Medication info
Lorestor 10mg (Rosuvastatin Calcium)

Lorestor 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
알보젠코리아(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201000972 · Approved 2010.01.28 · Insurance code 652604170

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer 5 mg once daily as an initial dose, regardless of meals. If a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted to 10 mg once daily. The maintenance dose should be appropriately adjusted every 4 weeks or more based on the LDL cholesterol levels, treatment objectives, and patient response, with a maximum daily dosage of 20 mg.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the typical dosage range is 5 mg to 20 mg once daily. The prescribed dosage should be adjusted based on the individual treatment goals of each patient.

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary 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 primarily used in patients with primary hypercholesterolemia and mixed dyslipidemia and serves as an adjunct when dietary changes and exercise do not achieve adequate control. Additionally, it complements dietary therapy or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It particularly helps to lower total cholesterol and LDL cholesterol levels in hypercholesterolemia patients, thereby delaying the progression of atherosclerosis. It is also used to reduce total cholesterol and LDL cholesterol in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia alongside dietary therapy. Patients with primary dysbetalipoproteinemia can also take this medication as an adjunct to their diet. Furthermore, it is prescribed to high-risk groups, including men over 50 and women over 60 with elevated high-sensitivity C-reactive protein levels, to reduce the risk of stroke, myocardial infarction, and reoccurrence after arterial revascularization. In summary, this medication is widely used for treatment and prevention of various cases of hypercholesterolemia and cardiovascular disease risk.

How to take

Adult dose

Administer 5 mg once daily as an initial dose, regardless of meals. If a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted to 10 mg once daily. The maintenance dose should be appropriately adjusted every 4 weeks or more based on the LDL cholesterol levels, treatment objectives, and patient response, with a maximum daily dosage of 20 mg.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the typical dosage range is 5 mg to 20 mg once daily. The prescribed dosage should be adjusted based on the individual treatment goals of each patient.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to any of its ingredients, those with severely impaired liver function, patients with muscle diseases, and patients with severely reduced kidney function should not receive it. Pregnant or nursing women should not use this medication, and women of childbearing age should only take it when they are highly unlikely to be pregnant. Particularly, high-dose administration is prohibited in patients at risk of muscle diseases. This medication can affect liver function, so patients with a history of liver disease or those who consume large amounts of alcohol should undergo regular liver function tests before and during treatment. If symptoms such as muscle pain or weakness occur, the patient should immediately inform their doctor, and if necessary, a blood test should be performed to check for muscle damage. If abnormal symptoms are severe or blood test results are high, medication may be discontinued. This medication can interact with other drugs; therefore, patients should inform their doctor or pharmacist about any other medications they are taking. Caution is especially needed when taking this medication alongside certain antiviral drugs, immunosuppressants, or fibrates. Reported side effects from clinical trials and post-marketing studies include headaches, dizziness, dyspepsia, muscle pain, and abnormal liver function, while rare but serious side effects include severe skin reactions, muscle damage, and liver damage. Appropriate contraception is required during the use of this medication, and patients should consult their healthcare provider immediately if they become pregnant or are planning to become pregnant. In the case of overdose, there is no specific antidote; hence symptomatic treatment and testing of liver and muscle function are necessary. Dizziness may occur while driving or operating machinery, so caution is advised. This medication may exhibit higher blood concentrations in Asian individuals, so this should be considered when determining the dosage.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, severe swelling (edema), severe rash accompanied by high fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin adverse reactions, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver failure, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
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  • hematuria
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • abnormal sensation
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)

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.