Medication info
Rosuton 5 mg (Rosuvastatin Calcium)

Rosuton 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Yellow round film-coated tablets
Packaging
28 tablets (14 tablets/Alu-Alu x 2)
Approval status
Active

MFDS item code 201400385 · Approved 2014.01.28 · Insurance code 670606780

Summary

Main use
Treatment of hypercholesterolemia and reduced cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
It can be administered at any time of the day, without regard to meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily, which is the dosing most patients will be adjusted to. The maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer.
Child dose
The usual dosing range is 5 mg to 20 mg once daily. The dose should be individually adjusted based on the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or longer.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Treatment of hypercholesterolemia and reduced cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • mixed familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
View approved original text

This medication is primarily used as an adjunct therapy when diet and exercise alone do not control primary hypercholesterolemia and mixed dyslipidemia, effectively lowering total cholesterol and LDL-cholesterol levels to slow the progression of atherosclerosis. It also helps in the treatment of patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. In specific pediatric patients aged 10 to 17 years, it can be used in conjunction with diet to reduce cholesterol levels. Additionally, it contributes to reducing the risks of stroke, myocardial infarction, and arterial revascularization procedures in adults at high cardiovascular risk. In summary, this medication is effectively used for the prevention of hypercholesterolemia and cardiovascular disease.

How to take

Adult dose

It can be administered at any time of the day, without regard to meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily, which is the dosing most patients will be adjusted to. The maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer.

Child dose

The usual dosing range is 5 mg to 20 mg once daily. The dose should be individually adjusted based on the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or longer.

Precautions

This medication should not be used in certain patients. For example, individuals allergic to this drug or those with liver disease, muscle disorders, severely impaired kidney function, pregnant or lactating women, and those taking certain drugs should not take this medication. Moreover, it is important to periodically monitor liver function and muscle condition while taking this medication. If there are signs of liver function deterioration or symptoms like muscle pain or weakness, consult a doctor immediately. This medication should be administered cautiously in individuals who consume large amounts of alcohol or have a history of liver disease, and treatments of any underlying conditions should be prioritized in cases of hypothyroidism or nephrotic syndrome. Rarely, muscle-related side effects may occur, so it is essential to inform healthcare personnel of any symptoms such as muscle pain, weakness, or cramps. Special caution is necessary for the elderly or those with impaired kidney function. This medication contains lactose, so individuals with lactose intolerance should not take it, and caution is also necessary for those with certain genetic muscle disorders or alcoholism. Women of childbearing potential should use appropriate contraception while taking this medication and must stop immediately if they become pregnant. Lactating women should also avoid using this medication. When combining this drug with others, potential interactions may occur, so patients must inform their doctor or pharmacist of any current medications. Caution is especially warranted when taking it with certain antivirals, immunosuppressants, antifungals, antibiotics, or fibrates. In case of overdose, as there is no specific antidote, treatment should be symptomatic, and monitoring of liver function and muscle enzyme levels is necessary. This medication is known to have little impact on the ability to drive or operate machinery, but rare instances of dizziness may occur, so caution is advised. Lastly, if severe skin reactions, significant liver damage, or symptoms of muscle disease occur while taking this medication, discontinue it immediately and consult healthcare personnel.

Side effects and when to seek care immediately

Serious side effects

Hives, allergic reactions including angioedema, chest tightness, difficulty breathing, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory distress with cough and fever, jaundice skin or eyes, extreme fatigue throughout the body, liver dysfunction (jaundice), sudden

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • fatigue
Show 17 more
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • diarrhea
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hematuria
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. Additionally, avoid storing it in excessively hot or cold places, and it is best kept at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets (14 tablets/Alu-Alu x 2)

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.