Medication info
Robaga 10 mg (Rosuvastatin Calcium)

Robaga 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)아리제약
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906849 · Approved 2019.09.26 · Insurance code 058200250

Summary

Main use
Treatment for improving hypercholesterolemia and dyslipidemia and reducing cardiovascular disease risk
Who uses it
Adults
Adult dosage
For primary hypercholesterolemia (type IIa), mixed dyslipidemia (type IIb), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia patients, it is administered once daily at any time of the day without regard to meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose

Ingredients

Manufacturer
(주)아리제약

Efficacy & effects

Treatment for improving hypercholesterolemia and dyslipidemia and reducing cardiovascular disease risk

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • 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 drug is used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary measures and exercise alone are insufficient. It is also effective as an adjunct to dietary and other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This drug helps lower total cholesterol and LDL-cholesterol levels to target levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia, particularly helping reduce risks of stroke, myocardial infarction, and arterial revascularization in middle-aged patients at high cardiovascular risk. Therefore, this drug is effective for lipid control and reducing cardiovascular disease risk.

Dosage and Administration

Adult dosage

For primary hypercholesterolemia (type IIa), mixed dyslipidemia (type IIb), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia patients, it is administered once daily at any time of the day without regard to meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to this drug, those with severely impaired liver function, muscular diseases, and severely deteriorated kidney function should not take this drug. Women who are pregnant or breastfeeding, or fertile women not using adequate contraception should also avoid this drug. This drug may affect muscles causing symptoms such as myalgia or muscle damage; thus, patients with a history of muscular diseases, elderly patients, or those who consume large amounts of alcohol should consult a doctor before taking it. During treatment, if symptoms such as myalgia, muscle weakness, or fatigue occur, the patient should inform the doctor immediately, and blood tests may be necessary to check for muscle damage. Liver function tests should also be conducted regularly, and if liver enzyme levels become abnormally high, the use of this drug should be discontinued. Extra caution is needed for those with a history of liver diseases or issues with liver function. This drug may interact with other medications, increasing the risk of side effects depending on co-administered drugs. Specifically, the risk of muscle damage may increase when used with certain antiviral agents, immunosuppressants, antifungals, some antibiotics, and fibrate class medications; therefore, it is essential to inform healthcare providers of any medications being taken. Pregnant or breastfeeding women should not take this drug, and women planning to become pregnant should definitely consult before use, as it could harm the fetus and affect the infant through breast milk. In case of overdose, there is no specific antidote, so one should visit a medical institution immediately for appropriate treatment and monitoring. Caution is advised while driving or operating machinery, as dizziness may occur. While taking this drug, regular blood tests and liver function tests are important to detect and manage adverse reactions early.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, jaundice, hepatitis, severe rash, blisters, skin peeling, severe swelling, thrombocytopenia, severe muscle weakness, ocular myasthenia, immune-mediated necrotizing myopathy, rhabdomyolysis, acute renal failure, oliguria, severe liver damage, hyperbilirubinemia

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 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.