Medication info
Rosunex Tablet 5mg (Rosuvastatin Calcium)

Rosunex Tablet 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201706842 · Approved 2017.08.27 · Insurance code 643104380

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of day, regardless of meals. The initial dose is 5 milligrams once daily, and if a larger reduction in LDL cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is usually 10 milligrams once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with intervals of 4 weeks or more.
Children's dosage
The usual dosage range is 5 to 20 milligrams once daily. The dose should be adjusted individually based on the recommended treatment goals for each patient, with intervals of 4 weeks or more between adjustments.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is primarily used as an adjunct therapy in patients with primary hypercholesterolemia and mixed hyperlipidemia that cannot be controlled by diet and exercise alone. It is also used in patients with homozygous familial hypercholesterolemia together with dietary therapy or other lipid-lowering therapies to effectively lower cholesterol levels. For patients with hypercholesterolemia, this drug helps reduce total cholesterol and LDL cholesterol levels to goal levels, thus delaying the progress of atherosclerosis. Particularly, for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, it serves as an adjunct to diet to lower LDL cholesterol and Apo-B levels. Additionally, it is used as an adjunct therapy in patients with primary dysbetalipoproteinemia and contributes to the reduction of the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged and older adults at high risk for cardiovascular diseases. Overall, this medication is used to improve hyperlipidemia and cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time of day, regardless of meals. The initial dose is 5 milligrams once daily, and if a larger reduction in LDL cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is usually 10 milligrams once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with intervals of 4 weeks or more.

Children's dosage

The usual dosage range is 5 to 20 milligrams once daily. The dose should be adjusted individually based on the recommended treatment goals for each patient, with intervals of 4 weeks or more between adjustments.

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to this drug, have severely impaired liver function, have muscle disease, or have greatly reduced kidney function should not use this medication. Additionally, it is recommended that pregnant or breastfeeding women, and fertile women not using adequate contraception avoid this medication. Patients at high risk for myopathy or rhabdomyolysis, such as those with moderate to severe renal dysfunction, hypothyroidism, a family history or those who are alcoholics should also avoid high doses of this medication. This drug can affect liver function, so patients with a history of liver disease or heavy alcohol consumption should undergo liver function tests before administration and regularly monitor liver enzymes during treatment. If symptoms such as muscle pain or weakness appear, healthcare professionals should be notified immediately, and blood tests may be necessary to check for muscle damage. Furthermore, this medication may slightly increase blood glucose levels; thus, patients at risk for diabetes should regularly check their blood glucose and HbA1c levels. This drug may interact with other medications, especially when taken with certain antiviral agents, immunosuppressants, antibiotics, and fibrate-class drugs, so caution is warranted. When used in combination, the risk of muscle-related adverse reactions may increase, so consultation with healthcare professionals is advised. During pregnancy or breastfeeding, it is safest not to use this medication, and women of childbearing age must use proper contraceptive methods. In cases of overdose, as there is no specific antidote, treatment should be symptomatic, and monitoring of liver function and muscle enzyme levels is necessary. Dizziness may occur when driving or operating machinery, so caution is required. Finally, this medication may rarely cause serious skin reactions, liver function abnormalities, or muscle damage in some patients; any unusual symptoms should be reported to healthcare professionals immediately, and treatment should be discontinued.

Side effects and when to seek care immediately

Serious side effects

Rash, allergic reactions including angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, hematuria, edema, dyspnea, ocular myasthenia, severe myasthenia, fatal and non-fatal liver failure, acute kidney failure, oliguria.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • fatigue
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  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain.

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

Storage

This medication must be stored in a tightly sealed container to protect it from exposure to air or moisture. It is advised to maintain the storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 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.