Medication info
Rovataryn Tablet 10 mg (Rosuvastatin Calcium)

Rovataryn Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (15 tablets/PTP x 2 pieces)
Approval status
Active

MFDS item code 201905929 · Approved 2019.08.22 · Insurance code 057700310

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Patients with primary hypercholesterolemia, mixed dyslipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia may take this drug at any time of day, regardless of meals. The initial dosage is 5 mg once daily, and if necessary, the maintenance dose can be adjusted to up to 10 mg once daily. The maintenance dose should be adjusted based on LDL cholesterol levels and treatment goals at intervals of at least 4 weeks.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the typical dosage is 5 mg to 20 mg once daily. The dose is adjusted according to individual treatment goals, with intervals of at least 4 weeks.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • risk of stroke
  • risk of myocardial infarction
View approved original text

This drug is used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary and exercise controls are insufficient. It is also used as an adjunct with other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This drug helps lower total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. In particular, it is used as an adjunct to diet in pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years, effectively managing cholesterol levels in high-risk patients. Additionally, it is used as an adjunct to diet in primary dysbetalipoproteinemia. With effects in reducing cardiovascular disease risk, it helps lower the risk of stroke, myocardial infarction, and arterial revascularization in high-risk patients over middle age.

Dosage and Administration

Adult dosage

Patients with primary hypercholesterolemia, mixed dyslipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia may take this drug at any time of day, regardless of meals. The initial dosage is 5 mg once daily, and if necessary, the maintenance dose can be adjusted to up to 10 mg once daily. The maintenance dose should be adjusted based on LDL cholesterol levels and treatment goals at intervals of at least 4 weeks.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the typical dosage is 5 mg to 20 mg once daily. The dose is adjusted according to individual treatment goals, with intervals of at least 4 weeks.

Precautions

This drug may not be suitable for certain patients. For example, patients with allergies to this drug's components, severe liver dysfunction, muscle diseases, and severe renal impairment should avoid it. Moreover, pregnant or nursing women should not use this drug, and women of childbearing potential should take appropriate contraceptive measures to reduce the possibility of pregnancy. This drug may cause muscle-related side effects, so immediate medical consultation is required if symptoms like muscle pain or weakness appear. Special caution is advised for patients with kidney or thyroid issues, or a history of muscle diseases. Regular liver function tests and muscle enzyme tests should be performed, and patients with a history of liver disease or high alcohol consumption should be prescribed this drug cautiously. Because this drug’s blood levels may increase and the risk of side effects may rise when taken with certain medications, inform medical personnel of any concurrent medications. Pregnant or nursing women should not take this drug, and women planning pregnancy must consult a doctor. In case of an overdose, there is no specific antidote, so immediate hospital treatment is necessary, and liver function and muscle enzyme levels should be monitored. While taking this drug, dizziness or headaches may occur, so caution is needed when driving or operating machinery. Finally, this drug contains lactose, so patients with lactose intolerance should consult before taking it.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • altered sensation
  • joint pain

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

Storage

Store this drug in a tightly sealed container to protect it from exposure to air or moisture, and keep it at a temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets (15 tablets/PTP x 2 pieces)

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.