Medication info
RosuGreen Tablet 5 mg (Rosuvastatin Calcium)

RosuGreen Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)시어스제약
Appearance
Yellow round film-coated tablets
Packaging
30 tablets (15 tablets/PTP x 2)
Approval status
Active

MFDS item code 201903083 · Approved 2019.05.13 · Insurance code 689000800

Summary

Main use
Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and effect of reducing cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to the maintenance dose as needed. The maintenance dose is typically 10 mg once daily, where most patients are controlled at this dosage. Dose adjustments should be made based on LDL-cholesterol levels, treatment goals, and patient responses at intervals of 4 weeks or more, and it may be increased up to a maximum of 20 mg daily.
Children's dosage
For pediatric patients with familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual treatment goals.

Ingredients

Manufacturer
(주)시어스제약

Efficacy & effects

Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and effect of reducing cardiovascular disease risk

  • Hypercholesterolemia
  • mixed dyslipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is primarily used as an adjunct for patients with primary hypercholesterolemia and mixed dyslipidemia when not controlled by diet and exercise. In addition, it may be used in conjunction with other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This medication helps to lower total cholesterol and LDL-cholesterol levels, thereby delaying the progression of atherosclerosis. It is also used as an adjunct to diet to enhance the effect in children and adolescents with familial heterozygous hypercholesterolemia. It is used as an adjunct to diet in patients with primary dysbetalipoproteinemia and helps to reduce the risk of stroke, myocardial infarction, and arterial revascularization in patients at high cardiovascular risk. Overall, this medication is effectively used for various dyslipidemias and to reduce cardiovascular risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to the maintenance dose as needed. The maintenance dose is typically 10 mg once daily, where most patients are controlled at this dosage. Dose adjustments should be made based on LDL-cholesterol levels, treatment goals, and patient responses at intervals of 4 weeks or more, and it may be increased up to a maximum of 20 mg daily.

Children's dosage

For pediatric patients with familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual treatment goals.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to this drug, severely impaired liver function, muscle diseases, severely reduced kidney function, pregnant women, or breastfeeding women should not take this medication. This medication may affect liver function, so patients with a history of liver disease or heavy alcohol consumption should have liver function tests before administration and regular monitoring of liver enzyme levels during treatment. Symptoms such as muscle pain or weakness may occur and, in severe cases, can progress to rhabdomyolysis, which involves muscle tissue destruction, so symptoms should be reported to a physician immediately. Particularly, patients with reduced kidney function, hypothyroidism, a family history of muscle disease, elderly patients, and people who abuse alcohol are at higher risk for muscle-related side effects and should be monitored closely. This drug contains lactose, so patients with lactose intolerance should avoid taking it, and Asian patients may show higher serum drug concentrations, necessitating dosage adjustments. While taking this medication, interactions with other drugs may occur, so especially in cases of concurrent use of cyclosporine, fibrate-class drugs, certain antifungals or antibiotics, consultation with a physician or pharmacist is advised. Women of childbearing potential should use appropriate contraception, and pregnant or breastfeeding women should not take this medication. In cases of overdose, there are no specific antidotes, and appropriate treatment should be provided based on symptoms, with periodic checks of liver function and muscle enzyme levels. This medication may cause side effects such as dizziness, thus caution is needed while driving or operating machinery. Finally, if severe allergic reactions such as rash or difficulty breathing occur while taking this medication, it should be discontinued immediately, and healthcare professionals should be contacted.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema (including rash and severe swelling), pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, memory loss, peripheral neuropathy, severe muscle weakness, dyspnea, oculomotor weakness, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction syndrome (DRESS), immune-mediated necrotizing myopathy, acute renal failure, oliguria, blood

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and urticaria
  • muscle pain
  • weakness
  • cough
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  • diarrhea
  • hematuria
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • sensory disturbance

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

Storage

This medication may be sensitive to air and moisture, so it should be kept in a tightly sealed container. The suitable storage temperature is room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets (15 tablets/PTP x 2)

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.