Medication info

Samsung Bi tablet 10/20 milligrams

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
White to off-white, double convex rectangular tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Expired

MFDS item code 201900195 · 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 taken once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg per day, with the commonly recommended initial dose being 10/20 mg per day. Patients with a lower need for LDL cholesterol reduction may start at 10/10 mg per day. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40 mg per day.

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 diseases due to hypercholesterolemia
  • dyslipidemia
View approved original text

This drug helps reduce elevated total cholesterol, LDL cholesterol, ApoB protein, and triglycerides in patients with primary hypercholesterolemia and mixed hyperlipidemia, while increasing HDL cholesterol. It is especially used as an adjunct or alternative to other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia. It is important to identify and treat secondary causes considering other health conditions or medications taken. Blood lipid levels should be regularly monitored to evaluate the therapeutic effect. This drug is effectively used to reduce the risk of hypercholesterolemia and its associated atherosclerotic vascular diseases.

How to take

Adult dose

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

Precautions

This drug can cause serious muscle-related side effects, such as myopathy and rhabdomyolysis. If you experience muscle pain or weakness, consult a doctor immediately. This drug is not to be administered to patients with impaired liver function or active liver disease. Pregnant or breastfeeding women should not take this medication. The risk of side effects may be increased when taken with certain medications, so it is crucial to inform your doctor if you are taking other drugs. In particular, co-administering with medications that inhibit the metabolism of this drug in the liver may increase the risk of muscle damage. Regular liver function and muscle status checks are important while taking this drug. Caution is advised when using this drug in children or the elderly, and it should be taken under a doctor's guidance if necessary. As there are no specific antidotes for overdose, it is important to adhere to the prescribed dosage. Notify medical personnel immediately if you experience unexplained muscle pain or weakness during treatment with this drug.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema and rash, pancreatitis, hepatitis, cholestatic jaundice, liver cirrhosis, fulminant hepatic necrosis, hepatic carcinoma, fatal hepatic failure, chest tightness, difficulty breathing, respiratory distress, toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, erythema multiforme, severe allergic reactions, severe cutaneous adverse reactions, serious neurological symptoms, myopathy, rhabdomyolysis, severe edema, elevated blood pressure

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • myalgia
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
Show 17 more
  • dyspepsia
  • flatulence
  • itching
  • rash
  • weakness
  • syncope
  • paresthesia
  • insomnia
  • gastritis
  • atrophic gastritis
  • mucous stools
  • irritable bowel syndrome
  • sore throat
  • nocturia
  • hematuria
  • alopecia
  • weight loss

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

Storage

This drug should be stored in a tightly closed container, protected from air and moisture, and kept at room temperature between 1°C and 30°C. This helps to maintain the drug's effectiveness for a long period.

Appearance and packaging

Appearance

White to off-white, double convex rectangular tablet

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.

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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.