Medication info

Dongseongro Rosuvastatin Tablet 20 mg (Rosuvastatin Calcium)

Prescription medicationExpired
Ingredient · strength
Rosuvastatin Calcium›Strength being verified
Manufacturer / importer
동성제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (15 tablets/PTP(AluAlu)×2)
Approval status
Expired

MFDS item code 201803584 · Approved 2018.09.03

This product's status changed to Expired on 2023.09.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose of 5 mg is administered once daily at any time, regardless of meals. The maintenance dose is 10 mg once daily for most patients, which is adjusted based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or more, with a maximum increase to 20 mg once daily.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual patient's treatment goals, with adjustments made every 4 weeks or more.

Ingredients

Manufacturer
동성제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • early coronary heart disease family history
View approved original text

This medication is used to help patients with primary hypercholesterolemia and mixed dyslipidemia who are not adequately controlled by diet and exercise. It is also used as an adjunct treatment for patients with homozygous familial hypercholesterolemia, in conjunction with dietary therapy or LDL apheresis. It effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is recommended as an adjunct to diet for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia who meet specific criteria. It is beneficial in treating primary dysbetalipoproteinemia and is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in middle-aged patients with a high risk of cardiovascular disease. Overall, this medication contributes to improving cardiovascular health and lowering the risk of related complications.

Dosage and Administration

Adult dosage

The initial dose of 5 mg is administered once daily at any time, regardless of meals. The maintenance dose is 10 mg once daily for most patients, which is adjusted based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or more, with a maximum increase to 20 mg once daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual patient's treatment goals, with adjustments made every 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any component of this drug, have severe liver dysfunction, have muscle disorders, have severe kidney impairment, or are pregnant or breastfeeding should not take this medication. Additionally, as this medication can affect muscles, symptoms such as muscle pain or myopathy may occur, so patients at high risk for muscle-related diseases should use it with caution. If symptoms such as muscle pain, weakness, or fever occur during treatment, immediate consultation with a physician is necessary. It can affect liver function, so patients with a history of liver disease or those who consume alcohol excessively should undergo regular liver function tests before and after taking this medication. This medication contains lactose, so patients with lactose intolerance should not take it, and caution is required for patients with certain genetic disorders. This medication can interact with other drugs, so it is advisable to consult a physician or pharmacist, especially when taken with drugs with a high risk of muscle toxicity. Concomitant use with certain medications may increase the blood concentration of this medication, raising the risk of side effects. Women who may become pregnant should use appropriate contraception during treatment and should stop taking the medication immediately if they become pregnant. There is no specific antidote in the case of overdose, so treatment according to symptoms and liver function and muscle enzyme tests are required. Lastly, this medication has been rarely reported to cause serious skin reactions, liver damage, or kidney abnormalities, so if such symptoms occur, immediate notification of healthcare personnel is essential. Caution should be taken as dizziness may occur when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, severe swelling (edema), chest tightness, breathing difficulty, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin adverse reactions, difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, hematuria, diarrhea, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, memory loss, peripheral neuropathy, cough, thrombocytopenia, hepatitis, increased transaminases, eosinophilia, and drug reaction with eosinophilia and systemic symptoms (DRESS), lupus-like syndrome

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, at a temperature between 1°C and 30°C. This helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (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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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.