Medication info
Rosuvastatin Calcium 10 mg Tablets

Rosuvastatin Calcium 10 mg Tablets

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

MFDS item code 201803054 · Approved 2018.07.24 · Insurance code 643802810

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of day, regardless of meals. The initial dose is 5 mg once daily, and if more LDL-cholesterol reduction is required, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, and most patients are controlled at this dosage. The maintenance dosage should be adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response.
Children's dosage
The usual dosage range is 5 mg to 20 mg once daily. The dose should be adjusted individually based on the recommended treatment goals for each patient. Dosage adjustments should be made at intervals of at least 4 weeks or more.

Ingredients

Manufacturer
신신제약(주)

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 levels
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is primarily used as an adjunct in patients with primary hypercholesterolemia, mixed dyslipidemia, and familial hypercholesterolemia who are not adequately controlled with diet and exercise alone. It helps lower total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It can be used safely in children over the age of 10 years who have very high LDL-cholesterol levels. Additionally, it is used as an adjunct to diet in patients with dysbetalipoproteinemia and is effective in reducing the risk of stroke, myocardial infarction, and the need for vascular revascularization in adults at high risk for cardiovascular disease. Overall, this medication plays a crucial role in the prevention of dyslipidemia and cardiovascular diseases, improving the health of patients.

Dosage and Administration

Adult dosage

This medication can be taken at any time of day, regardless of meals. The initial dose is 5 mg once daily, and if more LDL-cholesterol reduction is required, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, and most patients are controlled at this dosage. The maintenance dosage should be adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response.

Children's dosage

The usual dosage range is 5 mg to 20 mg once daily. The dose should be adjusted individually based on the recommended treatment goals for each patient. Dosage adjustments should be made at intervals of at least 4 weeks or more.

Precautions

It is very important not to use this medication in certain patients. For example, individuals allergic to any of the components of this medication or with active liver disease should not take it. Patients with muscular disorders or severely impaired kidney function should also avoid this medication. It is recommended that women who are pregnant or breastfeeding, as well as fertile women not using appropriate contraception, do not take this medication. Additionally, high-dose administration is contraindicated in patients at elevated risk of muscle disorders. This medication contains lactose, so those with genetic diseases such as lactose intolerance should not take it. When taking this medication, it is important to periodically check liver function and muscle status. Individuals who consume a lot of alcohol or have a history of liver disease must undergo liver enzyme tests. If symptoms such as muscle pain or weakness arise, healthcare providers should be notified immediately, and the medication may need to be stopped if symptoms are severe or blood test results are poor. In cases of serious illnesses or poor postoperative conditions, it may be necessary to temporarily cease taking this medication. This medication can rarely cause severe muscle weakness or ocular muscle weakness, so if such symptoms occur, the medication should be stopped and a consultation with healthcare providers should be made. Moreover, when combined with other medications, there is a risk of increased serum levels of this medication leading to muscle damage, hence it is crucial to inform doctors or pharmacists of any concurrent medications. Caution is especially needed when taken in conjunction with certain antiviral agents, immunosuppressants, antifungals, antibiotics, or fibrates. During pregnancy or breastfeeding, this medication should not be used, and women who may become pregnant should use appropriate contraceptive methods. If pregnancy occurs while taking this medication, it should be stopped immediately. There is no specific antidote for overdose, and treatment is based on symptoms. Liver function and muscle-related tests should be conducted to monitor the condition. Caution is also needed as dizziness may occur while driving or operating machinery. Finally, this medication can rarely cause severe skin reactions, liver dysfunction, kidney issues, and neurological problems, so if such symptoms arise, immediate consultation with healthcare providers is necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, eosinophilia and systemic symptoms accompanying drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, polyneuropathy, memory loss, peripheral neuropathy, jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, cardiac complications

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • 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
  • fatigue
  • numbness
  • sensory disturbances
  • joint pain

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. The storage temperature should be maintained between 1 degree and 30 degrees Celsius to preserve its efficacy longer.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

100 tablets/bottle, 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.