Medication info

Baitelin Tablets 10/10 mg

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

MFDS item code 201907234 · 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 hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening without regard to meals. In patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, and the generally recommended initial dose is 10/20 mg daily. Patients with a lower need for LDL-cholesterol reduction can start at 10/10 mg daily. After initiation of treatment or dose adjustment, lipid levels should be monitored after an interval of at least 4 weeks.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

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

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

This medication helps lower total cholesterol, LDL-cholesterol, ApoB protein, and triglycerides while increasing HDL-cholesterol in patients with primary hypercholesterolemia (particularly heterozygous familial and non-familial) and mixed hyperlipidemia. It is also used as an adjunctive therapy in patients with homozygous familial hypercholesterolemia when existing therapies are ineffective. This medication should be used in conjunction with an appropriate diet, and any secondary causes should be checked and treated beforehand. It should be applied cautiously in patients at high risk for atherosclerotic vascular disease due to hypercholesterolemia. Regular monitoring of serum lipid levels during treatment is essential. Overall, this medication is effectively used for improving dyslipidemia and preventing cardiovascular diseases.

How to take

Adult dose

This medication is administered once daily in the evening without regard to meals. In patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, and the generally recommended initial dose is 10/20 mg daily. Patients with a lower need for LDL-cholesterol reduction can start at 10/10 mg daily. After initiation of treatment or dose adjustment, lipid levels should be monitored after an interval of at least 4 weeks.

Precautions

This medication is primarily used to lower cholesterol levels and help reduce the risk of cardiovascular disease. While taking this medication, symptoms such as muscle pain or weakness may occur, which could signal serious muscle conditions such as myopathy or rhabdomyolysis, so caution is necessary. The risk of muscle problems may increase, especially when taking high doses or combining with certain other medications. This medication may affect liver function; therefore, patients with liver disease or elevated liver enzyme levels should not take it. Women who are pregnant or lactating should not take this medication, and women of childbearing age should only take it when the possibility of pregnancy is low. Combining this medication with potent CYP3A4 inhibitors such as certain antibiotics, antifungals, and antivirals can be dangerous, so it should not be taken together. Additionally, it should not be combined with drugs like Gemfibrozil, Cyclosporin, or Danazol. During treatment, do not take other medications without consulting a physician, and inform any healthcare provider of this medication when receiving new prescriptions. If symptoms of muscle pain or weakness occur, contact a physician immediately, and regular muscle-related testing is recommended. Elderly patients or those with kidney disease should be particularly cautious when taking this medication, and regular examinations of liver and muscle function are advised. This medication may raise blood sugar levels in some patients; thus, thorough blood sugar management is necessary for those at risk of diabetes. Avoid taking this medication with certain foods like grapefruit juice, as it may increase drug concentration and the risk of side effects. In the case of overdose, there is no specific antidote, so avoid unintentional overdose and seek medical attention immediately if problems arise.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • rash
  • pancreatitis
  • cholelithiasis
  • cholecystitis
  • eczema
  • pruritus
  • rash
  • myopathy
Show 18 more
  • rhabdomyolysis
  • immune-mediated necrotizing myopathy
  • specific cranial nerve dysfunction
  • tremor
  • dizziness
  • sensory abnormalities
  • peripheral neuropathy
  • peripheral nerve paralysis
  • psychiatric disorders
  • anxiety
  • sleep disorders
  • depression
  • severe muscle weakness
  • ocular myasthenia
  • interstitial lung disease
  • anaphylaxis
  • erythema lupus-like syndrome
  • polymyalgia rheumatica

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
Show 26 more
  • epigastric pain
  • vomiting
  • chest pain
  • chest discomfort
  • weakness
  • sensory loss
  • cough
  • edema
  • thirst
  • facial swelling
  • syncope
  • sensory abnormalities
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus stool
  • irritable bowel syndrome
  • sore throat
  • alopecia
  • pruritus
  • gynecomastia
  • decreased libido
  • erectile dysfunction
  • cataract progression
  • ophthalmoplegia

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

Storage

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is best to keep the medication at room temperature, between 1 and 30 degrees, avoiding extremely hot or cold environments.

Appearance and packaging

Appearance

White to pale yellow, biconvex, 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.