Medication info
Rosuvastatin Calcium Tablets 20 Milligrams (Rosuvastatin Calcium)

Rosuvastatin Calcium Tablets 20 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)한독
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging × 2)
Approval status
Active

MFDS item code 201400388 · Approved 2014.01.28 · Insurance code 652104650

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Starting dose is 5 milligrams once daily, at any time of the day regardless of meals. If more LDL cholesterol reduction is needed, adjust to a maintenance dose. The maintenance dose is typically 10 milligrams once daily, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. A maximum of 20 milligrams per day may be prescribed.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is from 5 milligrams to 20 milligrams taken once daily. The dosage should be adjusted individually based on the recommended treatment goals, at 4-week intervals.

Ingredients

Manufacturer
(주)한독

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • elevated 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 in patients with primary hypercholesterolemia and mixed dyslipidemia who cannot be controlled with diet and exercise. It also helps patients with homozygous familial hypercholesterolemia along with diet or other therapies. This drug lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is especially used in pediatric patients aged between 10 and 17 years with high LDL cholesterol levels despite dietary measures. It is also used as an adjunct in the treatment of primary dysbetalipoproteinemia. Additionally, it contributes to reducing the risks associated with cardiovascular diseases, such as stroke, myocardial infarction, and arterial revascularization. Therefore, this drug is effective in the prevention and treatment of dyslipidemia and cardiovascular diseases.

How to take

Adult dose

Starting dose is 5 milligrams once daily, at any time of the day regardless of meals. If more LDL cholesterol reduction is needed, adjust to a maintenance dose. The maintenance dose is typically 10 milligrams once daily, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. A maximum of 20 milligrams per day may be prescribed.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is from 5 milligrams to 20 milligrams taken once daily. The dosage should be adjusted individually based on the recommended treatment goals, at 4-week intervals.

Precautions

This medication should not be used in certain patients. For example, patients allergic to this drug, those with severe liver impairment, patients with muscle disorders, those with severe renal impairment, and women who are pregnant or nursing should not take this medication. Additionally, high-dose administration is prohibited in patients at high risk for muscle damage. This medication contains lactose, so caution is needed for patients with lactose intolerance. Before taking this medication, regular liver function tests and muscle-related tests should be conducted, and patients who consume significant amounts of alcohol or have a history of liver disease should exercise increased caution. Symptoms such as muscle pain, weakness, fatigue, and fever should be reported to healthcare professionals immediately. This drug may increase the risk of muscle damage when taken with certain other medications, so it is essential to consult healthcare professionals regarding concomitant drugs. Notably, dose adjustments or discontinuation may be required when used with fibrate drugs. Women who may become pregnant should use appropriate contraceptive methods while taking this medication, and it should not be used during pregnancy or if planning for pregnancy. In the case of overdose, there is no specific antidote, and treatment should be managed according to symptoms and liver function and muscle enzyme testing. When driving or operating machinery, caution is advised as dizziness may occur. Finally, if severe skin reactions such as rash, fever, or swelling of the face or neck occur during treatment, the medication should be discontinued immediately, and healthcare professionals should be consulted.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, severe skin adverse reactions, rhabdomyolysis, hematuria, acute renal failure, oliguria, myopathy, rhabdomyolysis, severe skin adverse reactions, severe allergic reactions, liver abnormalities (jaundice)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
Show 25 more
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • reduced appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • headache
  • dizziness
  • increased ALT
  • increased AST
  • increased CK
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • ocular muscle weakness
  • drug-induced lichenoid eruption
  • lupus-like symptoms

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or humidity, and it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Therefore, it is best to keep it away from direct sunlight and avoid placing it in locations that are too hot or too cold.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging × 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

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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.