Medication info
Ostatin Tablet 10 mg (Rosuvastatin Calcium)

Ostatin Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 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 201501556 · Approved 2015.03.24 · Insurance code 629700400

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Initiate treatment with 5 mg once daily at any time of day, regardless of meals. The maintenance dose is 10 mg once daily, and must be adjusted appropriately based on LDL cholesterol levels and patient response at intervals of 4 weeks or longer. The dose may be increased to a maximum of 20 mg once daily.
Children's dosage
For pediatric patients aged 10 to 17 years, the dose is 5 mg to 20 mg once daily, adjusted individually based on the recommended treatment goals. Dose adjustments should be made at intervals of 4 weeks or longer.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is primarily used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia who have difficulty controlling their condition through diet and exercise. It is also used as an adjunct to dietary therapy in patients with homozygous familial hypercholesterolemia and dysbetalipoproteinemia. In particular, it helps lower the total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and improving cholesterol levels in children aged 10 years and older with heterozygous familial hypercholesterolemia. Additionally, it is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged patients with cardiovascular disease risk factors. Overall, this medication effectively improves dyslipidemia and cardiovascular disease risk.

Dosage and Administration

Adult dosage

Initiate treatment with 5 mg once daily at any time of day, regardless of meals. The maintenance dose is 10 mg once daily, and must be adjusted appropriately based on LDL cholesterol levels and patient response at intervals of 4 weeks or longer. The dose may be increased to a maximum of 20 mg once daily.

Children's dosage

For pediatric patients aged 10 to 17 years, the dose is 5 mg to 20 mg once daily, adjusted individually based on the recommended treatment goals. Dose adjustments should be made at intervals of 4 weeks or longer.

Precautions

This medicine should not be used in certain patients. For example, patients with an allergy to this medication, severe liver dysfunction, muscle diseases, and those currently taking certain medications should not take this medication. Additionally, pregnant or breastfeeding women, as well as women of childbearing potential, should exercise caution when taking this medication, and should avoid taking it if they are not using appropriate contraception. This medication can affect liver function, so patients with a history of liver disease or excessive alcohol consumption must consult a physician before taking it. Regular liver function tests are recommended during treatment. Symptoms such as muscle pain or weakness may occur, so if such symptoms arise, immediate notification to a healthcare professional is necessary. If abnormalities are confirmed through muscle-related tests, the medication may need to be discontinued. Interactions may occur when this medication is taken with certain drugs, so it is important to inform the physician or pharmacist if other medications are being taken. Caution is especially needed when combined with some antiviral agents, immunosuppressants, and fibrate medications. It is safest not to take this medication during pregnancy or breastfeeding, and women planning to become pregnant must consult beforehand. In the case of overdose, there is no specific antidote, so it is essential to visit a medical institution immediately for appropriate treatment and examination. Caution is needed when driving or operating machinery, as side effects such as dizziness may occur. This medication contains lactose, so patients with lactose intolerance should check before taking it. During the course of treatment, regular blood tests and liver function tests to confirm safety are important.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, severe muscle weakness, ocular muscle weakness, jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, increased transaminases, severe skin adverse reactions, severe allergic reactions, dyspnea, significant edema, severe rash with high fever, blisters, skin exfoliation

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • cough
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • 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 advisable to keep it at room temperature between 1 degree and 30 degrees Celsius.

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.