Medication info
Aprogen Rosuvastatin Calcium Tablet 10mg

Aprogen Rosuvastatin Calcium Tablet 10mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Pink round film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle
Approval status
Active

MFDS item code 201403200 · Approved 2014.07.17 · Insurance code 645208330

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and dyslipidemia improvement, as well as cardiovascular disease risk reduction
Who takes it
Adults
Adult dose
This drug can be administered at any time of the day, regardless of meals. The initial dose is 5mg once daily, and if a greater reduction in LDL-cholesterol is required, the maintenance dose can be adjusted and administered. The maintenance dose is generally 10mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted based on LDL-cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol
  • smoking
  • family history of early coronary heart disease
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunct therapy in patients with primary hypercholesterolemia and mixed dyslipidemia who are unable to control their condition through diet and exercise. It can also be administered as an adjunct to dietary changes and other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This drug helps lower total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis. It is also used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Furthermore, it contributes to reducing the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged men and women at high risk for cardiovascular disease. It is used for various dyslipidemias and cardiovascular risk reduction.

How to take

Adult dose

This drug can be administered at any time of the day, regardless of meals. The initial dose is 5mg once daily, and if a greater reduction in LDL-cholesterol is required, the maintenance dose can be adjusted and administered. The maintenance dose is generally 10mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted based on LDL-cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more.

Precautions

This drug should not be administered to certain patients. For example, patients who are allergic to this drug or have severely impaired liver function, patients with muscle disorders, patients taking specific medications, patients with severe renal impairment, and women who are pregnant or breastfeeding should not use this medication. Additionally, high-dose use is prohibited for patients at risk of muscle-related disorders. Patients with lactose intolerance should also avoid taking this medication. Care should be taken when using this drug in individuals with a history of liver disease or heavy alcohol consumption. It is advisable to repeat liver function tests before and during treatment. In cases of specific conditions such as hypothyroidism or nephrotic syndrome, treatment of those conditions should be performed first. Muscle-related side effects, such as myalgia, muscle weakness, and, rarely, serious muscle damage, have been reported, so patients should promptly inform their doctor and get tested if they experience myalgia or muscle weakness. If there is a significant increase in muscle enzyme levels, it may be necessary to discontinue the medication. This drug can also affect liver function, potentially leading to increased liver enzyme levels. If symptoms of liver dysfunction arise, immediate consultation with a healthcare professional is necessary. Rarely, this drug can cause side effects such as skin rash, hives, or severe skin reactions, so if abnormal skin symptoms occur, treatment should be discontinued immediately, and the patient should go to a hospital. Interactions may occur when taken with other medications, particularly when combined with certain antivirals, immunosuppressants, some antibiotics, and fibrate class drugs, so caution is needed. Pregnant women or women who may become pregnant should not take this medication and should use appropriate contraceptive methods. Breastfeeding mothers should also avoid taking this medication. There is no specific antidote for overdose, so treatment should be symptomatic, and careful monitoring of liver function and muscle enzyme levels is required. This medication may cause dizziness, so caution is needed when driving or operating machinery. While taking this medication, it is important to undergo regular check-ups as directed by a physician and to consult with healthcare professionals immediately if side effects occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, very rarely, polyneuropathy, memory loss, peripheral neuropathy, severe muscle weakness, respiratory distress, ophthalmoplegia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, hematuria, edema, acute renal failure, anuria, chest

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • thrombocytopenia
  • diarrhea
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  • sensory abnormalities
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • systemic pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness

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

Storage

This medication may be sensitive to air and humidity, so it should be stored in a tightly closed container. It is also recommended to store it at room temperature, not too cold or too hot, ideally between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 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

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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.