Medication info

Y2Rose Tab 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
성이바이오제약주식회사
Appearance
Pink round film-coated tablet
Packaging
30 tablets/box [15 tablets/PTP (Alu-Alu) x 2]
Approval status
Active

MFDS item code 202106981 · Approved 2021.10.18

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
It can be taken at any time during the day regardless of meals. The initial dosage is 5 mg once daily, and if greater LDL-cholesterol reduction is required, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, with most patients being controlled at this dose. The maintenance dosage can be adjusted based on LDL-cholesterol levels, therapeutic goals, and patient response at intervals of at least 4 weeks.
Children's dosage
The usual dosage range is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to the recommended therapeutic goals for each patient. Dosage adjustments should occur at intervals of at least 4 weeks or longer.

Ingredients

Manufacturer
성이바이오제약주식회사

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • primary dysbetalipoproteinemia
  • 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 mainly used as an adjunctive therapy in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise are inadequate. It may also assist patients with homozygous familial hypercholesterolemia when combined with other lipid-lowering therapies. It lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and is also used as an adjunct to diet in pediatric patients between the ages of 10 and 17 with heterozygous familial hypercholesterolemia. It aids in the dietary management of patients with primary dysbetalipoproteinemia. In particular, it is used to reduce the risk of stroke, myocardial infarction, and vascular revascularization in men over 50 years and women over 60 years who have elevated high-sensitivity C-reactive protein levels and other cardiovascular risk factors. Thus, this medication is effectively used in various dyslipidemia and cardiovascular disease risk groups.

Dosage and Administration

Adult dosage

It can be taken at any time during the day regardless of meals. The initial dosage is 5 mg once daily, and if greater LDL-cholesterol reduction is required, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, with most patients being controlled at this dose. The maintenance dosage can be adjusted based on LDL-cholesterol levels, therapeutic goals, and patient response at intervals of at least 4 weeks.

Children's dosage

The usual dosage range is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to the recommended therapeutic goals for each patient. Dosage adjustments should occur at intervals of at least 4 weeks or longer.

Precautions

This drug should not be used in patients with certain diseases or conditions. For example, patients who are allergic to any component of this drug, those with severely impaired liver function, muscle disorders, severe renal impairment, and women who are pregnant or breastfeeding should not take this medication. Furthermore, due to the potential for muscular side effects, it should be used cautiously in patients at high risk of muscle pain, myopathy, or rhabdomyolysis. Such patients should regularly undergo blood tests to monitor muscle enzyme levels. Patients with liver function abnormalities or a history of excessive alcohol consumption also require caution, and regular liver function tests should be conducted during treatment. This medication may raise blood glucose levels in some patients, so individuals at risk of diabetes should regularly check their blood sugar levels. Additionally, this drug may interact with other medications, so patients should inform their healthcare provider of any other medications being taken, especially those that carry a risk of muscle toxicity. Women who may become pregnant should use appropriate contraception, and this drug should not be used during pregnancy. Its use is also not recommended while breastfeeding. In cases of overdose, there is no specific antidote; thus, treatment should focus on symptom management, along with monitoring of liver function and muscle enzymes. If symptoms such as dizziness or muscle pain occur during treatment, patients should immediately consult their healthcare provider, and discontinue use if serious side effects are suspected.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, respiratory distress, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, acute renal failure, oliguria, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), severe edema or urinary abnormalities

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
Show 25 more
  • thrombocytopenia
  • increased transaminases
  • ALT increase
  • CK increase
  • AST increase
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • general pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • hematuria
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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

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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.