Medication info
Rosuzal 20 mg (Rosuvastatin Calcium)

Rosuzal 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)새한제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets/PTP(Alu-Alu) - 30 tablets/PTP[(Alu-Alu)]
Approval status
Active

MFDS item code 201804175 · Approved 2018.10.23 · Insurance code 651300920

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time during the day, regardless of meals. The initial dosage is 5 mg once daily, and if necessary, it can be adjusted to a maintenance dose of 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or longer, and may be increased up to a maximum of 20 mg per day.
Children's dosage
Children aged 10 to 17 years are administered a dose of 5 mg to 20 mg once daily. The dosing should be adjusted individually according to treatment goals, with adjustments made at intervals of 4 weeks or longer.

Ingredients

Manufacturer
(주)새한제약

Efficacy & effects

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

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

This medication is primarily used as an adjunct therapy in patients with primary hypercholesterolemia or mixed dyslipidemia when diet and exercise alone do not provide sufficient control. It may also be used by patients with homozygous familial hypercholesterolemia in conjunction with diet or other treatment methods. It works by lowering total cholesterol and LDL-cholesterol levels, thereby slowing the progression of atherosclerosis. Specifically, it can also be used as an adjunct in pediatric patients aged 10 to 17 years who meet certain criteria for heterozygous familial hypercholesterolemia. It is beneficial for patients with primary dysbetalipoproteinemia and contributes positively to the reduction of cardiovascular disease risk. This medication reduces the risks of myocardial infarction, stroke, and revascularization procedures, thereby improving cardiovascular health.

Dosage and Administration

Adult dosage

This medication can be taken at any time during the day, regardless of meals. The initial dosage is 5 mg once daily, and if necessary, it can be adjusted to a maintenance dose of 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or longer, and may be increased up to a maximum of 20 mg per day.

Children's dosage

Children aged 10 to 17 years are administered a dose of 5 mg to 20 mg once daily. The dosing should be adjusted individually according to treatment goals, with adjustments made at intervals of 4 weeks or longer.

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to this medication, those with severely impaired liver function, patients with muscle disorders, those with significantly reduced kidney function, and women who are pregnant or breastfeeding should not take this medication. In addition, high-dose use is prohibited in patients at high risk for muscle-related disorders, which include factors such as impaired kidney function, hypothyroidism, and a family history of muscle disease. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should avoid it. Patients with a history of liver disease or those who consume alcohol excessively should have regular liver function tests while using this medication. If symptoms such as myalgia, muscle weakness, or muscle damage occur, the doctor should be notified immediately, and blood tests may be necessary to assess the degree of muscle damage. This medication may cause increased liver enzyme levels in some patients, so treatment should be discontinued if there are signs of liver dysfunction. Caution is especially required in elderly patients, those with reduced kidney function, and patients with hypothyroidism, as they are at higher risk for muscle damage. This medication may interact with other drugs, so it is essential to inform the healthcare provider of any other medications being taken, as the risk of muscle damage may be increased when used with specific drugs. Women who are pregnant or may become pregnant should use appropriate contraception and should not take this medication during pregnancy. In case of overdose, there is no specific antidote, and management should focus on symptomatic treatment, along with liver function and muscle enzyme testing. Caution is advised when driving or operating machinery, as dizziness may occur. This medication may show higher systemic concentrations in Asians, so dose adjustment may be necessary. If severe skin reactions occur, the use of the medication should be stopped immediately and healthcare advice should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, chest tightness, dyspnea, jaundice, severe skin reactions (Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms), rhabdomyolysis, severe muscle weakness, ocular muscle paralysis, thrombocytopenia, hepatitis, acute renal failure, oliguria, severe edema, polyneuropathy, amnesia, peripheral neuropathy, immune-mediated necrotizing myopathy, neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • asthenia
  • hematuria
  • diarrhea
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  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • muscle cramps
  • gout
  • joint pain
  • syncope
  • generalized pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safest when stored at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/PTP(Alu-Alu) - 30 tablets/PTP[(Alu-Alu)]

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.