Medication info
Megarosutin Tablet 5 mg (Rosuvastatin Calcium)

Megarosutin Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202000698 · Approved 2020.02.06 · Insurance code 060500240

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily at any time of day, with no regard to meals. If greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted to 10 mg once daily. The maintenance dose should be adjusted at intervals of 4 weeks or longer, up to a maximum of 20 mg daily.
Children's dosage
For patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage ranges from 5 mg to 20 mg once daily. The dosage may be adjusted at intervals of 4 weeks or longer.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased 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 as an adjunct when dietary and exercise regimens have not adequately controlled primary hypercholesterolemia and mixed dyslipidemia. It also helps lower cholesterol levels in patients with familial hypercholesterolemia and delays the progression of atherosclerosis, thereby reducing the risk of cardiovascular disease. It can be used as an adjunct to diet in certain adolescent patients aged 10 years and older with heterozygous familial hypercholesterolemia. It is also beneficial for patients with primary dysbetalipoproteinemia and reduces the risks of stroke and myocardial infarction in adults at high risk for cardiovascular disease. This medication effectively improves various conditions associated with dyslipidemia.

Dosage and Administration

Adult dosage

Administer 5 mg once daily at any time of day, with no regard to meals. If greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted to 10 mg once daily. The maintenance dose should be adjusted at intervals of 4 weeks or longer, up to a maximum of 20 mg daily.

Children's dosage

For patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage ranges from 5 mg to 20 mg once daily. The dosage may be adjusted at intervals of 4 weeks or longer.

Precautions

This medication should not be used in certain patients. For instance, patients with a history of allergic reactions to this drug or liver problems, patients with muscle disorders, and those with severe kidney function impairment should not take this medication. Additionally, pregnant or nursing women should avoid this drug, and women of childbearing age should use appropriate contraception to prevent pregnancy. This medication should be used with caution in patients who consume large amounts of alcohol or have a history of liver disease, and regular liver function tests should be performed before and during treatment. If symptoms such as muscle pain or weakness occur, patients should immediately inform their physician, and in severe cases, discontinuation of the drug may be necessary. This medication poses a risk of causing serious muscle disorders like myopathy or rhabdomyolysis, so patients with poor kidney function, hypothyroidism, alcohol dependence, and elderly patients over 70 years of age should be especially careful. As this medication contains lactose, it is advisable for patients with lactose intolerance to avoid taking it. While taking this medication, side effects such as liver dysfunction, muscle pain, headache, dyspepsia, skin rashes may occur, and patients should consult their physician if any abnormal symptoms appear. There may be potential interactions when taken with other medications, so patients should inform their doctor or pharmacist of any concomitant medications. Specifically, combining with certain antiviral drugs, immunosuppressants, antifungals, some antibiotics, and fibrate-class drugs may increase the risk of muscle-related side effects. Pregnant or nursing women should not take this medication, and women planning pregnancy must consult their physician before taking this medication. In case of overdose, as there is no specific antidote, immediate hospital treatment should be sought, and liver function and muscle enzyme levels should be monitored. This drug is known not to significantly affect driving or machine operation, but caution is advised as dizziness may occur. Finally, this drug may exhibit higher plasma levels in Asians; thus, dose adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, peeling skin, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urine changes

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • altered sensation
  • joint pain
  • hematuria
  • increased serum creatinine
  • elevated ALT
  • elevated AST
  • elevated CK
  • headache
  • dizziness
  • chest pain
  • cough

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius (room temperature) to ensure the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Pink round film-coated tablet

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.

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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.