Medication info
NewsTojeong 20mg (Rosuvastatin Calcium)

NewsTojeong 20mg (Rosuvastatin Calcium)

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

MFDS item code 201804841 · Approved 2018.11.30 · Insurance code 669907310

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For the treatment of primary hypercholesterolemia, administer an initial dose of 5 milligrams once daily at any time, regardless of meals. If necessary, maintain the dosage up to 10 milligrams once daily, and after an interval of more than 4 weeks, it can be increased up to a maximum of 20 milligrams based on patient response.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually according to the recommended therapeutic goals, with adjustments made every 4 weeks.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

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

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

This medication is primarily used as an adjunct when dietary changes and exercise are insufficient to control hypercholesterolemia and mixed hyperlipidemia. It is particularly applicable for patients with familial hypercholesterolemia and is effective as an adjunct to dietary therapy in young pediatric patients who meet specific criteria. Moreover, this medication lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. It is also helpful for patients with primary dysbetalipoproteinemia. Additionally, it is used in men over 50 years old and women over 60 years old with elevated high-sensitivity C-reactive protein levels and cardiovascular risk factors to reduce the risk of stroke, myocardial infarction, and endovascular procedures. Overall, this medication effectively improves cholesterol levels and cardiovascular disease risks.

Dosage and Administration

Adult dosage

For the treatment of primary hypercholesterolemia, administer an initial dose of 5 milligrams once daily at any time, regardless of meals. If necessary, maintain the dosage up to 10 milligrams once daily, and after an interval of more than 4 weeks, it can be increased up to a maximum of 20 milligrams based on patient response.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually according to the recommended therapeutic goals, with adjustments made every 4 weeks.

Precautions

This medication should not be used in certain patients. For instance, individuals allergic to the components of this medication, those with severe liver dysfunction, or patients with muscle disorders should avoid taking it. Furthermore, patients with severely impaired kidney function or those who are pregnant or breastfeeding should not use this medication. High-dose administration is prohibited for patients at high risk of muscle-related side effects. Patients with genetic lactose intolerance should also avoid taking this medication. Caution should be exercised when using this medication in patients with a history of liver disease or those who consume large amounts of alcohol, and it is advisable to perform liver function tests repeatedly before and after administration. Additionally, for conditions like hypothyroidism or nephrotic syndrome, it is safe to use this medication only after treating the underlying disease. Muscle-related side effects like muscle pain or myopathy may occur infrequently, so if any abnormal muscle symptoms arise, one should immediately inform the doctor and undergo testing. Since this medication can affect the liver and muscles, symptoms such as fatigue, muscle pain, and muscle weakness should be closely monitored during treatment. Especially after vigorous exercise, it is advisable to avoid testing for creatine kinase (CK), a muscle damage marker. If CK levels are too high before treatment, it is safest not to take this medication. This medication rarely causes serious skin reactions, liver damage, or kidney issues, so if symptoms such as rash or jaundice appear, one should immediately stop taking it and visit a hospital. Additionally, cognitive disorders such as memory decline or confusion have been reported in some patients; however, most symptoms improve after the discontinuation of the medication. This medication may interact with other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Especially when taken with certain antiviral agents, immunosuppressants, antibiotics, or fibrate-class drugs, the risk of muscle damage may increase. Dose adjustments or monitoring may be necessary when taken with this medication. Pregnant women or those planning to become pregnant should not take this medication and should use appropriate contraception. While breastfeeding, this medication can transfer to breast milk and affect the baby, so it should be avoided. In the case of overdose, there is no specific antidote, so treatment should be symptomatic, while closely monitoring liver function and muscle damage markers. This medication is known not to significantly affect the ability to operate vehicles or machinery; however, caution is advised due to possible dizziness symptoms. Lastly, this medication may show higher blood concentrations in Asians, so care should be taken when determining the dosage, and in the case of children or adolescents, it should be used while monitoring growth and development.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, severe muscle weakness, ocular myasthenia, jaundice, liver failure, acute kidney injury, oliguria, thrombocytopenia, increased serum creatinine, severe allergic reactions, severe skin adverse reactions, dyspnea, respiratory issues, liver abnormalities (jaundice), severe neurological symptoms, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • diabetes
  • itching
  • rash
  • muscle pain
  • weakness
Show 23 more
  • diarrhea
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • lupus-like syndrome
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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 advisable to keep it at a temperature between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 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.

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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.