Medication info
Rosvaton Tablet 10 mg (Rosuvastatin Calcium)

Rosvaton Tablet 10 mg (Rosuvastatin Calcium)

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

MFDS item code 200900690 · Notified 2009.01.16 · Insurance code 657304470

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
In the treatment of primary hypercholesterolemia and other related diseases, administer once daily at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily, most patients are adjusted at this dose. Dosage adjustments should be made every 4 weeks or longer intervals based on LDL cholesterol levels, treatment goals, and patient's response, with a maximum of 20 mg daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 years to 17 years), a dose of 5 mg to 20 mg is administered once daily, and the dosage is adjusted individually based on therapeutic goals. Dosage

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

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

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

This medicine is used as an adjunct in cases where dietary changes and exercise are insufficient to control primary hypercholesterolemia and mixed dyslipidemia. It also enhances efficacy when combined with dietary changes or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is also used as an adjunct to dietary therapy in certain pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. Additionally, it is applied to complement dietary therapy in patients with primary dysbetalipoproteinemia. Furthermore, in men over 50 years old or women over 60 years old with specific cardiovascular disease risk factors, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization. This medicine is effectively used in various dyslipidemia and cardiovascular risk reductions.

How to take

Adult dose

In the treatment of primary hypercholesterolemia and other related diseases, administer once daily at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily, most patients are adjusted at this dose. Dosage adjustments should be made every 4 weeks or longer intervals based on LDL cholesterol levels, treatment goals, and patient's response, with a maximum of 20 mg daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 years to 17 years), a dose of 5 mg to 20 mg is administered once daily, and the dosage is adjusted individually based on therapeutic goals. Dosage

Precautions

This drug should not be used in certain patients. For instance, patients allergic to any of its ingredients, those with severely impaired liver function, patients with muscular disorders, severely impaired renal function, and women who are pregnant or breastfeeding should not take this medication. Also, the high-dose use of this drug is forbidden in patients at high risk for myopathy, and caution is required in those with a history of genetic muscle disorders or hypothyroidism. This medication contains lactose, so patients with hereditary metabolic disorders such as lactose intolerance should avoid it. Patients with a history of liver disease or those who consume alcohol excessively should undergo regular liver function tests before and during the use of this medication, and hypercholesterolemia caused by hypothyroidism or nephrotic syndrome should be treated before using this drug. If symptoms such as myalgia, muscle weakness, myopathy, or rhabdomyolysis appear, inform medical personnel immediately for further examination, and if symptoms are severe, discontinue the drug. It is recommended to stop administering this drug during acute severe illness. This drug can rarely cause severe myasthenia gravis or ocular myasthenia, and if such symptoms occur, discontinue use. The concentration of this drug in the blood may increase when used with certain other medications, raising the risk of adverse muscle reactions, so always consult healthcare personnel about interactions with other medications being taken. Women of childbearing potential should use appropriate contraception, and this drug should not be taken during pregnancy or breastfeeding. In case of overdose, there are no specific antidotes, so symptomatic treatment as well as liver function and muscle enzyme tests are required. This drug may cause symptoms such as dizziness, necessitating caution when driving or operating machinery. During the course of treatment with this drug, regular checks of liver function, muscle condition, and blood glucose levels should be performed, and if abnormal symptoms appear, consult medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver failure, rhabdomyolysis, immune-mediated necrotizing myopathy, severe myasthenia gravis, ocular myasthenia, severe skin reactions, severe allergic reactions, respiratory distress, acute renal failure, oliguria, chest tightness, breathlessness

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • pruritus
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • increased transaminases
  • liver function test abnormalities
  • proteinuria
  • increased AST
  • increased ALT
  • increased CK
  • increased blood creatinine

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. This helps to maintain the medication's effectiveness for an extended period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 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.

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.