Medication info

Baitelins 10/20 mg Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
White to off-white, double-convex rectangular tablet
Packaging
30 Tablets/PTP [10 Tablets/PTPX3]
Approval status
Expired

MFDS item code 201907233 · Approved 2019.10.15

This product's status changed to Expired on 2024.10.15. 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, homozygous 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 10/10 mg to 10/40 mg daily, with the generally recommended initial dosage being 10/20 mg daily. Patients who require less reduction in LDL cholesterol can start with 10/10 mg daily. After initiation of therapy or dosage adjustment, lipid levels should be assessed at intervals of more than 4 weeks.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

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

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

This medication primarily serves to lower high total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolemia and mixed dyslipidemia, while raising levels of HDL cholesterol, the 'good' cholesterol, as an adjunct to dietary therapy. It is also used in patients with homozygous familial hypercholesterolemia either in conjunction with other therapies or as an alternative treatment when those therapies are not effective. As a lipid-regulating medication, it must be used alongside an appropriate diet, and it is essential to first identify and treat any secondary causes. During treatment, it is crucial to regularly monitor total cholesterol, LDL, HDL, and triglyceride levels, and especially if triglyceride levels are significantly elevated, more detailed testing may be necessary. Additionally, if acute coronary artery disease occurs, prompt lipid testing should be conducted to inform therapeutic planning. Therefore, this medication effectively aids in the treatment of hypercholesterolemia and related diseases.

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 10/10 mg to 10/40 mg daily, with the generally recommended initial dosage being 10/20 mg daily. Patients who require less reduction in LDL cholesterol can start with 10/10 mg daily. After initiation of therapy or dosage adjustment, lipid levels should be assessed at intervals of more than 4 weeks.

Precautions

This medication is used to lower blood cholesterol levels. The most crucial precaution while taking this medication is the potential for muscle-related side effects, such as myopathy or rhabdomyolysis. If you experience pain or weakness in your muscles, you must notify your physician immediately, and you may need to discontinue this medication. There may be a heightened risk of muscular side effects, particularly when taking high doses or in conjunction with certain medications. Patients with an allergy to any component of this medication, those with active liver disease or impaired liver function, and women who are pregnant or nursing should not take this medication. Additionally, the risk of side effects may increase when this medication is combined with certain antifungals, antibiotics, antivirals, or immunosuppressants. Therefore, if you are taking any of these medications, you must consult your physician. This medication could be harmful to the fetus during pregnancy. Thus, women planning to become pregnant or who might be pregnant should definitely consult their physician before taking this medication and immediately discontinue it if pregnancy is confirmed. While taking this medication, regular liver function tests and muscle function tests are recommended, and any unusual symptoms should be reported to healthcare professionals. Elderly patients or patients with compromised kidney function should exercise special caution when taking this medication. Finally, grapefruit juice or certain medications may interact with this medication, so you should inform your physician or pharmacist about your diet and any other medications you are taking.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe rash, skin peeling, oral/ocular mucosal pain, respiratory distress, breathing issues, pulmonary disease, jaundice, generalized malaise, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, decreased urine output, severe edema, increased blood pressure, severe allergic reactions, anaphylaxis, toxic epidermal necrolysis (Lyell syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), erythema multiforme, pancreatitis,

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • myalgia
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • epigastric pain
  • vomiting
  • chest pain
  • chest discomfort
  • weakness
  • sensory loss
  • cough
  • edema
  • thirst
  • facial edema
  • fainting
  • sensory abnormalities
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus in stools
  • irritable bowel syndrome
  • sore throat
  • alopecia
  • pruritus
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • progression of cataracts
  • eye muscle paralysis

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

White to off-white, double-convex rectangular tablet

Package unit

30 Tablets/PTP [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.