Medication info
Crown Tablet 10 mg (Rosuvastatin Calcium)

Crown Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Pink round film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP X 2]
Approval status
Active

MFDS item code 201906900 · Approved 2019.09.30 · Insurance code 057600310

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Patients with primary hypercholesterolemia, mixed dyslipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia are administered the initial dose of 5 mg once daily at any time regardless of meals. If necessary, the dose can be adjusted at intervals of 4 weeks or more to maintain a dose of 10 mg once daily, with a maximum dose of 20 mg once daily.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is administered once daily in the range of 5 mg to 20 mg. The dosage should be adjusted according to each patient's treatment goal at intervals of 4 weeks or more.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

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

This medication is used as an adjunct when diet and exercise alone are insufficient to control primary hypercholesterolemia and mixed dyslipidemia. It also helps reduce LDL cholesterol levels in patients with familial hypercholesterolemia when used in conjunction with diet or other treatments. It can maintain total cholesterol and LDL cholesterol levels at target levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is also used as an adjunct in pediatric and adolescent patients who meet specific criteria for heterozygous familial hypercholesterolemia. Furthermore, it is effective in reducing the risk of stroke, myocardial infarction, and revascularization procedures in adults at high risk for cardiovascular disease. This medication is utilized to improve dyslipidemia and related disorders.

Dosage and Administration

Adult dosage

Patients with primary hypercholesterolemia, mixed dyslipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia are administered the initial dose of 5 mg once daily at any time regardless of meals. If necessary, the dose can be adjusted at intervals of 4 weeks or more to maintain a dose of 10 mg once daily, with a maximum dose of 20 mg once daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is administered once daily in the range of 5 mg to 20 mg. The dosage should be adjusted according to each patient's treatment goal at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For instance, it should not be administered to patients who are allergic to it, those with active liver disease, those with muscle disorders, patients with severe renal impairment, pregnant or breastfeeding women, and women of childbearing age who are not using appropriate contraception. This medication may affect liver function; patients with a history of liver disease or excessive alcohol intake should have regular liver function tests. Additionally, if symptoms of muscle pain or weakness occur, they should consult a physician immediately, and in severe cases, they may need to discontinue the medication. While taking this medication, there may be interactions with other drugs, so any medications being taken must be disclosed to healthcare providers. In particular, the risk of muscle-related side effects may increase when used in combination with certain antiviral agents, immunosuppressants, and fibrate drugs. Pregnant or breastfeeding women should not take this medication, and women who can become pregnant should employ adequate contraception methods. If pregnancy is confirmed, the medication should be stopped immediately. In case of overdose, there is no specific antidote, and management should be based on symptoms along with liver function and muscle enzyme tests. This medication may rarely cause serious skin reactions, liver damage, kidney abnormalities, or neurological issues, so patients should consult healthcare providers immediately if unusual symptoms occur. Also, caution is advised while driving or operating machinery as dizziness may occur during the use of this medication.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, rhabdomyolysis, severe muscle weakness, severe skin reactions, immune-mediated necrotizing myopathy, severe edema, dyspnea, cough, thrombocytopenia, polyneuropathy, peripheral neuropathy, interstitial lung disease.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • thrombocytopenia
  • diarrhea
Show 18 more
  • ocular muscle weakness
  • erectile dysfunction
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • fatigue
  • joint pain
  • memory loss
  • sleep disturbances
  • depression
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture, at temperatures between 1 and 30 degrees Celsius. Proper storage can prolong the effectiveness of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP X 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

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.