Medication info
Megarojet Tablet 10/20 Milligrams

Megarojet Tablet 10/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)한독
Appearance
Pink oval film-coated tablets
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Active

MFDS item code 201506791 · Approved 2015.09.24 · Insurance code 652105490

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed) and prevention of atherosclerotic vascular disease risk
Who takes it
Adults
Adult dose
This medication is administered once daily without regard to meals. The dosage range for primary hypercholesterolemia is 10/5mg to 10/20mg daily. An initial dose of 10/5mg per day is recommended. For patients requiring more significant reduction in LDL-cholesterol, dosage adjustments can be made. After starting treatment or adjusting the dosage, blood lipid levels should be checked at intervals of 4 weeks or more, and adjustments should be based on the results.

Ingredients

Manufacturer
(주)한독

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed) and prevention of atherosclerotic vascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL-cholesterol
  • increased apo B protein
  • elevated triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
View approved original text

This medication is used in conjunction with diet to lower total cholesterol, LDL-cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It is administered particularly to individuals at high risk of atherosclerotic vascular disease due to hypercholesterolemia, and underlying causes of dyslipidemia should be checked and treated as necessary before starting drug therapy. This drug should be used alongside an appropriate diet, mainly used when there is insufficient response to dietary management or non-pharmacological measures. Monitoring and managing blood lipid levels is essential, and lipid testing should be done during hospitalization in the case of acute coronary events to determine treatment direction. This treatment helps control blood lipid levels and reduce the risk of cardiovascular diseases.

How to take

Adult dose

This medication is administered once daily without regard to meals. The dosage range for primary hypercholesterolemia is 10/5mg to 10/20mg daily. An initial dose of 10/5mg per day is recommended. For patients requiring more significant reduction in LDL-cholesterol, dosage adjustments can be made. After starting treatment or adjusting the dosage, blood lipid levels should be checked at intervals of 4 weeks or more, and adjustments should be based on the results.

Precautions

This drug lowers blood cholesterol levels by inhibiting cholesterol biosynthesis in the liver. Caution is advised as symptoms like muscle pain or weakness may occur before taking this medication. Patients at high risk of severe myopathy or rhabdomyolysis should temporarily discontinue or stop this medication. Since this drug may affect liver function, patients with liver disease or abnormally high liver enzyme levels should not use it. Additionally, patients with severely impaired kidney function or muscle disorders should also avoid this drug. Women who are pregnant or may become pregnant, as well as breastfeeding mothers, should not take this medication. Alcoholics or patients with a history of liver dysfunction should use this medication with caution and undergo regular liver function tests during treatment. If symptoms such as muscle pain, muscle cramps, or muscle weakness occur while taking this medication, one should inform a doctor immediately, and blood tests may be necessary to check for muscle damage. Furthermore, interactions may occur when used with other medications, so it is essential to inform healthcare professionals of any other medications being taken. This drug is not recommended for children as safety and efficacy have not been established, and caution is advised for the elderly due to the risk of myopathy. Caution is required when driving or operating machinery, as dizziness may occur. If skin reactions occur while taking this medication, it should be discontinued immediately, and consult with healthcare professionals. In cases of overdose, there is no specific antidote, and treatment and supportive care should be based on symptoms, while monitoring liver function and muscle enzyme levels.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), excessive lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Headache
  • dizziness
  • indigestion
  • ALT elevation
  • edema
  • muscle pain
  • CPK elevation
  • AST elevation
  • dry mouth
  • increased blood lactate dehydrogenase
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  • pruritus
  • nasopharyngitis
  • upper respiratory infection
  • elevated blood sugar
  • thrombocytopenia
  • paresthesia
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • fainting
  • myalgia
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • cough
  • sputum
  • runny nose
  • itching
  • rash
  • alopecia
  • urticaria

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

Storage

This drug should be stored in a sealed container to prevent air or moisture from entering, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy over a long period and ensure safe use.

Appearance and packaging

Appearance

Pink oval film-coated tablets

Package unit

30 tablets (10 tablets/PTP × 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.