Medication info
Dongkwang Rosuvastatin Calcium Tablet 5mg

Dongkwang Rosuvastatin Calcium Tablet 5mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 30 tablets/box [(10 tablets/PTP)×3]
Approval status
Active

MFDS item code 201702789 · Approved 2017.05.31 · Insurance code 645906290

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This drug can be taken at any time of the day regardless of meals. The initial dosage is 5 mg once daily, and for greater reduction of LDL cholesterol levels, the maintenance dosage can be adjusted accordingly. The maintenance dosage is 10 mg once daily, and most patients are controlled at this dosage. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and the patient’s response with intervals of 4 weeks or more.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment goals for individual patients.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • stroke risk
  • myocardial infarction risk
View approved original text

This medicine is mainly used as an adjunct therapy in patients with primary hypercholesterolemia, mixed dyslipidemia, and dysbetalipoproteinemia when dietary changes and exercise are insufficient. It is also effective in patients with homozygous familial hypercholesterolemia and specific pediatric patients aged between 10 and 17 years with familial hypercholesterolemia. This drug helps to lower total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis and reducing the risk of cardiovascular diseases such as stroke and myocardial infarction. It is particularly recommended for men over 50 years of age and women over 60 years of age with elevated high-sensitivity C-reactive protein levels and additional risk factors. In summary, this drug is used to lower the risk of hypercholesterolemia and related cardiovascular diseases.

Dosage and Administration

Adult dosage

This drug can be taken at any time of the day regardless of meals. The initial dosage is 5 mg once daily, and for greater reduction of LDL cholesterol levels, the maintenance dosage can be adjusted accordingly. The maintenance dosage is 10 mg once daily, and most patients are controlled at this dosage. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and the patient’s response with intervals of 4 weeks or more.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment goals for individual patients.

Precautions

This medicine should not be used in certain patients. For example, it should not be administered to patients allergic to this drug, patients with severe liver dysfunction, patients with muscle disorders, patients with severely impaired kidney function, and pregnant or breastfeeding women. Additionally, women who may become pregnant must use appropriate contraception while taking this drug and should discontinue use immediately if they become pregnant. This drug can affect the liver and muscles; therefore, patients with a history of liver disease or those who consume alcohol excessively should have their liver function tested before administration and regularly during treatment. If symptoms such as muscle pain or weakness occur, notify healthcare professionals immediately and if necessary, check for abnormalities with muscle enzyme tests. This drug may interact with other medications, so it is essential to inform healthcare professionals if taking other medications, especially when using specific antibiotics, immunosuppressants, antiviral drugs, or fibrate-type drugs. During the intake of this drug, it is possible to experience abnormal symptoms such as liver dysfunction, muscle abnormalities, or allergic reactions; therefore, consult a professional if such symptoms arise. There is no specific antidote for overdose; thus, one should seek proper treatment and examination at a hospital promptly, and although this drug has minimal effects on driving ability or machinery operation, caution is advised due to potential dizziness. Finally, this drug may result in higher blood concentrations in Asians, indicating that dosage adjustments may be necessary.

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), jaundice, hepatic failure, interstitial lung disease (dyspnea, cough), severe muscle weakness, ocular myasthenia, rhabdomyolysis, acute kidney injury, oliguria, thrombocytopenia, severe allergic reactions, severe dermatologic reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms,

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, diarrhea, thrombocytopenia, hepatitis, increased transaminases, lupus-like syndrome, arthralgia, immune-mediated necrotizing myopathy, hematuria, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disturbances (including insomnia and nightmares), sexual dysfunction, gynecomastia

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

Storage

This medicine should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is recommended to store the drug at room temperature between 1°C and 30°C. Avoid placing it in excessively hot or cold areas, and store it away from direct sunlight.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 30 tablets/box [(10 tablets/PTP)×3]

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.