Medication info

Omestr Soft Capsule 10/1000 Milligrams

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsuleRosuvastatin Calcium›10.4mg / 1 capsule
Manufacturer / importer
한미약품(주)
Appearance
A pink oblong soft capsule filled with a light yellow oily substance that is film-coated with a transparent color.
Packaging
PTP (Alu-Alu) - 30 capsules/box [10 capsules/PTPX3], PTP (Alu-Alu) - 60 capsules/box [10 capsules/PTPX6], PTP (Alu-Alu) - 100 capsules/box [10 capsules/PTPX10]
Approval status
Active

MFDS item code 202302555 · Approved 2023.08.30

Summary

Main use
Control of LDL cholesterol and treatment of mixed dyslipidemia.
Who takes it
Adults
Adult dose
This drug is administered only to adults; to avoid gastrointestinal disturbances, 2 capsules should be taken once daily with food.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Control of LDL cholesterol and treatment of mixed dyslipidemia.

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

This medication is used for the treatment of mixed dyslipidemia where triglyceride levels are not controlled, while managing LDL cholesterol levels with monotherapy of rosuvastatin in adult patients at high risk for coronary heart disease. Specifically, it is effective for patients requiring control of both LDL cholesterol and triglyceride levels among those with hyperlipidemia. This drug helps improve blood lipid levels and assists in the prevention of cardiovascular disease.

How to take

Adult dose

This drug is administered only to adults; to avoid gastrointestinal disturbances, 2 capsules should be taken once daily with food.

Precautions

This drug should not be used in certain patients. Individuals allergic to any component of this medication should not take it. Patients with severely impaired liver function or unexplained elevated liver enzyme levels should not take this drug. This medication is not indicated for patients with muscle disorders or issues related to muscles. It is also contraindicated in those taking the immunosuppressant cyclosporine. Patients with severely decreased renal function, pregnant or breastfeeding women, and fertile women not using adequate contraception should refrain from using this drug. Patients at high risk of myopathy should be especially cautious, and some high doses are prohibited. Safety and efficacy have not been established in children under 18 years of age. This drug should be administered with caution in patients who consume alcohol excessively or have a history of liver disease. If symptoms such as muscle pain or weakness occur, report to a physician immediately for evaluation. Treatment should be discontinued in cases where severe muscle problems or renal function deterioration is suspected. Caution is advised when used in combination with other medications, as this may increase the risk of muscle problems. Regular renal function tests should be conducted for high-dose prescriptions. Asian patients may have higher blood concentrations of this medication, necessitating dose adjustments. Caution should be taken in patients at risk of bleeding or with liver dysfunction. Patients with fish allergies should be cautious when taking this medication. It should be avoided in patients with severe myasthenia gravis. Mild side effects such as diarrhea, indigestion, nausea, vomiting, and dizziness may occur. Muscle pain, elevated liver enzyme levels, headache, and weakness may also appear; rarely, serious myopathy or liver damage has been reported. Consult medical personnel immediately if any abnormal symptoms occur during use. This medication should not be used during pregnancy, and women who could become pregnant should use appropriate contraceptive methods. Breastfeeding women are also advised against taking this medication. Safety and efficacy have not been established in children under 18 years of age. There are no specific restrictions for the elderly, but it is advisable to regularly monitor liver and kidney function. In case of overdose, as there is no specific antidote, symptoms should be observed and liver function and muscle enzyme levels should be monitored. Dizziness may occur during driving or operating machinery while taking this drug, so caution is advised. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, abnormal liver function tests, jaundice, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, thrombocytopenia, severe myasthenia gravis, ocular myasthenia gravis, dyspnea, asthmatic attacks, seizures, severe skin reactions, significant edema, confusional state, visual disturbances, paralysis, severe allergies.

Mild side effects

  • Diarrhea
  • indigestion
  • nausea
  • vomiting
  • dizziness
  • anemia
  • colorectal polyps
  • nasopharyngitis
  • headache
  • constipation
Show 23 more
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • increased serum alkaline phosphatase
  • increased potassium levels
  • hypokalemia
  • gallstones
  • increased ALT
  • increased AST
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thrombocytopenia
  • increased serum creatinine
  • urination.

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

Storage

This drug is sensitive to light and should be stored in light-protective containers. Additionally, it is important to keep it at room temperature between 1 degree and 30 degrees Celsius to maintain its potency.

Appearance and packaging

Appearance

A pink oblong soft capsule filled with a light yellow oily substance that is film-coated with a transparent color.

Package unit

PTP (Alu-Alu) - 30 capsules/box [10 capsules/PTPX3], PTP (Alu-Alu) - 60 capsules/box [10 capsules/PTPX6], PTP (Alu-Alu) - 100 capsules/box [10 capsules/PTPX10]

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.