Medication info
Rosumin 20 mg (Rosuvastatin Calcium)

Rosumin 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Pink, round film-coated tablet
Packaging
28 tablets/Alu-Alu, 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201707675 · Approved 2017.10.31 · Insurance code 662503720

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be administered at any time of the day regardless of meals. The initial dosage is 5 mg taken once daily, with a maintenance dosage of 10 mg once daily, which is sufficient for most patients. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or more, with a maximum increase up to 20 mg daily.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the daily dosage ranges from 5 mg to 20 mg administered once daily. Dosing should be adjusted based on individual patient needs every 4 weeks or more.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

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

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

This medication is primarily used as an adjunctive therapy when dietary changes and exercise alone do not control primary hypercholesterolemia and mixed dyslipidemia patients. It is also beneficial in the treatment of patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. It is particularly used to lower cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. This drug effectively lowers total cholesterol and LDL cholesterol to target levels, delaying the progression of atherosclerosis. Additionally, it helps reduce the risk of stroke, myocardial infarction, and revascularization procedures in high-risk patients with elevated high-sensitivity C-reactive protein. Consequently, it is widely used in the management of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication can be administered at any time of the day regardless of meals. The initial dosage is 5 mg taken once daily, with a maintenance dosage of 10 mg once daily, which is sufficient for most patients. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or more, with a maximum increase up to 20 mg daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the daily dosage ranges from 5 mg to 20 mg administered once daily. Dosing should be adjusted based on individual patient needs every 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients allergic to any components of this medication or those with active liver diseases should not take it. Patients with muscle disorders or severe renal impairment also should avoid taking this medication. Women who are pregnant or breastfeeding, and women of childbearing age who do not use appropriate contraception should also avoid this medication. This medication contains lactose, and it is important for individuals with lactose intolerance or related genetic disorders to refrain from taking it. When taking this medication, caution is advised if consuming alcohol excessively or if there is a history of liver disease. It is advisable to have regular liver function tests to monitor one’s condition. Patients with hypothyroidism or nephrotic syndrome must treat the underlying cause of their disorders before taking this medication. If symptoms of muscle pain or weakness occur, inform healthcare professionals immediately and undergo necessary tests. Particularly, if muscle enzyme levels significantly rise, treatment may need to be halted. Rarely, severe skin reactions or liver damage can occur in some patients when taking this medication; therefore, if skin rashes, jaundice, or severe fatigue appear, discontinue the medication immediately and consult a physician. This medication may interact with other drugs, so it is essential to inform healthcare providers about any other medications being taken. Caution is particularly needed when taken with specific antivirals, immunosuppressants, antifungals, certain antibiotics, and fibrate class medications. Women who are pregnant or planning to become pregnant must consult a specialist before deciding whether to take this medication, and breastfeeding mothers should avoid it as well. In case of overdose, since there is no specific antidote, one should visit a medical institution immediately for appropriate treatment and evaluation. This medication is not known to significantly affect driving or equipment operation, but caution is advised as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, respiratory distress, ophthalmoplegia, jaundice, Stevens-Johnson syndrome, severe allergic reactions, severe skin reactions, significant edema, severe myasthenia, acute renal failure, oliguria, severe liver damage, and hyperbilirubinemia. Serious allergic reactions, immune-mediated myopathy, severe neurological symptoms (e.g., seizures, altered consciousness).

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • asthenia
  • increased blood sugar
Show 23 more
  • increased ALT
  • increased AST
  • chest pain
  • cough
  • diarrhea
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory abnormalities
  • loss of appetite
  • abdominal distension
  • joint pain
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • eosinophilia
  • and generalized drug reactions.

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 room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's efficacy for a longer time.

Appearance and packaging

Appearance

Pink, 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

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.