Medication info
Rosuvastatin Calcium Tablet 20mg

Rosuvastatin Calcium Tablet 20mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Pink circular film-coated tablet
Packaging
28 tablets/Alu-Alu[(14 tablets/Alu-Alu x 2)]
Approval status
Active

MFDS item code 201601553 · Approved 2016.03.17 · Insurance code 660702950

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For patients with primary hypercholesterolemia, mixed hyperlipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the initial dose of 5 milligrams should be started without regard to meals, once daily. The maintenance dose can be adjusted to 10 milligrams once daily as necessary, based on LDL cholesterol levels, treatment goals, and patient response, with adjustments made every 4 weeks, up to a maximum of 20 milligrams once daily.
Children's dosage
For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the dose is administered once daily at 5 milligrams to 20 milligrams. Dosage is individually adjusted based on therapeutic goals.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • stroke
  • myocardial infarction
View approved original text

This drug is primarily used for patients with hypercholesterolemia and hyperlipidemia. It helps lower blood cholesterol levels in patients with primary hypercholesterolemia and mixed hyperlipidemia that are not controlled by diet and exercise. It is also used for pediatric patients with heterozygous familial hypercholesterolemia and homozygous familial hypercholesterolemia, reducing total and LDL cholesterol. Additionally, it is used as an adjunct to diet in patients with primary dysbetalipoproteinemia. In adults at high risk for cardiovascular disease, it aids in the reduction of the risk of complications related to stroke, myocardial infarction, and vascular revascularization. Overall, this medication is used to improve blood lipid levels and reduce the progression and risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

For patients with primary hypercholesterolemia, mixed hyperlipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the initial dose of 5 milligrams should be started without regard to meals, once daily. The maintenance dose can be adjusted to 10 milligrams once daily as necessary, based on LDL cholesterol levels, treatment goals, and patient response, with adjustments made every 4 weeks, up to a maximum of 20 milligrams once daily.

Children's dosage

For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the dose is administered once daily at 5 milligrams to 20 milligrams. Dosage is individually adjusted based on therapeutic goals.

Precautions

This medication should not be used in certain patients. Patients who are allergic to this medication, have severely impaired liver function, have muscle disorders, are taking certain immunosuppressants, have severe kidney function impairment, or are pregnant or breastfeeding should not take this medication. Women of childbearing potential may only take this medication if they are very likely not to be pregnant and fully understand the risks to the fetus. For the 40mg dose, it should not be administered to patients at high risk for muscle disorders, and patients with lactose intolerance should also avoid it. Furthermore, patients with a history of liver disease or those who consume excessive alcohol should frequently monitor their liver function while taking this medication. If someone has hypothyroidism or nephrotic syndrome, this medication should only be used after treating the underlying cause. If muscle pain or weakness occurs while taking this drug, the patient must immediately inform their doctor and undergo examination. If muscle-related symptoms are severe or laboratory findings are abnormal, the medication may need to be discontinued. Patients with acute severe illness or muscle weakness symptoms should also use this drug with caution. The risk of muscle-related side effects may increase when combined with other medications, so caution is necessary during concomitant use. This medication can affect liver function, so it should be discontinued promptly if symptoms of liver damage occur. Blood glucose levels may rise, so patients at risk for diabetes should regularly check their blood sugar levels. The concentration of the drug in the body may vary depending on certain genetic traits, necessitating dosage adjustments for individual patients. If serious skin reactions occur, the medication should be stopped immediately and medical consultation should occur. There may be interactions with other medications, so if any other medications are being taken, it is essential to inform healthcare providers. Special caution is required when combined with certain antiviral agents, immunosuppressants, and fibrates. Pregnant or breastfeeding women should not use this medication, and women planning to become pregnant should use appropriate birth control methods. In cases of overdose, there is no specific antidote, and treatment should be symptomatic, including monitoring liver function and muscle enzyme levels. Care should be taken while driving or operating machinery, as dizziness may occur. Long-term use of this drug may lead to rare side effects like interstitial lung disease, so if symptoms such as shortness of breath or cough appear, immediate consultation with a healthcare provider is necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, rhabdomyolysis, chest tightness, difficulty breathing, shortness of breath, jaundice, hepatitis, severe skin reactions (Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS)), severe muscle weakness, oculomotor muscle weakness, myopathy, immune-mediated necrotizing myopathy, severe allergic reactions, severe swelling, thrombocytopenia, increased serum creatinine

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • thrombocytopenia
  • diarrhea
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  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue

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 air and moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Pink circular film-coated tablet

Package unit

28 tablets/Alu-Alu[(14 tablets/Alu-Alu 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.

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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.