Medication info
Ostatin 20 mg (Rosuvastatin Calcium)

Ostatin 20 mg (Rosuvastatin Calcium)

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

MFDS item code 201501555 · Approved 2015.03.24 · Insurance code 629700390

Summary

Main use
Treatment to reduce high cholesterol and 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 milligrams once daily, and maintenance doses can be adjusted to 10 milligrams once daily if needed. Maintenance doses should be adjusted appropriately according to patient response at intervals of 4 weeks or more, and doses can be increased up to a maximum of 20 milligrams once daily.
Children's dosage
For pediatric patients aged 10 to 17 years, the dose is administered as 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually based on treatment goals with intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Treatment to reduce high cholesterol and cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • excess LDL cholesterol
  • dysbetalipoproteinemia
  • risk factors for coronary heart disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is used as an adjunct to diet for the treatment of primary hypercholesterolemia and mixed dyslipidemia in patients when dietary changes and exercise do not achieve adequate control. It also aids in patients with homozygous familial hypercholesterolemia along with diet or other lipid-lowering therapies and reduces total cholesterol and LDL cholesterol in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It is also used as an adjunct to diet for children aged 10 to 17 years with heterozygous familial hypercholesterolemia and is beneficial in patients with dysbetalipoproteinemia. Furthermore, it is used in men over 50 years and women over 60 years with risk factors for cardiovascular disease to reduce the risk of stroke, myocardial infarction, and vascular revascularization procedures. It is effective for various types of dyslipidemia and reduction of cardiovascular disease 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 milligrams once daily, and maintenance doses can be adjusted to 10 milligrams once daily if needed. Maintenance doses should be adjusted appropriately according to patient response at intervals of 4 weeks or more, and doses can be increased up to a maximum of 20 milligrams once daily.

Children's dosage

For pediatric patients aged 10 to 17 years, the dose is administered as 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually based on treatment goals with intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients with an allergy to this medication, severely impaired liver function, muscle disorders, severe renal impairment, or women who are pregnant or breastfeeding should not take this medication. This medication may affect liver function; therefore, patients with a history of liver disease or those who consume alcohol heavily should have regular liver function tests both prior to and during treatment. If symptoms such as muscle pain or weakness occur, it is important to inform a doctor immediately, and blood tests may be necessary to check for muscle damage. This medication can interact with other drugs; therefore, it is essential to inform your doctor or pharmacist of any other medications you are taking. Caution is especially needed when used in conjunction with specific antibiotics, antifungals, immunosuppressives, and fibrate drugs. Women of childbearing potential should use adequate contraception and should not take this medication during pregnancy. This medication is also not recommended while breastfeeding. In the case of overdose, since there is no specific antidote, it is crucial to go to the hospital immediately for appropriate treatment and to conduct liver function and muscle-related tests. This medication can rarely cause serious skin reactions, liver damage, or muscle damage; therefore, if skin rashes, jaundice symptoms, or severe muscle pain occur, use should be discontinued immediately and medical consultation sought. Caution is needed while driving or operating machinery as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, jaundice, hepatitis, liver failure, rhabdomyolysis, immune-mediated necrotizing myopathy, polyneuropathy, severe muscle weakness, shortness of breath, renal failure, hematuria, edema, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • urticaria
  • muscle pain
  • myopathy
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  • weakness
  • thrombocytopenia
  • cough
  • diarrhea
  • ocular muscle weakness
  • amnesia
  • peripheral neuropathy
  • fatigue
  • numbness
  • dysesthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment.

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 a storage temperature of 1 to 30 degrees Celsius. This will help to preserve the drug's effectiveness and safety.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [(15 tablets/PTP (AluAlu) * 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.