Medication info
Byterin Q Tablets 10/20mg

Byterin Q Tablets 10/20mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
White to off-white, biconvex, rectangular tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201900315 · Approved 2019.01.22 · Insurance code 661905140

Summary

Main use
Lipid improvement by reducing LDL-cholesterol and increasing HDL-cholesterol in hypercholesterolemia (primary, homozygous familial) and mixed dyslipidemia
Who takes it
Adults
Adult dose
Take this medication once daily in the evening, regardless of meals. The dosage range is 10/10mg to 10/40mg daily, with a commonly recommended initial dose of 10/20mg per day. Patients requiring less LDL-cholesterol reduction may start with 10/10mg per day. Check serum lipid levels after a minimum of 4 weeks following administration or dosage adjustment before altering the dosage.

Ingredients

Manufacturer
영풍제약(주)

Efficacy & effects

Lipid improvement by reducing LDL-cholesterol and increasing HDL-cholesterol in hypercholesterolemia (primary, homozygous familial) and mixed dyslipidemia

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

This drug is used primarily to reduce total cholesterol, LDL-cholesterol, apo B protein, and triglycerides, and to increase HDL-cholesterol levels in patients with primary hypercholesterolemia, both familial and non-familial, as well as mixed dyslipidemia. It can also be used as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia or alone if other therapies are ineffective. This medication should be used in conjunction with an appropriate diet and is mainly administered when dietary and non-drug treatments alone are insufficient. Active lipid control is also required for patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia. Before administration, other causes of dyslipidemia should be identified and treated, and the therapeutic effect should be monitored with regular lipid tests. Thus, this drug effectively improves cholesterol and lipid levels, helping to prevent cardiovascular diseases.

How to take

Adult dose

Take this medication once daily in the evening, regardless of meals. The dosage range is 10/10mg to 10/40mg daily, with a commonly recommended initial dose of 10/20mg per day. Patients requiring less LDL-cholesterol reduction may start with 10/10mg per day. Check serum lipid levels after a minimum of 4 weeks following administration or dosage adjustment before altering the dosage.

Precautions

This medication can cause muscle-related side effects such as myopathy or rhabdomyolysis. The risk may be higher, especially when taken at high doses or in combination with certain medications. Before taking this medication, individuals with allergic reactions or liver disease, as well as pregnant or breastfeeding women, should not use it. Additionally, it should not be co-administered with certain potent drugs. Caution should be exercised when administering this drug to patients with severe myasthenia or myalgia, and immediate consultation with a physician is required if these symptoms occur. It is advisable to undergo regular liver function tests while taking this medication, and use should be discontinued if there are abnormalities in liver function. This drug can interact with various other medications; therefore, inform your doctor or pharmacist if you are taking other medicines. Special caution is required when taken with certain antifungals, antibiotics, antivirals, and anticoagulants. Pregnant women or those planning to become pregnant should not take this medication, and if pregnancy is confirmed while taking it, immediate discontinuation and a consultation with a physician are necessary. Breastfeeding women should also discontinue breastfeeding while on this medication for safety. Safety in children and adolescents has not been sufficiently established, so it is not recommended for children under 10 years old. Elderly patients require special attention, and monitoring is necessary due to the possibility of adverse reactions. In case of overdose, since there are no specific antidotes, appropriate treatment according to symptoms is essential. If unexplained muscle pain or weakness occurs during treatment, inform healthcare providers immediately, and it is safe to check muscle status and liver function through regular blood tests.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, dyspnea or difficulty breathing, asthma attack, respiratory abnormality with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination issues.

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • myalgia
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • vomiting
  • pruritus
  • weakness
  • sensory impairment
  • cough
  • nocturia
  • hematuria
  • dizziness
  • insomnia
  • gastritis
  • atrophic gastritis
  • indigestion
  • mucus-filled stools
  • irritable bowel syndrome
  • sore throat
  • alopecia
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataracts
  • vertigo
  • tremors
  • mental disorders
  • anxiety
  • sleep disorders
  • etc.

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. The recommended storage temperature is between 1 degree and 30 degrees Celsius at room temperature. This helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

White to off-white, 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

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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.