Medication info
Rosuvaco Soft Capsule

Rosuvaco Soft Capsule

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsuleRosuvastatin Calcium›5.2mg / 1 capsule
Manufacturer / importer
한국프라임제약(주)
Appearance
Soft capsule with an elongated shape filled with a yellowish oily substance coated in white film.
Packaging
32 capsules/box [(8 capsules/PTP X 4)], 56 capsules/box [(8 capsules/PTP X 7)], 80 capsules/box [(8 capsules/PTP X 10)], 96 capsules/box [(8 capsules/PTP X 12)], 100 capsules/box [(10 capsules/PTP X 10)]
Approval status
Active

MFDS item code 202008412 · Approved 2020.12.01 · Insurance code 663608320

Summary

Main use
LDL cholesterol control and treatment of mixed dyslipidemia
Who takes it
Adults
Adult dose
For adults, take 2 to 4 capsules once daily with meals (1,000 mg of omega-3 fatty acid ethyl ester/5 mg of rosuvastatin per capsule).

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

LDL cholesterol control and treatment of mixed dyslipidemia

  • Coronary artery disease
  • abnormal LDL cholesterol levels
  • abnormal triglyceride levels
  • mixed dyslipidemia
View approved original text

This medication is used in adult patients at high risk of coronary artery disease and effectively controls LDL cholesterol levels with rosuvastatin monotherapy. However, it is suitable for the treatment of mixed type (IIb) dyslipidemia where triglyceride levels are not controlled. In other words, this medication helps improve blood lipid levels and reduce the risk of cardiovascular diseases.

How to take

Adult dose

For adults, take 2 to 4 capsules once daily with meals (1,000 mg of omega-3 fatty acid ethyl ester/5 mg of rosuvastatin per capsule).

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to its ingredients, patients with severe liver dysfunction, muscle diseases, and those with severely impaired kidney function. Additionally, it is not recommended for use in pregnant or breastfeeding women and in children under 18 years of age. Since this medication can affect liver function and muscle, patients with a history of liver disease or symptoms of muscle pain or myopathy should consult a physician before administration. During treatment, if symptoms such as muscle pain, muscle weakness, fatigue, or fever occur, medical personnel should be informed immediately and testing should be undertaken. Moreover, since this medication can increase liver enzyme levels, liver function should be monitored through regular blood tests. It is advisable to avoid or restrict alcohol intake while taking this medication, and any conditions such as hypothyroidism or nephrotic syndrome should be treated prior to use. This medication may interact with other drugs, so if you are taking any other medications, make sure to inform your healthcare provider. Special caution is needed when used in conjunction with certain antibiotics, antifungals, immunosuppressants, or fibrate-class drugs. Women of childbearing potential should ensure proper contraceptive methods are used before taking this medication and should not take it during pregnancy. Breastfeeding women should also avoid this medication. Elderly patients or those with decreased kidney function may require dosage adjustment and careful monitoring. In case of overdose, there are no specific antidotes; therefore, one should seek immediate medical attention for proper treatment and care. This medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe swelling (edema), chest tightness, shortness of breath, asthma attacks, difficulty breathing or catching breath, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, jaundice, yellowing of skin or eyes, extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly decreased urine output.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • joint pain
  • weakness
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  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal bloating
  • diarrhea
  • fainting
  • generalized pain
  • muscle cramping
  • gout
  • erectile dysfunction
  • increased blood alkaline phosphatase
  • increased blood potassium
  • hypokalemia
  • cholelithiasis
  • increased ALT
  • increased AST
  • increased γ-GT
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough

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 and should be kept at room temperature between 1 to 30 degrees Celsius. This storage method will help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Soft capsule with an elongated shape filled with a yellowish oily substance coated in white film.

Package unit

32 capsules/box [(8 capsules/PTP X 4)], 56 capsules/box [(8 capsules/PTP X 7)], 80 capsules/box [(8 capsules/PTP X 10)], 96 capsules/box [(8 capsules/PTP X 12)], 100 capsules/box [(10 capsules/PTP X 10)]

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.