Medication info
Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium)

Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium)

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

MFDS item code 201001026 · Approved 2010.01.29 · Insurance code 644307830

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) improvement and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken once daily at any time of the day, regardless of meals. The initial dose is 5 mg once daily, while the maintenance dose is 10 mg once daily. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum dosage of up to 20 mg once daily after an interval of 4 weeks or more.
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage is administered once daily ranging from 5 mg to 20 mg. The dosage may be adjusted based on individual treatment goals for more than 4 weeks.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • increased total cholesterol
  • increased LDL cholesterol
  • increased apo-B protein levels
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication helps patients with primary and familial hypercholesterolemia and mixed dyslipidemia who cannot control their condition with diet and exercise alone. It is particularly used to lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, slowing the progression of atherosclerosis. It can also be used as a dietary supplement for children aged 10 to 17 years with elevated LDL cholesterol levels and increased cardiovascular disease risk. It can help patients with primary dysbetalipoproteinemia. In men and women over middle age with high cardiovascular disease risk, it is effective in reducing the risk of stroke, myocardial infarction, and vascular revascularization. This medication is used for cholesterol control and improving cardiovascular health.

How to take

Adult dose

This medication can be taken once daily at any time of the day, regardless of meals. The initial dose is 5 mg once daily, while the maintenance dose is 10 mg once daily. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum dosage of up to 20 mg once daily after an interval of 4 weeks or more.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage is administered once daily ranging from 5 mg to 20 mg. The dosage may be adjusted based on individual treatment goals for more than 4 weeks.

Precautions

This medication should not be administered to certain patients. For example, it should not be given to patients with an allergy to its components, severe liver dysfunction, muscle diseases, and those on specific medications. It is also not safe for pregnant or breastfeeding women, and it is advised for fertile women who do not have proper contraception. Furthermore, high doses are contraindicated in patients at high risk for muscle diseases. It is important to periodically check liver function tests and muscle conditions when using this medication. Those who drink large amounts of alcohol or have a history of liver disease should be particularly cautious, and thyroid function should be treated beforehand if hypothyroidism is present. If symptoms such as muscle pain or weakness occur, inform a physician immediately and get tested. This medication may increase blood glucose levels in some patients, so individuals at risk of diabetes should manage their blood glucose levels properly. This medication can interact with various other drugs, so if you are taking other medications, it is essential to consult your doctor or pharmacist. Special caution should be taken when used alongside certain antivirals, immunosuppressants, antibiotics, and fibrate drugs. It should not be used during pregnancy, and women who plan to become pregnant or may become pregnant must use proper contraception. In case of overdose, there is no specific antidote, so visit a medical institution immediately for symptomatic treatment, and liver function and muscle enzyme levels should be monitored. Finally, the effect of this medication on driving or operating machinery is unclear, but caution is advised as dizziness may occur.

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, immune-mediated necrotizing myopathy, severe myopathy, ocular myopathy, hepatitis, jaundice, severe skin reactions, acute renal failure, oliguria, hyperbilirubinemia, severe edema, thrombocytopenia, fatal and non-fatal liver failure, dyspnea, respiratory distress

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • fatigue
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  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • sexual dysfunction
  • gynecomastia
  • depression
  • sleep disturbances

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink, convex, 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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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.