Medication info
Nellastone 10 mg (Rosuvastatin Calcium)

Nellastone 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
한국넬슨제약(주)
Appearance
Pink round film-coated tablet
Packaging
100 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202003216 · Approved 2020.04.29 · Insurance code 656702100

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and for patients requiring further LDL cholesterol reduction, the maintenance dose may be adjusted accordingly. The maintenance dose is 10 mg once daily, with most patients being managed at this dosage. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily increase up to 20 mg.
Children's dosage
The usual dose range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosing should be adjusted individually based on the therapeutic goals recommended for each patient.

Ingredients

Manufacturer
한국넬슨제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • 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 for various types of dyslipidemia related to hypercholesterolemia. It is used as an adjunctive therapy when dietary changes and exercise alone are insufficient for managing primary hypercholesterolemia and mixed dyslipidemia patients. It also helps reduce cholesterol levels when used in conjunction with dietary changes or other lipid-lowering therapies in patients with familial hypercholesterolemia. In particular, it is administered as an adjunct to diet in pediatric patients with heterozygous familial hypercholesterolemia to reduce cholesterol and apolipoprotein B levels. It also acts to complement dietary therapy in patients with primary dysbetalipoproteinemia. This medication lowers total cholesterol and LDL cholesterol levels, delays the progression of atherosclerosis, and improves health by reducing the risk of stroke, myocardial infarction, and vascular revascularization procedures in adults at high risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and for patients requiring further LDL cholesterol reduction, the maintenance dose may be adjusted accordingly. The maintenance dose is 10 mg once daily, with most patients being managed at this dosage. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily increase up to 20 mg.

Children's dosage

The usual dose range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosing should be adjusted individually based on the therapeutic goals recommended for each patient.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to this medication, those with liver problems, individuals with muscle disorders, those with severe renal impairment, and pregnant or breastfeeding women should not take this medication. Additionally, caution is necessary for patients at a higher risk of muscle-related side effects or those taking certain medications. This medication may affect liver function, so patients with a history of liver disease or those who consume alcohol excessively should undergo liver function tests before taking it and should have regular liver function monitoring during treatment. Muscle-related symptoms such as myalgia, myopathy, and rhabdomyolysis can occur, so patients experiencing symptoms like muscle pain, muscle weakness, or cramps should inform their doctor immediately. If blood tests show elevated indicators of muscle damage, the medication may need to be discontinued. The effects and risks of side effects from this medication can vary according to specific genetic factors, so dose adjustments may be necessary based on the patient's condition. Furthermore, this medication may interact with other drugs; therefore, patients should inform their doctor or pharmacist of any other medications they are currently taking, as co-administration with certain drugs can increase the blood concentration of this medication and raise the risk of side effects. Women who may become pregnant should ensure the use of appropriate contraception, and this medication should not be used during pregnancy or while breastfeeding. In cases of overdose, there is no specific antidote, so treatment should be symptomatic, and monitoring of liver function and muscle damage is essential. Lastly, this medication can rarely cause severe skin reactions, liver damage, kidney problems, and neurological complications, so patients should contact medical personnel immediately if any unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, sudden and severe headaches, thunderclap headaches, seizures, confusion of consciousness, visual disturbances

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, malaise, diarrhea, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, hematological disorders (thrombocytopenia), abnormal liver function tests, increased ALT, increased AST, increased CK, hematuria, proteinuria, memory loss, peripheral neuropathy, cough, thrombocytopenia, ocular myasthenia, lupus-like syndrome

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

Storage

This drug is sensitive to air and moisture, so it must be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.