Medication info

Baiduol Tablet 10/10mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
White to pale yellow, double convex rectangular tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Expired

MFDS item code 201902086 · Approved 2019.04.05

This product's status changed to Expired on 2024.04.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, familial) and mixed dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg once daily. The recommended starting dose is 10/20mg once daily, and patients who require less LDL-cholesterol reduction can start with 10/10mg daily. After starting treatment or adjusting the dose, check lipid levels at intervals of at least 4 weeks before making further adjustments.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, familial) and mixed dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
View approved original text

This medication helps to reduce elevated total cholesterol, LDL-cholesterol, ApoB proteins, and triglyceride levels in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial hypercholesterolemia, as well as mixed dyslipidemia, and to increase HDL-cholesterol levels. Additionally, in patients with homozygous familial hypercholesterolemia (HoFH), it is used as an adjunct to other lipid-lowering therapies or as a substitute when other treatments are ineffective. This medication should be used in conjunction with an appropriate diet that limits saturated fats and cholesterol, contributing to a reduction in the risk of atherosclerotic vascular disease caused by hypercholesterolemia through improvement of lipid levels. It is important to identify and treat any secondary causes such as diabetes and hypothyroidism prior to treatment, and to determine the treatment strategy based on lipid test results. This medication is used safely and effectively to manage blood lipid levels and improve cardiovascular health.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg once daily. The recommended starting dose is 10/20mg once daily, and patients who require less LDL-cholesterol reduction can start with 10/10mg daily. After starting treatment or adjusting the dose, check lipid levels at intervals of at least 4 weeks before making further adjustments.

Precautions

This medication may have side effects that affect the muscles, so if muscle pain or weakness occurs, it must be reported to a doctor immediately. Care must be taken, especially when taking high doses or certain medications together, as there is an increased risk of myopathy or rhabdomyolysis. This medication may affect liver function, so it should not be administered if there is liver disease or elevated liver function tests, and liver function should be regularly monitored during treatment. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraception. This medication can interact with various other drugs, so if other medications are being taken, it is essential to inform a healthcare provider or pharmacist. Elderly patients or those with impaired kidney function need to take extra precautions when using this medication, and dosage adjustments or further testing may be needed. During the use of this medication, unexplained muscle pain, fatigue, dyspepsia, headache, or symptoms of infection may occur; if abnormal symptoms arise, consultation with a healthcare professional is advised. There is no specific antidote for overdose, so caution must be taken not to exceed the prescribed amount, and if unusual symptoms occur, immediate medical attention is necessary. During the use of this medication, it is important to limit the intake of certain foods such as grapefruit juice, and dietary and lifestyle management is also essential.

Side effects and when to seek care immediately

Serious side effects

Myopathy, rhabdomyolysis, elevated serum creatine kinase (CK) levels (more than 10 times the normal upper limit), severe allergic reactions (urticaria, angioedema), severe edema (swelling, facial swelling), severe skin reactions (including rash and angioedema), severe liver damage, liver failure, jaundice (yellowing of the skin or eyes), acute renal failure, severe respiratory problems (dyspnea, asthma attacks), toxic epidermal necrolysis (Lyell syndrome)

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • dyspepsia
  • flatulence
  • vomiting
  • itching
  • rash
  • nocturia
  • hematuria
  • alopecia
  • facial swelling
  • sensory impairment
  • insomnia
  • gastritis
  • atrophic gastritis
  • mucus stool
  • irritable bowel syndrome
  • sore throat
  • weight loss
  • cataracts
  • weakness
  • dizziness
  • sensory disturbance
  • syncope
  • urticaria
  • angioedema
  • fever
  • chills
  • flushing
  • malaise
  • respiratory difficulty

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. Moreover, avoid excessively hot or cold locations, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to pale yellow, double convex rectangular tablet

Package unit

30 tablets (10 tablets/PTPX3)

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.