Medication info
Dabiduo Tablet 10/5 mg (Ezetimibe, Rosuvastatin Calcium)

Dabiduo Tablet 10/5 mg (Ezetimibe, Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
White to nearly white round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201601225 · Approved 2016.02.29 · Insurance code 643605150

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dosage of 10/5 mg once a day is recommended. For patients requiring greater LDL-cholesterol reduction, the dosage can be adjusted. Blood lipid levels should be checked after an interval of more than 4 weeks after starting treatment or adjusting the dosage, and the dosage can be adjusted accordingly. The maximum dosage can be increased up to 10/20 mg daily.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed) and suppression of the risk of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • increased LDL-cholesterol
  • increased apo B proteins
  • increased triglycerides
  • increased non-HDL-cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication helps improve blood lipid levels related to blood cholesterol in patients with primary hypercholesterolemia, particularly familial and non-familial, as well as in patients with mixed dyslipidemia. It reduces total cholesterol, LDL-cholesterol, apo B proteins, triglycerides, and non-HDL-cholesterol while increasing good HDL-cholesterol levels. Improvement of these lipid levels has the effect of lowering the risk of cardiovascular diseases, including atherosclerotic vascular diseases. It is used with dietary measures, serving as an adjunct when lifestyle management is insufficient. Additionally, it maximizes effectiveness by identifying and treating other conditions or medications that cause dyslipidemia. Overall, this medication is used to improve cardiovascular health by regulating blood lipids.

How to take

Adult dose

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dosage of 10/5 mg once a day is recommended. For patients requiring greater LDL-cholesterol reduction, the dosage can be adjusted. Blood lipid levels should be checked after an interval of more than 4 weeks after starting treatment or adjusting the dosage, and the dosage can be adjusted accordingly. The maximum dosage can be increased up to 10/20 mg daily.

Precautions

This medication may cause serious muscle problems, so if sudden muscle pain or weakness occurs, the doctor should be informed immediately. There is a risk of renal function deterioration due to muscle damage, so caution is needed if there are renal diseases or risk factors. Patients who are allergic to the ingredients in this medication, patients with severe liver disease, patients with muscle disorders, severely impaired renal function patients, and women who are pregnant or nursing should not use this medication. Patients, especially those at high risk for myopathy, should have blood tests to check for muscle damage indicators before starting treatment and undergo regular tests during treatment. Because liver function abnormalities may occur, liver function test results should be periodically checked, and if liver damage is suspected, medication should be stopped immediately. This medication should be used cautiously in individuals with a history of excessive alcohol use or liver disease. Interactions may occur when used with other medications, so any medications currently being taken must be reported to the doctor or pharmacist. Women of childbearing potential should use proper contraceptive methods while taking this medication, and medical treatment should be discontinued immediately upon confirmation of pregnancy. Symptoms such as dizziness may occur, so caution is needed when driving or operating machinery. The safety of this medication has not been established in children and is not recommended. There is no specific antidote for overdose; therefore, treatment should be provided based on symptoms, and monitoring of liver function and muscle damage indicators is necessary. When storing this medication, keep it out of reach of children and do not 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, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice with skin or eye yellowing, extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urine

Mild side effects

  • Headache
  • nasopharyngitis
  • arthralgia
  • dizziness
  • upper respiratory tract infection
  • myalgia
  • fatigue
  • weakness
  • itching
  • rash
Show 28 more
  • pruritus
  • diarrhea
  • abdominal pain
  • nausea
  • constipation
  • cough
  • sputum
  • nasal congestion
  • sensory disturbances
  • nausea
  • loss of appetite
  • abdominal bloating
  • hair loss
  • urticaria
  • chest discomfort
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • syncope
  • dizziness
  • tremor
  • depression
  • sensory disturbances
  • thrombocytopenia
  • edema
  • increased serum creatinine
  • blood pressure

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should ideally be maintained between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

White to nearly white round film-coated tablet

Package unit

30 tablets/bottle

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.