Medication info

Samsung Bi Tablet 10/10mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
White to pale yellow, biconvex, rectangular tablets
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Expired

MFDS item code 201900196 · Approved 2019.01.16

This product's status changed to Expired on 2024.01.16. 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 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 dosing range is between 10/10mg to 10/40mg daily, with the generally recommended starting dose being 10/20mg daily. Patients who have a lower need for LDL cholesterol reduction may start with 10/10mg daily, and dosage adjustments should be made after confirming blood lipid levels at intervals of 4 weeks or more.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

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

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

This medication is used as an adjunct to dietary measures to lower total cholesterol, LDL cholesterol, ApoB protein, and triglycerides, and to increase HDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. In patients with homozygous familial hypercholesterolemia, it may be used as an adjunct to other lipid-lowering therapies or can be used alone if other treatments are not effective. Appropriate dietary measures and non-pharmacological interventions should be prioritized when administering this medication, and other causes of dyslipidemia should be ruled out. Careful use is required in patients at high risk of atherosclerotic cardiovascular disease due to hypercholesterolemia, and a lipid test prior to treatment is essential for accurate diagnosis. This medication helps improve blood lipid levels when combined with a proper lifestyle.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosing range is between 10/10mg to 10/40mg daily, with the generally recommended starting dose being 10/20mg daily. Patients who have a lower need for LDL cholesterol reduction may start with 10/10mg daily, and dosage adjustments should be made after confirming blood lipid levels at intervals of 4 weeks or more.

Precautions

This medication is primarily used to lower blood cholesterol levels. However, caution is needed as it may cause muscle-related issues during use. If muscle pain or weakness occurs, consult a doctor immediately. This medication should not be taken by individuals with liver disease or elevated liver enzymes. Women who are pregnant or breastfeeding should not take this medication. The risk of side effects may increase when taken with certain other medications, so inform your doctor if you are taking other medications. Elderly patients or those with impaired kidney function should also use it with caution, and regular blood tests to monitor liver and muscle status are recommended. There is no specific antidote for overdose, so comply with the prescribed dosage and consult medical personnel immediately if abnormal symptoms appear. Finally, it is advisable to avoid certain foods like grapefruit juice during the medication period.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, rash, toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, abnormal breathing with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • viral infection
  • pharyngitis
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  • sinusitis
  • joint pain
  • back pain
  • cough
  • weakness
  • cataract
  • constipation
  • dyspepsia
  • flatulence
  • nausea
  • eczema
  • itching
  • rash
  • muscle cramps
  • muscle pain
  • joint pain
  • taste disturbance
  • oculomotor dysfunction
  • facial nerve paresis
  • tremor
  • dizziness
  • sensory disturbance
  • peripheral neuropathy
  • peripheral nerve paralysis
  • psychiatric disorders
  • anxiety
  • sleep disturbance

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 sealed container. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

White to pale yellow, 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.