Medication info
Nellastone 20 mg (Rosuvastatin Calcium)

Nellastone 20 mg (Rosuvastatin Calcium)

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

MFDS item code 202003263 · Approved 2020.05.04 · Insurance code 656702110

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Patients with primary hypercholesterolemia, combined hyperlipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia may take this medication at any time of day regardless of meals. The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol levels is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, which is the dose most patients are adjusted to.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. Clinical data for doses exceeding 20 mg in the pediatric population is not available.

Ingredients

Manufacturer
한국넬슨제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of early coronary artery disease
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunctive therapy in patients with hyperlipidemia, including primary hypercholesterolemia and heterozygous familial hypercholesterolemia, when diet and exercise alone do not adequately control cholesterol levels. Additionally, it serves as an adjunct therapy to diet or other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia. This medication lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis and protecting cardiovascular health. It is also effective in reducing cholesterol levels in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. It is used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Particularly in adult patients at high risk for cardiovascular disease, it helps to reduce the risk of stroke, myocardial infarction, and arterial revascularization. Therefore, this medication is effectively used for various types of hypercholesterolemia and cardiovascular risk reduction.

Dosage and Administration

Adult dosage

Patients with primary hypercholesterolemia, combined hyperlipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia may take this medication at any time of day regardless of meals. The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol levels is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, which is the dose most patients are adjusted to.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. Clinical data for doses exceeding 20 mg in the pediatric population is not available.

Precautions

This medication should not be used in certain patients. For instance, patients who are allergic to this medication, have severe liver dysfunction, have muscle disorders, have significantly impaired kidney function, or are pregnant or breastfeeding should not take this medication. Additionally, this medication may affect muscles, so caution is required in patients at risk for muscle pain or severe muscle damage. In such cases, it is important to regularly check muscle status through blood tests. Patients with liver function issues or those who consume high amounts of alcohol also need to undergo frequent liver function tests while taking this medication. Patients with conditions such as hypothyroidism or nephrotic syndrome should first treat these conditions before taking this medication. This medication can interact with other drugs; therefore, consultation with a healthcare professional is necessary, especially when taking certain antivirals, immunosuppressants, antibiotics, and fibrate medications. Concomitant use with certain drugs may increase the blood concentration of this medication and raise the risk of side effects. Women with the possibility of pregnancy must use effective contraception and should not take this medication during pregnancy. Additionally, breastfeeding women should avoid this medication. During the course of taking this medication, if symptoms such as muscle pain, muscle weakness, dizziness, or liver function abnormalities occur, they should immediately inform healthcare personnel. If there are severe skin reactions or allergic symptoms, the medication should be discontinued immediately, and medical advice should be sought. In cases of overdose, there are no specific antidotes, and treatment should be symptom-driven with monitoring of liver function and muscle enzymes. Caution is advised when driving or operating machinery, as dizziness may occur. Lastly, this medication may exhibit higher blood concentrations in Asians, so dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, severe allergic reactions, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain of oral/ocular mucosa, severe adverse skin reactions, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, respiratory problems, jaundice characterized by yellowing of skin or eyes, profound lethargy, liver abnormalities

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • myalgia
  • weakness
  • thrombocytopenia
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  • diarrhea
  • hematuria
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • 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 recommended to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and ensure safe usage.

Appearance and packaging

Appearance

Pink, round film-coated tablets

Package unit

100 tablets/bottle, 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.

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.