Medication info
Rosuvastatin Calcium Tablets 10mg

Rosuvastatin Calcium Tablets 10mg

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

MFDS item code 201603595 · Approved 2016.06.20 · Insurance code 052400150

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer once daily at an initial dose of 5 milligrams at any time of day regardless of meals. If necessary, the maintenance dose can be adjusted up to 10 milligrams once daily, and can be increased to a maximum of 20 milligrams per day based on treatment response at intervals of at least 4 weeks.
Children's dosage
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer once daily at a dosage range of 5 milligrams to 20 milligrams. The dosage should be adjusted individually based on treatment goals at intervals of at least 4 weeks.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • personal history of early coronary artery disease
View approved original text

This medication is mainly used as an adjunct for patients with hypercholesterolemia and hyperlipidemia when diet and exercise alone are not sufficient. It is especially effective in patients with familial hypercholesterolemia or primary dysbetalipoproteinemia. It lowers the total cholesterol and LDL cholesterol levels, slowing the progression of atherosclerosis, and can be used in pediatric patients aged 10 years and older under specific criteria. Furthermore, in adult patients at high risk for cardiovascular disease, it also reduces the risks of stroke, myocardial infarction, and arterial revascularization. Therefore, this drug is used to improve hyperlipidemia and cardiovascular disease risk.

Dosage and Administration

Adult dosage

Administer once daily at an initial dose of 5 milligrams at any time of day regardless of meals. If necessary, the maintenance dose can be adjusted up to 10 milligrams once daily, and can be increased to a maximum of 20 milligrams per day based on treatment response at intervals of at least 4 weeks.

Children's dosage

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer once daily at a dosage range of 5 milligrams to 20 milligrams. The dosage should be adjusted individually based on treatment goals at intervals of at least 4 weeks.

Precautions

This drug should not be administered to certain patients. For example, patients who are allergic to any component of this medication, those with severely impaired liver function, patients with muscular diseases, and pregnant or breastfeeding women should not use this medication. Since this drug may affect liver function, patients with a history of liver disease or those who consume alcohol heavily should undergo multiple liver function tests before using it. Additionally, patients with conditions such as hypothyroidism or nephrotic syndrome should first treat the underlying disease. Since muscle-related side effects such as muscle pain or weakness may occur, immediate notification to healthcare professionals is required if these symptoms appear, and the medication may need to be discontinued if necessary. Special caution is advised for patients with impaired kidney function, elderly patients, and those with alcohol abuse, as they are at higher risk for muscle side effects. This medication contains lactose, so genetically predisposed patients with lactose intolerance should not use it. It is recommended to regularly undergo liver function tests and muscle enzyme tests while taking this medication. If severe liver damage or severe skin reactions occur, the medication should be discontinued immediately. This drug may interact with other medications, so especially when taken with specific antiviral agents, immunosuppressants, and fibrate drugs, consultation with healthcare professionals is necessary. Co-administration with certain drugs may increase the blood concentration of this medication, raising the risk of side effects. Women who are pregnant or planning to become pregnant should not take this medication and should be on effective contraception. It is also advisable for breastfeeding women to avoid using this drug. In the case of overdose, as there is no specific antidote, symptomatic treatment and liver function and muscle enzyme tests are necessary. This medication can cause dizziness, so caution is advised when driving or operating machinery. In summary, this medication may impact the liver and muscles, thus requiring regular examinations and careful monitoring before and after usage. Immediate consultation with healthcare professionals is required if any abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, eosinophilia accompanied by systemic symptoms drug reaction syndrome (DRESS), jaundice, hepatitis, severe muscle weakness, ocular myasthenia, rhabdomyolysis, immune-mediated necrotizing myopathy, severe edema, acute kidney injury, oliguria, myopathy (including myositis), fatal and non-fatal liver failure, severe skin reactions, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • loss of appetite
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  • abdominal bloating
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thrombocytopenia
  • increased transaminase levels
  • increased ALT
  • increased AST
  • hematuria
  • increased proteinuria
  • increased CK
  • memory loss
  • peripheral neuropathy
  • cough

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius.

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.

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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.