Medication info
Rosumin 10 mg (Rosuvastatin Calcium)

Rosumin 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Pink round film-coated tablets
Packaging
28 tablets/Alu-Alu, 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201707674 · Approved 2017.10.31 · Insurance code 662503730

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This drug can be administered at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily. The maintenance dose is adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and the patient's response, with a maximum daily dose of up to 20 mg.
Children's dosage
In pediatric patients with familial hypercholesterolemia (ages 10 to 17), the usual dose is between 5 mg to 20 mg once daily. The dosage should be adjusted based on the recommended treatment goals for each individual patient, at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

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

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

This drug is used as an adjunct when dietary control and exercise are insufficient in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct to diet or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia, lowering blood cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. In pediatric patients aged 10 to 17 years with familial hypercholesterolemia, it helps to lower total cholesterol and LDL cholesterol levels when used in conjunction with dietary therapy. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Furthermore, it contributes to reducing the risk of stroke, myocardial infarction, and arterial revascularization procedures in men aged 50 years and older and women aged 60 years and older who have high sensitivity C-reactive protein and one or more risk factors for cardiovascular disease. Therefore, this drug is effective in controlling blood lipid levels and reducing the risk of cardiovascular diseases in various situations related to hypercholesterolemia.

Dosage and Administration

Adult dosage

This drug can be administered at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily. The maintenance dose is adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and the patient's response, with a maximum daily dose of up to 20 mg.

Children's dosage

In pediatric patients with familial hypercholesterolemia (ages 10 to 17), the usual dose is between 5 mg to 20 mg once daily. The dosage should be adjusted based on the recommended treatment goals for each individual patient, at intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, patients with allergies to this drug, those with liver function problems, muscle disorders, severe renal dysfunction, and women who are pregnant or nursing should not take this drug. Liver function and muscle status should be regularly monitored while taking this drug, especially in patients who consume large amounts of alcohol or have a history of liver disease. If symptoms such as muscle pain, weakness, or cramps occur, contact a physician immediately and discontinue use if necessary. Additionally, this drug may increase blood concentration levels when taken with certain medications, heightening the risk of muscle disorders, so always consult healthcare providers if taking other medications. Women of childbearing potential should use appropriate contraception to avoid pregnancy, and if pregnancy occurs, this medication should be immediately discontinued. This drug can affect the liver and kidneys, so regular monitoring of liver and kidney functions is necessary. In case of overdose, there is no specific antidote, and treatment should be based on symptoms, while monitoring liver function and muscle enzyme levels. Caution is advised while driving or operating machinery as dizziness may occur. Finally, this drug contains lactose, so patients with lactose intolerance should avoid it, and if severe skin reactions occur, discontinue immediately and consult with healthcare providers.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, angioedema
  • Severe allergic reactions
  • Stevens-Johnson syndrome
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Jaundice, hepatitis, increased transaminases
  • Severe liver damage and hyperbilirubinemia
  • Liver abnormalities (jaundice)
  • Difficulty breathing, respiratory distress with fever
  • Respiratory problems
  • Severe muscular weakness, ocular muscle weakness
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  • Severe myopathy and rhabdomyolysis
  • Myositis, immune-mediated necrotizing myopathy
  • Severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • myalgia
  • weakness
  • itching
  • rash
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • anorexia
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion

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

Storage

Store this drug in a tightly closed container to protect it from air and moisture. It is recommended to maintain room temperature between 1 degree Celsius and 30 degrees Celsius. This helps to retain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Pink round film-coated tablets

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.