Medication info
Baitab Tablet 10/10 mg

Baitab Tablet 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
White to light yellow, double-convex, rectangular tablet.
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201601734 · Approved 2016.03.31 · Insurance code 671704990

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, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with the commonly recommended starting dose being 10/20 mg once daily. Patients who have less need for LDL cholesterol reduction may start at 10/10 mg once daily. Blood lipid levels should be monitored after a gap of more than 4 weeks after initiating treatment or adjusting the dose.

Ingredients

Manufacturer
주식회사제뉴원사이언스

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.
View approved original text

This medication is used as an adjunct to diet to lower total cholesterol and LDL cholesterol levels, ApoB protein, and triglycerides in patients with primary hypercholesterolemia, particularly in those with heterozygous familial and non-familial hypercholesterolemia as well as mixed hyperlipidemia. Additionally, it is used in patients with homozygous familial hypercholesterolemia either as an adjunct to other lipid-lowering therapies or when other treatments are ineffective. This medication is applied in conjunction with a diet that includes restrictions on saturated fat and cholesterol intake, and is given when diet alone is insufficiently effective. Prior to use, secondary causes such as diabetes and hypothyroidism should be identified and treated if necessary, and continuous lipid level monitoring is important. This medication safely and effectively improves total cholesterol and bad cholesterol levels to reduce the risk of vascular diseases associated with hypercholesterolemia.

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 commonly recommended starting dose being 10/20 mg once daily. Patients who have less need for LDL cholesterol reduction may start at 10/10 mg once daily. Blood lipid levels should be monitored after a gap of more than 4 weeks after initiating treatment or adjusting the dose.

Precautions

This medication can cause serious muscle-related side effects such as myopathy or rhabdomyolysis, so if muscle pain or weakness occurs, it is important to consult a doctor immediately. This medication should not be used in patients with certain diseases or allergies to medications, patients with active liver disease, or in women who are pregnant or breastfeeding. Particularly, patients with compromised liver function or abnormally elevated liver enzyme levels should use this medication with caution and undergo regular liver function tests. This medication may interact with other drugs; therefore, patients must inform their healthcare provider of any other medications they are currently taking, especially with certain antibiotics, antifungals, immunosuppressants, and some cardiovascular drugs. During treatment with this medication, if unexplained muscle pain, tenderness, or weakness occurs, it is essential to stop taking it immediately and inform a doctor. Women planning to become pregnant or who may be pregnant should not take this medication, and if pregnancy is confirmed, it should be stopped immediately. Women who are breastfeeding should also discontinue breastfeeding if taking this medication, and use in children or adolescents should be approached with caution as safety and efficacy have not been fully established. Elderly patients require special caution, and since this medication can elevate blood sugar levels, those at risk of diabetes should regularly monitor their blood glucose levels. In case of overdose, there is no specific antidote, so symptomatic treatment will be provided. While taking this medication, it is recommended to avoid grapefruit juice, and regular blood tests should be conducted to monitor liver function and muscle status.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, rash, anaphylaxis, myopathy, rhabdomyolysis, skin and mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), polymorphic erythema, severe allergic reactions, severe skin adverse reactions, jaundice of the skin or eyes, liver abnormalities (jaundice), hepatitis, pancreatitis, fulminant liver necrosis, liver failure, severe edema, hypertension, sudden and severe headaches, seizures, confusion.

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • epigastric pain
  • vomiting
  • chest pain
  • chest discomfort
  • weakness
  • sensory loss
  • cough
  • edema
  • thirst
  • facial edema
  • syncope
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucous stools
  • irritable bowel syndrome
  • sore throat
  • joint pain
  • hematuria
  • itching
  • weight loss
  • dizziness
  • paresthesia
  • depression
  • cholelithiasis
  • cholecystitis
  • hair loss

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is crucial to maintain the storage temperature between 1 and 30 degrees Celsius to keep the medication effective and stable for a long period.

Appearance and packaging

Appearance

White to light 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.