Medication info
New Tomega Soft Capsule 5/1000 mg

New Tomega Soft Capsule 5/1000 mg

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

MFDS item code 202202839 · Approved 2022.07.08 · Insurance code 669908310

Summary

Main use
Control of LDL cholesterol and treatment of dyslipidemia in adults at high risk of coronary artery disease.
Who uses it
Adults
Adult dosage
For adults only, to avoid gastrointestinal disturbances, administer 4 capsules once daily with food (1,000 mg omega-3 fatty acid ethyl ester/5 mg atorvastatin per capsule).

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Control of LDL cholesterol and treatment of dyslipidemia in adults at high risk of coronary artery disease.

  • Coronary artery disease
  • dyslipidemia
  • elevated LDL cholesterol levels
  • elevated triglyceride levels.
View approved original text

In patients with a high risk of coronary artery disease, atorvastatin 20 mg as monotherapy effectively lowers LDL cholesterol levels, helping to reduce the risk of cardiovascular diseases. However, additional treatment may be necessary for patients with mixed dyslipidemia who do not sufficiently control triglyceride levels with this treatment alone. Therefore, atorvastatin is primarily used to improve LDL cholesterol and assists in the overall management of hyperlipidemia.

Dosage and Administration

Adult dosage

For adults only, to avoid gastrointestinal disturbances, administer 4 capsules once daily with food (1,000 mg omega-3 fatty acid ethyl ester/5 mg atorvastatin per capsule).

Precautions

This medication should be discontinued immediately if any muscle-related abnormalities occur. Especially, in cases of muscle pain or weakness, and a significant increase in creatine kinase levels in blood tests, immediate consultation with a physician is necessary. This medication should not be administered to certain patients. For example, individuals who are allergic to this medication or its components, those with severely impaired liver function, patients with muscle diseases, pregnant women or those who may become pregnant, nursing mothers, children under 18 years of age, and patients taking certain antiviral drugs should not use this medication. Patients with a history of alcohol abuse or liver disease, as well as those with compromised kidney function, hypothyroidism, a history of hereditary muscle disorders, patients who have previously experienced muscle toxicity, and elderly individuals should use this medication with caution. These patients should verify their muscle condition through blood tests before medication and undergo regular monitoring during treatment. During the use of this medication, adverse reactions such as liver dysfunction, muscle pain, rashes, digestive disorders, headaches, and dizziness may occur, so notify healthcare professionals immediately if any of these symptoms arise. Pregnant or nursing women should not use this medication, and women of childbearing age must use appropriate contraception while taking it. The safety and effectiveness of this medication have not been established in children under 18 years of age, so it is not used in this population. Caution should be exercised in administering this medication to the elderly due to the risk of impaired liver and muscle function, and regular examinations are necessary. In case of overdose, there is no specific antidote; therefore, symptomatic treatment should be provided, and liver function and muscle enzyme levels should be monitored. This medication may interact with other drugs, especially those metabolized in the liver or those affecting muscle function, so consult a physician or pharmacist before co-administration. Lastly, this medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Constipation
  • esophagitis
  • elevated ALT
  • elevated CPK
  • increased TG
  • elevated blood sugar
  • osteoarthritis
  • back pain
  • limb pain
  • diabetic neuropathy
Show 22 more
  • fourth cranial nerve palsy
  • bruising
  • upper limb fractures
  • acute otitis media
  • erectile dysfunction
  • cough
  • papules
  • hearing impairment
  • fatty liver
  • hematuria
  • weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • abdomen.

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is advisable to store it at room temperature between 1 to 30 degrees Celsius, away from excessively hot or cold environments.

Appearance and packaging

Appearance

Soft capsule in an elongated shape filled with a white, film-coated, light yellow oily substance containing the active ingredient.

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.