Medication info
Megalosutin Tablet 20 mg (Rosuvastatin Calcium)

Megalosutin Tablet 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201804899 · Approved 2018.12.04 · Insurance code 060500150

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 the day, regardless of meals. A typical maintenance dose is 10 mg once daily, which can be adjusted according to LDL-cholesterol levels and the patient's response, potentially increasing up to a maximum of 20 mg once daily after a gap of 4 weeks or more.
Children's dosage
For pediatric patients aged 10 to under 17 years with heterozygous familial hypercholesterolemia, it is administered once daily at doses ranging from 5 mg to 20 mg. The dosage is adjusted individually according to the treatment goals after a gap of 4 weeks or more.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used for various dyslipidemia disorders. It serves as an adjunct when dietary changes and exercise do not adequately control conditions such as primary hypercholesterolemia, heterozygous familial hypercholesterolemia, and mixed dyslipidemia. It also aids in the treatment of patients with homozygous familial hypercholesterolemia. In addition, it effectively lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It is also used as an adjunct to dietary therapy in pediatric patients aged 10 to 17 years who meet specific criteria for heterozygous familial hypercholesterolemia. Patients with primary dysbetalipoproteinemia are also treated, and it helps reduce cardiovascular disease risk in elderly patients with elevated high-sensitivity C-reactive protein levels. This medication is used in the treatment of various diseases related to dyslipidemia and in reducing the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

Administer 5 mg once daily at any time of the day, regardless of meals. A typical maintenance dose is 10 mg once daily, which can be adjusted according to LDL-cholesterol levels and the patient's response, potentially increasing up to a maximum of 20 mg once daily after a gap of 4 weeks or more.

Children's dosage

For pediatric patients aged 10 to under 17 years with heterozygous familial hypercholesterolemia, it is administered once daily at doses ranging from 5 mg to 20 mg. The dosage is adjusted individually according to the treatment goals after a gap of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, individuals who are allergic to any of the ingredients of this medication, those with severely impaired liver function, or those with muscle diseases should avoid its use. Additionally, individuals with significantly decreased kidney function, pregnant or breastfeeding women, and women of childbearing potential who do not use proper contraception should not take this medication. This medication may cause muscle problems, so caution is required for those with myalgia or myopathy, those with a family history of muscle disease, or those taking it with certain other medications. In particular, high-dose use may increase the risk of muscle damage, so it should be taken according to medical advice. This medication contains lactose and should not be taken by individuals who are lactose intolerant or have specific genetic metabolic disorders. Patients with liver dysfunction, excessive alcohol intake, or hypothyroidism must consult a physician before taking this medication and should undergo regular liver function tests during treatment. If symptoms such as myalgia, weakness, or fever occur, they should immediately inform healthcare professionals, and blood tests may be necessary to check for muscle damage. This medication may increase blood glucose levels in some patients, so those at high risk for diabetes should manage their blood sugar levels carefully and be aware of the possibility of developing diabetes during treatment. Furthermore, drug interactions may occur when used with other medications, so individuals taking other medications should inform their doctor or pharmacist. In particular, caution is needed when used with certain antiviral agents, immunosuppressive agents, and fibrate class drugs, as this may increase the risk of muscle disease. Pregnant or breastfeeding women should not use this medication, and women who may become pregnant should use proper contraception before taking it. In case of overdose, there is no specific antidote, so immediate medical attention is required for appropriate treatment and monitoring. Finally, this medication is unlikely to affect driving or operating machinery, but caution is necessary as dizziness may occur after administration. It is important to consult healthcare professionals immediately if any adverse reactions occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, severe swelling (edema), chest tightness, difficulty breathing, severe muscle weakness, oculobulbar weakness, severe allergic reactions, Stevens-Johnson syndrome, eosinophilia and systemic symptoms of drug reaction syndrome, severe skin reactions, jaundice, hepatitis, fatal and non-fatal liver failure, acute renal failure, severe edema or urinary abnormalities, thrombocytopenia, severe neurological symptoms.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • abnormal sensation
  • discomfort in chest
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion.

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. The appropriate storage temperature is room temperature between 1 and 30 degrees Celsius, avoiding excessively hot or cold places.

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.

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.