Medication info
Rosujal 5 mg Tablets (Rosuvastatin Calcium)

Rosujal 5 mg Tablets (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)새한제약
Appearance
Yellow circular film-coated tablets
Packaging
30 tablets/PTP (Alu-Alu) - 30 tablets/PTP [(Alu-Alu)]
Approval status
Active

MFDS item code 201804174 · Approved 2018.10.23 · Insurance code 651300910

Summary

Main use
Effectiveness in treating hypercholesterolemia and familial hypercholesterolemia (hyperlipidemia, dyslipidemia) and reducing the risk of cardiovascular disease.
Who uses it
Adults · Children
Adult dosage
Can be taken at any time of the day regardless of meals. The initial dosage is 5 mg once daily, and if greater reductions in LDL cholesterol are required, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, with most patients being managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer.
Children's dosage
For pediatric patients with atypical familial hypercholesterolemia (ages 10 to 17), the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual patient's treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)새한제약

Efficacy & effects

Effectiveness in treating hypercholesterolemia and familial hypercholesterolemia (hyperlipidemia, dyslipidemia) and reducing the risk of cardiovascular disease.

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

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are not enough to control the condition. It is also used as an adjunct in patients with homozygous familial hypercholesterolemia who are not adequately managed with diet or other lipid-lowering therapies. This medication effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is especially used as an adjunct in children aged 10 to 17 years with familial hypercholesterolemia when LDL cholesterol levels are high and cannot be managed with diet alone. It is also used as an adjunct in patients with primary dysbetalipoproteinemia. Additionally, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization in males over 50 years of age and females over 60 years of age who have elevated high-sensitivity C-reactive protein levels. This medication effectively improves cardiovascular disease risk through lipid management.

Dosage and Administration

Adult dosage

Can be taken at any time of the day regardless of meals. The initial dosage is 5 mg once daily, and if greater reductions in LDL cholesterol are required, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, with most patients being managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer.

Children's dosage

For pediatric patients with atypical familial hypercholesterolemia (ages 10 to 17), the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual patient's treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who have an allergic reaction to this medication, have severe liver problems, have muscle disorders, have severely impaired kidney function, are pregnant or nursing, or are taking certain medications should not take this medication. Also, this medication can affect liver function, so patients with a history of liver disease or who consume excessive alcohol should use it with caution. Liver function tests should be performed regularly before and during treatment. Symptoms such as muscle pain or weakness may occur; if these symptoms arise, medical personnel should be informed immediately. Special caution is required in cases of elevated muscle enzyme levels or a history of muscle-related disorders. This medication may interact with other drugs, so it is essential to inform healthcare personnel about any other medications being taken. Certain drugs can increase this medication's blood concentration, raising the risk of side effects. Women who are pregnant or are of childbearing potential must use appropriate contraception before taking this medication, and it should be avoided during pregnancy. Nursing mothers should also refrain from using this medication. In cases of overdose, no specific antidote exists, so treatment must be symptomatic, and liver function and muscle enzyme levels should be monitored. Finally, dizziness may occur while taking this medication, so caution is advised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, immune-mediated necrotizing myopathy, rhabdomyolysis, severe muscle weakness, ocular myasthenia, acute renal failure, oliguria, severe edema, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities, severe neurological symptoms, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • increased serum creatinine
  • elevated ALT
  • elevated AST
  • increased transaminases
  • proteinuria
  • increased CK
  • depression
  • sleep disturbances

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. It is preferable to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow circular film-coated tablets

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.