Medication info
Rosukoma Soft Capsule

Rosukoma Soft Capsule

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsuleRosuvastatin Calcium›5.2mg / 1 capsule
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Oblong soft capsule filled with a yellowish oily substance coated in white film.
Packaging
100 capsules/box [10 capsules/PTP X10]
Approval status
Active

MFDS item code 202008417 · Approved 2020.12.01 · Insurance code 649105080

Summary

Main use
LDL cholesterol control and treatment of dyslipidemia
Who takes it
Adults
Adult dose
Administered only to adults, 2-4 capsules should be taken once daily with meals to avoid gastrointestinal disturbances (1,000mg of omega-3 acid ethyl ester/5mg of Rosuvastatin per capsule).

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

LDL cholesterol control and treatment of dyslipidemia

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

Rosuvastatin helps effectively lower LDL cholesterol levels in adult patients at high risk of coronary artery disease. However, some patients may experience complex dyslipidemia where triglyceride levels are not adequately regulated. This medication is used to manage these lipid levels and reduce the risk of cardiovascular disease. Regular blood tests are required to monitor lipid levels, and additional treatment options may be considered if necessary. Monotherapy with Rosuvastatin helps improve major lipid abnormalities, assisting in the maintenance of cardiovascular health.

How to take

Adult dose

Administered only to adults, 2-4 capsules should be taken once daily with meals to avoid gastrointestinal disturbances (1,000mg of omega-3 acid ethyl ester/5mg of Rosuvastatin per capsule).

Precautions

This medication should not be used by certain patients. For example, individuals with allergies to its ingredients, patients with severe liver dysfunction, patients with muscle disorders, patients taking certain immunosuppressants, patients with severe kidney dysfunction, women who are pregnant or breastfeeding, and children under 18 years old should not take this medication. Additionally, before taking this medication, regular liver function tests and muscle-related tests should be conducted, and if symptoms such as muscle pain, muscle weakness, fatigue, or fever occur, patients should immediately inform their doctor or pharmacist. Individuals who consume a lot of alcohol or have a history of liver disease should take this medication with caution, and those with hypothyroidism or nephrotic syndrome should treat these conditions first before using this medication. This medication is used for the treatment of hyperlipidemia, but the risk of side effects such as muscle damage or worsening kidney function can increase with higher doses; therefore, doses above 40mg are not recommended for patients at high risk of muscle disorders. During the use of this medication, liver function and muscle enzyme levels should be regularly checked, and if any abnormal symptoms occur, the medication should be discontinued immediately and the patient should consult healthcare professionals. Particularly, when used in conjunction with certain other medications, the blood concentration of this medication may increase, raising the risk of side effects; therefore, patients must inform their healthcare provider if they are taking other medications. Women who are pregnant or breastfeeding should not use this medication, and women who may become pregnant should use appropriate contraception. For children and the elderly, caution is required as the safety and efficacy of this medication have not been sufficiently established. In the event of an overdose, there is no specific antidote available, so immediate medical attention should be sought for appropriate treatment, and liver function and muscle enzyme tests should be conducted to assess the condition. Lastly, this medication should be stored in a safe place out of reach of children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied breathing difficulties, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • redness
  • myalgia
  • arthralgia
  • weakness
  • itching
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  • rash
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • paresthesia
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • back pain
  • cold symptoms
  • nasopharyngitis
  • periodontitis
  • upper respiratory infection
  • gastritis
  • increased tear production
  • presbyopia
  • ovarian cancer
  • increased serum alkaline phosphatase
  • increased potassium levels
  • hypokalemia
  • cholelithiasis
  • emotional instability

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. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to prolong the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Oblong soft capsule filled with a yellowish oily substance coated in white film.

Package unit

100 capsules/box [10 capsules/PTP X10]

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.