Medication info
New statin A Tablets 5 Milligrams (Rosuvastatin Calcium)

New statin A Tablets 5 Milligrams (Rosuvastatin Calcium)

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

MFDS item code 201401265 · Approved 2014.03.19 · Insurance code 647803950

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, this medication can be taken at any time during the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is adjusted to 10 milligrams once daily. The maintenance dose should be adjusted at intervals of at least 4 weeks based on LDL cholesterol levels, treatment goals, and patient response.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted according to individual treatment goals at intervals of at least 4 weeks.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • risk factors for coronary heart disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used in cases of primary hypercholesterolemia or mixed dyslipidemia that are difficult to control with diet and exercise. Additionally, it is used as an adjunct to other therapies in patients with homozygous familial hypercholesterolemia to lower cholesterol levels in the blood. It reduces total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged between 10 and 17 years who exceed certain LDL cholesterol criteria. It is also utilized in the treatment of primary dysbetalipoproteinemia. It helps reduce the risks of stroke, myocardial infarction, and vascular reintervention in high-risk individuals with cardiovascular disease risk factors. This medication is effective in treating cholesterol-related diseases.

How to take

Adult dose

For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, this medication can be taken at any time during the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is adjusted to 10 milligrams once daily. The maintenance dose should be adjusted at intervals of at least 4 weeks based on LDL cholesterol levels, treatment goals, and patient response.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted according to individual treatment goals at intervals of at least 4 weeks.

Precautions

This medication should not be used in certain patients. For example, those who are allergic to any of its ingredients, patients with severely impaired liver function, those with muscle diseases, patients with severely compromised kidney function, and women who are pregnant or breastfeeding should not take this medication. Furthermore, liver function tests and muscle condition should be checked before taking this medication, and patients with a history of liver disease or excessive alcohol consumption need to exercise caution. If symptoms such as muscle pain or weakness, or sudden muscle pain occur, contact a physician immediately, and if these symptoms are severe, medication should be stopped. This medication may cause increased blood sugar levels in some patients; therefore, patients at risk of diabetes should regularly check their blood sugar and hemoglobin A1c levels. Additionally, this medication may increase blood concentration when taken with certain other drugs, raising the risk of muscle damage, so consult a physician or pharmacist if other medications are being taken. Women of childbearing potential should use appropriate contraception, and this medication should not be used during pregnancy or if planning to become pregnant. Patients should also watch for unusual symptoms such as abnormal liver function, muscle issues, or skin rashes while taking this medication, and consult medical personnel immediately if such symptoms occur. In the case of an overdose, there is no specific antidote, and treatment according to symptoms, along with liver function and muscle enzyme testing, is required. Lastly, since this medication may cause side effects such as dizziness, caution is required when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ophthalmoplegia, jaundice, hepatitis, severe liver failure, acute kidney failure, oliguria, thrombocytopenia, severe edema, respiratory distress, cough, interstitial lung disease

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
Show 22 more
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow circular film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP*3], 100 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.

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.