Medication info
Myeongmun Rosuvastatin Calcium Tablet 10 mg

Myeongmun Rosuvastatin Calcium Tablet 10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
Pink round film-coated tablets
Packaging
For domestic use - 30 tablets/bottle, for export - 30 tablets/box [(10 tablets/PTP*3)]
Approval status
Active

MFDS item code 201400005 · Approved 2014.01.02 · Insurance code 649806400

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
The initial dose is 5 mg once daily, and if greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or more, and may be increased up to a maximum of 20 mg once daily.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • hyperlipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • coronary artery heart disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary artery heart disease
  • stroke
  • myocardial infarction
  • arterial revascularization
View approved original text

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed hyperlipidemia when dietary changes and exercise alone do not achieve control. It is also used as an adjunct to dietary changes or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis and aiding the dietary management of patients with dysbetalipoproteinemia. It is effective in reducing the risk of cardiovascular disease, particularly in middle-aged patients with elevated high-sensitivity C-reactive protein levels and other cardiovascular risk factors, reducing the risk of stroke, myocardial infarction, and recurrence after arterial revascularization. Through these various effects, it plays an important role in improving cardiovascular health.

How to take

Adult dose

The initial dose is 5 mg once daily, and if greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or more, and may be increased up to a maximum of 20 mg once daily.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this drug, those with severely impaired liver function, those with muscle disorders, those taking certain immunosuppressants, patients with severe renal impairment, women who are pregnant or breastfeeding, and women who are capable of becoming pregnant but do not use proper contraception should not take this medication. Additionally, liver function and muscle status should be regularly monitored before and during treatment with this medication, and those with a history of alcohol abuse or liver disease should exercise particular caution. If symptoms such as muscle pain or weakness occur, a doctor should be notified immediately, and if necessary, the medication can be discontinued. This medication contains lactose, so individuals with lactose intolerance or certain genetic metabolic disorders should not take it. This medication can interact with other drugs, so any other medications being taken should be disclosed to a physician or pharmacist. In particular, co-administration with certain antibiotics, antifungal agents, immunosuppressants, and fibrates may increase the risk of muscle-related side effects. Women who are pregnant or breastfeeding should not take this medication, and women who are capable of becoming pregnant should use appropriate contraception. If pregnancy is confirmed, the use of this medication should be immediately discontinued. In the case of overdose, since there is no specific antidote, immediate medical attention should be sought for appropriate treatment and evaluation. This medication may rarely cause side effects such as skin rash, headache, dizziness, gastrointestinal disturbance, muscle pain, and malaise; if serious skin reactions or liver dysfunction symptoms occur, immediate medical evaluation is required. Caution is needed as dizziness may occur while driving or operating machinery. When administering this medication to children and adolescents, assessment of growth and sexual development is necessary, and dose adjustment and caution are required.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy, severe muscle weakness, ocular muscle weakness, dyspnea, cough, hepatitis, jaundice, fatal and non-fatal liver failure, acute renal failure, anuria, chest tightness

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • fatigue
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  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thrombocytopenia
  • transaminase elevation
  • ALT increase
  • AST increase
  • CK increase
  • hematuria
  • proteinuria
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive dysfunction

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 storage temperature should be kept at room temperature between 1°C and 30°C. This will help maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, for export - 30 tablets/box [(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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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.