Medication info

Y2Rosuva Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
성이바이오제약주식회사
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 30 tablets/box [15 tablets/PTP (Alu-Alu) x 2]
Approval status
Active

MFDS item code 202106980 · Approved 2021.10.18

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be administered at any time of day, regardless of meals. The initial dose is 5mg once a day, and if more LDL cholesterol reduction is required, the maintenance dose can be adjusted. The maintenance dose is typically 10mg once a day for most patients. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response.
Children's dosage
The usual dosage range for pediatric patients (aged 10 to 17 years) with heterozygous familial hypercholesterolemia is 5mg to 20mg once a day. The dose should be adjusted according to the individual treatment goals of each patient.

Ingredients

Manufacturer
성이바이오제약주식회사

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct for patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are insufficient. It can also be prescribed in conjunction with diet or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. This drug effectively lowers total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis. In particular, it is used as an adjunct to diet for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, helping to reduce cholesterol levels above specific thresholds. Additionally, it is useful in patients with primary dysbetalipoproteinemia and may be expected to reduce the risk of stroke, myocardial infarction, and arterial revascularization in elderly patients at high risk for cardiovascular disease. Therefore, this medication is used to improve the risks of hypercholesterolemia and related cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication can be administered at any time of day, regardless of meals. The initial dose is 5mg once a day, and if more LDL cholesterol reduction is required, the maintenance dose can be adjusted. The maintenance dose is typically 10mg once a day for most patients. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response.

Children's dosage

The usual dosage range for pediatric patients (aged 10 to 17 years) with heterozygous familial hypercholesterolemia is 5mg to 20mg once a day. The dose should be adjusted according to the individual treatment goals of each patient.

Precautions

This medication should not be used in certain patients. For example, it is contraindicated for patients who are allergic to any of its components, patients with severe liver impairment, patients with muscle disorders, patients with severe kidney diseases, and women who are pregnant or breastfeeding. This drug may affect liver function, so patients with a history of liver disease or heavy alcohol consumption should use it with caution. It is advisable to undergo regular liver function tests during treatment. Symptoms such as muscle pain or weakness may occur, and rarely, serious muscle damage may arise; therefore, if any such symptoms appear, they should be immediately reported to medical staff. Moreover, muscle-related tests should be performed to check for abnormalities. This medication may interact with other drugs, so if taking other medications, patients must inform their healthcare provider. Caution is especially needed when used concurrently with certain antibiotics, antifungals, immunosuppressants, or fibrates. Women of childbearing potential should use proper contraceptive methods while taking this medication, and if pregnancy is confirmed, they must stop taking it immediately. In the case of overdose, since there is no specific antidote, symptomatic treatment should be administered, and liver function and muscle enzyme levels should be monitored. This medication may rarely cause serious skin reactions or liver dysfunction; therefore, if symptoms like skin rash, jaundice, or severe fatigue occur, patients should consult with healthcare professionals immediately. Dizziness may occur during driving or operating machinery, so caution is required. When used in children and adolescents, careful monitoring of growth and development is essential.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
Show 24 more
  • thrombocytopenia
  • hematuria
  • edema
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive disorders
  • confusion
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory abnormalities
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • joint pain

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 30 tablets/box [15 tablets/PTP (Alu-Alu) 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

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.