Medication info

Rosuvastatin Calcium Tablet 20mg

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
알파제약(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets (14 tablets/PTP X 2) - 14 tablets/PTP, 28 tablets (14 tablets/PTP X 2) - 2 PTPs/box
Approval status
Expired

MFDS item code 201903276 · Approved 2019.05.21

This product's status changed to Expired on 2024.05.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of day, regardless of meals. The initial dosage is 5 mg once daily, which can be adjusted as a maintenance dose if needed. The maintenance dose is typically 10 mg once daily, and most patients are managed at this dosage. Dosage adjustments should be made with intervals of at least 4 weeks based on LDL-cholesterol levels and therapeutic goals, and it may be increased to a maximum of 20 mg once daily.
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 individually based on the therapeutic goal and maintained for more than 4 weeks.

Ingredients

Manufacturer
알파제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atypical familial hypercholesterolemia
  • primary dysbeta-lipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of premature coronary heart disease
View approved original text

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia who are not adequately controlled by diet and exercise. It is particularly effective in patients with familial hypercholesterolemia, lowering total cholesterol and LDL-cholesterol levels and delaying the progression of atherosclerosis. It may also be prescribed as an adjunct to diet in pediatric patients aged 10 to under 17 years who meet specific criteria. Additionally, it is beneficial for patients with primary dysbeta-lipoproteinemia. In middle-aged and older patients at high risk for cardiovascular disease, it is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization. Thus, this medication is effectively used for various dyslipidemias and the reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time of day, regardless of meals. The initial dosage is 5 mg once daily, which can be adjusted as a maintenance dose if needed. The maintenance dose is typically 10 mg once daily, and most patients are managed at this dosage. Dosage adjustments should be made with intervals of at least 4 weeks based on LDL-cholesterol levels and therapeutic goals, and it may be increased to a maximum of 20 mg once daily.

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 individually based on the therapeutic goal and maintained for more than 4 weeks.

Precautions

This medication should not be administered to certain patients. For example, patients with allergies to the ingredients of this medication, patients with severe liver dysfunction, those with muscle diseases, and those with severe kidney diseases should not take it. Women who are pregnant or breastfeeding, or fertile women not using appropriate contraception should not use this medication. Additionally, high-dose administration is prohibited in patients at high risk for muscle-related side effects. This medication contains lactose, so patients with lactose intolerance or related genetic diseases should not take it. It is important to periodically check liver function and muscle status while taking this medication. Patients who consume large amounts of alcohol or have a history of liver disease should exercise extra caution, and patients with hypothyroidism or nephrotic syndrome should treat their underlying conditions before taking this medication. If symptoms such as muscle pain, muscle weakness, or cramps occur, the physician should be informed immediately, and in severe cases, discontinuation of the medication may be necessary. Patients at high risk for severe muscle disease or rhabdomyolysis should have muscle enzyme levels tested before and during treatment. If sudden, severe muscle pain, weakness, or fever occurs while taking this medication, consult healthcare personnel immediately. This medication may interact with some drugs, so if you are taking other medications, it is essential to inform your doctor or pharmacist. Care should be taken, especially when taking it with certain antiviral medications, immunosuppressants, antibiotics, or fibrate classes, as the risk of muscle side effects may increase. If pregnant or breastfeeding, this medication should not be used as safety has not been established, and women who may become pregnant should use appropriate contraceptive methods. In case of overdose, as there is no specific antidote, treatment according to symptoms and tests for liver function and muscle enzymes is necessary. This medication does not significantly affect the ability to drive or operate machinery, but caution is advised due to the possibility of dizziness. Finally, if severe skin reactions, liver dysfunction, or significant muscle abnormalities occur while taking this medication, discontinuation should be immediate, and consultation with healthcare personnel is necessary.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), chest tightness, difficulty breathing, respiratory distress, asthma attacks, jaundice, hepatitis, severe rash, blisters, skin exfoliation, pain in the mucous membranes of the mouth/eyes, severe allergic reactions, liver abnormalities (jaundice), acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, serious neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • thrombocytopenia
  • diarrhea
Show 22 more
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • memory loss
  • peripheral neuropathy
  • cough
  • hematuria
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • confusion

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. By storing it this way, the efficacy can be maintained, and degradation can be prevented.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets/PTP X 2) - 14 tablets/PTP, 28 tablets (14 tablets/PTP X 2) - 2 PTPs/box

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

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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.