Medication info

Baiete Tablet 10/20 Milligrams

Prescription medicationApproval withdrawn
Ingredient · strength
Ezetimibe›Strength being verifiedSimvastatin›Strength being verified
Manufacturer / importer
풍림무약(주)
Appearance
White to off-white, biconvex, rectangular tablets
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Approval withdrawn

MFDS item code 201901140 · Approved 2019.02.22

This product's status changed to Approval withdrawn on 2023.08.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of lipid levels by reducing LDL cholesterol and increasing HDL cholesterol in primary hypercholesterolemia (familial and non-familial) and mixed dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily in the evening, regardless of meals. The dose range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, with the generally recommended initial dose being 10/20mg. Patients with a lesser need for LDL cholesterol reduction may start at 10/10mg per day. Patients with homozygous familial hypercholesterolemia should take 10/40mg once daily in the evening.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Improvement of lipid levels by reducing LDL cholesterol and increasing HDL cholesterol in primary hypercholesterolemia (familial and non-familial) and mixed dyslipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atherosclerotic vascular disease
  • dyslipidemia
View approved original text

This medication helps lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and raises good cholesterol (HDL). It also lowers total cholesterol and LDL cholesterol levels in patients with homozygous familial hypercholesterolemia when used in conjunction with other treatments or alone. This drug is prescribed in conjunction with dietary changes when simple dietary modification is insufficient. Before treatment, secondary causes such as diabetes or hypothyroidism should be checked, and lipid levels should be regularly monitored through blood tests. Lipid levels should also be checked during acute cardiovascular events to inform treatment plans. Therefore, this medication is used effectively to improve hypercholesterolemia and its associated cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication is administered once daily in the evening, regardless of meals. The dose range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, with the generally recommended initial dose being 10/20mg. Patients with a lesser need for LDL cholesterol reduction may start at 10/10mg per day. Patients with homozygous familial hypercholesterolemia should take 10/40mg once daily in the evening.

Precautions

This medication can cause muscle-related side effects such as myopathy or rhabdomyolysis, so if symptoms of muscle pain or weakness occur, the doctor should be informed immediately. This medication should not be used in individuals with allergies to certain components, active liver disease, or in women who are pregnant or breastfeeding. Patients with impaired liver function should consult a doctor before taking this medication, and treatment should be discontinued immediately if symptoms of liver dysfunction occur. This medication has a high potential for interactions with other medicines, so patients must inform their doctor or pharmacist of any other medications being taken. Particularly, concurrent use with strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol, and other medications may increase the risk of muscle-related side effects. During the use of this medication, regular blood tests to check liver function and muscle enzyme levels are recommended. Women planning to become pregnant or who may be pregnant should consult a doctor before taking this medication, and it should be discontinued immediately if pregnancy is confirmed. The safety and efficacy of this medication in children and adolescents have not been sufficiently proven, so caution is advised for use. Elderly patients may respond more sensitively to this medication, so caution is needed when taking it. In case of overdose, there are no specific antidotes, so immediate medical attention should be sought for appropriate treatment. Additionally, during the use of this medication, unexplained muscle pain or weakness, fatigue, indigestion, headache, and other symptoms may occur, and patients should consult a doctor if these symptoms arise.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • indigestion
  • flatulence
  • itching
  • rash
  • asthenia
  • facial paresis
  • tremors
  • dizziness
  • sensory disturbances
  • peripheral neuropathy
  • mental disorders
  • anxiety
  • sleep disorders
  • depression
  • cough
  • angioedema
  • rash
  • pancreatitis
  • cholelithiasis
  • cholecystitis
  • cataracts
  • alopecia
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • anemia

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy and prevent deterioration.

Appearance and packaging

Appearance

White to off-white, biconvex, rectangular tablets

Package unit

30 tablets (10 tablets/PTP X 3)

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.