney function should also refrain from using this drug. This medication may affect muscles, potentially causing symptoms such as muscle pain or myopathy, so if muscle pain or weakness occurs, one should consult a doctor immediately. Patients who consume alcohol heavily or have a history of liver disease should have regular liver function tests, and certain conditions such as hypothyroidism should be managed before treatment. The risk of side effects may vary depending on individual genetic factors, so dosage adjustments might be necessary based on individual conditions. Furthermore, interactions may occur when taken with other medications, so it is essential to inform your doctor or pharmacist about any other medications being taken. Women of childbearing potential should use appropriate contraception and avoid taking this medication during pregnancy. In case of overdose, since there is no specific antidote, symptomatic treatment and liver and muscle function tests are required. This medication does not significantly impair driving or operating machinery, but caution is advised as dizziness may occur. Side effects may include headaches, dizziness, muscle pain, gastrointestinal disturbances, and if severe skin reactions or liver function abnormalities occur, treatment should be discontinued and medical advice sought immediately.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, severe swelling (edema), tightness in the chest, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular myasthenia, rhabdomyolysis, immune-mediated necrotizing myopathy, acute kidney failure, oliguria, thrombocytopenia, elevated serum creatinine, severe allergic reactions, severe skin reactions

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • chest pain
  • muscle rupture
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • hepatitis
  • drug-induced lichenoid eruption
  • lupus-like syndrome
  • depression

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/Alu-Alu, 30 tablets/bottle, 300 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.