Medication info
Rosunex Tablet 10mg (Rosuvastatin Calcium)

Rosunex Tablet 10mg (Rosuvastatin Calcium)

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

MFDS item code 201400352 · Approved 2014.01.27 · Insurance code 643103730

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily, and if more reduction in LDL cholesterol is needed, the maintenance dosage can be adjusted accordingly. The maintenance dose is usually 10 mg once daily; most patients are managed at this dosage. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, therapeutic goals, and patient responses, and may be increased to a maximum of 20 mg per day.
Child dose
The usual dosage range is 5 mg to 20 mg once daily. The administered dose should be adjusted individually according to the recommended therapeutic objectives for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is primarily used as an adjunctive therapy in cases of primary hypercholesterolemia, mixed dyslipidemia, and homozygous familial hypercholesterolemia where dietary management and exercise are insufficient. It also helps reduce total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It is effective for children aged 10 to 17 with heterozygous familial hypercholesterolemia, reducing LDL cholesterol and Apo-B levels to lower the risk of cardiovascular diseases. Additionally, it can be used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Moreover, it contributes to reducing the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 and women over 60 with specific cardiovascular risk factors. Thus, it is effectively used for the reduction of various dyslipidemias and cardiovascular disease risks.

How to take

Adult dose

The initial dose is 5 mg once daily, and if more reduction in LDL cholesterol is needed, the maintenance dosage can be adjusted accordingly. The maintenance dose is usually 10 mg once daily; most patients are managed at this dosage. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, therapeutic goals, and patient responses, and may be increased to a maximum of 20 mg per day.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The administered dose should be adjusted individually according to the recommended therapeutic objectives for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any ingredient of this medication, those with severely impaired liver function, patients with muscle disorders, patients taking certain immunosuppressants, those with significantly decreased kidney function, pregnant or breastfeeding women, and patients with genetic metabolic disorders like lactose intolerance should avoid this medication. Additionally, caution should be exercised when administering this medication to patients who consume large amounts of alcohol or have a history of liver disease, and it is essential to repeat liver function tests before and during treatment. Patients with hypercholesterolemia caused by hypothyroidism or nephrotic syndrome should first treat the underlying condition. If symptoms like muscle pain, muscle weakness, or cramps occur while taking this medication, the healthcare provider should be informed immediately, and muscle enzyme tests may be necessary to check for muscle damage. Especially patients with decreased kidney function, the elderly, alcohol abusers, and those with a family history of muscle disorders should be monitored more closely for the risk of muscle abnormalities. This medication may affect liver function, potentially raising liver enzyme levels, so it should be discontinued immediately if signs of liver dysfunction occur. Rarely, severe skin reactions or severe muscle weakness, interstitial lung disease, etc., can occur, and if such symptoms arise, treatment should be stopped immediately, and a healthcare provider should be consulted. This medication may interact with other drugs; therefore, caution is needed, particularly when taken in conjunction with certain antivirals, immunosuppressants, fibrates, some antibiotics, and antifungals. When co-administered with some medications, the blood concentration of this drug may increase, raising the risk of muscle damage. Therefore, dosage adjustments and close monitoring are necessary when used in combination. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use appropriate contraceptive methods. If pregnancy is confirmed during treatment, the medication should be discontinued immediately. In case of overdose, there are no specific antidotes, so treatment is symptomatic, and liver function and muscle enzyme levels should be monitored continuously. Finally, while this medication is not known to significantly affect driving or operating machinery, caution is advised as symptoms like dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, severe swelling, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver failure, severe muscle weakness, ocular myasthenia, immune-mediated necrotizing myopathy, rhabdomyolysis, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice), severe neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • 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 prevent air or moisture exposure. It is best to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink 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.

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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.