Medication info

Hutomega Soft Capsule 5/1000 mg (Atorvastatin, Omega-3 Fatty Acids Ethyl Esters 90)

Prescription medicationSoft capsule
Ingredient · strength
Atorvastatin Calcium Trihydrate›5.425mg / 1 capsuleOmega-3-Acid Ethyl Esters 90›1000mg / 1 capsule
Manufacturer / importer
(주)휴온스
Appearance
Soft capsule in oblong shape filled with a white film-coated pale yellow oily substance containing the active ingredients.
Packaging
80 capsules/box [(8 capsules/AluAlu*10)], 100 capsules/box [(10 capsules/PTP*10)]
Approval status
Active

MFDS item code 202202838 · Approved 2022.07.08 · Insurance code 670609160

Summary

Main use
LDL-cholesterol control and treatment of dyslipidemia in high-risk adults with coronary artery disease.
Who uses it
Adults
Adult dosage
Adults should take 4 capsules (1,000 mg Omega-3 fatty acids ethyl esters / 5 mg atorvastatin per capsule) once daily with food to avoid gastrointestinal disturbances.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

LDL-cholesterol control and treatment of dyslipidemia in high-risk adults with coronary artery disease.

  • Coronary artery disease
  • dyslipidemia
View approved original text

This medication is used to effectively lower LDL-cholesterol levels in adult patients at high risk for coronary artery disease. It is particularly suitable for patients with mixed dyslipidemia who do not achieve sufficient triglyceride reduction with 20 mg monotherapy of atorvastatin, although LDL-cholesterol is well controlled. This helps reduce the risk of cardiovascular disease by maintaining a balanced lipid profile and improving overall lipid status. Ultimately, it contributes to the improvement of cardiovascular health.

Dosage and Administration

Adult dosage

Adults should take 4 capsules (1,000 mg Omega-3 fatty acids ethyl esters / 5 mg atorvastatin per capsule) once daily with food to avoid gastrointestinal disturbances.

Precautions

This medication may pose a risk of muscle problems, so if there are symptoms such as muscle pain or weakness, or if blood tests show markedly elevated creatine kinase levels, immediate discontinuation and consultation with a doctor is required. Patients with liver function issues or those whose liver enzyme levels exceed three times the normal range should not use this medication and should undergo regular liver function tests. Women who are pregnant, may become pregnant, or are breastfeeding should not use this medication, and women of childbearing age should use appropriate contraception during treatment. It is recommended that this medication not be used in children under 18 years of age, as safety and effectiveness have not been established. Persons with a history of alcohol dependency or liver disease, impaired kidney function, hypothyroidism, muscle disease, and the elderly should use this medication with caution. This medication may interact with certain drugs; therefore, if you are taking other medications, it is essential to inform your doctor or pharmacist, especially when taking specific antibiotics, antifungals, antivirals, immunosuppressants, some antihypertensives, oral contraceptives, or grapefruit juice. During the course of this medication, if symptoms such as muscle pain, muscle weakness, fatigue, or fever occur, immediate consultation with a doctor is necessary. Moreover, if symptoms indicating liver dysfunction such as nausea, vomiting, jaundice, or fatigue appear, discontinue the medication and seek help from a hospital. Periodic monitoring of liver enzyme levels or creatine kinase levels through blood tests is essential, and if any abnormalities are found, treatment should be adjusted or discontinued. There is no specific antidote for overdose, so appropriate treatment should be based on symptoms and should particularly include vigilant liver function and muscle-related tests. This medication should be stored out of reach of children and should not be transferred to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough+fever, yellowing of skin or eyes (jaundice), profound drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine retention

Mild side effects

  • Constipation
  • esophagitis
  • elevated ALT
  • elevated CPK
  • increased TG
  • increased blood glucose
  • osteoarthritis
  • back pain
  • limb pain
  • diabetic neuropathy
Show 22 more
  • paralysis of cranial nerve IV
  • bruising
  • upper limb fracture
  • acute otitis media
  • erectile dysfunction
  • cough
  • rash
  • hearing loss
  • fatty liver
  • hematuria
  • weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • abdominal pain

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Soft capsule in oblong shape filled with a white film-coated pale yellow oily substance containing the active ingredients.

Package unit

80 capsules/box [(8 capsules/AluAlu*10)], 100 capsules/box [(10 capsules/PTP*10)]

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.