Medication info

Byetta Tablet 10/10 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Ezetimibe›Strength being verifiedSimvastatin›Strength being verified
Manufacturer / importer
풍림무약(주)
Appearance
White to light yellow, biconvex, rectangular tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Approval withdrawn

MFDS item code 201901141 · Approved 2019.02.22

This product's status changed to Approval withdrawn on 2023.08.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and mixed hyperlipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day, with the normally recommended starting dose being 10/20 mg per day. Patients with less need for LDL-cholesterol reduction may start with 10/10 mg per day. After initiating treatment or adjusting the dosage, lipid levels should be checked after an interval of at least 4 weeks.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular diseases due to hypercholesterolemia
View approved original text

This medication helps to lower total cholesterol, LDL-cholesterol, ApoB, and triglyceride levels in patients with primary hypercholesterolemia and mixed hyperlipidemia, while helping to raise HDL-cholesterol levels. It is also used as an adjunct to other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia or when other treatments are ineffective. This medication should be taken along with dietary therapy and should be effective when combined with non-pharmacological measures such as limiting saturated fat and cholesterol intake. It is important to identify and treat other conditions or medications that may cause dyslipidemia before administration. In patients with acute coronary events, lipid levels should also be evaluated to inform appropriate treatment initiation. Thus, this medication is used to regulate blood lipid levels associated with hypercholesterolemia and improve vascular health.

Dosage and Administration

Adult dosage

This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day, with the normally recommended starting dose being 10/20 mg per day. Patients with less need for LDL-cholesterol reduction may start with 10/10 mg per day. After initiating treatment or adjusting the dosage, lipid levels should be checked after an interval of at least 4 weeks.

Precautions

This medication helps lower blood cholesterol levels, reducing the risk of cardiovascular disease. However, when taking this medication, one should be cautious as symptoms such as muscle pain or weakness may occur. Particularly, serious muscle damage symptoms such as myopathy or rhabdomyolysis may rarely occur, and in such cases, one should consult a doctor immediately. This medication can affect liver function; therefore, it is advisable to avoid taking it if there is liver disease or if liver function test levels are abnormally high. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use it only if the chance of pregnancy is very low. Additionally, this medication can increase the risk of muscle damage when taken with certain antifungal agents, antibiotics, or immunosuppressants, so if other medications are being taken, it is essential to inform a doctor or pharmacist. It is important to regularly check liver function and muscle status through blood tests while taking this medication. Elderly patients or those with poor kidney function need to be more careful, and symptoms should be reported to healthcare personnel immediately. It is advisable to avoid grapefruit juice during treatment, and there is no specific antidote in the case of overdose, so one should visit a medical institution immediately.

Side effects and when to seek care immediately

Serious side effects

  • Myopathy
  • rhabdomyolysis
  • angioedema
  • rash
  • pancreatitis
  • cholelithiasis
  • cholecystitis
  • weakness
  • eczema
  • itching
Show 22 more
  • rash
  • anaphylaxis
  • angioedema
  • lupus erythematosus-like syndrome
  • polymyalgia rheumatica
  • dermatomyositis
  • vasculitis
  • purpura
  • thrombocytopenia
  • leukopenia
  • hemolytic anemia
  • positive antinuclear antibody
  • increased erythrocyte sedimentation rate
  • eosinophilia
  • arthritis
  • arthralgia
  • urticaria
  • photosensitivity
  • fever
  • chills
  • flushing
  • dizziness

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, muscle pain, limb pain, fatigue, nausea, abdominal pain, constipation, epigastric pain, vomiting, chest pain, chest discomfort, numbness, cough, edema, thirst, facial swelling, fainting, insomnia, gastritis, atrophic gastritis, indigestion, mucus stool, irritable bowel syndrome, sore throat, itching, gynecomastia, decreased libido, sexual dysfunction (including erectile dysfunction), cataract progression, eye muscle paralysis, anemia, weight loss

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Also, it is best to store it at room temperature between 1 degree and 30 degrees. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White to light yellow, biconvex, 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.

Questions about this medicine

No questions yet.

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.