Medication info
Dongsung Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium)

Dongsung Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
동성제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (15 tablets/PTP (AluAlu) * 2)
Approval status
Active

MFDS item code 201803165 · Approved 2018.07.31 · Insurance code 643203010

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For adults with primary hypercholesterolemia, the medication is started at a dose of 5 mg once daily at any time during the day, irrespective of meals. If necessary, the dosage can be adjusted to 10 mg once daily with an interval of at least 4 weeks, up to a maximum of 20 mg once daily.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended dosage is 5 mg to 20 mg once a day. The dosage should be adjusted individually with an interval of at least 4 weeks.

Ingredients

Manufacturer
동성제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used in conjunction with diet and exercise for patients with primary hypercholesterolemia and mixed dyslipidemia when not controlled by these methods. It is also used as an adjunct to diet in patients with homozygous familial hypercholesterolemia and dysbetalipoproteinemia. It lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia and helps delay the progression of atherosclerosis. It is also suitable for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia who meet certain criteria. This medication helps reduce the risk of cardiovascular diseases, especially associated with stroke, myocardial infarction, and revascularization procedures. Overall, it is used to improve cholesterol levels and manage cardiovascular health.

Dosage and Administration

Adult dosage

For adults with primary hypercholesterolemia, the medication is started at a dose of 5 mg once daily at any time during the day, irrespective of meals. If necessary, the dosage can be adjusted to 10 mg once daily with an interval of at least 4 weeks, up to a maximum of 20 mg once daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended dosage is 5 mg to 20 mg once a day. The dosage should be adjusted individually with an interval of at least 4 weeks.

Precautions

This medication should not be used in certain patients. For example, it should be avoided by those allergic to it, patients with severely impaired liver function, or those with muscle diseases. Women who are pregnant or breastfeeding, as well as fertile women who do not use appropriate contraception, should also avoid this medication. It may affect liver function, so individuals with a history of liver disease or those who consume alcohol heavily should consult their doctor before use and undergo regular liver function tests. If symptoms such as muscle pain or weakness occur, they should immediately inform healthcare professionals, and in severe cases, discontinuation of the medication may be necessary. Special caution is warranted for individuals with decreased kidney function, hypothyroidism, or a family history of muscle disease. The risk of side effects may increase when this medication is taken with certain drugs, so patients should inform healthcare professionals if they are taking other medications. Women who may become pregnant should use appropriate contraception while on this medication and should discontinue use immediately if pregnancy occurs. In case of overdose, as there is no specific antidote, immediate hospital treatment should be sought, and liver function and muscle-related tests should be performed. Dizziness may occur during the use of this medication, so caution is needed when driving or operating machinery. Finally, as this medication contains lactose, it should not be taken by patients with lactose intolerance.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms drug reaction syndrome, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myasthenia, jaundice, hepatitis, acute renal failure, severe edema, chest tightness, difficulty breathing, respiratory distress, interstitial lung disease, severe liver damage, hyperbilirubinemia, severe allergic reactions, severe skin abnormalities

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, muscle pain, weakness, diarrhea, hematuria, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal bloating, syncope, myalgia, muscle cramps, gout, erectile dysfunction, thrombocytopenia, memory loss, peripheral neuropathy, cough, sexual dysfunction, gynecomastia, depression, sleep disorders (including insomnia and nightmares)

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 recommended storage temperature is between 1 and 30 degrees Celsius at room temperature. Proper storage helps maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.