Medication info
Megalosutin Tablet 2.5 mg (Rosuvastatin Calcium)

Megalosutin Tablet 2.5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›2.6mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202401442 · Approved 2024.06.13 · Insurance code 060500960

Summary

Main use
Improvement of hypercholesterolemia and hyperlipidemia
Who uses it
Adults
Adult dosage
This medication should be administered in conjunction with a standard cholesterol-lowering diet and can be taken at any time of the day, regardless of meals. The initial dose is 2.5 or 5 mg once daily, and if greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted. The maintenance dose typically is 10 mg once daily, and most patients are adjusted at this dose, with follow-up on their LDL cholesterol levels at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Improvement of hypercholesterolemia and hyperlipidemia

  • Primary hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • mixed dyslipidemia
View approved original text

This medication is used for primary hypercholesterolemia and mixed dyslipidemia. These conditions occur mainly when cholesterol and lipid levels in the blood are elevated and are not controlled by diet and exercise alone. It is particularly effective for patients with genetic hypercholesterolemia such as familial heterozygous hypercholesterolemia. Therefore, this medication is used as an adjunct to diet to improve blood lipid levels.

Dosage and Administration

Adult dosage

This medication should be administered in conjunction with a standard cholesterol-lowering diet and can be taken at any time of the day, regardless of meals. The initial dose is 2.5 or 5 mg once daily, and if greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted. The maintenance dose typically is 10 mg once daily, and most patients are adjusted at this dose, with follow-up on their LDL cholesterol levels at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, patients with allergies to this medication, severely impaired liver function, muscle diseases, significantly reduced kidney function, women who are pregnant or breastfeeding, and women of childbearing age who are not using adequate contraception should not take this medication. Additionally, high-dose administration of this medication is contraindicated in patients at high risk for myopathy or rhabdomyolysis. Risk factors include moderate kidney dysfunction, hypothyroidism, a history of genetic muscle disorders, alcohol abuse, and concurrent use of certain medications. This medication contains lactose, so patients with lactose intolerance should also avoid taking it. While taking this medication, attention should be paid to liver function, and patients with a history of liver disease or heavy alcohol consumption require regular liver enzyme checks. Furthermore, if symptoms such as muscle pain or weakness arise, healthcare personnel should be informed immediately, and blood tests should be performed if necessary to check for muscle damage. This medication can interact with other drugs, so it is essential to inform healthcare personnel of any current medications being taken. Caution is particularly needed when taken in conjunction with certain antibiotics, antifungals, immunosuppressants, and fibrate-class drugs. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use appropriate contraception. In case of overdose, there is no specific antidote; treatment will depend on symptoms, along with checks on liver function and muscle enzymes. Finally, this medication may cause side effects such as dizziness, so caution is advised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria, facial edema, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, increased transaminases, liver failure, severe myopathy (including myositis), rhabdomyolysis, immune-mediated necrotizing myopathy, edema, chest tightness, difficulty breathing, dyspnea, severe muscle weakness, ocular myasthenia, thrombocytopenia, acute kidney injury

Mild side effects

  • Indigestion
  • pruritus
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • itching
  • myalgia
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  • weakness
  • joint pain
  • fatigue
  • numbness
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • hematuria
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is safe to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication over time.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 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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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.